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1. Hurskainen R, Paavonen J: Levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding. Curr Opin Obstet Gynecol; 2004 Dec;16(6):487-90
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding.
  • The levonorgestrel-releasing intrauterine system is an effective medical treatment for menorrhagia.
  • Emerging clinical and research evidence suggests that this new treatment modality has major health benefits.
  • RECENT FINDINGS: The levonorgestrel-releasing intrauterine system is a cost-effective treatment modality for menorrhagia.
  • Unscheduled breakthrough bleeding is the most common side effect of the treatment.
  • Women with endometriosis or fibroids also benefit from this treatment.
  • It is the most effective medical treatment for menorrhagia and comparable to surgical interventions.
  • Although not all women are successfully treated, about 60% avoid hysterectomy and are satisfied with the treatment.
  • Thus, the levonorgestrel-releasing intrauterine system should be the first line of treatment for heavy menstrual bleeding.
  • [MeSH-major] Contraceptive Agents, Female / therapeutic use. Intrauterine Devices, Medicated. Levonorgestrel / therapeutic use. Menorrhagia / drug therapy
  • [MeSH-minor] Endometriosis / drug therapy. Female. Humans. Leiomyoma / drug therapy

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  • (PMID = 15534445.001).
  • [ISSN] 1040-872X
  • [Journal-full-title] Current opinion in obstetrics & gynecology
  • [ISO-abbreviation] Curr. Opin. Obstet. Gynecol.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Contraceptive Agents, Female; 5W7SIA7YZW / Levonorgestrel
  • [Number-of-references] 30
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2. McClure DL, Valuck RJ, Glanz M, Murphy JR, Hokanson JE: Statin and statin-fibrate use was significantly associated with increased myositis risk in a managed care population. J Clin Epidemiol; 2007 Aug;60(8):812-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • OBJECTIVE: We quantified the risk of myositis associated with statin and fibrate drug use with other covariates within a managed care organization (MCO) population.
  • Myositis cases had creatine kinase (CK) >or=10x upper limit of normal and a myopathy diagnosis.
  • Exposures of statins, fibrates, and other drugs were assessed with age, gender, and indicators of suspected myopathy risk.
  • RESULTS: Myositis was significantly associated with statin monotherapy (RR 2.8 [95% confidence interval, CI=1.3-5.9]), statin-fibrate combination therapy (9.1 [95% CI=3.5-23]), comorbid liver disease (4.3 [95% CI=1.5-13], and/or renal disease (2.5 [95% CI=1.3-5.0]).
  • The mean time to event was 1.7 years for statin-fibrate use, 2.0 years for statins alone, and 2.1 years for unexposed.
  • Within the secondary cohort, RRs increased up to 10 times further away from the null.
  • [MeSH-minor] Age Factors. Aged. Cohort Studies. Confidence Intervals. Confounding Factors (Epidemiology). Creatine Kinase / blood. Drug Administration Schedule. Drug Therapy, Combination. Female. Humans. Hyperlipidemias / blood. Hyperlipidemias / complications. Hyperlipidemias / drug therapy. Kidney Diseases / complications. Liver Diseases / complications. Male. Managed Care Programs. Middle Aged. Odds Ratio. Proportional Hazards Models. Risk. Risk Assessment. Sex Factors. Time Factors

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  • (PMID = 17606177.001).
  • [ISSN] 0895-4356
  • [Journal-full-title] Journal of clinical epidemiology
  • [ISO-abbreviation] J Clin Epidemiol
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0 / Hypolipidemic Agents; 53PF01Q249 / Clofibric Acid; EC 2.7.3.2 / Creatine Kinase
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3. Berns JS: Should the target hemoglobin for patients with chronic kidney disease treated with erythropoietic replacement therapy be changed? Semin Dial; 2005 Jan-Feb;18(1):22-9
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  • [Title] Should the target hemoglobin for patients with chronic kidney disease treated with erythropoietic replacement therapy be changed?
  • Recombinant human erythropoietin (rHuEPO, epoetin) revolutionized the treatment of anemia in patients with chronic kidney disease (CKD) when it was approved for use in the United States in 1989.
  • Among patients with CKD not on dialysis, epoetin use has not been as broadly applied as among dialysis patients, and although the mean Hb level in this patient population has increased, the impact has been less than in patients on dialysis.
  • The optimal treatment target for epoetin remains controversial.
  • Consistent with clinical practice guidelines, current practice in dialysis patients in the United States aims to maintain a target Hb of 11-12 g/dl, a level that is still well below the normal range.
  • Quality of life clearly improves in many individuals as Hb rises into the normal range from lower levels.
  • In retrospective studies, higher Hb levels have been associated with lower risks of hospitalization and mortality.
  • However, one large, prospective clinical trial has raised concern about normalizing Hb in hemodialysis patients with cardiac disease, and other prospective studies have not yet provided convincing evidence of significant benefits from normalizing Hb in dialysis-dependent and non-dialysis-dependent patients with CKD.
  • A relative lack of information on non-dialysis-dependent patients with CKD and changes in fiscal policies regulating reimbursement for epoetin have contributed to uncertainty as to the best practices for anemia management in patients with CKD.
  • There is increasing interest in the potential benefits of broadening the current target Hb range or eliminating an upper limit altogether and instead establishing a minimum Hb goal.
  • While some extension of the upper limit of the currently recommended target Hb range might appear to be reasonable, the extent to which this should be extended, the benefits, risks, and costs of maintaining higher Hb levels in patients with CKD, and whether target Hb levels should be different in different CKD patient groups remains to be determined.
  • Future efforts are likely to focus on selecting patient populations most likely to benefit from normalizing Hb, while adjusting the range of a subnormal Hb target for others.
  • [MeSH-major] Erythropoietin / therapeutic use. Hemoglobins / drug effects. Hemoglobins / metabolism. Kidney Failure, Chronic / blood. Kidney Failure, Chronic / therapy
  • [MeSH-minor] Anemia / blood. Anemia / therapy. Clinical Trials as Topic. Humans. Practice Guidelines as Topic. Prospective Studies. Recombinant Proteins. Retrospective Studies. United States. United States Food and Drug Administration / standards

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  • (PMID = 15663760.001).
  • [ISSN] 0894-0959
  • [Journal-full-title] Seminars in dialysis
  • [ISO-abbreviation] Semin Dial
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hemoglobins; 0 / Recombinant Proteins; 11096-26-7 / Erythropoietin
  • [Number-of-references] 68
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4. Klaase JM, Hulscher JB, Offerhaus GJ, ten Kate FJ, Obertop H, van Lanschot JJ: Surgery for unusual histopathologic variants of esophageal neoplasms: a report of 23 cases with emphasis on histopathologic characteristics. Ann Surg Oncol; 2003 Apr;10(3):261-7
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  • Unusual pathologic variants are encountered in only 1% to 7% of patients, and therefore data evaluating the treatment and survival in this group of esophageal neoplasms are sparse.
  • The following unusual histopathologic variants were seen: basaloid squamous cell carcinoma (n = 3), small-cell carcinoma (n = 1), leiomyoma (n = 5), gastrointestinal stromal tumor (n = 2), leiomyosarcoma (n = 1), adenosquamous carcinoma (n = 5), carcinosarcoma (n = 4), collision tumor (n = 1), and melanoma (n = 1).
  • Presentation, histopathologic characteristics, treatment, and prognosis are described in reference to the existing literature.
  • Only in case of small-cell carcinoma does there seem to be a definite role for chemotherapy, especially in a multimodality treatment protocol.

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  • (PMID = 12679311.001).
  • [ISSN] 1068-9265
  • [Journal-full-title] Annals of surgical oncology
  • [ISO-abbreviation] Ann. Surg. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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5. Rubenfire M, Impact of Medical Subspecialty on Patient Compliance to Treatment Study Group: Safety and compliance with once-daily niacin extended-release/lovastatin as initial therapy in the Impact of Medical Subspecialty on Patient Compliance to Treatment (IMPACT) study. Am J Cardiol; 2004 Aug 1;94(3):306-11
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  • [Title] Safety and compliance with once-daily niacin extended-release/lovastatin as initial therapy in the Impact of Medical Subspecialty on Patient Compliance to Treatment (IMPACT) study.
  • Niacin extended-release/lovastatin is a new combination product approved for treatment of primary hypercholesterolemia and mixed dyslipidemia.
  • This open-labeled, multicenter study evaluated the safety of bedtime niacin extended-release/lovastatin when dosed as initial therapy and patient compliance to treatment in various clinical practice settings.
  • A total of 4,499 patients with dyslipidemia requiring drug intervention was enrolled at 1,081 sites.
  • Primary end points were study compliance, increases in liver transaminases to >3 times the upper limit of normal, and clinical myopathy.
  • Incidence of increased aspartate aminotransferase and/or alanine aminotransferase >3 times the upper limit of normal was <0.3%.
  • An increase of creatine phosphokinase to >5 times the upper limit of normal occurred in 0.24% of patients, and no cases of drug-induced myopathy were observed.
  • Niacin extended-release/lovastatin 1,000/40 mg, dosed as initial therapy, was associated with good compliance and safety and had very low incidences of increased liver and muscle enzymes.
  • [MeSH-major] Delayed-Action Preparations / administration & dosage. Hyperlipidemias / drug therapy. Lovastatin / administration & dosage. Niacin / administration & dosage. Patient Compliance / statistics & numerical data
  • [MeSH-minor] Administration, Oral. Dose-Response Relationship, Drug. Drug Administration Schedule. Drug Combinations. Female. Follow-Up Studies. Humans. Liver Function Tests. Male. Middle Aged. Muscular Diseases / chemically induced. Muscular Diseases / epidemiology. Probability. Prospective Studies. Risk Assessment. Severity of Illness Index. Treatment Outcome

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  • (PMID = 15276093.001).
  • [ISSN] 0002-9149
  • [Journal-full-title] The American journal of cardiology
  • [ISO-abbreviation] Am. J. Cardiol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Comparative Study; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Delayed-Action Preparations; 0 / Drug Combinations; 2679MF687A / Niacin; 9LHU78OQFD / Lovastatin
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6. Laine L, Goldkind L, Curtis SP, Connors LG, Yanqiong Z, Cannon CP: How common is diclofenac-associated liver injury? Analysis of 17,289 arthritis patients in a long-term prospective clinical trial. Am J Gastroenterol; 2009 Feb;104(2):356-62
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • OBJECTIVES: Few data are available from prospective trials to define the hepatotoxicity of diclofenac, the most widely prescribed non-steroidal anti-inflammatory drug (NSAID) in the world.
  • We determined the rate of laboratory and clinical adverse hepatic effects in a large double-blind trial of diclofenac.
  • Causality assessment was performed for liver-related hospitalizations, Hy's cases (serious adverse events with AST or ALT >3 x upper limit of normal (ULN) and bilirubin >2 xULN), and liver failure/transplant/death.
  • RESULTS: A total of 17,289 patients received diclofenac for a mean of 18 months.
  • Aminotransferase elevations occurred primarily within the first 4-6 months of therapy, whereas liver-related hospitalizations occurred between 9 days and 21 months.
  • CONCLUSIONS: Diclofenac is commonly associated with aminotransferase elevations, generally in the first 4-6 months of therapy.
  • Clinical liver events requiring hospitalization are relatively rare (23/100,000 patients), but may develop early or late in therapy.
  • [MeSH-major] Anti-Inflammatory Agents, Non-Steroidal / adverse effects. Arthritis, Rheumatoid / drug therapy. Diclofenac / adverse effects. Drug-Induced Liver Injury. Liver Diseases / epidemiology. Osteoarthritis / drug therapy


7. Krishna G, AbuTarif M, Xuan F, Martinho M, Angulo D, Cornely OA: Pharmacokinetics of oral posaconazole in neutropenic patients receiving chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome. Pharmacotherapy; 2008 Oct;28(10):1223-32
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  • [Title] Pharmacokinetics of oral posaconazole in neutropenic patients receiving chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome.
  • STUDY OBJECTIVE: To analyze the pharmacokinetics of posaconazole administered as prophylaxis for invasive fungal infection (IFI) in neutropenic patients receiving chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).
  • DESIGN: Pharmacokinetic subanalysis of a phase III, prospective, randomized, multicenter, evaluator-blinded trial comparing posaconazole with standard azoles (fluconazole and itraconazole).
  • PATIENTS: One hundred ninety-four patients with AML or MDS who received posaconazole oral suspension 200 mg 3 times/day with meals or a nutritional supplement for a minimum of 7 days to achieve steady state and for a maximum of 12 weeks.
  • INTERVENTION: For the first 20 patients, blood samples were collected before the first dose on day 8 and at 2, 4, 6, and 24 hours after that first dose; for all other patients, blood samples were collected at 1 and 3 hours after the first dose on day 8 and during the first episode of evaluation for a possible IFI.
  • MEASUREMENTS AND MAIN RESULTS: The effects of the following covariates on average (Cav) and maximum (Cmax) posaconazole plasma concentrations at steady state were explored: age, sex, and race-ethnicity; proven or probable IFI; baseline body weight and body surface area; and baseline (on or before day 7) increases in liver enzyme levels, mucositis, neutropenia, diarrhea, vomiting, or use of an H2-receptor antagonist or proton pump inhibitor.
  • Diarrhea, proton pump inhibitor use, gamma-glutamyl transferase level of 2 or more times the upper limit of normal, and race-ethnicity reduced Cav.
  • Mean Cav and Cmax values did not appear different in the six patients with IFIs (three with proven IFIs, three with probable IFIs) compared with the entire sample of 194 patients; however, a definitive conclusion cannot be made due to the small sample size of patients with IFI.
  • CONCLUSION: Oral posaconazole 200 mg 3 times/day provided plasma concentrations adequate for preventing IFIs.
  • [MeSH-major] Antifungal Agents / pharmacokinetics. Antineoplastic Agents / adverse effects. Leukemia, Myeloid, Acute / drug therapy. Mycoses / prevention & control. Myelodysplastic Syndromes / drug therapy. Neutropenia / chemically induced. Triazoles / pharmacokinetics


8. Huang SC, Tang MJ, Hsu KF, Cheng YM, Chou CY: Fas and its ligand, caspases, and bcl-2 expression in gonadotropin-releasing hormone agonist-treated uterine leiomyoma. J Clin Endocrinol Metab; 2002 Oct;87(10):4580-6
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Fas and its ligand, caspases, and bcl-2 expression in gonadotropin-releasing hormone agonist-treated uterine leiomyoma.
  • GnRH agonist (GnRH-a) therapy is known to shrink uterine leiomyoma, although the molecular mechanisms responsible for this effect remain poorly understood.
  • Conflicting results exist as to whether GnRH-a treatment increases apoptosis in leiomyoma cells.
  • The aim of this study is to investigate the effects of GnRH-a on uterine leiomyomas by profiling the expression levels of apoptosis-related molecules such as Fas/Fas ligand (FasL), caspases 3, 6, 7, 8, 9, and 10, and Bcl-2 from specimens of 20 patients receiving Leuplin Depot (LA), a long-acting GnRH-a, of 3 doses before myomectomy, as well as 24 controls.
  • We found that uterine leiomyomas had up-regulated expressions of FasL and caspase 3 as compared with their homologous normal myometrium control.
  • Both leiomyomas and myometria from LA-treated patients, however, presented a significant decrease in the expressions of FasL and caspase 3 as compared with those from LA-naive control patients.
  • In addition, it was at the posttranscription level that the tumorigenesis of leiomyoma modulated the expressions of FasL and caspase 3 higher, whereas LA suppressed them at gene transcription.
  • Unlike the case of FasL and caspase 3 mentioned above, no significant difference was found between leiomyomas and homologous myometria in the expressions of Fas and caspases 6, 7, 8, 9, and 10.
  • The LA effect made drug-treated leiomyomas produce less Fas and caspases 7, 9, and 10 as compared with nontreated leiomyomas.
  • Moreover, leiomyomas had an up-regulated Bcl-2 level, which remained high even in the LA-treated cells.
  • Our findings provide molecular evidence to support our previous observations that GnRH-a therapy fails to increase apoptosis in uterine leiomyomas.
  • [MeSH-major] Antigens, CD95 / analysis. Caspases / analysis. Leiomyoma / drug therapy. Membrane Glycoproteins / analysis. Proto-Oncogene Proteins c-bcl-2 / analysis. Uterine Neoplasms / drug therapy
  • [MeSH-minor] Adult. Apoptosis. Caspase 3. Fas Ligand Protein. Female. Gene Expression. Humans. Leuprolide / administration & dosage. Leuprolide / therapeutic use. RNA, Messenger / analysis. Reverse Transcriptase Polymerase Chain Reaction

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  • (PMID = 12364438.001).
  • [ISSN] 0021-972X
  • [Journal-full-title] The Journal of clinical endocrinology and metabolism
  • [ISO-abbreviation] J. Clin. Endocrinol. Metab.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antigens, CD95; 0 / FASLG protein, human; 0 / Fas Ligand Protein; 0 / Membrane Glycoproteins; 0 / Proto-Oncogene Proteins c-bcl-2; 0 / RNA, Messenger; EC 3.4.22.- / CASP3 protein, human; EC 3.4.22.- / Caspase 3; EC 3.4.22.- / Caspases; EFY6W0M8TG / Leuprolide
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9. Salomir R, Delemazure AS, Palussière J, Rouvière O, Cotton F, Chapelon JY: Image-based control of the magnetic resonance imaging-guided focused ultrasound thermotherapy. Top Magn Reson Imaging; 2006 Jun;17(3):139-51
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  • Magnetic resonance imaging (MRI)-guided focused ultrasound surgery (FUS) is a full noninvasive approach for localized thermal ablation of deep tissues, coupling the following:.
  • (1) a versatile, nonionizing physical agent for therapy and (2) a state-of-the art diagnosis and on-line monitoring tool.
  • A commercially available, Food and Drug Administration-approved device using the MRI-guided FUS exists since 2004 for the ablation of benign tumors (uterine fibroids); however, the ultimate goal of the technological, methodological, and medical research in this field is to provide a clinical-routine tool for fighting localized cancer.
  • Contiguous destruction of the target volume must be achieved in a minimum time, whereas sparing as much as possible the neighboring healthy tissues and especially when some adjacent regions are critical.
  • This paper reviews some significant developments reported in the literature related to the image-based control of the FUS therapy for kidney, breast, prostate, and brain, including the own experience of the authors on the active feedback control of the temperature during FUS ablation.
  • [MeSH-major] Brain Neoplasms / therapy. Breast Neoplasms / therapy. Kidney Neoplasms / therapy. Magnetic Resonance Imaging / methods. Prostatic Neoplasms / therapy. Ultrasonic Therapy / methods


10. Wong IH, Yeo W, Leung T, Lau WY, Johnson PJ: Circulating tumor cell mRNAs in peripheral blood from hepatocellular carcinoma patients under radiotherapy, surgical resection or chemotherapy: a quantitative evaluation. Cancer Lett; 2001 Jun 26;167(2):183-91
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  • [Title] Circulating tumor cell mRNAs in peripheral blood from hepatocellular carcinoma patients under radiotherapy, surgical resection or chemotherapy: a quantitative evaluation.
  • We assessed whether current therapies could lead to hematogenous dissemination of malignant hepatocytes in hepatocellular carcinoma (HCC) patients using semi-quantitative reverse transcription-polymerase chain reaction (RT-PCR) for alpha-fetoprotein (afp) and albumin (alb) mRNAs.
  • We analyzed 137 peripheral blood samples before, during and after treatment from 84 patients under radiotherapy, surgical resection or chemotherapy.
  • As compared to the upper limit for 53 healthy/non-HCC controls, alb- mRNA levels increased 2-10-fold in 6% of patients pre-treatment and 2-2.6x10(4)-fold in 32% post-treatment.
  • Levels of afp- mRNA increased 3-210-fold in 17% pre-treatment and 4-5x10(5)-fold in 30% post-treatment.
  • During a longitudinal follow-up of eight patients under radiotherapy or radiotherapy/resection, alb-mRNA levels were normal before treatment, whereas afp-mRNA levels increased 10-fold in two patients.
  • During treatment, alb-mRNA and afp-mRNA levels increased 2-61-fold in three patients and 2.5-5-fold in two patients, respectively.
  • After treatment, alb-mRNA levels declined to normal in all three patients within 3.5 months, but afp-mRNA levels increased 127-5x10(5)-fold in three patients within 5 months.
  • We show evidence that HCC cells disseminating mostly post-treatment may be the 'seed' of recurrence/metastasis.
  • [MeSH-major] Biomarkers, Tumor / blood. Carcinoma, Hepatocellular / blood. Liver Neoplasms / blood. Neoplastic Cells, Circulating / metabolism. alpha-Fetoproteins / metabolism
  • [MeSH-minor] Combined Modality Therapy. Follow-Up Studies. Humans. Prognosis. RNA, Messenger / blood. Serum Albumin / genetics. Serum Albumin / metabolism. Survival Analysis. Treatment Outcome. Tumor Cells, Cultured

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  • (PMID = 11369140.001).
  • [ISSN] 0304-3835
  • [Journal-full-title] Cancer letters
  • [ISO-abbreviation] Cancer Lett.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Biomarkers, Tumor; 0 / RNA, Messenger; 0 / Serum Albumin; 0 / alpha-Fetoproteins
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11. Liang M, Wang H, Zhang Y, Lu S, Wang Z: Expression and functional analysis of platelet-derived growth factor in uterine leiomyomata. Cancer Biol Ther; 2006 Jan;5(1):28-33
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Expression and functional analysis of platelet-derived growth factor in uterine leiomyomata.
  • OBJECTIVE: To examine the expression of PDGF and its receptors in leiomyoma tissue and to investigate the regulation of PDGF on leiomyoma cell proliferation.
  • MATERIALS AND METHODS: The expression of PDGF and its receptors was examined in 21 pairs of uterine leiomyoma and the adjacent myometrium tissues using an immunostaining method.
  • Paired cultures of leiomyoma and normal myometrium cells were established and treated with PDGF.
  • Total RNA was extracted from leiomyoma and myometrial cells for detection of the expression of proliferating cell nuclear antigen (PCNA) and collagen alpha1 (I, III) by semi-quantitative PCR.
  • RESULT: The expression of PDGF-AA and PDGF-BB in leiomyoma tissue is obviously higher than that in the matched myometrial tissue (P < 0.05).
  • In addition, the expression of PDGF-BB in secretory phase is higher than that in proliferative phase of the menstrual cycle (P = 0.027) in leiomyoma tissue.
  • The expression of PCNA and collagen alpha1 (I) were increased in both leiomyoma and myometrial cells after treatment of PDGF, whereas the expression levels were greater in leiomyoma cells than that in myometrial cells.
  • CONCLUSION: The expression of PDGF and its receptors in leiomyoma and myometrial tissue varied during the menstrual cycle.
  • PDGF may play a role in the pathogenesis of leiomyomas through a mechanism involved in not only the proliferation of leiomyoma cells but also excessive expression of extra cellular molecules.
  • [MeSH-major] Leiomyoma / metabolism. Platelet-Derived Growth Factor / metabolism. Receptor, Platelet-Derived Growth Factor alpha / metabolism. Receptor, Platelet-Derived Growth Factor beta / metabolism. Uterine Neoplasms / metabolism
  • [MeSH-minor] Cell Proliferation. Collagen Type I / analysis. Collagen Type I / genetics. Collagen Type I / metabolism. Collagen Type III / analysis. Collagen Type III / genetics. Collagen Type III / metabolism. Female. Humans. Menstrual Cycle / genetics. Menstrual Cycle / metabolism. Myocytes, Smooth Muscle / drug effects. Myocytes, Smooth Muscle / metabolism. Proliferating Cell Nuclear Antigen / analysis. Proliferating Cell Nuclear Antigen / genetics. Proliferating Cell Nuclear Antigen / metabolism. Proto-Oncogene Proteins c-sis. RNA, Messenger / analysis. RNA, Messenger / metabolism

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  • (PMID = 16294022.001).
  • [ISSN] 1538-4047
  • [Journal-full-title] Cancer biology & therapy
  • [ISO-abbreviation] Cancer Biol. Ther.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Collagen Type I; 0 / Collagen Type III; 0 / Platelet-Derived Growth Factor; 0 / Proliferating Cell Nuclear Antigen; 0 / Proto-Oncogene Proteins c-sis; 0 / RNA, Messenger; 0 / platelet-derived growth factor A; 0 / platelet-derived growth factor BB; EC 2.7.10.1 / Receptor, Platelet-Derived Growth Factor alpha; EC 2.7.10.1 / Receptor, Platelet-Derived Growth Factor beta
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12. Spitz IM: Mifepristone: where do we come from and where are we going? Clinical development over a quarter of a century. Contraception; 2010 Nov;82(5):442-52
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  • [Title] Mifepristone: where do we come from and where are we going? Clinical development over a quarter of a century.
  • Mifepristone administered for 3 months or longer to women with uterine leiomyomas, is associated with a reduction in pain and bleeding with improvement in quality of life and decrease in fibroid size.
  • In both these conditions, serum estradiol levels are in the range of those in the early follicular phase.
  • [MeSH-minor] Abortifacient Agents, Steroidal / administration & dosage. Abortifacient Agents, Steroidal / adverse effects. Abortifacient Agents, Steroidal / pharmacology. Abortion, Legal. Animals. Antineoplastic Agents, Hormonal / administration & dosage. Antineoplastic Agents, Hormonal / adverse effects. Antineoplastic Agents, Hormonal / pharmacology. Contraceptives, Postcoital, Synthetic / administration & dosage. Contraceptives, Postcoital, Synthetic / adverse effects. Contraceptives, Postcoital, Synthetic / pharmacology. Female. Genital Diseases, Female / drug therapy. Humans. Pregnancy. Women's Health

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  • [Copyright] Copyright © 2010 Elsevier Inc. All rights reserved.
  • (PMID = 20933118.001).
  • [ISSN] 1879-0518
  • [Journal-full-title] Contraception
  • [ISO-abbreviation] Contraception
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Abortifacient Agents, Steroidal; 0 / Antineoplastic Agents, Hormonal; 0 / Contraceptives, Postcoital, Synthetic; 0 / Receptors, Progesterone; 320T6RNW1F / Mifepristone
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13. Muneyyirci-Delale O, Richard-Davis G, Morris T, Armstrong J: Goserelin acetate 10.8 mg plus iron versus iron monotherapy prior to surgery in premenopausal women with iron-deficiency anemia due to uterine leiomyomas: results from a Phase III, randomized, multicenter, double-blind, controlled trial. Clin Ther; 2007 Aug;29(8):1682-91
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  • [Title] Goserelin acetate 10.8 mg plus iron versus iron monotherapy prior to surgery in premenopausal women with iron-deficiency anemia due to uterine leiomyomas: results from a Phase III, randomized, multicenter, double-blind, controlled trial.
  • BACKGROUND: Women with symptomatic uterine leiomyomas (fibroids) may have iron-deficiency anemia (IDA); therefore, surgery places them at risk of blood-borne morbidity from perioperative transfusions.
  • Such women might benefit from a preoperative treatment that restores hematologic normality and alleviates fibroid symptoms.
  • OBJECTIVE: The purpose of this study was to examine the effects of a single preoperative depot injection of goserelin acetate plus iron treatment compared with iron monotherapy, in premenopausal women with IDA due to uterine leiomyomas.
  • METHODS: This Phase III, randomized, multicenter, double-blind, controlled trial (12 weeks of treatment plus a 24-week follow-up period) was conducted from October 1997 to August 1999.
  • Patients received an injection of goserelin acetate 10.8 mg (3-month formulation) or a sham, with both groups receiving PO iron (ferrous sulfate) 325-mg tablets TID during the 12-week treatment period.
  • Hemoglobin (Hb) level, symptoms of uterine leiomyomas, requirement for blood transfusion throughout, ability to donate blood for autologous transfusion, and leiomyoma and uterine volume were assessed for efficacy.
  • The tolerability assessment included bone mineral density measurements and subjective symptomatology (ie, menstrual bleeding [uterine hemorrhage], fatigue, pelvic pain, and pelvic pressure).
  • RESULTS: A total of 110 women received treatment (n = 54, goserelin acetate 10.8 mg; n = 56, sham).
  • The majority of patients (69.1%) were black and the mean age at study entry was 39.9 years, with a mean weight of 80.1 kg.
  • At approximately 12 weeks, Hb levels were significantly higher in the goserelin group compared with the sham group (difference of least squares mean, 1.17 g/dL; 95% CI, 0.68-1.66; P < 0.001), and significantly more patients in the goserelin group had an increase in Hb concentration of >or=2 g/dL (odds ratio 6.36; 95% CI, 2.00-20.18; P < 0.001).
  • A nonsignificant decrease in both uterine and leiomyoma volume was experienced by patients who administered goserelin compared with increases in the sham group.
  • Uterine hemorrhage was also experienced numerically less often by goserelin-treated patients compared with those given the sham injection (9.3% vs 28.6%, respectively).
  • One or more adverse events (AEs) were reported by 89% of patients in each treatment group.
  • Goserelin acetate 10.8 mg was generally well tolerated by patients, with no serious drug-related AEs reported during this 36-week trial.
  • CONCLUSION: A single, preoperative injection of goserelin acetate 10.8 mg in addition to PO iron 325 mg TID was associated with improved Hb levels in these premenopausal women with IDA due to uterine leiomyomas.
  • [MeSH-major] Anemia, Iron-Deficiency / drug therapy. Antineoplastic Agents, Hormonal / therapeutic use. Ferrous Compounds / therapeutic use. Goserelin / therapeutic use. Gynecologic Surgical Procedures. Hematinics / therapeutic use. Leiomyoma / drug therapy. Premedication. Uterine Neoplasms / drug therapy
  • [MeSH-minor] Administration, Oral. Adult. Double-Blind Method. Drug Therapy, Combination. Female. Hemoglobins / metabolism. Humans. Injections, Subcutaneous. North America. Premenopause. Time Factors. Treatment Outcome

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  • [Copyright] Copyright 2007 Excerpta Medica, Inc.
  • (PMID = 17919549.001).
  • [ISSN] 0149-2918
  • [Journal-full-title] Clinical therapeutics
  • [ISO-abbreviation] Clin Ther
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 0 / Ferrous Compounds; 0 / Hematinics; 0 / Hemoglobins; 0F65R8P09N / Goserelin; 39R4TAN1VT / ferrous sulfate
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14. Jondeau G, Neuder Y, Eicher JC, Jourdain P, Fauveau E, Galinier M, Jegou A, Bauer F, Trochu JN, Bouzamondo A, Tanguy ML, Lechat P, B-CONVINCED Investigators: B-CONVINCED: Beta-blocker CONtinuation Vs. INterruption in patients with Congestive heart failure hospitalizED for a decompensation episode. Eur Heart J; 2009 Sep;30(18):2186-92
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  • [Title] B-CONVINCED: Beta-blocker CONtinuation Vs. INterruption in patients with Congestive heart failure hospitalizED for a decompensation episode.
  • AIMS: Whether or not beta-blocker therapy should be stopped during acutely decompensated heart failure (ADHF) is unsure.
  • METHODS AND RESULTS: In a randomized, controlled, open labelled, non-inferiority trial, we compared beta-blockade continuation vs. discontinuation during ADHF in patients with LVEF below 40% previously receiving stable beta-blocker therapy.
  • After 3 days, 92.8% of patients pursuing beta-blockade improved for both dyspnoea and general well-being according to a physician blinded for therapy vs. 92.3% of patients stopping beta-blocker.
  • This was the main endpoint and the upper limit for unilateral 95% CI (6.6%) is lower that of the predefined upper limit (12.5%), indicating non-inferiority.
  • Beta-blocker therapy at 3 months was given to 90% of patients vs. 76% (P < 0.05).
  • CONCLUSION: In conclusion, during ADHF, continuation of beta-blocker therapy is not associated with delayed or lesser improvement, but with a higher rate of chronic prescription of beta-blocker therapy after 3 months, the benefit of which is well established.
  • [MeSH-major] Adrenergic beta-Antagonists / administration & dosage. Disease Progression. Heart Failure / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Blood Pressure / physiology. Dyspnea / etiology. Dyspnea / prevention & control. Female. Heart Rate / physiology. Humans. Length of Stay. Male. Middle Aged. Stroke Volume / physiology. Treatment Outcome. Ventricular Dysfunction, Left / drug therapy. Ventricular Dysfunction, Left / physiopathology. Withholding Treatment. Young Adult

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  • [CommentIn] Eur Heart J. 2009 Sep;30(18):2177-9 [19717852.001]
  • (PMID = 19717851.001).
  • [ISSN] 1522-9645
  • [Journal-full-title] European heart journal
  • [ISO-abbreviation] Eur. Heart J.
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Adrenergic beta-Antagonists
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15. Akdim F, Stroes ES, Sijbrands EJ, Tribble DL, Trip MD, Jukema JW, Flaim JD, Su J, Yu R, Baker BF, Wedel MK, Kastelein JJ: Efficacy and safety of mipomersen, an antisense inhibitor of apolipoprotein B, in hypercholesterolemic subjects receiving stable statin therapy. J Am Coll Cardiol; 2010 Apr 13;55(15):1611-8
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  • [Title] Efficacy and safety of mipomersen, an antisense inhibitor of apolipoprotein B, in hypercholesterolemic subjects receiving stable statin therapy.
  • OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of mipomersen in hypercholesterolemic subjects taking stable statin therapy.
  • METHODS: A randomized, placebo-controlled, dose-escalation Phase 2 study was designed to evaluate the effects of mipomersen in hypercholesterolemic subjects taking stable statin therapy.
  • RESULTS: The apo B and LDL cholesterol were reduced by 19% to 54% and 21% to 52%, respectively, at doses of 100 mg/week mipomersen and higher in the 5-week treatment cohorts.
  • Efficacy seemed to increase upon treatment for 13 weeks at a dose of 200 mg/week.
  • In the 13-week treatment cohort, 5 of 10 subjects (50%) had elevations >or=3x the upper limit of normal, 4 of which persisted on 2 consecutive occasions.
  • CONCLUSIONS: Mipomersen might hold promise for treatment of patients not reaching target LDL cholesterol levels on stable statin therapy.
  • Further studies are needed to address the mechanisms and clinical relevance of transaminase changes after mipomersen administration. (Dose-Escalating Safety Study in Subjects on Stable Statin Therapy; NCT00231569).
  • [MeSH-major] Apolipoproteins B / antagonists & inhibitors. Cholesterol, LDL / blood. Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use. Hypercholesterolemia / drug therapy. Oligonucleotides / therapeutic use
  • [MeSH-minor] Dose-Response Relationship, Drug. Double-Blind Method. Drug Administration Schedule. Drug Therapy, Combination. Female. Follow-Up Studies. Humans. Injections, Subcutaneous. Male. Middle Aged. Prevalence. Retrospective Studies. Treatment Outcome

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  • [Copyright] Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  • (PMID = 20378080.001).
  • [ISSN] 1558-3597
  • [Journal-full-title] Journal of the American College of Cardiology
  • [ISO-abbreviation] J. Am. Coll. Cardiol.
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00231569
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Apolipoproteins B; 0 / Cholesterol, LDL; 0 / Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0 / Oligonucleotides; 9GJ8S4GU0M / mipomersen
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16. Hroch M, Chladek J, Simkova M, Vaneckova J, Grim J, Martinkova J: A pilot study of pharmacokinetically guided dosing of oral methotrexate in the initial phase of psoriasis treatment. J Eur Acad Dermatol Venereol; 2008 Jan;22(1):19-24
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  • [Title] A pilot study of pharmacokinetically guided dosing of oral methotrexate in the initial phase of psoriasis treatment.
  • BACKGROUND: Clinical studies of low-dose oral methotrexate (MTX) in the treatment of psoriasis and rheumatoid arthritis document a large interpatient variability in the pharmacokinetics of MTX, including its polyglutamates (MTXPGs) in erythrocytes (RBC).
  • This can be a factor contributing to the variability of therapeutic and toxic effects.
  • AIM: This pilot trial aimed to investigate the MTXPG concentrations in RBC as well as their relation to therapeutic and adverse effects during the initial 4 months of pharmacokinetically guided therapy with a divided-dose schedule (three doses of MTX separated by 12-h intervals once a week).
  • The area under the concentration-time curve of plasma MTX in the interval 0-8 h post-dose (AUC(0-8 h)) was measured after a test bolus dose of 10 mg, and the starting weekly dose was individualized in order to achieve the target AUC(0-8 h) of 1800 nmol.h/L.
  • The PASI, biochemistry, and haematology tests and MTXPGs levels in RBC were evaluated at baseline and at 4-week intervals.
  • However, only two patients had the ALT activity transiently elevated above twice the upper limit of normal.
  • CONCLUSION: Results of this pilot trial show that the steady-state levels of MTXPGs in RBC vary less than threefold between patients and did not correlate with the change in PASI observed after 4 months of therapy with an individualised weekly dose of MTX.
  • Whether pharmacokinetically guided dosing can improve the results of psoriasis therapy with MTX should be prospectively tested in large controlled studies.
  • [MeSH-major] Dermatologic Agents / administration & dosage. Dermatologic Agents / pharmacokinetics. Methotrexate / administration & dosage. Methotrexate / pharmacokinetics. Psoriasis / drug therapy
  • [MeSH-minor] Administration, Oral. Adult. Aged. Dose-Response Relationship, Drug. Drug Administration Schedule. Drug-Related Side Effects and Adverse Reactions. Erythrocytes / metabolism. Female. Humans. Male. Middle Aged. Pilot Projects. Severity of Illness Index. Treatment Outcome

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  • (PMID = 18031504.001).
  • [ISSN] 1468-3083
  • [Journal-full-title] Journal of the European Academy of Dermatology and Venereology : JEADV
  • [ISO-abbreviation] J Eur Acad Dermatol Venereol
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Dermatologic Agents; YL5FZ2Y5U1 / Methotrexate
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17. Bensmaïne MA, Marty M, de Gramont A, Brienza S, Lévi F, Ducreux M, François E, Gamelin E, Bleiberg H, Cvitkovic E: Factors predicting efficacy of oxaliplatin in combination with 5-fluorouracil (5-FU) +/- folinic acid in a compassionate-use cohort of 481 5-FU-resistant advanced colorectal cancer patients. Br J Cancer; 2001 Aug 17;85(4):509-17
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  • A statistical analysis was performed on the patient data collected from two compassionate-use programmes using oxaliplatin (Eloxatin(R)) + 5-fluorouracil (5-FU) +/- folinic acid (FA), to identify predictive factors for oxaliplatin-based salvage treatment in patients with 5-FU-resistant advanced colorectal cancer (ACRC).
  • 481 5-FU-resistant ACRC patients, most with performance status < or = 2, > or = 3 involved sites, and > or = 2 prior lines of chemotherapy, received oxaliplatin + 5-FU +/- FA.
  • Prognostic factors associated with overall response rate (ORR), time to progression (TTP) and overall survival (OS) were identified using univariate and multivariate logistic and/or Cox proportional hazards analyses.
  • The multivariate analysis indicated poor (> or = 2 WHO) performance status (PS), a large number of prior chemotherapy regimens (> or = 3), a low baseline haemoglobin level (< 10 g/dl), and a triweekly (vs biweekly) treatment administration schedule as significantly associated (P< 0.05) with a lower ORR.
  • Sex (male), number of organs involved (> or =3) and alkaline phosphatase (AP) level (> or = 2 x the upper limit of normal) were associated (P< 0.05) with shorter TTP.
  • Poor PS, a large number of organs involved, and elevated AP were independently and significantly correlated with shorter OS.
  • Our analysis identified a relationship between efficacy results of oxaliplatin + 5-FU +/- FA treatment in 5-FU-resistant ACRC patients and baseline prognostic factors related to PS, extent of disease and number of prior regimens.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colorectal Neoplasms / drug therapy. Organoplatinum Compounds / therapeutic use
  • [MeSH-minor] Adult. Aged. Disease Progression. Drug Resistance, Neoplasm. Female. Fluorouracil / administration & dosage. Fluorouracil / pharmacology. Humans. Leucovorin / administration & dosage. Male. Middle Aged. Prognosis. Salvage Therapy. Survival Analysis. Treatment Outcome

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  • [Copyright] Copyright 2001 Cancer Research Campaign.
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  • (PMID = 11506488.001).
  • [ISSN] 0007-0920
  • [Journal-full-title] British journal of cancer
  • [ISO-abbreviation] Br. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Scotland
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
  • [Other-IDs] NLM/ PMC2364084
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18. Saukkonen JJ, Cohn DL, Jasmer RM, Schenker S, Jereb JA, Nolan CM, Peloquin CA, Gordin FM, Nunes D, Strader DB, Bernardo J, Venkataramanan R, Sterling TR, ATS (American Thoracic Society) Hepatotoxicity of Antituberculosis Therapy Subcommittee: An official ATS statement: hepatotoxicity of antituberculosis therapy. Am J Respir Crit Care Med; 2006 Oct 15;174(8):935-52
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  • [Title] An official ATS statement: hepatotoxicity of antituberculosis therapy.
  • Drug-induced liver injury (DILI) is a problem of increasing significance, but has been a long-standing concern in the treatment of tuberculosis (TB) infection.
  • The liver has a central role in drug metabolism and detoxification, and is consequently vulnerable to injury.
  • The pathogenesis and types of DILI are presented, ranging from hepatic adaptation to hepatocellular injury.
  • Knowledge of the metabolism of anti-TB medications and of the mechanisms of TB DILI is incomplete.
  • During treatment of latent TB infection (LTBI) alanine aminotransferase (ALT) monitoring is recommended for those who chronically consume alcohol, take concomitant hepatotoxic drugs, have viral hepatitis or other preexisting liver disease or abnormal baseline ALT, have experienced prior isoniazid hepatitis, are pregnant or are within 3 months postpartum.
  • During treatment of TB disease, in addition to these individuals, patients with HIV infection should have ALT monitoring.
  • Treatment should be interrupted and, generally, a modified or alternative regimen used for those with ALT elevation more than three times the upper limit of normal (ULN) in the presence of hepatitis symptoms and/or jaundice, or five times the ULN in the absence of symptoms.
  • Priorities for future studies to develop safer treatments for LTBI and for TB disease are presented.
  • [MeSH-major] Antitubercular Agents / adverse effects. Drug-Induced Liver Injury. Liver / drug effects. Societies, Medical. Tuberculosis / drug therapy

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  • [CommentIn] Am J Respir Crit Care Med. 2007 Apr 15;175(8):858; author reply 858-9 [17405943.001]
  • (PMID = 17021358.001).
  • [ISSN] 1073-449X
  • [Journal-full-title] American journal of respiratory and critical care medicine
  • [ISO-abbreviation] Am. J. Respir. Crit. Care Med.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antitubercular Agents
  • [Number-of-references] 184
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19. Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG: Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst; 2006 Feb 15;98(4):273-84
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  • [Title] Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia.
  • BACKGROUND: In the United States, darbepoetin alfa (Aranesp) is often used to treat patients with chemotherapy-induced anemia using weekly or every-2-week administration schedules.
  • The every-3-week schedule can be synchronized with many chemotherapy regimens, resulting in fewer visits and reducing burden to patients, but the safety and efficacy of this regimen have not been clear.
  • Eligible patients (age > or = 18 years) were anemic (hemoglobin level < 11 g/dL), had a nonmyeloid malignancy, and were to receive at least 12 weeks of chemotherapy.
  • Patients were randomly assigned 1:1 to darbepoetin alfa treatment every 3 weeks (500-microg dose) or weekly (2.25-microg/kg) for 15 weeks.
  • We compared red blood cell transfusion incidence among the two arms from week 5 to the end of the treatment phase using a noninferiority study design.
  • Noninferiority was determined if the upper limit of the 95% confidence interval (CI) for the difference in blood transfusions between groups, calculated using Kaplan-Meier methods, did not exceed 12.5%, a margin based on previous placebo-controlled studies.
  • Fewer patients in the every-3-week arm than in the weekly arm received blood transfusions from week 5 to the end of the treatment phase (unadjusted Kaplan-Meier estimates = 23% versus 30%, difference = -6.8%; 95% CI = -13.6 to 0.1).
  • Percentages of patients achieving the target hemoglobin level (> or = 11 g/dL, consistent with evidence-based practice guidelines) were 84% (every 3 weeks) and 77% (weekly).
  • CONCLUSIONS: Patients with chemotherapy-induced anemia can safely and effectively be treated with 500 microg of darbepoetin alfa every 3 weeks.
  • [MeSH-major] Anemia, Hypochromic / chemically induced. Anemia, Hypochromic / drug therapy. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Erythropoiesis / drug effects. Erythropoietin / analogs & derivatives
  • [MeSH-minor] Adult. Darbepoetin alfa. Double-Blind Method. Drug Administration Schedule. Erythrocyte Transfusion / statistics & numerical data. Europe. Female. Humans. Male. Middle Aged

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  • (PMID = 16478746.001).
  • [ISSN] 1460-2105
  • [Journal-full-title] Journal of the National Cancer Institute
  • [ISO-abbreviation] J. Natl. Cancer Inst.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 11096-26-7 / Erythropoietin; 15UQ94PT4P / Darbepoetin alfa
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20. Djeddi D, Kongolo G, Lefaix C, Mounard J, Léké A: Effect of domperidone on QT interval in neonates. J Pediatr; 2008 Nov;153(5):663-6
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  • RESULTS: Oral domperidone is associated with QTc prolongation except in infants with a gestational age less than 32 weeks of amenorrhea (P < .005).
  • On multivariate analysis, after adjustment for gestational age, serum potassium was the only factor independently associated with interval QT prolongation during treatment.
  • CONCLUSIONS: This study shows a significant association between oral domperidone therapy and QTc prolongation.
  • Two risk factors were identified: advanced gestational age and serum potassium at the upper limit of normal.
  • It is recommended that measurement of the QT interval be done before and after oral domperidone therapy.
  • [MeSH-major] Domperidone / adverse effects. Domperidone / pharmacology. Long QT Syndrome / drug therapy. Long QT Syndrome / etiology
  • [MeSH-minor] Administration, Oral. Arrhythmias, Cardiac / diagnosis. Dopamine Antagonists / adverse effects. Drug-Related Side Effects and Adverse Reactions. Gastroesophageal Reflux / drug therapy. Gestational Age. Humans. Infant. Infant, Newborn. Myocardial Contraction / drug effects. Potassium / blood. Risk. Risk Factors

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  • [CommentIn] J Pediatr. 2008 Nov;153(5):596-8 [18940349.001]
  • (PMID = 18589449.001).
  • [ISSN] 1097-6833
  • [Journal-full-title] The Journal of pediatrics
  • [ISO-abbreviation] J. Pediatr.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Dopamine Antagonists; 5587267Z69 / Domperidone; RWP5GA015D / Potassium
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21. Voora D, Shah SH, Spasojevic I, Ali S, Reed CR, Salisbury BA, Ginsburg GS: The SLCO1B1*5 genetic variant is associated with statin-induced side effects. J Am Coll Cardiol; 2009 Oct 20;54(17):1609-16
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  • BACKGROUND: Statin-induced side effects can interfere with therapy.
  • We defined a composite adverse event (CAE) as discontinuation for any side effect, myalgia, or CK >3x upper limit of normal during follow-up.
  • Furthermore, there was evidence for a gene-dose effect (percent with CAE in those with 0, 1, or 2 alleles: 19%, 27%, and 50%, trend p = 0.01).
  • These findings expand the results of a recent genome-wide association study of statin myopathy with CK >3x normal to milder, statin-induced, muscle side effects.

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  • (PMID = 19833260.001).
  • [ISSN] 1558-3597
  • [Journal-full-title] Journal of the American College of Cardiology
  • [ISO-abbreviation] J. Am. Coll. Cardiol.
  • [Language] ENG
  • [Grant] United States / NCRR NIH HHS / RR / M01 RR001032; United States / NHLBI NIH HHS / HL / T32 HL007101
  • [Publication-type] Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Heptanoic Acids; 0 / Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0 / Hypolipidemic Agents; 0 / Organic Anion Transporters; 0 / Pyrroles; 0 / SLCO1B1 protein, human; 48A5M73Z4Q / Atorvastatin Calcium; AGG2FN16EV / Simvastatin; EC 2.7.3.2 / Creatine Kinase; KXO2KT9N0G / Pravastatin
  • [Other-IDs] NLM/ NIHMS160347; NLM/ PMC3417133
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22. Reubi JC: In vitro evaluation of VIP/PACAP receptors in healthy and diseased human tissues. Clinical implications. Ann N Y Acad Sci; 2000;921:1-25
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  • [Title] In vitro evaluation of VIP/PACAP receptors in healthy and diseased human tissues. Clinical implications.
  • The evaluation of peptide receptors in man is relevant to identifying the physiological target tissues of a given peptide and to selecting diseases with a sufficient receptor overexpression for diagnostic or therapeutic intervention.
  • VIP/PACAP receptors have been evaluated in normal and diseased human non-neuronal tissues by using in vitro receptor autoradiography with 125I-VIP or 125I-PACAP in tissue sections.
  • As assessed by subtype-selective VIP analogs, VIP receptors of the VPAC1 subtype are found in a wide variety of tissues including liver, breast, kidney, prostate, ureter, bladder, pancreatic ducts, gastrointestinal mucosa, lung, thyroid, adipose, and lymphoid tissues.
  • VIP/PACAP receptors are expressed in the majority of the most frequently occurring human tumors, including breast, prostate, pancreas, lung, colon, stomach, liver, and bladder carcinomas, as well as lymphomas and meningiomas, predominantly as VPAC1 receptors, as do their tissues of origin.
  • Although leiomyomas predominantly express VPAC2 receptors, glial tumors, pituitary adenomas, neuroblastomas, paragangliomas, pheochromocytomas, and endometrial carcinomas preferentially express PAC1 receptors.
  • The very wide distribution of VIP/PACAP receptors in the normal human body is indicative of the key role of these peptides in human physiology and pathophysiology.
  • Moreover, the receptor expression in tumors is the molecular basis for clinical applications of VIP/PACAP such as in vivo scintigraphy and radiotherapy of tumors as well as VIP/PACAP analog treatment for tumor growth inhibition.
  • [MeSH-minor] Autoradiography. Epithelium / metabolism. Female. Humans. In Vitro Techniques. Male. Neoplasm Metastasis. Neoplasms / drug therapy. Neoplasms / metabolism. Neoplasms / radiotherapy. Receptors, Pituitary Adenylate Cyclase-Activating Polypeptide. Receptors, Pituitary Adenylate Cyclase-Activating Polypeptide, Type I. Receptors, Vasoactive Intestinal Peptide, Type II. Receptors, Vasoactive Intestinal Polypeptide, Type I. Tissue Distribution


23. Samsioe G, Dvorak V, Genazzani AR, Hamann B, Heikkinen J, Mueck AO, Suzin J, Kawakami FT, Ferreira A, Sun D, Arguinzoniz M: One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women. Maturitas; 2007 Jun 20;57(2):171-81
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  • [Title] One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women.
  • OBJECTIVE: To evaluate the safety and endometrial protection of low-dose transdermal estradiol (E2)/norethisterone acetate (NETA) patches (Estalis 25/125) in terms of post-treatment incidence of endometrial hyperplasia/cancer after 1 year of treatment in postmenopausal women with intact uteri.
  • RESULTS: Six hundred and seventy-seven patients were randomized (507 in the transdermal group and 169 in the oral group; one did not receive study drug) and >80% completed the study.
  • There were no cases of endometrial hyperplasia or cancer in either group and the upper limit of the one-sided 95% confidence interval in the transdermal group was 0.85%.
  • Over time, both treatments were associated with a decreasing frequency of spotting/bleeding days.
  • [MeSH-major] Estradiol / administration & dosage. Estrogen Replacement Therapy. Hot Flashes / drug therapy. Norethindrone / administration & dosage
  • [MeSH-minor] Administration, Cutaneous. Aged. Drug Therapy, Combination. Endometrium / drug effects. Endometrium / pathology. Female. Humans. Middle Aged. Postmenopause. Treatment Outcome

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  • (PMID = 17317046.001).
  • [ISSN] 0378-5122
  • [Journal-full-title] Maturitas
  • [ISO-abbreviation] Maturitas
  • [Language] eng
  • [Publication-type] Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Ireland
  • [Chemical-registry-number] 4TI98Z838E / Estradiol; T18F433X4S / Norethindrone
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24. Humblet Y, Van Cutsem E, Dubois C, Gillard P: Compassionate use of Gemzar in advanced pancreatic cancer: a Belgian experience. Acta Gastroenterol Belg; 2001 Oct-Dec;64(4):305-8
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  • Gemzar is a nucleoside analog that has been shown to be superior to 5-fluorouracil for the treatment of advanced pancreatic cancer in terms of both clinical benefit and survival.
  • Patients eligible for this program had advanced or metastatic pancreatic cancer, received up to one previous chemotherapy, a baseline Karnofsky performance status (KPS) of at least 50, measurable or evaluable disease, adequate organ function defined as: absolute leucocyte count > 3 x 10(9)/L, platelet count > 100 x 10(9)/L, hemoglobin > 9 gr/dL, total bilirubin < 2 x upper limit of normal (ULN), creatinine < 2 x ULN, ALT and AST levels < 5 x ULN and were at least 18 years.
  • The median age at inclusion was 64 years, 52% of the patients were male, 27% were 70 year or older, 66% had stage IV disease, 66% had a KPS of 80 or higher and 34% had received no prior chemotherapy.
  • A time-to-first-serious-event analysis was performed since only a limited number of dates of death were available.
  • The median time to FSE was 4 months, the free FSE rate at 1 year was 14%.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / pathology. Antimetabolites, Antineoplastic / administration & dosage. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Pancreatic Neoplasms / drug therapy. Pancreatic Neoplasms / pathology
  • [MeSH-minor] Adult. Aged. Belgium. Biopsy, Needle. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Male. Middle Aged. Neoplasm Staging. Probability. Survival Analysis. Treatment Outcome

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  • (PMID = 11887632.001).
  • [ISSN] 1784-3227
  • [Journal-full-title] Acta gastro-enterologica Belgica
  • [ISO-abbreviation] Acta Gastroenterol. Belg.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study
  • [Publication-country] Belgium
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine
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26. Premkumar A, Venzon DJ, Avila N, Johnson DV, Remaley AT, Forman MR, Eng-Wong J, Zujewski J, Stratton P: Gynecologic and hormonal effects of raloxifene in premenopausal women. Fertil Steril; 2007 Dec;88(6):1637-44
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  • OBJECTIVE: To assess the effects of raloxifene on the ovaries, uterus, and serum hormone levels in premenopausal women.
  • DESIGN: Prospective study comparing pretreatment findings with findings for those on treatment.
  • Changes in endometrial thickness, fibroid size, hormone levels, and menstrual-cycle length.
  • RESULT(S): Fifteen subjects developed some cycles with asymptomatic ovarian stimulation, and 9 developed benign endometrial polyps, compared with 2 subjects and 1 subject pretreatment, respectively.
  • Uterine fibroid size was unchanged during raloxifene use in 16 subjects with fibroids.
  • On treatment, E(2) levels increased significantly only during the follicular phase, with peak E(2) levels significantly higher in cycles showing ovarian stimulation compared with those without.
  • Sex hormone-binding globulin increased, but levels of LH, FSH, P, DHEAS, and T did not.
  • Endometrial thickness, cycle length, and fibroid size were unchanged.
  • Benign asymptomatic endometrial polyps developed in some.
  • [MeSH-major] Breast Neoplasms / prevention & control. Carcinoma / prevention & control. Genitalia, Female / drug effects. Gonadal Steroid Hormones / blood. Premenopause / drug effects. Raloxifene Hydrochloride / therapeutic use
  • [MeSH-minor] Adult. Calcium Carbonate / administration & dosage. Dehydroepiandrosterone Sulfate / blood. Drug Administration Schedule. Drug Therapy, Combination. Female. Humans. Menstrual Cycle / blood. Middle Aged. Polyps / chemically induced. Polyps / diagnostic imaging. Risk Factors. Selective Estrogen Receptor Modulators / administration & dosage. Selective Estrogen Receptor Modulators / adverse effects. Selective Estrogen Receptor Modulators / therapeutic use. Ultrasonography. Uterine Diseases / chemically induced. Uterine Diseases / diagnostic imaging

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  • [CommentIn] Aust N Z J Psychiatry. 2017 Mar;51(3):294 [27687775.001]
  • (PMID = 17662283.001).
  • [ISSN] 1556-5653
  • [Journal-full-title] Fertility and sterility
  • [ISO-abbreviation] Fertil. Steril.
  • [Language] eng
  • [Grant] United States / Intramural NIH HHS / /
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Research Support, N.I.H., Intramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Gonadal Steroid Hormones; 0 / Selective Estrogen Receptor Modulators; 4F86W47BR6 / Raloxifene Hydrochloride; 57B09Q7FJR / Dehydroepiandrosterone Sulfate; H0G9379FGK / Calcium Carbonate
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27. Dodos F, Halbsguth T, Erdmann E, Hoppe UC: Usefulness of myocardial performance index and biochemical markers for early detection of anthracycline-induced cardiotoxicity in adults. Clin Res Cardiol; 2008 May;97(5):318-26
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  • [Title] Usefulness of myocardial performance index and biochemical markers for early detection of anthracycline-induced cardiotoxicity in adults.
  • BACKGROUND: Anthracycline therapy is limited by cardiotoxicity.
  • Currently no diagnostic parameter is available allowing ubiquitous and reliable detection of preclinical anthracycline cardiomyopathy and prediction of prognosis.
  • PATIENTS AND METHODS: In 100 consecutive patients receiving anthracycline-based chemotherapy serial measurements of left ventricular systolic and diastolic function, Tei index (a Doppler echocardiographic parameter of global ventricular function), cardiac troponin T (cTnT) and NT-probrain natriuretic peptides (BNP) at baseline and during 1-year follow-up were performed.
  • RESULTS: Mean ejection fraction (LVEF) significantly decreased immediately after completion of anthracycline therapy (mean dose 226.1 +/- 8.3 mg/m(2)) und further declined during follow-up (65.9 +/- 0.6% vs. 61.6 +/- 0.7%; P < 0.001), while mean E/A ratio decreased after 6 months (P = 0.05).
  • The Tei index increased after therapy in the majority of patients (78.8%) compared with pre-therapy values indicating myocardial alteration in more patients than previously recognized. cTnT levels did not exceed the upper limit of the normal range in any patient.
  • Seven patients had low-level elevations of cTnT.
  • Only one of these patients developed a concomitant decrease in LVEF.
  • Mean N-terminal-pro-BNP (NT-proBNP) levels did not significantly change after anthracycline administration.
  • However, in 13 patients (15.3%) a marked, transient increase of NT-proBNP was obtained after the first anthracycline cycle without cardiac dysfunction presumably due to altered cardiac loading conditions during chemotherapy.
  • Our results do not support that assessment of cTnT or BNP levels may safely replace serial echocardiographic evaluation of systolic and diastolic function for the monitoring of anthracycline cardiotoxicity.
  • [MeSH-major] Anthracyclines / adverse effects. Cardiomyopathies / physiopathology. Heart Ventricles / physiopathology. Myocardial Contraction / drug effects. Natriuretic Peptide, Brain / blood. Peptide Fragments / blood. Troponin T / blood
  • [MeSH-minor] Adult. Aged. Biomarkers / blood. Echocardiography, Doppler. Female. Follow-Up Studies. Humans. Immunoassay. Male. Middle Aged. Neoplasms / drug therapy. Prognosis. Protein Precursors. Time Factors. Ventricular Function, Left / drug effects

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  • (PMID = 18193371.001).
  • [ISSN] 1861-0684
  • [Journal-full-title] Clinical research in cardiology : official journal of the German Cardiac Society
  • [ISO-abbreviation] Clin Res Cardiol
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Anthracyclines; 0 / Biomarkers; 0 / Peptide Fragments; 0 / Protein Precursors; 0 / Troponin T; 0 / pro-brain natriuretic peptide (1-76); 114471-18-0 / Natriuretic Peptide, Brain
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28. Spitz IM: Clinical utility of progesterone receptor modulators and their effect on the endometrium. Curr Opin Obstet Gynecol; 2009 Aug;21(4):318-24
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  • PURPOSE OF REVIEW: In view of the spate of recent publications related to mifepristone and some second generation progesterone receptor modulators (PRMs), this appears to be an opportune time to view the clinical status of these compounds.
  • All these PRMs are effective in the treatment of uterine fibroids where they are associated with a reduction in pain, bleeding and improvement in quality of life and decrease in fibroid size.
  • Long-term treatment with PRMs may be associated with endometrial thickening on ultrasound and there have been reports of endometrial hyperplasia.
  • Even over this time, there is improvement of symptoms associated with fibroids and endometriosis.
  • [MeSH-major] Endometrium / drug effects. Endometrium / pathology. Hormone Antagonists / pharmacology. Receptors, Progesterone / drug effects
  • [MeSH-minor] Drug Administration Schedule. Endometriosis / drug therapy. Endometriosis / pathology. Estrenes / administration & dosage. Estrenes / pharmacology. Female. Humans. Leiomyoma / drug therapy. Leiomyoma / pathology. Mifepristone / administration & dosage. Mifepristone / pharmacology. Norpregnadienes / administration & dosage. Norpregnadienes / pharmacology. Oximes / administration & dosage. Oximes / pharmacology. Randomized Controlled Trials as Topic. Time Factors. Uterine Neoplasms / drug therapy. Uterine Neoplasms / pathology

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  • (PMID = 19602929.001).
  • [ISSN] 1473-656X
  • [Journal-full-title] Current opinion in obstetrics & gynecology
  • [ISO-abbreviation] Curr. Opin. Obstet. Gynecol.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Estrenes; 0 / Hormone Antagonists; 0 / Norpregnadienes; 0 / Oximes; 0 / Receptors, Progesterone; 1K9EYK92PQ / telapristone acetate; 320T6RNW1F / Mifepristone; 6J5J15Q2X8 / ulipristal; 72W09924WP / asoprisnil
  • [Number-of-references] 45
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29. Ripplinger CM, Li W, Hadley J, Chen J, Rothenberg F, Lombardi R, Wickline SA, Marian AJ, Efimov IR: Enhanced transmural fiber rotation and connexin 43 heterogeneity are associated with an increased upper limit of vulnerability in a transgenic rabbit model of human hypertrophic cardiomyopathy. Circ Res; 2007 Nov 9;101(10):1049-57
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  • [Title] Enhanced transmural fiber rotation and connexin 43 heterogeneity are associated with an increased upper limit of vulnerability in a transgenic rabbit model of human hypertrophic cardiomyopathy.
  • Langendorff-perfused hearts from TG (n=6) and wild-type (WT) rabbits (n=6) were optically mapped.
  • The upper and lower limits of vulnerability, action potential duration (APD) restitution, and conduction velocity were measured.
  • The upper limit of vulnerability was significantly increased in TG versus WT hearts (13.3+/-2.1 versus 7.4+/-2.3 V/cm; P=3.2e(-5)), whereas the lower limits of vulnerability were similar.
  • Because a nearly 2-fold increase in upper limit of vulnerability was observed in the TG hearts without significant changes in APD restitution, conduction velocity, or the anisotropy ratio, we conclude that structural remodeling may underlie the elevated upper limit of vulnerability in human hypertrophic cardiomyopathy.

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  • (PMID = 17885214.001).
  • [ISSN] 1524-4571
  • [Journal-full-title] Circulation research
  • [ISO-abbreviation] Circ. Res.
  • [Language] ENG
  • [Grant] United States / NHLBI NIH HHS / HL / R01 HL067322-05A2; None / None / / P50 HL054313-090012; United States / NHLBI NIH HHS / HL / P50 HL054313; United States / NHLBI NIH HHS / HL / R01 HL074283; None / None / / P50 HL054313-060012; United States / NHLBI NIH HHS / HL / P50 HL054313-080012; United States / NHLBI NIH HHS / HL / HL067322-05A2; United States / NHLBI NIH HHS / HL / R01-HL68884; United States / NHLBI NIH HHS / HL / R01 HL068884; United States / NHLBI NIH HHS / HL / P50 HL054313-070012; None / None / / P50 HL054313-100012; None / None / / P50 HL054313-08S10012; None / None / / P50 HL054313-080012; United States / NHLBI NIH HHS / HL / P50 HL054313-08S10012; United States / NHLBI NIH HHS / HL / P50 HL054313-090012; None / None / / P50 HL054313-070012; United States / NHLBI NIH HHS / HL / R01-HL67322; United States / NHLBI NIH HHS / HL / P50 HL054313-100012; United States / NHLBI NIH HHS / HL / R01 HL067322; United States / NHLBI NIH HHS / HL / P50 HL054313-060012; United States / NHLBI NIH HHS / HL / R01-HL074283
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Connexin 43
  • [Other-IDs] NLM/ NIHMS45455; NLM/ PMC2366809
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30. McHutchison JG, Patel K, Pockros P, Nyberg L, Pianko S, Yu RZ, Dorr FA, Kwoh TJ: A phase I trial of an antisense inhibitor of hepatitis C virus (ISIS 14803), administered to chronic hepatitis C patients. J Hepatol; 2006 Jan;44(1):88-96
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  • RESULTS: In most patients, the 4-week treatment did not reduce plasma HCV RNA.
  • These reductions were accompanied by asymptomatic, self-resolving elevations in serum alanine transaminase (ALT) levels to >10x the upper limit of normal.
  • No clinical signs, symptoms of hepatic dysfunction, or laboratory changes in albumin or prothrombin time accompanied ALT elevations.
  • CONCLUSIONS: ISIS 14803 treatment was associated with HCV reductions in only 3/28 patients.
  • Further studies to evaluate ISIS 14803 treatment and the mechanisms of the ALT flares are now required.
  • [MeSH-major] Hepacivirus / drug effects. Hepatitis C, Chronic / drug therapy. Oligonucleotides, Antisense / therapeutic use. Thionucleotides / therapeutic use
  • [MeSH-minor] Adult. Alanine Transaminase / blood. Drug Administration Routes. Female. Follow-Up Studies. Humans. Male. Middle Aged. RNA, Viral / analysis. Treatment Outcome. Viremia / drug therapy. Viremia / virology

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  • (PMID = 16274834.001).
  • [ISSN] 0168-8278
  • [Journal-full-title] Journal of hepatology
  • [ISO-abbreviation] J. Hepatol.
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / M01 RR 00833
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Oligonucleotides, Antisense; 0 / RNA, Viral; 0 / Thionucleotides; EC 2.6.1.2 / Alanine Transaminase
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31. Lee WM, Larrey D, Olsson R, Lewis JH, Keisu M, Auclert L, Sheth S: Hepatic findings in long-term clinical trials of ximelagatran. Drug Saf; 2005;28(4):351-70
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  • OBJECTIVE: In clinical trials, the efficacy and safety of the oral direct thrombin inhibitor ximelagatran have been evaluated in the prevention or treatment of thromboembolic conditions known to have high morbidity and mortality.
  • In these studies, raised aminotransferase levels were observed during long-term use (>35 days).
  • Of these, 6931 patients received ximelagatran for a mean of 357 days and 6216 patients received comparator for a mean of 389 days.
  • An algorithm was developed for frequent testing of hepatic enzyme levels.
  • A panel of four hepatologists analysed all cases of potential concern with regard to causal relation to ximelagatran treatment using an established evaluation tool (Roussel Uclaf Causality Assessment Method [RUCAM]).
  • RESULTS: An elevated alanine aminotransferase (ALT) level of >3 x the upper limit of normal (ULN) was found in 7.9% of patients in the ximelagatran group versus 1.2% in the comparator group.
  • The increase in ALT level occurred 1-6 months after initiation of therapy and data were available to confirm recovery of the ALT level to <2 x ULN in 96% of patients, whether they continued to receive ximelagatran or not.
  • There was some variability in the incidence of ALT level elevation between indications, those with simultaneous acute illnesses (acute myocardial infarction or venous thromboembolism) having higher incidences.
  • Combined elevations of ALT level of >3 x ULN and total bilirubin level of >2 x ULN (within 1 month of the ALT elevation), regardless of aetiology, were infrequent, occurring in 37 patients (0.5%) treated with ximelagatran, of whom one sustained a severe hepatic illness that appeared to be resolving when the patient died from a gastrointestinal haemorrhage.
  • CONCLUSION: Treatment with ximelagatran has been associated with mainly asymptomatic elevation of ALT levels in a mean of 7.9% of patients in the long-term clinical trial programme and nearly all of the cases occurred within the first 6 months of therapy.
  • An algorithm has been developed for testing ALT to ensure appropriate management of patients with elevated ALT levels.
  • [MeSH-major] Alanine Transaminase / drug effects. Anticoagulants. Azetidines. Liver / drug effects. Thromboembolism / drug therapy

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  • (PMID = 15783243.001).
  • [ISSN] 0114-5916
  • [Journal-full-title] Drug safety
  • [ISO-abbreviation] Drug Saf
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Anticoagulants; 0 / Azetidines; 0 / Benzylamines; 49HFB70472 / ximelagatran; EC 2.6.1.2 / Alanine Transaminase
  • [Number-of-references] 51
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32. Fraser IS: Non-contraceptive health benefits of intrauterine hormonal systems. Contraception; 2010 Nov;82(5):396-403
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Non-contraceptive health benefits of intrauterine hormonal systems.
  • Non-contraceptive health benefits are now recognized as an important aspect of the overall impact of all hormonal contraceptives.
  • The levonorgestrel-releasing intrauterine systems (LNG IUS) are particularly effective at producing a number of health benefits for women using the LNG IUS as a contraceptive (reduced menstrual bleeding; reduced dysmenorrhea and the potential for prevention of a number of gynecological conditions in the longer term, such as iron-deficiency anemia, endometrial hyperplasia, uterine fibroids, acute episodes of pelvic inflammatory disease, endometriosis and perhaps others).
  • The LNG IUS also has the potential to specifically treat a range of pre-existing gynecological conditions such as heavy menstrual bleeding due to a wide range of underlying causes, endometrial hyperplasia, uterine fibroids, adenomyosis, and endometriosis.
  • These health benefits should be recognized as a key component in the decision-making process for individual women in choosing a specific type of hormonal or other contraceptive.
  • [MeSH-major] Contraceptive Agents, Female / administration & dosage. Contraceptive Agents, Female / therapeutic use. Intrauterine Devices, Medicated. Women's Health
  • [MeSH-minor] Adolescent. Adult. Anemia, Iron-Deficiency / drug therapy. Decision Making. Drug Repositioning. Female. Genital Diseases, Female / drug therapy. Genital Diseases, Female / prevention & control. Humans. Levonorgestrel / administration & dosage. Levonorgestrel / therapeutic use. Pelvic Pain / drug therapy. Young Adult

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  • [Copyright] Copyright © 2010 Elsevier Inc. All rights reserved.
  • (PMID = 20933112.001).
  • [ISSN] 1879-0518
  • [Journal-full-title] Contraception
  • [ISO-abbreviation] Contraception
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Contraceptive Agents, Female; 5W7SIA7YZW / Levonorgestrel
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33. Istre O, Qvigstad E: Current treatment options for abnormal uterine bleeding: an evidence-based approach. Best Pract Res Clin Obstet Gynaecol; 2007 Dec;21(6):905-13
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  • [Title] Current treatment options for abnormal uterine bleeding: an evidence-based approach.
  • Heavy menstrual bleeding is the predominant complaint in women with abnormal uterine bleeding.
  • Treatment options are drug therapy, and first- and second-generation endometrial resection.
  • Uterine fibroids are the most common solid pelvic tumours in women, and although many fibroids seem to cause no symptoms, they can have serious adverse effects and impact on quality of life.
  • As women postpone having children, gynaecologists will have to manage fibroids and polyps in a conservative manner.
  • The past decade has witnessed the development of highly sophisticated diagnostic and therapeutic technology for women suffering from menorrhagia, fibroids and polyps, including minimally invasive uterine therapy.
  • This chapter reviews the evidence-based approach and minimally invasive therapy.
  • [MeSH-major] Menorrhagia / therapy
  • [MeSH-minor] Embolization, Therapeutic / methods. Endometrium / surgery. Evidence-Based Medicine. Female. Humans. Hysterectomy. Hysteroscopy. Leiomyoma / complications. Leiomyoma / therapy. Uterus / blood supply

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  • (PMID = 17499553.001).
  • [ISSN] 1521-6934
  • [Journal-full-title] Best practice & research. Clinical obstetrics & gynaecology
  • [ISO-abbreviation] Best Pract Res Clin Obstet Gynaecol
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Number-of-references] 54
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34. Gordon SC, Fang JW, Silverman AL, McHutchison JG, Albrecht JK: The significance of baseline serum alanine aminotransferase on pretreatment disease characteristics and response to antiviral therapy in chronic hepatitis C. Hepatology; 2000 Aug;32(2):400-4
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  • [Title] The significance of baseline serum alanine aminotransferase on pretreatment disease characteristics and response to antiviral therapy in chronic hepatitis C.
  • We sought to determine whether pretreatment serum alanine aminotransferase (ALT) levels in patients with chronic hepatitis C virus (HCV) correlate with demographic features and other disease characteristics and whether these values influence response to therapy.
  • Of these, 105 individuals (6%) had minimally raised serum ALT determinations at entry visit of </=1.3 x the upper limit of normal (ULN).
  • By analysis of variance both pretreatment histologic activity index (HAI) scores (P <.0001) and fibrosis scores (P =.003) were significantly lower among patients with baseline ALT levels </=1.3 x ULN.
  • Baseline ALT was not related to gender, race, baseline viral level, or HCV genotype.
  • There was no difference in sustained response between patients with baseline ALT levels </=1.3 x ULN and those with >1.3 x ULN, in all treatment groups (26 of 105, 24.8% for ALT </=1.3 x ULN; 440 of 1, 639, 26.8% for ALT >1.3 x ULN).
  • We conclude that HCV patients with minimally raised ALT values (</=1.3 x ULN) weigh less, and have lower histologic inflammatory scores than patients with more conventionally elevated ALT levels.
  • Despite these differences, these patients have a similar sustained response to antiviral therapy.
  • [MeSH-major] Alanine Transaminase / blood. Antiviral Agents / therapeutic use. Hepatitis C, Chronic / drug therapy. Interferon-alpha / therapeutic use
  • [MeSH-minor] Adult. Aged. Double-Blind Method. Drug Therapy, Combination. Female. Humans. Male. Middle Aged. Multivariate Analysis. Prospective Studies. Recombinant Proteins. Ribavirin / administration & dosage

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  • [CommentIn] Hepatology. 2001 Jan;33(1):313 [11124852.001]
  • (PMID = 10915749.001).
  • [ISSN] 0270-9139
  • [Journal-full-title] Hepatology (Baltimore, Md.)
  • [ISO-abbreviation] Hepatology
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Antiviral Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 49717AWG6K / Ribavirin; 99210-65-8 / interferon alfa-2b; EC 2.6.1.2 / Alanine Transaminase
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35. Kilickap S, Barista I, Akgul E, Aytemir K, Aksoyek S, Aksoy S, Celik I, Kes S, Tekuzman G: cTnT can be a useful marker for early detection of anthracycline cardiotoxicity. Ann Oncol; 2005 May;16(5):798-804
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  • [Title] cTnT can be a useful marker for early detection of anthracycline cardiotoxicity.
  • BACKGROUND: The level of serum cardiac troponin-T (cTnT) increases with myocardial damage.
  • We sought to assess whether cTnT level could be a useful marker for the early detection of anthracycline cardiotoxicity.
  • PATIENTS AND METHODS: Forty-one patients who had been scheduled to receive anthracycline-containing combination chemotherapy were included in the study.
  • Serum cTnT levels were measured before (baseline) and after the first cycle of chemotherapy, and again, after the last cycle of chemotherapy.
  • In all patients, the left ventricular ejection fraction (LVEF), fractional shortening (FS), early peak flow/atrial flow velocity (E/A) ratio, and the isovolemic relaxation time (IRT) were measured echocardiographically, both before and after the completion of chemotherapy.
  • In 21 patients (49%), the E/A ratio decreased after therapy as compared to the pre-treatment values.
  • The post-treatment IRT was prolonged compared with the pretreatment IRT (94.0 +/- 2.0 versus 85.6 +/- 10.5 ms, respectively).
  • cTnT levels after completion of therapy were elevated in 14 (34%) patients, and exceeded the upper limit of the normal range (>0.1 ng/ml) in only one patient. cTnT levels measured after completion of therapy were significantly higher, compared with those measured at baseline and after the first cycle of therapy.
  • In the younger age group (< or =44 years old), there was a two-fold decrease in the E/A ratio in those patients whose cTnT levels increased during the therapy, when compared with those whose cTnT levels did not change (21% versus 43%, respectively).
  • CONCLUSION: Increased serum cTnT level can be detected in the early stages of anthracycline therapy and it is associated with diastolic dysfunction of the left ventricle.
  • Therefore, serum cTnT level could be a useful measure for early detection of anthracycline-induced cardiotoxicity.

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  • [CommentIn] Ann Oncol. 2006 Jan;17(1):173; author reply 173-4 [16100231.001]
  • (PMID = 15774486.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Anthracyclines; 0 / Biomarkers; 0 / Troponin T
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36. Starczewski A, Iwanicki M: [Intrauterine therapy with levonorgestrel releasing IUD of women with hypermenorrhea secondary to uterine fibroids]. Ginekol Pol; 2000 Sep;71(9):1221-5
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  • [Title] [Intrauterine therapy with levonorgestrel releasing IUD of women with hypermenorrhea secondary to uterine fibroids].
  • [Transliterated title] Wewnatrzmaciczna terapia levonorgestrelem obfitych miesiaczek spowodowanych mieśniakami macicy--doniesienie wstepne.
  • OBJECTIVES: The aim of the study was to evaluate the effectiveness of Mirena IUD (Schering) treatment in women with severe menstrual bleedings secondary to uterine fibroids.
  • MATERIAL AND METHODS: The study comprised 12 women in the age of 30 to 43 years (average 36.4) with uterine fibroids and severe menstrual bleedings.
  • Eight patients developed anemia with hemoglobin levels below 12 g/dL.
  • Intensity of menstrual bleedings was evaluated prior and after the treatment.
  • US evaluation comprised measurements of endometrium and the fibroids.
  • After twelve weeks 3 out of 6 women with intramural fibroids developed ammenorrhea, the remaining 3 had scanty menstrual bleedings.
  • Hemoglobin levels were normal in 11 women already 6 months after the insertion of IUD.
  • Post treatment US revealed endometrium thickness of no more then 4 mm, and no change in the fibroids volume.
  • CONCLUSION: Insertion of levonorgestrel releasing Mirena IUD (Schering) reduces intensity of menstrual bleedings secondary to uterine fibroids.
  • [MeSH-major] Contraceptives, Oral, Synthetic / therapeutic use. Leiomyoma / complications. Levonorgestrel / therapeutic use. Menorrhagia / drug therapy. Menorrhagia / etiology. Uterine Neoplasms / complications
  • [MeSH-minor] Adult. Drug Administration Routes. Female. Humans. Intrauterine Devices, Medicated

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  • (PMID = 11083008.001).
  • [ISSN] 0017-0011
  • [Journal-full-title] Ginekologia polska
  • [ISO-abbreviation] Ginekol. Pol.
  • [Language] pol
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] Poland
  • [Chemical-registry-number] 0 / Contraceptives, Oral, Synthetic; 5W7SIA7YZW / Levonorgestrel
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37. Cebo C, Da Rocha S, Wittnebel S, Turhan AG, Abdelali J, Caillat-Zucman S, Bourhis JH, Chouaib S, Caignard A: The decreased susceptibility of Bcr/Abl targets to NK cell-mediated lysis in response to imatinib mesylate involves modulation of NKG2D ligands, GM1 expression, and synapse formation. J Immunol; 2006 Jan 15;176(2):864-72
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  • In the present study, using UT-7/9 cells, a high level Bcr/Abl transfectant of UT-7 cells, we show that the treatment of Bcr/Abl target by imatinib mesylate (IM), a specific Abl tyrosine kinase inhibitor, hampers the formation of the NK/target immunological synapse.
  • IM also affects cell surface glycosylation of targets, as assessed by binding of specific lectins resulting in the subsequent modulation of their binding to lectin type NK receptor, particularly NKG2D.
  • In addition, we demonstrate that the tyrosine kinase activity repression results in a decrease of MHC-related Ags-A/B and UL-16-binding protein expression on Bcr/Abl transfectants UT-7/9.
  • We show that NKG2D controls the NK-mediated lysis of UT-7/9 cells, and IM treatment inhibits this activating pathway.
  • [MeSH-minor] Antineoplastic Agents / pharmacology. Benzamides. Cell Line, Tumor. Cytotoxicity, Immunologic. Genes, abl. Histocompatibility Antigens Class I / genetics. Histocompatibility Antigens Class I / metabolism. Humans. Imatinib Mesylate. In Vitro Techniques. Leukemia, Myelogenous, Chronic, BCR-ABL Positive / drug therapy. Leukemia, Myelogenous, Chronic, BCR-ABL Positive / enzymology. Leukemia, Myelogenous, Chronic, BCR-ABL Positive / genetics. Leukemia, Myelogenous, Chronic, BCR-ABL Positive / immunology. Membrane Microdomains / drug effects. Membrane Microdomains / metabolism. NK Cell Lectin-Like Receptor Subfamily K. Receptors, Natural Killer Cell. Transfection

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  • (PMID = 16393970.001).
  • [ISSN] 0022-1767
  • [Journal-full-title] Journal of immunology (Baltimore, Md. : 1950)
  • [ISO-abbreviation] J. Immunol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzamides; 0 / Histocompatibility Antigens Class I; 0 / KLRK1 protein, human; 0 / MHC class I-related chain A; 0 / MICB antigen; 0 / NK Cell Lectin-Like Receptor Subfamily K; 0 / Piperazines; 0 / Pyrimidines; 0 / Receptors, Immunologic; 0 / Receptors, Natural Killer Cell; 37758-47-7 / G(M1) Ganglioside; 8A1O1M485B / Imatinib Mesylate; EC 2.7.10.2 / Fusion Proteins, bcr-abl
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38. Dediu M: [Controversy in the treatment of non-small cell lung cancer. Timing of chemotherapy in relation to surgery: before or after?]. Pneumologia; 2004 Jul-Sep;53(3):105-8
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  • [Title] [Controversy in the treatment of non-small cell lung cancer. Timing of chemotherapy in relation to surgery: before or after?].
  • [Transliterated title] Controverse in tratamentul cancerului pulmonar non-microcelular. Timing-ul chimioterapiei faţă de chirurgie: pre sau post-operator?
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Carcinoma, Non-Small-Cell Lung / surgery. Lung Neoplasms / drug therapy. Lung Neoplasms / surgery. Neoadjuvant Therapy
  • [MeSH-minor] Chemotherapy, Adjuvant. Humans. Randomized Controlled Trials as Topic. Time Factors


39. Vural B, Ozkan S, Ciftçi E, Bodur H, Yücesoy I: Spontaneous vaginal expulsion of an infected necrotic cervical fibroid through a cervical fistula after uterine artery embolization: a case report. J Reprod Med; 2007 Jun;52(6):563-6
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  • [Title] Spontaneous vaginal expulsion of an infected necrotic cervical fibroid through a cervical fistula after uterine artery embolization: a case report.
  • BACKGROUND: Uterine artery embolization (UAE) is promising, minimally invasive therapy being offered to women for treatment of fibroids.
  • CASE: A patient treated with UAE for a huge cervical fibroid presented with an infected, necrotic cervical mass lesion 4 weeks after the procedure.
  • Spontaneous vaginal expulsion of the infected cervical fibroid from the left lateral cervical fistula tract occurred 3 weeks later while the patient was receiving antibiotic therapy.
  • After 6 months of intervention, an approximately 99% regression rate in the fibroid volume was achieved.
  • CONCLUSION: UAE appears to be associated with a significant reduction in fibroid volume.
  • Expulsion of the infected, necrotic parts of the fibroid after UAE may be accepted as a natural process.
  • [MeSH-major] Embolization, Therapeutic / adverse effects. Fistula / etiology. Leiomyoma / therapy. Uterine Cervical Diseases / etiology. Uterine Neoplasms / therapy
  • [MeSH-minor] Adult. Anti-Bacterial Agents / therapeutic use. Cervix Uteri / pathology. Female. Humans. Necrosis / drug therapy. Uterus / blood supply. Vaginal Discharge


40. Segarra-Newnham M, Parra D, Martin-Cooper EM: Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy; 2007 Jun;27(6):845-51
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  • DESIGN: Retrospective review of a registry of patients with HCV.
  • PATIENTS: One hundred forty-six male patients who were seropositive for HCV and had received statin therapy between January 1, 1995, and September 9, 2003.
  • MEASUREMENTS AND MAIN RESULTS: Demographic and clinical data were collected for each patient; lipid and alanine aminotransferase (ALT) levels at baseline (within 6 mo of starting a statin), at 3 and 6 months after starting a statin, and at long-term follow-up (mean 22 mo) were also recorded.
  • The primary efficacy end point was a significant decrease from baseline to long-term follow-up low-density lipoprotein cholesterol (LDL) level; the primary safety end point was a significant increase from baseline in ALT level.
  • The mean change in LDL level was a reduction of 22% (p<0.01).
  • No significant increases in ALT levels were observed; only one patient discontinued therapy due to ALT level elevations greater than 3 times the upper limit of normal.
  • CONCLUSION: In men seropositive for HCV, statins were effective in reducing LDL levels and did not result in significant increases in ALT levels from baseline.
  • Thus, statin therapy should be considered for patients with HCV who are at risk for coronary heart disease and do not have significantly elevated serum transaminase levels at baseline.
  • [MeSH-major] Drug-Induced Liver Injury. Hepatitis C / complications. Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use. Hypercholesterolemia / drug therapy. Liver / drug effects
  • [MeSH-minor] Aged. Alanine Transaminase / blood. Alanine Transaminase / drug effects. Cholesterol, LDL / blood. Cholesterol, LDL / drug effects. Coronary Disease / prevention & control. Hepatitis C Antibodies / blood. Hospitals, Veterans. Humans. Liver Function Tests. Male. Middle Aged. Retrospective Studies


41. Machtinger R, Inbar Y, Ben-Baruch G, Korach J, Rabinovici J: MRgFUS for pain relief as palliative treatment in recurrent cervical carcinoma: a case report. Gynecol Oncol; 2008 Jan;108(1):241-3
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  • [Title] MRgFUS for pain relief as palliative treatment in recurrent cervical carcinoma: a case report.
  • INTRODUCTION: Focused ultrasound under real-time MR guidance and control (MRgFUS) can be used for the thermal ablation of tissue.
  • Currently this technique is used clinically for the noninvasive treatment of uterine leiomyomas and is in clinical evaluation for breast cancer, adenomyosis and other indications.
  • CASE REPORT: A 29-year-old patient with recurrent squamous cell carcinoma of cervix following radical hysterectomy, chemotherapy and radiation was treated by MRgFUS due to pelvic mass unresponsive to conventional treatment that caused intractable pain.
  • Following two treatments the patient experienced a marked reduction in pain and increase in Karnovsky Performance Status (KPS) from 50% to 80%.
  • DISCUSSION: Palliative treatment of pain with noninvasive MRgFUS in cases of recurrent cervical carcinoma may be a safe and efficient alternative to other invasive techniques.
  • [MeSH-major] Carcinoma, Squamous Cell / therapy. Cervical Intraepithelial Neoplasia / therapy. Neoplasm Recurrence, Local / therapy. Pain, Intractable / therapy. Uterine Cervical Neoplasms / therapy
  • [MeSH-minor] Adult. Female. Humans. Magnetic Resonance Imaging. Ultrasonic Therapy / methods


42. van Roon EN, Yska JP, Raemaekers J, Jansen TL, van Wanrooy M, Brouwers JR: A rapid and simple determination of A77 1726 in human serum by high-performance liquid chromatography and its application for optimization of leflunomide therapy. J Pharm Biomed Anal; 2004 Sep 21;36(1):17-22
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  • [Title] A rapid and simple determination of A77 1726 in human serum by high-performance liquid chromatography and its application for optimization of leflunomide therapy.
  • Leflunomide is a disease-modifying antirheumatic drug, which is bioactivated by formation of A77 1726.
  • In this study a rapid and simple quantitative assay using a reversed phase HPLC-UV method is validated for detection of A77 1726 in human serum.
  • A77 1726 is detected by UV-absorption at 295 nm with a retention time of 8.9 min.
  • Validation showed lower and upper limits of quantitation of 0.5 and 100 mg/L, respectively.
  • Commonly prescribed drugs to treat rheumatoid arthritis like disease-modifying antirheumatic drugs, analgesics and corticosteroids, and their main metabolites, are separated from A77 1726 with a resolution >2.
  • Serum levels of A77 1726 in 37 patients on leflunomide therapy were determined using this HPLC-UV method.
  • Measured serum A77 1726 serum concentrations in patient samples showed large variability with a range of 3-176 mg/L.
  • [MeSH-major] Aniline Compounds / blood. Antirheumatic Agents / therapeutic use. Chromatography, High Pressure Liquid / methods. Hydroxybutyrates / blood. Isoxazoles / therapeutic use
  • [MeSH-minor] Buffers. Humans. Sensitivity and Specificity. Spectrophotometry, Ultraviolet. Time Factors

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  • (PMID = 15351043.001).
  • [ISSN] 0731-7085
  • [Journal-full-title] Journal of pharmaceutical and biomedical analysis
  • [ISO-abbreviation] J Pharm Biomed Anal
  • [Language] eng
  • [Publication-type] Journal Article; Validation Studies
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Aniline Compounds; 0 / Antirheumatic Agents; 0 / Buffers; 0 / Hydroxybutyrates; 0 / Isoxazoles; 108605-62-5 / A 771726; G162GK9U4W / leflunomide
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43. Gutt B, Wowra B, Alexandrov R, Uhl E, Schaaf L, Stalla GK, Schopohl J: Gamma-knife surgery is effective in normalising plasma insulin-like growth factor I in patients with acromegaly. Exp Clin Endocrinol Diabetes; 2005 Apr;113(4):219-24
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  • OBJECTIVE: For patients in whom acromegaly persists despite pituitary surgery or drug treatment, gamma-knife surgery represents an additional treatment option.
  • Considering carefully the different reported biochemical outcomes, the central point is whether gamma-knife radiosurgery has advantages compared to conventional radiotherapy or, furthermore, to newer medical therapies, such as long-acting somatostatin analogues or growth hormone receptor antagonists.
  • The median follow-up time was 1.9 years (0.5-4.3 years) post-radiosurgery.
  • RESULTS: Immediately prior to gamma-knife surgery, median xULN of patients' serum IGF-I was 1.9 times above upper limit of normal (range: 0.5-8.9 xULN [multiple of upper limit of normal range]).
  • Furthermore, as the number of treated patients increased, we found an improvement in remission rate, which let us assume that there was a learning effect for the gamma-knife performing team over time.
  • In addition, the median adenoma size decreased from 1.5 ml (0.1-6.9 ml) prior to gamma-knife therapy to 0.3 ml (no rest vol. detectable-2.4 ml) at patients' last visit.
  • CONCLUSION: We have shown that pituitary gamma-knife surgery is effective in lowering serum IGF-I levels.
  • At the end of the follow-up period, 48 % of our cohort had normal age-adjusted IGF-I levels.
  • [MeSH-minor] Adenoma / surgery. Adult. Aged. Biomarkers / blood. Female. Follow-Up Studies. Humans. Male. Middle Aged. Pituitary Neoplasms / surgery. Reference Values. Retrospective Studies. Time Factors

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  • (PMID = 15891958.001).
  • [ISSN] 0947-7349
  • [Journal-full-title] Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association
  • [ISO-abbreviation] Exp. Clin. Endocrinol. Diabetes
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Biomarkers; 67763-96-6 / Insulin-Like Growth Factor I
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44. Sharma VK, Tsivgoulis G, Lao AY, Flaster M, Frey JL, Malkoff MD, Alexandrov AV: Thrombotic occlusion of the common carotid artery (CCA) in acute ischemic stroke treated with intravenous tissue plasminogen activator (TPA). Eur J Neurol; 2007 Feb;14(2):237-40
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  • [Title] Thrombotic occlusion of the common carotid artery (CCA) in acute ischemic stroke treated with intravenous tissue plasminogen activator (TPA).
  • Three patients with acute CCA occlusions were treated with systemic tissue plasminogen activator (TPA).
  • Blood pressures were kept at the upper limits allowed with TPA therapy with fluid balance and the 'head-down' position.
  • [MeSH-major] Brain Ischemia / etiology. Carotid Artery Thrombosis / complications. Carotid Artery Thrombosis / drug therapy. Carotid Artery, Common. Fibrinolytic Agents / therapeutic use. Stroke / etiology. Tissue Plasminogen Activator / therapeutic use
  • [MeSH-minor] Acute Disease. Aged. Aged, 80 and over. Angiography, Digital Subtraction. Cerebral Angiography. Female. Humans. Male. Nervous System / drug effects. Nervous System / physiopathology. Recovery of Function. Tomography, X-Ray Computed. Treatment Outcome. Ultrasonography, Doppler, Duplex

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  • (PMID = 17250737.001).
  • [ISSN] 1468-1331
  • [Journal-full-title] European journal of neurology
  • [ISO-abbreviation] Eur. J. Neurol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Fibrinolytic Agents; EC 3.4.21.68 / Tissue Plasminogen Activator
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45. Farrell G: Hepatitis B e antigen seroconversion: effects of lamivudine alone or in combination with interferon alpha. J Med Virol; 2000 Jul;61(3):374-9
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  • Seroconversion of hepatitis B e antigen (HBeAg) is an important marker for resolution of active hepatitis B virus (HBV) infection and for a long-term positive response to treatment.
  • Lamivudine, a nucleoside analogue, is the first effective oral treatment for chronic hepatitis B in patients with evidence of viral replication and liver disease.
  • When appropriate patient groups are compared, treatment with lamivudine for 1 year leads to HBeAg seroconversion in a similar proportion of patients as a standard course of interferon (IFN) alpha therapy.
  • Seroconversion increases during prolonged therapy (up to 3 years), and is sustained post-treatment in more than three-quarters of patients.
  • Response rates are related to the pretreatment level of serum alanine aminotransferase (ALT) and reach 65% in those patients with serum ALT > 5 x upper limit of normal (ULN) after one year.
  • Furthermore, because seroconversion after lamivudine is not normally associated with a severe flare of liver disease, as seen with IFN, it is more suitable for use in patients with active liver disease and cirrhosis.
  • In conclusion, lamivudine is more suitable than IFN for a broad range of patients, including those with severe liver disease, recurrent flares, pre-core mutant HBV and those who have failed previously IFN treatment or are immunosuppressed.
  • [MeSH-major] Antiviral Agents / therapeutic use. Hepatitis B e Antigens / immunology. Hepatitis B, Chronic / drug therapy. Interferon-alpha / therapeutic use. Lamivudine / therapeutic use
  • [MeSH-minor] Drug Therapy, Combination. Hepatitis B Antibodies / blood. Humans

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  • [Copyright] Copyright 2000 Wiley-Liss, Inc.
  • (PMID = 10861649.001).
  • [ISSN] 0146-6615
  • [Journal-full-title] Journal of medical virology
  • [ISO-abbreviation] J. Med. Virol.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Antiviral Agents; 0 / Hepatitis B Antibodies; 0 / Hepatitis B e Antigens; 0 / Interferon-alpha; 2T8Q726O95 / Lamivudine
  • [Number-of-references] 45
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46. Stevens JR, Kymissis PI, Baker AJ: Elevated prolactin levels in male youths treated with risperidone and quetiapine. J Child Adolesc Psychopharmacol; 2005 Dec;15(6):893-900
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  • [Title] Elevated prolactin levels in male youths treated with risperidone and quetiapine.
  • The aim of this study was to report on the serum prolactin levels in 70 male youths at a residential treatment center who were treated with either risperidone or quetiapine.
  • Serum prolactin levels were drawn according to a protocol, after at least 6 weeks of treatment.
  • Prolactin was above the upper limit of normal for 68% of the patients on risperidone and 20% of the patients on quetiapine (chi2 analysis: R>Q; p<0.001).
  • Both risperidone and quetiapine produced dose-related increases in serum prolactin levels (R, r=0.34, p=0.017; Q, r=0.45, p=0.05).
  • No correlation was found between duration of treatment and prolactin levels.
  • Given that hyperprolactinemia secondary to antipsychotic treatment may result in reproductive and growth irregularities, periodic long-term monitoring during treatment with these two atypical antipsychotics (and perhaps others as well) may be warranted.
  • [MeSH-minor] Adolescent. Child. Cross-Sectional Studies. Drug Therapy, Combination. Humans. Male. Quetiapine Fumarate. Residential Treatment

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  • (PMID = 16379509.001).
  • [ISSN] 1044-5463
  • [Journal-full-title] Journal of child and adolescent psychopharmacology
  • [ISO-abbreviation] J Child Adolesc Psychopharmacol
  • [Language] eng
  • [Publication-type] Case Reports; Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antipsychotic Agents; 0 / Dibenzothiazepines; 2S3PL1B6UJ / Quetiapine Fumarate; L6UH7ZF8HC / Risperidone
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47. Ishimi Y: [Prevention of osteoporosis by foods and dietary supplements. Soybean isoflavone and bone metabolism]. Clin Calcium; 2006 Oct;16(10):1661-67
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  • Recently, isoflavones have received a great deal of attention for their preventive roles against hormone dependent diseases including postmenopausal osteoporosis, hyperlipidemia and cancer.
  • On the other hand, since a kind of tablet with concentrated isoflavones has been recently applied for foods for specified health use (FOSHU), which are functional foods permitted to label a health claim by the Ministry of Health, Labor and Welfare in Japan, Food Safety Commission submitted a report the upper limit of daily isoflavone aglycon intake from FOSHU as well as from soybean products.
  • [MeSH-minor] Animals. Female. Humans. Male. Osteoporosis / drug therapy. Postmenopause

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  • (PMID = 17012819.001).
  • [ISSN] 0917-5857
  • [Journal-full-title] Clinical calcium
  • [ISO-abbreviation] Clin Calcium
  • [Language] jpn
  • [Publication-type] English Abstract; Journal Article; Review
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Isoflavones; 0 / Phytoestrogens
  • [Number-of-references] 19
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48. Fitter S, Dewar AL, Kostakis P, To LB, Hughes TP, Roberts MM, Lynch K, Vernon-Roberts B, Zannettino AC: Long-term imatinib therapy promotes bone formation in CML patients. Blood; 2008 Mar 1;111(5):2538-47
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  • [Title] Long-term imatinib therapy promotes bone formation in CML patients.
  • Imatinib inhibits tyrosine kinases important in osteoclast (c-Fms) and osteoblast (platelet-derived growth factor receptor [PDGF-R], c-Abl) function, suggesting that long-term therapy may alter bone homeostasis.
  • To investigate this question, we measured the trabecular bone volume (TBV) in iliac crest bone biopsies taken from chronic myeloid leukemia (CML) patients at diagnosis and again after 2 to 4 years of imatinib therapy.
  • Half the patients (8 of 17) showed a substantive increase in TBV (> 2-fold), after imatinib therapy, with the TBV in the posttreatment biopsy typically surpassing the normal upper limit for the patient's age group.
  • Imatinib-treated patients exhibited reduced serum calcium and phosphate levels with hypophosphatemia evident in 53% (9 of 17) of patients.
  • Using pharmacologic inhibitors, inhibition of PI3-kinase/Akt activation promoted mineral formation, suggesting a possible molecular mechanism for the imatinib-mediated increase in TBV in vivo.
  • Further investigation is required to determine whether the increase in TBV associated with imatinib therapy may represent a novel therapeutic avenue for the treatment of diseases that are characterized by generalized bone loss.
  • [MeSH-major] Antineoplastic Agents / pharmacology. Antineoplastic Agents / therapeutic use. Leukemia, Myelogenous, Chronic, BCR-ABL Positive / drug therapy. Osteogenesis / drug effects. Piperazines / pharmacology. Piperazines / therapeutic use. Pyrimidines / pharmacology. Pyrimidines / therapeutic use
  • [MeSH-minor] Adipogenesis / drug effects. Adipogenesis / genetics. Adult. Aged. Benzamides. Calcification, Physiologic / drug effects. Calcium / blood. Cell Proliferation / drug effects. Enzyme Activation / drug effects. Female. Gene Expression Regulation, Leukemic / drug effects. Humans. Imatinib Mesylate. Male. Mesenchymal Stromal Cells / drug effects. Mesenchymal Stromal Cells / pathology. Middle Aged. Organ Size / drug effects. Phosphates / blood. Platelet-Derived Growth Factor / pharmacology. Proto-Oncogene Proteins c-akt / metabolism. Proto-Oncogene Proteins c-crk / metabolism. Time Factors

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  • (PMID = 18042796.001).
  • [ISSN] 0006-4971
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzamides; 0 / Phosphates; 0 / Piperazines; 0 / Platelet-Derived Growth Factor; 0 / Proto-Oncogene Proteins c-crk; 0 / Pyrimidines; 8A1O1M485B / Imatinib Mesylate; EC 2.7.11.1 / Proto-Oncogene Proteins c-akt; SY7Q814VUP / Calcium
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49. Zhou YF, Yang DZ, Hu LN, Zheng SR: [Clinical trial on the effectiveness and safety of triptorelin in treatment of uterine leiomyoma]. Zhonghua Fu Chan Ke Za Zhi; 2005 Jul;40(7):460-3
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  • [Title] [Clinical trial on the effectiveness and safety of triptorelin in treatment of uterine leiomyoma].
  • OBJECTIVE: To evaluate the effectiveness and safety of triptorelin in the treatment of uterine leiomyoma.
  • A total of 125 qualified patients with uterine leiomyoma were randomly divided into either triptorelin group (63 cases) treated with 3.75 mg triptorelin injected intramuscularly or leuprorelin group (62 cases) treated with 3.75 mg leuprorelin injected subcutaneously.
  • Both drugs were injected every 28 days for a total of 3 months.
  • The uterine volumes were similar before treatment between the triptorelin group and the leuprorelin group and were decreased significantly after drug therapy (P < 0.01) in both groups, with a median decrease rate of 51% and 49%, respectively, without significant difference between two groups (P > 0.05).
  • The volumes of the largest leiomyoma decreased significantly after drug therapy (P < 0.01) in both groups, with a median decrease rate of 50% and 48% in the triptorelin and leuprorelin groups, respectively, without significant difference between them (P > 0.05).
  • Patients with serum level of 17beta-estradiol < 183 pmol/L accounted for 94% in both groups.
  • The hemoglobin and serum ferrum levels were both significantly increased in the two groups after treatment (P < 0.05).
  • The amenorrhea rates after 3 months of treatment were 97% in the triptorelin group and 95% in the leuprorelin group (P > 0.05).
  • Dysmenorrhea, noncyclic pelvic pain and pressure-like symptoms were relieved quickly and remarkably in both groups after treatment.
  • Nine patients in the triptorelin group and 6 in the leuprorelin group received add-back therapy with tibolone 1.25-2.50 mg/d because of remarkable climacteric-like symptoms.
  • CONCLUSION: Treatment of uterine leiomyoma with triptorelin for 3 months is both effective and safe in Chinese women.
  • [MeSH-major] Antineoplastic Agents, Hormonal / therapeutic use. Leiomyoma / drug therapy. Triptorelin Pamoate / therapeutic use. Uterine Neoplasms / drug therapy
  • [MeSH-minor] Female. Humans. Leuprolide / therapeutic use. Prospective Studies. Treatment Outcome

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  • (PMID = 16080872.001).
  • [ISSN] 0529-567X
  • [Journal-full-title] Zhonghua fu chan ke za zhi
  • [ISO-abbreviation] Zhonghua Fu Chan Ke Za Zhi
  • [Language] chi
  • [Publication-type] English Abstract; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] China
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 57773-63-4 / Triptorelin Pamoate; EFY6W0M8TG / Leuprolide
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50. Yoffe B, Bagri AS, Tran T, Dural AT, Shtenberg KM, Khaoustov VI: Hyperlipasemia associated with hepatitis C virus. Dig Dis Sci; 2003 Aug;48(8):1648-53
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  • Following the observation that several HCV patients had elevated lipase levels, this retrospective study was conducted to assess the association between hyperlipasemia and/or pancreatitis with hepatitis C infection.
  • Of 204 subjects who underwent evaluation for hepatitis C, 103 had lipase levels determined at baseline.
  • The control group consisted of 41 nonHCV subjects with a variety of gastrointestinal diseases including 18 with nonalcoholic liver disease.
  • Mean lipase levels were 253 +/- 72 units/liter (normal range 114-286 units/liter and 210 +/- 42 units/liter for the HCV and control groups, respectively (P = 0.002).
  • There was a significant association between ALT (> 1.5 times the upper limit of normal) and lipase (P = 0.02; OR = 3.0; 95% CI: 1.1-7.5).
  • Among 30 patients who received interferon-based therapy +/- ribavirin, 11 had elevated lipase at baseline.
  • Six of these patients responded to therapy and demonstrated normalization of lipase levels.
  • In contrast, all nonresponders with baseline hyperlipasemia continued to have high lipase levels (P = 0.17; OR = 4.0; 95% CI: 0.6-28.4).
  • Furthermore, only 3 of 8 (37.5%) patients with normal lipase responded to treatment as compared to 6 of 10 (60%) of hyperlipasemic patients (P = 0.36; OR = 2.5; 95% CI: 0.4-16.9).
  • In conclusion, hyperlipasemia and/or subclinical pancreatitis may represent extrahepatic manifestations of HCV infection and should not preclude treatment.
  • [MeSH-major] Hepatitis C, Chronic / diagnosis. Lipase / blood. Pancreatitis / diagnosis
  • [MeSH-minor] Adult. Antiviral Agents / therapeutic use. Drug Therapy, Combination. Female. Follow-Up Studies. Hepacivirus. Humans. Interferons / therapeutic use. Liver Function Tests. Male. Middle Aged. Retrospective Studies. Ribavirin / therapeutic use. Viral Load

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  • (PMID = 12924663.001).
  • [ISSN] 0163-2116
  • [Journal-full-title] Digestive diseases and sciences
  • [ISO-abbreviation] Dig. Dis. Sci.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antiviral Agents; 49717AWG6K / Ribavirin; 9008-11-1 / Interferons; EC 3.1.1.3 / Lipase
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51. Sakakura C, Takemura M, Miyagawa K, Fukuda K, Shimomura K, Kin S, Nakase Y, Kuriu Y, Nakashima S, Yoshikawa T, Ueda Y, Fujiyama J, Sonoyama T, Okazaki Y, Hayashizaki Y, Hagiwara A, Yamagishi H: [Utility of dopa decarboxylase as a novel marker for the detection of peritoneal micro-metastases of gastric cancer with realtime RT-PCR]. Gan To Kagaku Ryoho; 2004 Oct;31(11):1906-8
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  • [Title] [Utility of dopa decarboxylase as a novel marker for the detection of peritoneal micro-metastases of gastric cancer with realtime RT-PCR].
  • We have examined the utility of DDC as a novel marker for the detection of peritoneal micrometastases of gastric cancer.
  • DDC mRNA in the peritoneal wash from 114 gastric cancer patients was quantified for a comparison of carcinoembryonic antigen (CEA) mRNA by means of real-time RT-PCR with a fluorescently labeled probe to predict peritoneal recurrence.
  • The cut-off value was set at the upper limit of the quantitative value for non-cancer patients, and those above this cut-off value constituted the micrometastasis (MM+) group.
  • DDC levels in peritoneal washes from patients with synchronous peritoneal metastases were more than 50 times higher than in those from patients without metastasis (p<0.01).
  • For 15 cases of peritoneal dissemination (seven cases were cytologically positive), DDC was positive in 13 cases (87% sensitivity), but CEA failed to detect micrometastases in four cases (73% sensitivity), indicating that DDC is in some cases superior to CEA for the detection of peritoneal micrometastases of gastric cancer in terms of sensitivity as well as specificity, especially for poorly differentiated adenocarcinomas.
  • Combination of CEA and DDC improved the accuracy of diagnosis up to 93%.
  • These results suggest that DDC is potentially a novel marker for peritoneal dissemination of gastric cancer and that quantitative RT-PCR of DDC is reliable and efficient for the selection of patients for adjuvant intraperitoneal chemotherapy to prevent peritoneal recurrence.
  • [MeSH-major] Biomarkers, Tumor / analysis. Dopa Decarboxylase / analysis. Peritoneal Neoplasms / diagnosis. Peritoneal Neoplasms / secondary. Reverse Transcriptase Polymerase Chain Reaction / methods. Stomach Neoplasms / pathology
  • [MeSH-minor] Carcinoembryonic Antigen / analysis. Carcinoembryonic Antigen / genetics. Fluorescent Dyes. Humans. Neoplasm Seeding. RNA, Messenger / analysis. Sensitivity and Specificity. Tumor Cells, Cultured

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  • (PMID = 15553755.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Comparative Study; English Abstract; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Biomarkers, Tumor; 0 / Carcinoembryonic Antigen; 0 / Fluorescent Dyes; 0 / RNA, Messenger; EC 4.1.1.- / Dopa Decarboxylase
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52. Hurskainen R, Grenman S, Komi I, Kujansuu E, Luoto R, Orrainen M, Patja K, Penttinen J, Silventoinen S, Tapanainen J, Toivonen J: Diagnosis and treatment of menorrhagia. Acta Obstet Gynecol Scand; 2007;86(6):749-57
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  • [Title] Diagnosis and treatment of menorrhagia.
  • Half of all women who consult for hypermenorrhea have some uterine abnormality, most often fibroids (among patients under 40 years of age) and endometrial polyps (above 40 years of age).
  • Appropriate treatment considerably improves the quality of life of these patients, and it is important to make a rigorous assessment of the patient to provide the best treatment options.
  • Vaginal sonography combined with an endometrial biopsy is a reliable method for diagnosing endometrial hyperplasia or carcinoma, but it is insufficient for diagnosing endometrial polyps and fibroids; these can be diagnosed more reliably by sonohysterography or hysteroscopy.
  • Non-steroidal anti-inflammatory drugs and tranexamic acid reduce menstrual blood loss by 20-60%, and the effectiveness of a hormonal intrauterine system (IUS) is comparable with that of endometrial ablation or hysterectomy.
  • Treatment should be started with one of the drug therapies, i.e. the IUS, tranexamic acid, anti-inflammatory drugs, or oral contraceptive.
  • Drug treatment should be used and evaluated before surgical interventions are considered.
  • With an effective training and feedback system, it is possible to organise the diagnostics, medical treatment and follow-up of heavy menstrual bleeding in the primary health care setting or in outpatient clinics, which reduces the burden on specialist health care.
  • [MeSH-major] Menorrhagia / diagnosis. Menorrhagia / therapy

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  • (PMID = 17520411.001).
  • [ISSN] 0001-6349
  • [Journal-full-title] Acta obstetricia et gynecologica Scandinavica
  • [ISO-abbreviation] Acta Obstet Gynecol Scand
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Denmark
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53. Bjørge L, Iversen OE: [Mifepristone--a controversial drug with great potential]. Tidsskr Nor Laegeforen; 2001 Nov 20;121(28):3286-91
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  • [Title] [Mifepristone--a controversial drug with great potential].
  • BACKGROUND: Antiprogestins, agents that inhibit the action of progesterone, are among the most controversial and yet the more interesting therapeutic compounds developed over the past 20 years.
  • MATERIAL AND METHODS: We present a review of the literature identified through limited searches on Medline, Cochrane and the Internet, with a discussion of the biological, clinical, political and ethical aspects of this important drug.
  • It may also be used as a contraceptive and delivery-inducing agent and in the treatment of spontaneous abortion, ectopic pregnancies, leiomyoma, endometriosis, intrauterine fetal death, Cushing's syndrome and progesterone-dependent malignancies.
  • [MeSH-minor] Female. Genital Diseases, Female / drug therapy. History, 20th Century. Humans. Labor, Induced. Neoplasms / drug therapy. Pregnancy. Pregnancy Complications / drug therapy. Receptors, Progesterone / drug effects

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  • (PMID = 11826459.001).
  • [ISSN] 0029-2001
  • [Journal-full-title] Tidsskrift for den Norske lægeforening : tidsskrift for praktisk medicin, ny række
  • [ISO-abbreviation] Tidsskr. Nor. Laegeforen.
  • [Language] nor
  • [Publication-type] English Abstract; Historical Article; Journal Article; Review
  • [Publication-country] Norway
  • [Chemical-registry-number] 0 / Abortifacient Agents, Steroidal; 0 / Contraceptives, Oral, Synthetic; 0 / Hormone Antagonists; 0 / Receptors, Progesterone; 320T6RNW1F / Mifepristone
  • [Number-of-references] 92
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54. El-Kamary SS, Shardell MD, Abdel-Hamid M, Ismail S, El-Ateek M, Metwally M, Mikhail N, Hashem M, Mousa A, Aboul-Fotouh A, El-Kassas M, Esmat G, Strickland GT: A randomized controlled trial to assess the safety and efficacy of silymarin on symptoms, signs and biomarkers of acute hepatitis. Phytomedicine; 2009 May;16(5):391-400
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  • METHODS: This is a randomized, placebo-controlled trial in which participants, treating physicians and data management staff were blinded to treatment group.
  • The study was conducted at two fever hospitals in Tanta and Banha, Egypt where patients with symptoms compatible with acute clinical hepatitis and serum alanine aminotransferase (ALT) levels >2.5 times the upper limit of normal were enrolled.
  • The intervention consisted of three times daily ingestion of either a standard recommended dose of 140 mg of silymarin (Legalon, MADAUS GmbH, Cologne, Germany), or a vitamin placebo for four weeks with an additional four-week follow-up.
  • Despite a modest sample size and multiple etiologies for acute clinical hepatitis, our results suggest that standard recommended doses of silymarin are safe and may be potentially effective in improving symptoms of acute clinical hepatitis despite lack of a detectable effect on biomarkers of the underlying hepatocellular inflammatory process.
  • [MeSH-major] Hepatitis, Viral, Human / drug therapy. Liver / drug effects. Milk Thistle. Phytotherapy. Plant Extracts / therapeutic use. Silymarin / therapeutic use
  • [MeSH-minor] Adolescent. Adult. Alanine Transaminase / blood. Aspartate Aminotransferases / blood. Bilirubin / blood. Biomarkers / blood. Biomarkers / urine. Double-Blind Method. Egypt. Female. Humans. Jaundice / drug therapy. Male. Sclera. Seeds. Urine / chemistry. Young Adult

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  • (PMID = 19303273.001).
  • [ISSN] 1618-095X
  • [Journal-full-title] Phytomedicine : international journal of phytotherapy and phytopharmacology
  • [ISO-abbreviation] Phytomedicine
  • [Language] eng
  • [Grant] United States / NIAID NIH HHS / AI / U01 AI058372-04; United Kingdom / Wellcome Trust / / 059113/z/99/z; United Kingdom / Wellcome Trust / / 059113/z/99/a; United States / NIAID NIH HHS / AI / U01AI058372; United States / NIAID NIH HHS / AI / U01 AI058372; United States / NIAID NIH HHS / AI / U01 AI058372-05
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Biomarkers; 0 / Plant Extracts; 0 / Silymarin; EC 2.6.1.1 / Aspartate Aminotransferases; EC 2.6.1.2 / Alanine Transaminase; RFM9X3LJ49 / Bilirubin
  • [Other-IDs] NLM/ NIHMS95436; NLM/ PMC2733865
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56. den Brinker M, Wit FW, Wertheim-van Dillen PM, Jurriaans S, Weel J, van Leeuwen R, Pakker NG, Reiss P, Danner SA, Weverling GJ, Lange JM: Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection. AIDS; 2000 Dec 22;14(18):2895-902
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  • [Title] Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection.
  • OBJECTIVE: To investigate the risk of hepatotoxicity after initiation of protease inhibitor-containing highly active antiretroviral therapy (HAART) for HIV-1 infected patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) co-infection.
  • METHODS: Liver enzyme elevation (LEE) was defined as alanine aminotransferase or aspartate aminotransferase at least five times the upper limit of normal and an absolute increase of > 100 U/l.
  • Relative risks for time to LEE were estimated using Cox proportional hazards models.
  • Of patients with chronic HBV infection 38% lost HBeAg or developed anti-HBe after initiation of HAART, and one seroconverted from HBsAg-positive to anti-HBs-positive.
  • CONCLUSIONS: HIV-1-infected patients co-infected with HBV or HCV were at considerably higher risk of developing LEE when HAART was initiated compared with patients without co-infection, but it is usually not necessary to modify antiretroviral therapy.
  • [MeSH-major] Anti-HIV Agents / adverse effects. Drug-Induced Liver Injury / etiology. HIV Infections / complications. HIV Infections / drug therapy. Reverse Transcriptase Inhibitors / adverse effects
  • [MeSH-minor] Adult. Alanine Transaminase / blood. Aspartate Aminotransferases / blood. Drug Therapy, Combination. Female. HIV-1. Hepatitis B, Chronic / complications. Hepatitis C / complications. Humans. Liver Function Tests. Male


57. Jungmann E: Prevention and treatment of diabetic nephropathy in older patients. Drugs Aging; 2003;20(6):419-35
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  • [Title] Prevention and treatment of diabetic nephropathy in older patients.
  • Therefore, prevention and treatment of diabetic nephropathy has become a prominent goal in the treatment of patients with diabetes mellitus.
  • Preventive treatment should begin no later than at the stage of microalbuminuria, and regular screening for microalbuminuria is recommended for all patients with diabetes, irrespective of age.
  • Target glycosylated haemoglobin levels should be below 7%, or 1% above the upper limit of normal of non-diabetic subjects.
  • The use of an intensified treatment regimen is recommended.
  • Insulin therapy has no adverse effects on renal indexes.
  • Treatment with ACE inhibitors or angiotensin II receptor antagonists (angiotensin II receptor blockers;.
  • ARBs) is superior to other pharmacological therapy, and should be initiated as first-line treatment.
  • Non-dihydropyridine derivatives and calcium channel antagonists, such as nitrendipine, may be nephroprotective and have favourable effects on patients outcomes.
  • However, as add-on treatment to ACE inhibitors or ARBs, they are particularly beneficial in nephropathic patients at risk of cardiovascular disease or with arrhythmias, in whom they may prove life-saving.
  • [MeSH-major] Diabetic Nephropathies / prevention & control. Diabetic Nephropathies / therapy
  • [MeSH-minor] Aged. Albuminuria / prevention & control. Antihypertensive Agents / therapeutic use. Aspirin / therapeutic use. Blood Glucose / metabolism. Clinical Trials as Topic. Humans. Hypertension / drug therapy. Hypolipidemic Agents / therapeutic use. Obesity / therapy

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  • (PMID = 12710862.001).
  • [ISSN] 1170-229X
  • [Journal-full-title] Drugs & aging
  • [ISO-abbreviation] Drugs Aging
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Antihypertensive Agents; 0 / Blood Glucose; 0 / Hypolipidemic Agents; R16CO5Y76E / Aspirin
  • [Number-of-references] 74
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58. Jillella AP, Helman SW, Larison J, Litaker MS, Cook LO: High-dose chemotherapy followed by reinfusion of a high number of CD34+ progenitor cells is frequently associated with development of fever in the postengraftment period. J Hematother Stem Cell Res; 2000 Dec;9(6):849-54
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  • [Title] High-dose chemotherapy followed by reinfusion of a high number of CD34+ progenitor cells is frequently associated with development of fever in the postengraftment period.
  • Twenty-nine patients received high-dose chemotherapy and autologous stem cell transplantation from June 1997 to December 1998.
  • Twelve patients developed a fever in the immediate postengraftment period.
  • In our series of 29 patients, 9 of the 11 (82%) patients who received > 20 x 10(6) CD34+ cells/kg developed fever in the postengraftment period.
  • Even though they engrafted promptly (7 to 9 days), the fever required evaluation for infection, blood cultures, antibiotic treatment, and observation.
  • Should there be an upper limit in the number of reinfused CD34+ cells is a question that has to be addressed and possibly studied.
  • [MeSH-major] Antigens, CD34 / blood. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Fever / etiology. Hematopoietic Stem Cell Transplantation / adverse effects
  • [MeSH-minor] Adult. Age Factors. Aged. Breast Neoplasms / complications. Breast Neoplasms / therapy. Female. Graft vs Host Disease / etiology. Granulocyte Colony-Stimulating Factor / therapeutic use. Hematopoietic Stem Cells / immunology. Humans. Middle Aged. Neoplasms / complications. Neoplasms / therapy. Odds Ratio. Retrospective Studies. Sex Factors. Transplantation, Autologous

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  • (PMID = 11177596.001).
  • [ISSN] 1525-8165
  • [Journal-full-title] Journal of hematotherapy & stem cell research
  • [ISO-abbreviation] J. Hematother. Stem Cell Res.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antigens, CD34; 143011-72-7 / Granulocyte Colony-Stimulating Factor
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59. Tseng TC, Liu CJ, Wang CC, Chen PJ, Lai MY, Chen DS, Kao JH: Association of baseline viral factors with response to lamivudine therapy in chronic hepatitis B patients with high serum alanine aminotransferase levels. Antivir Ther; 2009;14(2):203-10
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  • [Title] Association of baseline viral factors with response to lamivudine therapy in chronic hepatitis B patients with high serum alanine aminotransferase levels.
  • BACKGROUND: With the exception of alanine aminotransferase (ALT) level, baseline factors predictive of therapeutic response to lamivudine in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) remain unknown.
  • We thus studied the influence of pre-therapy viral factors on end-of-treatment responses to lamivudine.
  • METHODS: A total of 116 treatment-naive HBeAg-positive CHB patients who had pre-therapy ALT level >5x the upper limit of normal (ULN) and received lamivudine for 12-18 months were enrolled.
  • HBeAg seroclearance and combined HBeAg seroclearance, ALT normalization and undetectable hepatitis B virus DNA at the end of therapy were defined as primary and secondary endpoints, respectively.
  • Pre-therapy viral factors including viral load, genotype, precore (PC) stop codon status, basal core promoter status and pre-S deletion were determined to correlate with therapeutic endpoints.
  • After the end of 12-18 months of lamivudine therapy, the overall HBeAg seroclearance rate was 56.0%.
  • CONCLUSIONS: For lamivudine-treated HBeAg-positive CHB patients with pre-therapy ALT levels >5xULN, the PC stop codon mutation could predict a higher HBeAg seroclearance rate at the end of 12-18 months of therapy.
  • [MeSH-major] Alanine Transaminase / blood. Hepatitis B, Chronic. Lamivudine / therapeutic use
  • [MeSH-minor] Adolescent. Adult. Aged. Codon, Nonsense. DNA, Viral / blood. DNA, Viral / genetics. Drug Resistance, Viral. Female. Hepatitis B e Antigens / blood. Hepatitis B virus / genetics. Hepatitis B virus / immunology. Humans. Male. Middle Aged. Predictive Value of Tests. Reverse Transcriptase Inhibitors / therapeutic use. Viral Load

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  • (PMID = 19430095.001).
  • [ISSN] 1359-6535
  • [Journal-full-title] Antiviral therapy
  • [ISO-abbreviation] Antivir. Ther. (Lond.)
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Codon, Nonsense; 0 / DNA, Viral; 0 / Hepatitis B e Antigens; 0 / Reverse Transcriptase Inhibitors; 2T8Q726O95 / Lamivudine; EC 2.6.1.2 / Alanine Transaminase
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60. Faderl S, Wierda W, O'Brien S, Ferrajoli A, Lerner S, Keating MJ: Fludarabine, cyclophosphamide, mitoxantrone plus rituximab (FCM-R) in frontline CLL &lt;70 Years. Leuk Res; 2010 Mar;34(3):284-8
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  • Randomized trials demonstrated the superiority of chemoimmunotherapy over chemotherapy in the frontline treatment of CLL.
  • Thirty patients with previously untreated, symptomatic CLL, <70 years, and beta-2-microglobulin <twice upper limit of normal were evaluated.
  • Treatment consisted of F 25mg/m(2)/day on days 2-4, C 250 mg/m(2)/day on days 2-4, M 6 mg/m(2) on day 2, and R 375 mg/m(2) on day 1.
  • With a median follow up of 38.5 months, the median time to treatment failure (TTF) has not been reached.
  • A comparison with a historical group of FCR-treated patients showed no significant differences with respect to response and toxicities.
  • FCM-R is highly active in patients < 70 years with favorable beta-2-microglobulin levels and previously untreated CLL.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal / adverse effects. Antibodies, Monoclonal, Murine-Derived. Cell Separation. Cyclophosphamide / administration & dosage. Cyclophosphamide / adverse effects. Female. Flow Cytometry. Humans. Male. Middle Aged. Mitoxantrone / administration & dosage. Mitoxantrone / adverse effects. Pilot Projects. Remission Induction. Rituximab. Treatment Outcome. Vidarabine / administration & dosage. Vidarabine / adverse effects. Vidarabine / analogs & derivatives. beta 2-Microglobulin / blood

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  • [Copyright] Copyright (c) 2009 Elsevier Ltd. All rights reserved.
  • [CommentIn] Leuk Res. 2010 Mar;34(3):272-5 [19682742.001]
  • (PMID = 19646755.001).
  • [ISSN] 1873-5835
  • [Journal-full-title] Leukemia research
  • [ISO-abbreviation] Leuk. Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / P30 CA016672
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / beta 2-Microglobulin; 4F4X42SYQ6 / Rituximab; 8N3DW7272P / Cyclophosphamide; BZ114NVM5P / Mitoxantrone; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
  • [Other-IDs] NLM/ NIHMS675210; NLM/ PMC4845644
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61. Perrillo RP, Jacobson IM: Halting the natural history of hepatitis B viral infection: a paradigm shift. Semin Liver Dis; 2007 Aug;27 Suppl 1:3-8
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  • The 2007 American Association for the Study of Liver Diseases (AASLD) practice guidelines for managing chronic hepatitis B virus (HBV) infection recommend pharmacologic therapy for patients with alanine aminotransferase (ALT) activity higher than 2 times the upper limit of normal and serum HBV DNA concentration higher than 20,000 IU/mL.
  • Findings reported over the past several years, however, indicate that HBV infection associated with ALT activity and serum HBV DNA concentrations below these treatment thresholds can progress to serious liver disease, such as cirrhosis or hepatocellular carcinoma.
  • These findings suggest that these treatment thresholds may be too conservative.
  • Moreover, emerging data suggest that, in some patient populations, the appropriate goal of therapy may be sustained suppression of HBV DNA with maintenance antiviral therapy.
  • [MeSH-major] Alanine Transaminase / blood. Antiviral Agents / therapeutic use. DNA, Viral / blood. Hepatitis B virus. Hepatitis B, Chronic / drug therapy. Hepatitis B, Chronic / metabolism

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  • (PMID = 17701844.001).
  • [ISSN] 0272-8087
  • [Journal-full-title] Seminars in liver disease
  • [ISO-abbreviation] Semin. Liver Dis.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antiviral Agents; 0 / DNA, Viral; EC 2.6.1.2 / Alanine Transaminase
  • [Number-of-references] 34
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62. Ho CC, Chen YC, Hu FC, Yu CJ, Yang PC, Luh KT: Safety of fluoroquinolone use in patients with hepatotoxicity induced by anti-tuberculosis regimens. Clin Infect Dis; 2009 Jun 1;48(11):1526-33
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  • BACKGROUND: Fluoroquinolones are frequently used to replace agents in first-line anti-tuberculosis (anti-TB) regimens in patients with TB who have drug-induced hepatic dysfunction.
  • We investigated the safety of using fluoroquinolone in an area where TB is endemic and where there is a high incidence of drug-induced liver injury.
  • METHODS: From September 2003 through August 2006, patients who had aspartate aminotransferase and/or alanine aminotransferase levels >3 times the upper limit of normal in the presence of hepatitis symptoms or who had aspartate aminotransferase and/or alanine aminotransferase levels >5 times the upper limit of normal after receipt of anti-TB treatment were enrolled.
  • The outcome measurement was the time from onset of hepatitis to normalization of liver functions.
  • RESULTS: One hundred thirty-four (11.3%) of 1191 patients received a diagnosis of hepatotoxicity and needed to stop anti-TB treatment.
  • The risk factor was abnormal baseline transaminase levels.
  • Twenty-two of the 134 patients received the control medication, 40 received levofloxacin, and 45 received moxifloxacin; the remaining patients were excluded from the study.
  • Time to liver function normalization was almost the same for all groups (mean +/- standard deviation, 29.1+/-21.4, 25.5+/-17.6, and 29.7+/-14.3 days, respectively).
  • CONCLUSIONS: Abnormal baseline transaminase levels are the independent risk factors for anti-TB therapy-induced hepatitis.
  • Levofloxacin and moxifloxacin caused no additional hepatotoxicity when they were used by patients with hepatitis induced by first-line anti-TB drugs.
  • [MeSH-major] Anti-Bacterial Agents / adverse effects. Antitubercular Agents / adverse effects. Fluoroquinolones / adverse effects. Hepatic Insufficiency / chemically induced. Tuberculosis / complications. Tuberculosis / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Alanine Transaminase / blood. Aspartate Aminotransferases / blood. Aza Compounds / adverse effects. Aza Compounds / therapeutic use. Ethambutol / adverse effects. Ethambutol / therapeutic use. Female. Humans. Levofloxacin. Male. Middle Aged. Ofloxacin / adverse effects. Ofloxacin / therapeutic use. Quinolines / adverse effects. Quinolines / therapeutic use. Streptomycin / adverse effects. Streptomycin / therapeutic use. Treatment Outcome. Young Adult

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  • (PMID = 19400686.001).
  • [ISSN] 1537-6591
  • [Journal-full-title] Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • [ISO-abbreviation] Clin. Infect. Dis.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anti-Bacterial Agents; 0 / Antitubercular Agents; 0 / Aza Compounds; 0 / Fluoroquinolones; 0 / Quinolines; 6GNT3Y5LMF / Levofloxacin; 8G167061QZ / Ethambutol; A4P49JAZ9H / Ofloxacin; EC 2.6.1.1 / Aspartate Aminotransferases; EC 2.6.1.2 / Alanine Transaminase; U188XYD42P / moxifloxacin; Y45QSO73OB / Streptomycin
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63. Morant R, Hsu Schmitz SF, Bernhard J, Thürlimann B, Borner M, Wernli M, Egli F, Forrer P, Streit A, Jacky E, Hanselmann S, Bauer J, Hering F, Schmid HP: Vinorelbine in androgen-independent metastatic prostatic carcinoma--a phase II study. Eur J Cancer; 2002 Aug;38(12):1626-32
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  • The purpose of this study was to evaluate the efficacy of vinorelbine treatment in terms of prostate-specific antigen (PSA) response and clinical benefit (decrease of pain or analgesic score for the subgroup of patients with pain), as well as its toxicity in patients with progressive metastatic androgen-independent prostatic carcinoma.
  • 44 patients with prostatic carcinoma progressing after orchiectomy or during treatment with hormonal agents were treated with vinorelbine at a dose of 30 mg/m(2) intravenously (i.v.) on days 1 and 8 of a 21-day cycle.
  • Inclusion criteria were metastatic progressive prostatic carcinoma with prostate-specific antigen (PSA) serum levels >/=3 x upper limit of normal, World Health Organization (WHO) performance status </=2, age <85 years and adequate bone marrow, liver and renal functions.
  • Treatment was continued until progression or a maximum of 12 cycles.
  • Treatment was delayed for a week if haematological toxicity grade >/=2 was observed on the day of scheduled vinorelbine administration.
  • Treatment at day 1 had to be delayed in 13.7% of 183 cycles.
  • Treatment at day 8 had to be omitted in 19.7% of all cycles.
  • In 7 patients (15.9%, Confidence Interval (CI) 6.6-30.1%), a PSA response (>/=50% reduction of PSA levels) was observed.
  • Median time to PSA progression in 43 assessable patients was 11.9 weeks (range 3-52 weeks).
  • Vinorelbine is a fairly well tolerated drug with a moderate single agent activity in patients with androgen-refractory prostate cancer.
  • [MeSH-major] Antineoplastic Agents, Phytogenic / therapeutic use. Prostatic Neoplasms / drug therapy. Vinblastine / analogs & derivatives. Vinblastine / therapeutic use
  • [MeSH-minor] Aged. Aged, 80 and over. Disease Progression. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Metastasis / drug therapy. Prostate-Specific Antigen / blood. Survival Analysis. Treatment Outcome

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  • (PMID = 12142053.001).
  • [ISSN] 0959-8049
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Phytogenic; 5V9KLZ54CY / Vinblastine; EC 3.4.21.77 / Prostate-Specific Antigen; Q6C979R91Y / vinorelbine
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64. Raal FJ, Santos RD, Blom DJ, Marais AD, Charng MJ, Cromwell WC, Lachmann RH, Gaudet D, Tan JL, Chasan-Taber S, Tribble DL, Flaim JD, Crooke ST: Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet; 2010 Mar 20;375(9719):998-1006
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  • BACKGROUND: Homozygous familial hypercholesterolaemia is a rare genetic disorder in which both LDL-receptor alleles are defective, resulting in very high concentrations of LDL cholesterol in plasma and premature coronary artery disease.
  • Patients aged 12 years and older with clinical diagnosis or genetic confirmation of homozygous familial hypercholesterolaemia, who were already receiving the maximum tolerated dose of a lipid-lowering drug, were randomly assigned to mipomersen 200 mg subcutaneously every week or placebo for 26 weeks.
  • Randomisation was computer generated and stratified by weight (<50 kg vs >/=50 kg) in a centralised blocked randomisation, implemented with a computerised interactive voice response system.
  • All clinical, medical, and pharmacy personnel, and patients were masked to treatment allocation.
  • 45 patients completed the 26-week treatment period (28 mipomersen, 17 placebo).
  • Four (12%) patients in the mipomersen group but none in the placebo group had increases in concentrations of alanine aminotransferase of three times or more the upper limit of normal.
  • INTERPRETATION: Inhibition of apolipoprotein B synthesis by mipomersen represents a novel, effective therapy to reduce LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia who are already receiving lipid-lowering drugs, including high-dose statins.
  • [MeSH-major] Anticholesteremic Agents / therapeutic use. Cholesterol, LDL / blood. Hyperlipoproteinemia Type II / drug therapy. Oligonucleotides / therapeutic use. Oligonucleotides, Antisense / therapeutic use

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  • [Copyright] Copyright 2010 Elsevier Ltd. All rights reserved.
  • [CommentIn] Lancet. 2010 Mar 20;375(9719):959-61 [20227757.001]
  • [CommentIn] Lancet. 2013 Apr 6;381(9873):1182 [23561997.001]
  • (PMID = 20227758.001).
  • [ISSN] 1474-547X
  • [Journal-full-title] Lancet (London, England)
  • [ISO-abbreviation] Lancet
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00607373
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Anticholesteremic Agents; 0 / Apolipoprotein B-100; 0 / Cholesterol, LDL; 0 / Lipids; 0 / Oligonucleotides; 0 / Oligonucleotides, Antisense; 9GJ8S4GU0M / mipomersen; EC 2.6.1.2 / Alanine Transaminase
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65. Sokal E: Drug treatment of pediatric chronic hepatitis B. Paediatr Drugs; 2002;4(6):361-9
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  • [Title] Drug treatment of pediatric chronic hepatitis B.
  • As in adults, treatments in children accelerate the virological response (DNA negativity and HBeAg loss, with anti-HBe seroconversion), which is associated with normalization of transaminase levels.
  • Treatments also favor subsequent loss of hepatitis B surface antigen (HbsAg), the ultimate goal for minimizing long-term consequences.
  • Interferon-alpha was the first approved treatment for pediatric chronic hepatitis B, and was shown to promote DNA negativity and HBeAg loss in 26% of treated patients (6 MU/m(2) body surface area for 6 months) at 1 year and 33% at 18 months (versus 11% in controls).
  • Adverse effects mainly included fever, flu-like symptoms and growth impairment during the treatment phase.
  • Nucleotide analogs have now emerged as promising alternatives for the treatment of chronic hepatitis B.
  • Efficacy trials showed complete virological response (HBeAg loss and DNA negativity) in 23% of all treated patients after 1 year, and in 34% of patients with initial transaminase levels >2 x the upper limit of normal.
  • Finally, therapeutic vaccines aiming to induce a cellular immune response towards hepatitis B antigens are being tested in adults, but no clinical benefit has so far been established.
  • [MeSH-major] Hepatitis B, Chronic / drug therapy
  • [MeSH-minor] Antiviral Agents / administration & dosage. Antiviral Agents / therapeutic use. Child. Clinical Trials as Topic. Drug Resistance, Viral. Drug Therapy, Combination. Female. Hepatitis B Vaccines / administration & dosage. Hepatitis B Vaccines / therapeutic use. Humans. Interferon-alpha / administration & dosage. Interferon-alpha / therapeutic use. Lamivudine / administration & dosage. Lamivudine / therapeutic use. Male. Pediatrics

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  • (PMID = 12038872.001).
  • [ISSN] 1174-5878
  • [Journal-full-title] Paediatric drugs
  • [ISO-abbreviation] Paediatr Drugs
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Antiviral Agents; 0 / Hepatitis B Vaccines; 0 / Interferon-alpha; 2T8Q726O95 / Lamivudine
  • [Number-of-references] 55
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66. Moerenhout CM, Claeys MJ, Haine S, Miljoen H, Bosmans JM, Vertessen F, Kluppels K, Van der Planken M, Vrints CJ: Clinical relevance of clopidogrel unresponsiveness during elective coronary stenting: experience with the point-of-care platelet function assay-100 C/ADP. Am Heart J; 2010 Mar;159(3):434-8
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  • All patients received dual antiplatelet therapy with 160 mg aspirin and a 300 mg loading dose of clopidogrel >12 hours before PCI.
  • A platelet aggregation test was performed at the time of the intervention using a point-of-care assay, the Platelet Function Assay (PFA-100C/ADP; Dade-Behring, Deerfield, IL).
  • Nonresponders were defined as having a PFA closure time of <71 seconds under dual oral antiplatelet therapy, reflecting normal platelet reactivity.
  • Myonecrosis post-PCI constituted the primary end point and was defined as the release of creatine kinase-MB >1x the upper limit of normal on a sample taken 12 to 24 hours after intervention.
  • RESULTS: The PFA closure time was available in 242 patients and ranged from 31 to 300 seconds with a mean value of 147 seconds.
  • [MeSH-major] Coronary Vessels. Drug Resistance. Platelet Aggregation Inhibitors / administration & dosage. Platelet Function Tests. Point-of-Care Systems. Stents / adverse effects. Thrombosis / etiology. Ticlopidine / analogs & derivatives
  • [MeSH-minor] Administration, Oral. Aged. Angioplasty, Balloon, Coronary / adverse effects. Aspirin / administration & dosage. Death, Sudden, Cardiac / etiology. Drug Therapy, Combination. Humans. Myocardial Infarction / etiology. Predictive Value of Tests. Preoperative Care. Prospective Studies. Risk Factors. Time Factors

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  • (PMID = 20211306.001).
  • [ISSN] 1097-6744
  • [Journal-full-title] American heart journal
  • [ISO-abbreviation] Am. Heart J.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Platelet Aggregation Inhibitors; A74586SNO7 / clopidogrel; OM90ZUW7M1 / Ticlopidine; R16CO5Y76E / Aspirin
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67. Dong JF, Cruz MA, Aboulfatova K, Martin C, Choi H, Bergeron AL, Martini SR, Kroll MH, Kent TA: Magnesium maintains endothelial integrity, up-regulates proteolysis of ultra-large von Willebrand factor, and reduces platelet aggregation under flow conditions. Thromb Haemost; 2008 Mar;99(3):586-93
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  • [Title] Magnesium maintains endothelial integrity, up-regulates proteolysis of ultra-large von Willebrand factor, and reduces platelet aggregation under flow conditions.
  • We investigated the roles of MgSO(4) in regulating the release and cleavage of the prothrombotic ultra-large (UL) von Willebrand factor (VWF) and VWF-mediated platelet adhesion and aggregation.
  • Release and cleavage of ULVWF by ADAMTS-13 was measured in the absence or presence of physiological or therapeutic levels of MgSO(4).
  • Maintenance of endothelial integrity required physiological levels of MgSO(4), but exogenous MgSO(4) showed no additional benefits.
  • These results provide a new insight into additional mechanisms involved with magnesium therapy.
  • [MeSH-major] ADAM Proteins / metabolism. Blood Platelets / drug effects. Endothelial Cells / drug effects. Fibrinolytic Agents / pharmacology. Magnesium Sulfate / pharmacology. Platelet Adhesiveness / drug effects. Platelet Aggregation / drug effects. von Willebrand Factor / metabolism
  • [MeSH-minor] Cell Culture Techniques. Cell Shape / drug effects. Cells, Cultured. Dose-Response Relationship, Drug. Hemorheology. Humans. Magnesium / metabolism. Stress, Mechanical. Time Factors

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  • (PMID = 18327408.001).
  • [ISSN] 0340-6245
  • [Journal-full-title] Thrombosis and haemostasis
  • [ISO-abbreviation] Thromb. Haemost.
  • [Language] eng
  • [Grant] United States / NICHD NIH HHS / HD / HD39833; United States / NHLBI NIH HHS / HL / HL71895; United States / NHLBI NIH HHS / HL / HL72886
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Fibrinolytic Agents; 0 / von Willebrand Factor; 7487-88-9 / Magnesium Sulfate; EC 3.4.24.- / ADAM Proteins; EC 3.4.24.- / ADAMTS13 protein, human; I38ZP9992A / Magnesium
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68. Abaci A, Yilmaz Y, Caliskan M, Bayram F, Cetin M, Unal A, Cetin S: Effect of increasing doses of aspirin on platelet function as measured by PFA-100 in patients with diabetes. Thromb Res; 2005;116(6):465-70
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  • METHODS: We have included one hundred and two patients with type 2 diabetes mellitus.
  • Platelet function was measured as closure time (CT) with the Platelet Function Analyzer (PFA)-100 before the administration of aspirin.
  • If the CT exceeded the upper limit of 300 s, the study was terminated.
  • If not, the patients continued the aspirin therapy with a dose of 300 mg daily for another seven days, and the CTs were measured again.
  • The PFA-100 closure time may be used to separate those patients who require a higher dose of aspirin to achieve desired antiplatelet effect.
  • [MeSH-major] Aspirin / administration & dosage. Blood Coagulation Tests / methods. Diabetes Mellitus, Type 2 / drug therapy. Platelet Aggregation Inhibitors / pharmacology
  • [MeSH-minor] Adult. Dose-Response Relationship, Drug. Drug Resistance. Female. Humans. Male. Middle Aged. Platelet Aggregation / drug effects. Platelet Function Tests. Time Factors


69. Narciso-Schiavon JL, Freire FC, Suarez MM, Ferrari MV, Scanhola GQ, Schiavon Lde L, de Carvalho Filho RJ, Ferraz ML, Silva AE: Antinuclear antibody positivity in patients with chronic hepatitis C: clinically relevant or an epiphenomenon? Eur J Gastroenterol Hepatol; 2009 Apr;21(4):440-6
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  • AIM: To assess the association of ANA positivity with clinical and histological features, and with the outcome of antiviral therapy in patients with HCV infection.
  • These patients showed significantly higher median alanine aminotransferase level (3.52 vs. 2.39 x upper limit of normal, P=0.009) when compared with ANA-negative patients.
  • Alanine aminotransferase flares (> or =1.5-fold the baseline) during treatment were observed in 28 patients (12%), irrespective of the presence of ANA and without any clinical significance.
  • It neither influences clinical, biochemical, and histological features of chronic hepatitis C nor predicts response to antiviral treatment.
  • [MeSH-minor] Adult. Alanine Transaminase / blood. Antiviral Agents / therapeutic use. Biomarkers / blood. Cross-Sectional Studies. Drug Therapy, Combination. Female. Fluorescent Antibody Technique, Indirect / methods. Humans. Interferon-alpha / therapeutic use. Male. Middle Aged. Ribavirin / therapeutic use. Treatment Failure. Treatment Outcome

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  • (PMID = 19382301.001).
  • [ISSN] 1473-5687
  • [Journal-full-title] European journal of gastroenterology & hepatology
  • [ISO-abbreviation] Eur J Gastroenterol Hepatol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Antinuclear; 0 / Antiviral Agents; 0 / Biomarkers; 0 / Interferon-alpha; 49717AWG6K / Ribavirin; EC 2.6.1.2 / Alanine Transaminase
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70. Yazaki H, Goto N, Uchida K, Kobayashi T, Gatanaga H, Oka S: Outbreak of Pneumocystis jiroveci pneumonia in renal transplant recipients: P. jiroveci is contagious to the susceptible host. Transplantation; 2009 Aug 15;88(3):380-5
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  • Recent advances in immunosuppressive therapy have considerably reduced acute rejection.
  • CONCLUSION: On documentation of a PCP case, we recommend PCP prophylaxis for a maximum period of 6 months (upper limit of incubation period) in all renal transplant recipients including those on regular maintenance immunosuppressive therapy.
  • [MeSH-minor] AIDS-Related Opportunistic Infections / virology. Adult. Antifungal Agents / administration & dosage. Bronchoalveolar Lavage Fluid / microbiology. Disinfection. Drug Administration Schedule. Female. Genotype. Humans. Immunosuppressive Agents / adverse effects. Japan / epidemiology. Male. Middle Aged. Mouth / microbiology. Phylogeny. Sputum / microbiology. Time Factors. Young Adult

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  • (PMID = 19667941.001).
  • [ISSN] 1534-6080
  • [Journal-full-title] Transplantation
  • [ISO-abbreviation] Transplantation
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antifungal Agents; 0 / DNA, Fungal; 0 / Immunosuppressive Agents
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71. Oei AL, Sweep FC, Massuger LF, Olthaar AJ, Thomas CM: Transient human anti-mouse antibodies (HAMA) interference in CA 125 measurements during monitoring of ovarian cancer patients treated with murine monoclonal antibody. Gynecol Oncol; 2008 May;109(2):199-202
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  • OBJECTIVE: To investigate the influence of human anti-mouse antibodies (HAMA) on serial CA 125 measurements in serum of patients with epithelial ovarian cancer following single intraperitoneal (IP) therapy with Yttrium-90-labeled human milk fat globule 1 murine monoclonal antibody ((90)Y-muHMFG1) as part of a large international randomized phase III trial.
  • METHODS: We monitored CA 125 concentrations in longitudinally collected serum samples from 224 patients after IP (90)Y-muHMFG1 (study group) and from 223 patients who received standard treatment (control group).
  • In the first 8 weeks after IP (90)Y-muHMFG1 administration significantly more patients of the study group (144/224) demonstrated CA 125 concentrations above the upper limit of normal of 23 U/mL, as compared to those of the control group (37/223).
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. CA-125 Antigen / blood. Glycolipids / immunology. Glycoproteins / immunology. Ovarian Neoplasms / drug therapy
  • [MeSH-minor] Animals. Chromatography, Affinity. Drug Interactions. Female. Humans. Injections, Intraperitoneal. Mice. Osmolar Concentration. Population Surveillance. Time Factors

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  • (PMID = 18304620.001).
  • [ISSN] 1095-6859
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / CA-125 Antigen; 0 / Glycolipids; 0 / Glycoproteins; 0 / milk fat globule
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72. Jauregizar N, Calvo R, Suarez E, Quintana A, Raczka E, Lukas JC: Altered disposition and effect of lerisetron in rats with elevated alpha 1-acid glycoprotein levels. Pharm Res; 2001 Jun;18(6):838-45
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  • [Title] Altered disposition and effect of lerisetron in rats with elevated alpha 1-acid glycoprotein levels.
  • PURPOSE: To examine the effect of changes in plasma alpha1-acid glycoprotein (AAG) levels on the pharmacokinetics (PK) and pharmacodynamics (PD) of lerisetron, a novel serotonin 5-HT3 receptor antagonist, in the rat.
  • The PK of unchanged lerisetron (UL; high-performance liquid chromatography with radioactivity monitoring) and total lerisetron (TL; unchanged + changed, scintillation counting) was characterized post intravenous (i.v.
  • Volume of distribution (V) and clearance for UL and TL were significantly decreased when compared to the controls (P < 0.0001 for UL and P < 0.05 for TL).
  • Plasma clearance based on unbound concentration for UL did not differ between groups but the unbound V and steady-state unbound V remained decreased (P < 0.05 and P < 0.0001).
  • Pretreated rats showed a significantly diminished drug effect: the area under the E-t curve over 180 min was (mean +/- SEM) 5,189 +/- 657.7 in control animals vs. 3,486 +/- 464.4 in the pretreated group (P < 0.05).
  • The EC50 (concentration at half maximum effect) for UL and TL were increased in pretreated rats and were not compensated when the unbound concentration was used.
  • [MeSH-minor] Animals. Bradycardia / chemically induced. Bradycardia / drug therapy. Bradycardia / metabolism. Female. Protein Binding / physiology. Rats. Rats, Sprague-Dawley

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  • (PMID = 11474789.001).
  • [ISSN] 0724-8741
  • [Journal-full-title] Pharmaceutical research
  • [ISO-abbreviation] Pharm. Res.
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / 5 P41 RR-12609
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Benzimidazoles; 0 / Orosomucoid; 0 / Piperidines; 0 / Serotonin Antagonists; Q36R82SXRG / lerisetron
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73. Prakash J, Sandovici M, Saluja V, Lacombe M, Schaapveld RQ, de Borst MH, van Goor H, Henning RH, Proost JH, Moolenaar F, Këri G, Meijer DK, Poelstra K, Kok RJ: Intracellular delivery of the p38 mitogen-activated protein kinase inhibitor SB202190 [4-(4-fluorophenyl)-2-(4-hydroxyphenyl)-5-(4-pyridyl)1H-imidazole] in renal tubular cells: a novel strategy to treat renal fibrosis. J Pharmacol Exp Ther; 2006 Oct;319(1):8-19
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  • We hypothesized that local inhibition of p38 within these cells may be an interesting approach for the treatment of renal fibrosis.
  • To effectuate this, we developed a renal-specific conjugate of the p38 inhibitor SB202190 [4-(4-fluorophenyl)-2-(4-hydroxyphenyl)-5-(4-pyridyl)1H-imidazole] and the carrier lysozyme.
  • However, this conjugate rapidly released the drug upon incubation in serum.
  • Therefore, we applied a new platinum(II)-based linker approach, the so-called universal linkage system (ULS), which forms a coordinative bond with SB202190.
  • The SB202190-ULS-lysozyme remained stable in serum but released the drug in kidney homogenates.
  • SB202190-ULS-lysozyme accumulated efficiently in renal tubular cells and provided a local drug reservoir during a period of 3 days after a single intravenous injection.
  • Treatment with SB202190-ULS-lysozyme inhibited TGF-beta1-induced gene expression for procollagen-Ialpha1 by 64% in HK-2 cells.
  • Lastly, we evaluated the efficacy of a single dose of the conjugate in the unilateral renal ischemia-reperfusion rat model.
  • A reduction of intrarenal p38 phosphorylation and alpha-smooth muscle actin protein expression was observed 4 days after the ischemia-reperfusion injury.
  • In conclusion, we have developed a novel strategy for local delivery of the p38 MAPK inhibitor SB202190, which may be of use in the treatment of renal fibrosis.
  • [MeSH-major] Imidazoles / pharmacokinetics. Kidney / pathology. Kidney Tubules, Proximal / metabolism. Protein Kinase Inhibitors / pharmacokinetics. Pyridines / pharmacokinetics. p38 Mitogen-Activated Protein Kinases / antagonists & inhibitors
  • [MeSH-minor] Animals. Biological Transport. Cisplatin / toxicity. Fibrosis. Male. Muramidase / administration & dosage. Muramidase / metabolism. Rats. Rats, Wistar. Reperfusion Injury / drug therapy

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  • (PMID = 16807361.001).
  • [ISSN] 0022-3565
  • [Journal-full-title] The Journal of pharmacology and experimental therapeutics
  • [ISO-abbreviation] J. Pharmacol. Exp. Ther.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / 4-(4-fluorophenyl)-2-(4-hydroxyphenyl)-5-(4-pyridyl)imidazole; 0 / Imidazoles; 0 / Protein Kinase Inhibitors; 0 / Pyridines; EC 2.7.11.24 / p38 Mitogen-Activated Protein Kinases; EC 3.2.1.17 / Muramidase; Q20Q21Q62J / Cisplatin
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74. Huang SC, Tang MJ, Cheng YM, Hsu KF, Ho CL, Chou CY: Enhanced polyadenosine diphosphate-ribosylation in gonadotropin-releasing hormone agonist-treated uterine leiomyoma. J Clin Endocrinol Metab; 2003 Oct;88(10):5009-16
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  • [Title] Enhanced polyadenosine diphosphate-ribosylation in gonadotropin-releasing hormone agonist-treated uterine leiomyoma.
  • This study aimed to examine the activation of poly(ADP-ribose) polymerase (PARP) and the accumulation of its end product, poly(ADP-ribose) (PAR), in uterine leiomyoma specimens obtained from 25 patients receiving Leuplin depot [leuprorelin acetate, depot (LA)] treatment and 46 control patients and explore their correlation with tumor shrinkage and degeneration caused by the therapy.
  • The numbers of both PARP- and PAR-immunolabeled cells were higher in leiomyoma with LA treatment.
  • This was correlated with the clinical response of LA therapy that LA induced more leiomyoma degeneration.
  • The analysis of power Doppler sonography indicated a progressive decrease in blood supply to tumor following LA treatment.
  • In vitro experiments using primarily cultured leiomyoma cells exhibited that the deprivation of serum or ovarian hormones or LA directly failed to induce PARP and PAR production.
  • Our results suggested that reduced blood flow and subsequent ischemic damages in leiomyoma could be responsible for PARP overexpression and PAR accumulation, clinical response, and tumor degeneration caused by LA treatment.
  • [MeSH-major] Gonadotropin-Releasing Hormone / agonists. Leiomyoma / drug therapy. Leiomyoma / metabolism. Poly(ADP-ribose) Polymerases / metabolism. Uterine Neoplasms / drug therapy. Uterine Neoplasms / metabolism
  • [MeSH-minor] Antimutagenic Agents / pharmacology. Antineoplastic Agents, Hormonal / pharmacology. Antineoplastic Agents, Hormonal / therapeutic use. Cobalt / pharmacology. Female. Gonadal Steroid Hormones / pharmacology. Humans. Leuprolide / pharmacology. Leuprolide / therapeutic use. Poly Adenosine Diphosphate Ribose / metabolism. Tumor Cells, Cultured / drug effects. Tumor Cells, Cultured / physiology. Ultrasonography, Doppler, Color. Up-Regulation / drug effects

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  • (PMID = 14557488.001).
  • [ISSN] 0021-972X
  • [Journal-full-title] The Journal of clinical endocrinology and metabolism
  • [ISO-abbreviation] J. Clin. Endocrinol. Metab.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antimutagenic Agents; 0 / Antineoplastic Agents, Hormonal; 0 / Gonadal Steroid Hormones; 26656-46-2 / Poly Adenosine Diphosphate Ribose; 33515-09-2 / Gonadotropin-Releasing Hormone; 3G0H8C9362 / Cobalt; EC 2.4.2.30 / Poly(ADP-ribose) Polymerases; EFY6W0M8TG / Leuprolide; EVS87XF13W / cobaltous chloride
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75. Farrell E: Medical choices available for management of menopause. Best Pract Res Clin Endocrinol Metab; 2003 Mar;17(1):1-16
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  • The indications for hormone therapy (HT) have changed markedly since the 1980s; they now include the treatment of menopausal symptoms and the prevention and treatment of osteoporosis in the short term.
  • Long-term therapy is discouraged because of the small increase in risk of breast cancer after 5 years of therapy.
  • Careful assessment of the midlife woman allows for individualized risk-benefit analysis with the formulation of a specific health management plan.
  • Lifestyle advice and modification form the cornerstone of management-followed by therapeutic options if appropriate indications exist.
  • In some industrialized countries alternative therapies are preferred despite little scientific evidence of their efficacy.
  • The choices of hormonal products have increased, with the introduction of new formulations and routes of administration allowing for more optimal treatment of the menopause, especially in the presence of concurrent medical conditions, for example, diabetes, breast cancer or fibroids.
  • [MeSH-major] Estrogen Replacement Therapy. Isoflavones. Menopause / drug effects
  • [MeSH-minor] Complementary Therapies. Estrogens, Non-Steroidal / therapeutic use. Female. Hot Flashes / drug therapy. Humans. Life Style. Mood Disorders / drug therapy. Osteoporosis, Postmenopausal / prevention & control. Phytoestrogens. Plant Preparations

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  • (PMID = 12763509.001).
  • [ISSN] 1521-690X
  • [Journal-full-title] Best practice & research. Clinical endocrinology & metabolism
  • [ISO-abbreviation] Best Pract. Res. Clin. Endocrinol. Metab.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Estrogens, Non-Steroidal; 0 / Isoflavones; 0 / Phytoestrogens; 0 / Plant Preparations
  • [Number-of-references] 67
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76. Filippi L, la Marca G, Fiorini P, Poggi C, Cavallaro G, Malvagia S, Pellegrini-Giampietro DE, Guerrini R: Topiramate concentrations in neonates treated with prolonged whole body hypothermia for hypoxic ischemic encephalopathy. Epilepsia; 2009 Nov;50(11):2355-61
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  • [Title] Topiramate concentrations in neonates treated with prolonged whole body hypothermia for hypoxic ischemic encephalopathy.
  • PURPOSE: Therapeutic hypothermia reduces mortality and neurologic impairment in neonates with hypoxic-ischemic encephalopathy.
  • The influence of hypothermia on topiramate pharmacokinetics was evaluated in asphyxiated neonates treated with prolonged whole-body hypothermia and topiramate.
  • METHODS: Thirteen term newborns were treated with mild or deep whole body hypothermia for 72 h; all received oral topiramate, 5 mg/kg once a day for the first 3 days of life, and seven had concomitant phenobarbital treatment.
  • RESULTS: Topiramate concentrations were within the reference range in 11 of 13 newborns, whereas concentrations exceeded the upper limit in 2 of 13, both newborns on deep hypothermia.
  • Values of topiramate maximal and minimal concentration, half-life, average concentration, and area under the time-concentration curve resulted in considerably higher values than those reported in normothermic infants.
  • With respect to normothermic infants, time of maximal concentration was mildly delayed and apparent total body clearance was lower, suggesting slower absorption and elimination.
  • CONCLUSION: Most neonates on prolonged hypothermia treated with topiramate 5 mg/kg once a day exhibited drug concentrations within the reference range for the entire treatment duration.
  • [MeSH-major] Fructose / analogs & derivatives. Hypothermia, Induced / methods. Hypoxia-Ischemia, Brain / therapy
  • [MeSH-minor] Asphyxia Neonatorum / therapy. Combined Modality Therapy. Drug Therapy, Combination. Female. Humans. Infant, Newborn. Male. Neuroprotective Agents / pharmacokinetics. Neuroprotective Agents / therapeutic use. Phenobarbital / therapeutic use. Treatment Outcome

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  • (PMID = 19744111.001).
  • [ISSN] 1528-1167
  • [Journal-full-title] Epilepsia
  • [ISO-abbreviation] Epilepsia
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Neuroprotective Agents; 0H73WJJ391 / topiramate; 30237-26-4 / Fructose; YQE403BP4D / Phenobarbital
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77. Kalantaridou SN, Calis KA, Mazer NA, Godoy H, Nelson LM: A pilot study of an investigational testosterone transdermal patch system in young women with spontaneous premature ovarian failure. J Clin Endocrinol Metab; 2005 Dec;90(12):6549-52
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  • CONTEXT: Evidence suggests that young women with spontaneous premature ovarian failure (sPOF) have significantly lower androgen levels than age-matched regularly menstruating women.
  • DESIGN: This was an open-label study (2-month baseline period followed by 2-month treatment period).
  • PATIENTS: Nine women with sPOF and a history of regular bleeding patterns on standard estrogen/progestogen cyclic treatment participated in the study.
  • One subject with abnormal baseline levels was excluded.
  • INTERVENTION: Four consecutive 28-d cycles of transdermal estradiol (E2; 0.1 mg/d) and sequential oral medroxyprogesterone acetate (MPA; 10 mg/d for the last 12 d of each cycle).
  • RESULTS: The mean (95% confidence interval) of the time-average free testosterone levels during TTP treatment was 7.5 (4.9-9.9) pg/ml; 26.0 (17.2-34.6) pmol/liter (with E2), and 6.9 (4.9-8.8) pg/ml; 23.9 (17.2-30.5) pmol/liter (with E2 and MPA).
  • The confidence intervals of the means include the upper limit of normal for premenopausal women, i.e.
  • CONCLUSIONS: The addition of TTP to cyclic E2/MPA therapy in women with sPOF produced mean free testosterone levels that approximate the upper limit of normal.
  • [MeSH-major] Androgens / administration & dosage. Primary Ovarian Insufficiency / drug therapy. Testosterone / administration & dosage
  • [MeSH-minor] Administration, Cutaneous. Adult. Female. Hormones / blood. Humans. Menstrual Cycle / drug effects. Pilot Projects

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  • (PMID = 16174721.001).
  • [ISSN] 0021-972X
  • [Journal-full-title] The Journal of clinical endocrinology and metabolism
  • [ISO-abbreviation] J. Clin. Endocrinol. Metab.
  • [Language] eng
  • [Grant] United States / Intramural NIH HHS / /
  • [Publication-type] Journal Article; Research Support, N.I.H., Intramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Androgens; 0 / Hormones; 3XMK78S47O / Testosterone
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78. Jacober SJ, Scism-Bacon JL, Zagar AJ: A comparison of intensive mixture therapy with basal insulin therapy in insulin-naïve patients with type 2 diabetes receiving oral antidiabetes agents. Diabetes Obes Metab; 2006 Jul;8(4):448-55
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  • [Title] A comparison of intensive mixture therapy with basal insulin therapy in insulin-naïve patients with type 2 diabetes receiving oral antidiabetes agents.
  • AIM: In patients with type 2 diabetes, insulin therapy is commonly initiated with either a single dose of basal insulin or twice-daily premixed (basal plus prandial) insulin despite no widely accepted recommendation.
  • We compared the glycaemic control, as measured by a change in HbA1c, of intensive mixture therapy (IMT), a basal plus prandial regimen using insulin lispro mixture 50/50 (50% lispro and 50% NPL) before breakfast and lunch and insulin lispro mixture 25/75 (25% lispro and 75% NPL) before dinner, vs. once-daily insulin glargine therapy, while continuing patients on oral antidiabetes medications.
  • METHODS: Following inadequate glycaemic control (HbA1c 1.2-2.0 times the upper limit of normal) and at least 2 months of two or more oral antidiabetes agent therapy, 60 insulin-naïve patients with type 2 diabetes were randomized to one of the insulin regimens for 4 months with crossover to the alternative regimen for an additional 4 months.
  • Overall hypoglycaemia throughout the complete treatment period was infrequent (IMT vs.
  • Glargine: 3.98 +/- 4.74 vs. 2.57 +/- 3.22 episodes/patient/30 days, p = 0.0013), and no severe hypoglycaemia was observed during the study with either therapy.
  • There was no difference in nocturnal hypoglycaemia between the two therapies.
  • The mean insulin dose at the end of therapy was greater for IMT than for once-daily insulin glargine (0.353 +/- 0.256 vs. 0.276 +/- 0.207 IU/kg, p = 0.0107).
  • CONCLUSIONS: In combination with oral antidiabetes agents, multiple daily injections of a basal plus prandial insulin IMT regimen (using premixed insulin lispro formulations) resulted in greater improvements and a lower endpoint in HbA1c compared with a basal-only insulin regimen.
  • IMT also resulted in improved postprandial blood glucose control at each meal and enabled administration of a greater daily dose of insulin, which most likely contributed to these lower HbA1c measures.
  • [MeSH-major] Diabetes Mellitus, Type 2 / drug therapy. Hypoglycemic Agents / therapeutic use. Insulin / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Blood Glucose / metabolism. Body Weight / drug effects. Cross-Over Studies. Drug Administration Schedule. Female. Hemoglobin A, Glycosylated / metabolism. Humans. Hypoglycemia / chemically induced. Insulin Glargine. Insulin, Long-Acting. Male. Middle Aged

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  • (PMID = 16776752.001).
  • [ISSN] 1462-8902
  • [Journal-full-title] Diabetes, obesity & metabolism
  • [ISO-abbreviation] Diabetes Obes Metab
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Blood Glucose; 0 / Hemoglobin A, Glycosylated; 0 / Hypoglycemic Agents; 0 / Insulin; 0 / Insulin, Long-Acting; 2ZM8CX04RZ / Insulin Glargine
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79. Kefford RF, Clingan PR, Brady B, Ballmer A, Morganti A, Hersey P: A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy. Mol Cancer; 2010 Mar 30;9:69
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  • [Title] A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy.
  • We evaluated the effects of bosentan - a dual endothelin receptor antagonist - in patients receiving first-line dacarbazine therapy for stage IV metastatic cutaneous melanoma in a phase 2, proof-of-concept study.
  • RESULTS: Eligible patients had metastatic cutaneous melanoma naïve to chemotherapy or immunotherapy, no central nervous system involvement, and serum lactate dehydrogenase <1.5 x upper limit of normal.
  • Treatment comprised bosentan 500 mg twice daily or matching placebo, in addition to dacarbazine 1000 mg/m2 every three weeks.
  • Eighty patients were randomized (double-blind) and 38 in each group received study treatment.
  • Median time to tumor progression (primary endpoint) was not significantly different between the two groups (placebo, 2.8 months; bosentan, 1.6 months; bosentan/placebo hazard ratio, 1.144; 95% CI, 0.717-1.827; p = 0.5683).
  • Incidences of most adverse events and clinically relevant increases in hepatic transaminases were similar between treatment groups although hemoglobin decrease to >8 and < or = 10 g/dL and < or = 8 g/dL was more common in the bosentan group.
  • CONCLUSIONS: In patients receiving dacarbazine as first-line chemotherapy for metastatic melanoma, the addition of high-dose bosentan had no effect on time to tumor progression or other efficacy parameters.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / administration & dosage. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Sulfonamides / administration & dosage

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  • (PMID = 20350333.001).
  • [ISSN] 1476-4598
  • [Journal-full-title] Molecular cancer
  • [ISO-abbreviation] Mol. Cancer
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT01009177
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Sulfonamides; 7GR28W0FJI / Dacarbazine; Q326023R30 / bosentan
  • [Other-IDs] NLM/ PMC2856553
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80. Avis HJ, Vissers MN, Stein EA, Wijburg FA, Trip MD, Kastelein JJ, Hutten BA: A systematic review and meta-analysis of statin therapy in children with familial hypercholesterolemia. Arterioscler Thromb Vasc Biol; 2007 Aug;27(8):1803-10
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  • [Title] A systematic review and meta-analysis of statin therapy in children with familial hypercholesterolemia.
  • OBJECTIVE: Functional and morphological changes of the arterial wall already present in young children with heterozygous familial hypercholesterolemia (HeFH) suggest that treatment should be initiated early in life to prevent premature atherosclerotic cardiovascular disease.
  • The purpose of this study was to assess the efficacy and particularly safety of statin therapy in children with HeFH.
  • METHODS AND RESULTS: We performed a meta-analysis of randomized, double-blind, placebo-controlled trials evaluating statin therapy in children aged 8 to 18 years with HeFH.
  • Six studies (n=798 children) with 12 to 104 weeks of treatment were included.
  • Total cholesterol, LDL cholesterol, and apolipoprotein B were significantly reduced, whereas HDL cholesterol and apolipoprotein A1 were significantly increased by statin therapy.
  • No statistically significant differences were found between statin- and placebo-treated children with respect to the occurrence of adverse events (RR 0.99; 95% CI: 0.79 to 1.25), sexual development (RR of advancing > or = 1 stage in Tanner classification 0.96; 95% CI: 0.79 to 1.17), muscle toxicity (RR of CK > or = 10 times the upper limit of normal [ULN] 1.38; 95% CI: 0.18 to 10.82), or liver toxicity (RR of > or = 3 times the ULN for ASAT 0.98; 95% CI: 0.23 to 4.26 and for ALAT 2.03; 95% CI: 0.24 to 16.95).
  • CONCLUSION: In addition to the fact that statin treatment is efficacious, our results support the notion that statin treatment in children with HeFH is safe.
  • Thus, even though further studies are required to assess lifelong safety, statin treatment should be considered for all children aged 8 to 18 with HeFH.
  • [MeSH-major] Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage. Hyperlipoproteinemia Type II / diagnosis. Hyperlipoproteinemia Type II / drug therapy
  • [MeSH-minor] Adolescent. Age Factors. Child. Cholesterol, HDL / blood. Cholesterol, HDL / drug effects. Cholesterol, LDL / blood. Cholesterol, LDL / drug effects. Confidence Intervals. Dose-Response Relationship, Drug. Double-Blind Method. Drug Administration Schedule. Female. Follow-Up Studies. Humans. Male. Probability. Randomized Controlled Trials as Topic. Risk Assessment. Severity of Illness Index. Sex Factors. Treatment Outcome


81. Rustin GJ, Marples M, Nelstrop AE, Mahmoudi M, Meyer T: Use of CA-125 to define progression of ovarian cancer in patients with persistently elevated levels. J Clin Oncol; 2001 Oct 15;19(20):4054-7
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  • [Title] Use of CA-125 to define progression of ovarian cancer in patients with persistently elevated levels.
  • PURPOSE: To determine an accurate definition for progression of ovarian cancer in patients with a persistently elevated serum CA-125.
  • The date of progression according to clinical or radiologic criteria was ascertained in the 88 patients with persistently elevated CA-125 levels (> 23 U/mL).
  • This was compared with the date of progression according to CA-125, defined as the date on which the CA-125 level first increased to >or= twice its nadir level, confirmed by a second sample also >or= twice the nadir.
  • Only one patient had a false-positive prediction of progression according to CA-125; the patient died as a result of a myocardial infarct before evidence of clinical progression.
  • CONCLUSION: In patients whose CA-125 level decreases to normal after chemotherapy, a doubling from the upper limit of normal has been shown to predict progression.
  • In those with persistently elevated levels, doubling of CA-125 from its nadir level has now been shown to accurately define progression.
  • [MeSH-minor] Disease Progression. Female. Humans. Retrospective Studies. Sensitivity and Specificity. Survival Analysis. Time Factors. Up-Regulation

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  • (PMID = 11600607.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / CA-125 Antigen
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82. Schweizer A, Dejager S, Bosi E: Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial. Diabetes Obes Metab; 2009 Aug;11(8):804-12
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  • [Title] Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial.
  • AIMS: The study evaluated the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor, vildagliptin, and metformin in drug-naïve elderly patients with type 2 diabetes.
  • The primary objective was to demonstrate non-inferiority of vildagliptin vs. metformin in glycated haemoglobin (HbA1c) reduction.
  • METHODS: This was a double-blind, randomized, multicentre, active-controlled, parallel-group study of 24-week treatment with vildagliptin (100 mg daily, n=169) or metformin (titrated to 1500 mg daily, n=166) in drug-naïve patients with type 2 diabetes aged>or=65 years (baseline HbA1c 7-9%).
  • At end-point, vildagliptin was as effective as metformin, improving HbA1c by -0.64+/-0.07% and -0.75+/-0.07%, respectively, meeting the predefined statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference<or=0.3%).
  • Body weight changes were -0.45+/-0.20 kg in vildagliptin-treated patients (p=0.02) and -1.25+/-0.19 kg in metformin-treated patients (p<0.001; p=0.004 vs. vildagliptin).
  • A low incidence of hypoglycaemia was observed in both treatment groups (0% with vildagliptin and 1.2% with metformin).
  • CONCLUSIONS: Vildagliptin is an effective and well-tolerated treatment option in elderly patients with type 2 diabetes, demonstrating similar improvement in glycaemic control as metformin, with superior GI tolerability.
  • [MeSH-major] Adamantane / analogs & derivatives. Diabetes Mellitus, Type 2 / drug therapy. Dipeptidyl-Peptidase IV Inhibitors / therapeutic use. Hypoglycemic Agents / therapeutic use. Metformin / therapeutic use. Nitriles / therapeutic use. Pyrrolidines / therapeutic use
  • [MeSH-minor] Aged. Aged, 80 and over. Blood Glucose. Body Weight / drug effects. Double-Blind Method. Drug Therapy, Combination. Female. Gastrointestinal Diseases / epidemiology. Hemoglobin A, Glycosylated / drug effects. Humans. Hypoglycemia / epidemiology. Incidence. Male

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  • (PMID = 19476473.001).
  • [ISSN] 1463-1326
  • [Journal-full-title] Diabetes, obesity & metabolism
  • [ISO-abbreviation] Diabetes Obes Metab
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00246619
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Blood Glucose; 0 / Dipeptidyl-Peptidase IV Inhibitors; 0 / Hemoglobin A, Glycosylated; 0 / Hypoglycemic Agents; 0 / Nitriles; 0 / Pyrrolidines; 9100L32L2N / Metformin; I6B4B2U96P / vildagliptin; PJY633525U / Adamantane
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83. Ou HY, Hung CJ, Hsu WH, Yu EH, Wu TJ: Variability of clinical presentations in three cases of parathyroid carcinoma. J Formos Med Assoc; 2003 Apr;102(4):266-9
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  • The prognosis depends largely on the extent of successful resection at the time of initial operation.
  • Therefore, early diagnosis before surgery is important.
  • The first patient, a 20-year-old uremic female, had refractory hypercalcemia after 5 years of hemodialysis treatment.
  • He underwent resection of the parathyroid tumor.
  • All three patients were relatively young and had extremely high intact parathyroid hormone (iPTH) level (15 to 31 times the upper limit of normal).
  • The first patient died of hypercalcemia and respiratory failure and the other 2 were treated successfully with surgical excision and, in case 2, combined chemotherapy and radiotherapy.
  • Our experience with these cases suggests that the combination of the following characteristics are highly suggestive of parathyroid carcinoma: young age, palpable neck mass, concomitant renal and skeletal disease, and extremely high iPTH level in patients with PTH-dependent hypercalcemia.

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  • (PMID = 12833192.001).
  • [ISSN] 0929-6646
  • [Journal-full-title] Journal of the Formosan Medical Association = Taiwan yi zhi
  • [ISO-abbreviation] J. Formos. Med. Assoc.
  • [Language] ENG
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Singapore
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84. Douchi T, Kuwahata R, Yamasaki H, Yamamoto S, Oki T, Nakae M, Nagata Y: Inverse relationship between the changes in trunk lean and fat mass during gonadotropin-releasing hormone agonist therapy. Maturitas; 2002 May 20;42(1):31-5
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  • [Title] Inverse relationship between the changes in trunk lean and fat mass during gonadotropin-releasing hormone agonist therapy.
  • OBJECTIVE: The aim of the present study was to investigate the relationship between the changes in lean and fat mass during gonadotropin-releasing hormone agonist (GnRH agonist) therapy.
  • METHODS: Subjects were 24 premenopausal women (mean age, 39.5+/-9.4 years; range, 32-52 years) with uterine leiomyomas.
  • Body weight, regional and total body composition, and the ratio of trunk fat mass to leg fat mass (trunk-leg fat ratio) were assessed by whole body scanning with dual-energy X-ray absorptiometry.
  • However, body weight, and lean and fat mass component in the extremities did not change.
  • CONCLUSION: Inverse relationship between the changes in trunk lean and fat mass is observed during GnRH agonist therapy.
  • [MeSH-major] Antineoplastic Agents, Hormonal / pharmacology. Body Composition / drug effects. Gonadotropin-Releasing Hormone / analogs & derivatives. Leuprolide / pharmacology
  • [MeSH-minor] Absorptiometry, Photon. Adipose Tissue / drug effects. Adult. Arm. Female. Humans. Leg. Leiomyoma / drug therapy. Leiomyoma / ultrasonography. Middle Aged. Premenopause. Thorax. Treatment Outcome. Uterine Neoplasms / drug therapy. Uterine Neoplasms / ultrasonography. Uterus / drug effects

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  • (PMID = 12020977.001).
  • [ISSN] 0378-5122
  • [Journal-full-title] Maturitas
  • [ISO-abbreviation] Maturitas
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 33515-09-2 / Gonadotropin-Releasing Hormone; EFY6W0M8TG / Leuprolide
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85. Nagasaka H, Yorifuji T, Hirano K, Ota A, Toyama-Nakagawa Y, Takatani T, Tsukahara H, Kobayashi K, Takayanagi M, Inomata Y, Uemoto S, Miida T: Effects of bezafibrate on dyslipidemia with cholestasis in children with familial intrahepatic cholestasis-1 deficiency manifesting progressive familial intrahepatic cholestasis. Metabolism; 2009 Jan;58(1):48-54
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  • No appropriate pharmaceutical therapy has been established for dyslipidemia with cholestasis in progressive familial intrahepatic cholestasis (PFIC)-1.
  • We monitored the clinical presentation and lipoprotein metabolism of 3 patients, aged 3, 4, and 8 years, with FIC1 deficiency, manifesting PFIC-1, over 12 months of bezafibrate therapy.
  • Serum lipoprotein X, which was at normal levels before treatment, was elevated to levels above the upper limit of the reference range.
  • High serum triglyceride levels decreased by 15% to 30%, to normal levels, after treatment initiation.
  • Liver expression of multidrug resistance protein-3, which regulates lipoprotein X synthesis, was enhanced by bezafibrate therapy.
  • Bezafibrate treatment favorably affected pruritus, dyslipidemia, and cholestasis in PFIC-1.
  • [MeSH-major] Adenosine Triphosphatases / deficiency. Bezafibrate / therapeutic use. Dyslipidemias / drug therapy. Hypolipidemic Agents / therapeutic use
  • [MeSH-minor] Adult. Biopsy. Blotting, Western. Child. Child, Preschool. Cholestasis, Intrahepatic / drug therapy. Cholestasis, Intrahepatic / genetics. Cholestasis, Intrahepatic / metabolism. Cholesterol / blood. Cholesterol / metabolism. Female. Histocytochemistry. Humans. Liver / metabolism. Liver Function Tests. Male. P-Glycoproteins / metabolism. Triglycerides / blood. Triglycerides / metabolism

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  • (PMID = 19059530.001).
  • [ISSN] 1532-8600
  • [Journal-full-title] Metabolism: clinical and experimental
  • [ISO-abbreviation] Metab. Clin. Exp.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hypolipidemic Agents; 0 / P-Glycoproteins; 0 / Triglycerides; 0 / multidrug resistance protein 3; 97C5T2UQ7J / Cholesterol; EC 3.6.1.- / Adenosine Triphosphatases; EC 3.6.1.3. / ATP8B1 protein, human; Y9449Q51XH / Bezafibrate
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86. Liaw YF, Tsai SL, Chien RN, Yeh CT, Chu CM: Prednisolone priming enhances Th1 response and efficacy of subsequent lamivudine therapy in patients with chronic hepatitis B. Hepatology; 2000 Sep;32(3):604-9
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  • [Title] Prednisolone priming enhances Th1 response and efficacy of subsequent lamivudine therapy in patients with chronic hepatitis B.
  • Asian lamivudine trial has shown that hepatitis B e antigen (HBeAg) seroconversion rate during 1 year of lamivudine therapy was only 16% but was 64% in the subgroup of patients with a pretherapy serum alanine transaminase (ALT) level over 5 times the upper limit of normal (ULN).
  • To test whether ALT rebound following corticosteroid priming enhances response to lamivudine therapy, a pilot study was conducted in 30 patients with ALT levels less than 5x ULN (43-169; N < 36 U/L).
  • They received 30 mg of prednisolone daily for 3 weeks, 15 mg daily for 1 week, no treatment for 2 weeks, and then 150 mg of lamivudine daily for 9 months.
  • The HBeAg seroconversion sustained in 70% of the patients 3 to 6 months after the end of lamivudine therapy.
  • These results suggest that corticosteroid priming induced immune/ALT rebound greatly enhances response to lamivudine therapy in chronic hepatitis B.
  • [MeSH-major] Hepatitis B, Chronic / drug therapy. Lamivudine / therapeutic use. Prednisolone / therapeutic use. Reverse Transcriptase Inhibitors / therapeutic use. Th1 Cells / physiology
  • [MeSH-minor] Adolescent. Adult. Alanine Transaminase / blood. DNA, Viral / metabolism. Drug Therapy, Combination. Female. Hepatitis B e Antigens / analysis. Hepatitis B virus / genetics. Humans. Male. Middle Aged. Pilot Projects

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  • [CommentIn] Hepatology. 2000 Sep;32(3):663-5 [10960466.001]
  • (PMID = 10960456.001).
  • [ISSN] 0270-9139
  • [Journal-full-title] Hepatology (Baltimore, Md.)
  • [ISO-abbreviation] Hepatology
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / DNA, Viral; 0 / Hepatitis B e Antigens; 0 / Reverse Transcriptase Inhibitors; 2T8Q726O95 / Lamivudine; 9PHQ9Y1OLM / Prednisolone; EC 2.6.1.2 / Alanine Transaminase
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87. Cefali EA, Simmons PD, Stanek EJ, Shamp TR: Improved control of niacin-induced flushing using an optimized once-daily, extended-release niacin formulation. Int J Clin Pharmacol Ther; 2006 Dec;44(12):633-40
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  • INTRODUCTION: Niacin is a recognized treatment for dyslipidemia due to its favorable effects on all lipid parameters.
  • To increase the probability of flushing, subjects were administered niacin ER at the upper limit of the approved dosage range (2,000 mg), and were precluded from using aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) during the study.
  • The primary flushing variable was the occurrence of a flushing event.
  • Of 133 subjects who received at least 1 dose of study medication in at least 2 study periods, 89% of subjects experienced flushing during treatment with reformulated niacin ER, and 98% of subjects experienced flushing during treatment with commercial niacin ER.
  • During the study, 29% of subjects (45/156) experienced treatment-emergent adverse events, which were mostly mild in intensity and considered to be remotely related or unrelated to the study drug.
  • CONCLUSION: The 1,000 mg reformulated niacin ER tablet substantially decreases the incidence, intensity and duration of flushing relative to the commercially available 1,000 mg niacin ER tablet, and represents an improved niacin therapy option.
  • [MeSH-major] Delayed-Action Preparations / therapeutic use. Flushing / prevention & control. Niacin / therapeutic use
  • [MeSH-minor] Administration, Oral. Adolescent. Adult. Aged. Body Mass Index. Cross-Over Studies. Dizziness / chemically induced. Double-Blind Method. Drug Administration Schedule. Headache / chemically induced. Humans. Hypertension / chemically induced. Hypolipidemic Agents / administration & dosage. Hypolipidemic Agents / adverse effects. Hypolipidemic Agents / therapeutic use. Male. Middle Aged. Nausea / chemically induced. Patient Dropouts. Pruritus / chemically induced. Tablets. Treatment Outcome

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  • (PMID = 17190373.001).
  • [ISSN] 0946-1965
  • [Journal-full-title] International journal of clinical pharmacology and therapeutics
  • [ISO-abbreviation] Int J Clin Pharmacol Ther
  • [Language] eng
  • [Publication-type] Journal Article; Randomized Controlled Trial
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Delayed-Action Preparations; 0 / Hypolipidemic Agents; 0 / Tablets; 2679MF687A / Niacin
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88. Cohen P, Rogol AD, Howard CP, Bright GM, Kappelgaard AM, Rosenfeld RG, American Norditropin Study Group: Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study. J Clin Endocrinol Metab; 2007 Jul;92(7):2480-6
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  • [Title] Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study.
  • OBJECTIVE: The objective of the study was to test whether IGF-I levels achieved during GH therapy are determinants of the growth responses to GH treatment.
  • Prepubertal short children [n = 172, mean age 7.53 yr, mean height sd score (HT-SDS) -2.64] with low IGF-I levels (mean IGF-I SDS -3.56) were randomized to receive one of two GH dose-titration arms in which GH dosage was titrated to achieve an IGF-I SDS at the mean [IGF((low)) group, n = 70] or the upper limit of the normal range [+2 SDS, IGF((high)) group, n = 68] or to a comparison group of conventional GH dose of 40 microg/kg/d (n = 34).
  • Target IGF-I levels were achieved in the dose-titration arms within 6-9 months.
  • The IGF((high)) arm required higher doses (>2.5 times) than the IGF((low)) arm, and these GH doses were highly variable (20-346 microg/kg/d).
  • Multivariate analyses suggested that the rise in the IGF-I SDS significantly impacted height outcome along with the GH dose and the pretreatment peak-stimulated GH level.
  • [MeSH-major] Drug Monitoring / methods. Growth Disorders / blood. Growth Disorders / drug therapy. Human Growth Hormone / administration & dosage. Insulin-Like Growth Factor I / metabolism
  • [MeSH-minor] Biomarkers / blood. Body Height / drug effects. Child. Child, Preschool. Female. Humans. Male. Multivariate Analysis. Treatment Outcome

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  • [CommentIn] Nat Clin Pract Endocrinol Metab. 2007 Oct;3(10):682-3 [17667897.001]
  • [CommentIn] J Clin Endocrinol Metab. 2007 Jul;92(7):2436-8 [17616638.001]
  • (PMID = 17356043.001).
  • [ISSN] 0021-972X
  • [Journal-full-title] The Journal of clinical endocrinology and metabolism
  • [ISO-abbreviation] J. Clin. Endocrinol. Metab.
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Biomarkers; 12629-01-5 / Human Growth Hormone; 67763-96-6 / Insulin-Like Growth Factor I
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89. Melagatran and ximelagatran: new drug. No real simplification of anticoagulant therapy. Prescrire Int; 2005 Aug;14(78):127-32
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  • [Title] Melagatran and ximelagatran: new drug. No real simplification of anticoagulant therapy.
  • (1) The reference drug for prophylaxis against venous thromboembolism after hip or knee replacement surgery is a low-molecular-weight heparin (LMWH), given subcutaneously for 1 to 5 weeks.
  • Melagatran, unlike LMWH, is a specific thrombin inhibitor. (3) There are four randomised double-blind trials in more than 9000 patients comparing these agents with a LMWH (enoxaparin in three trials, dalteparin in one).
  • Treatment lasted 7 to 12 days.
  • Ximelagatran was no better than warfarin when assessed using clinical endpoints. (5) In these trials melagatran-ximelagatran did not increase the risk of bleeding compared with LMWH or warfarin. (6) Melagatran-ximelagatran can cause an increase in serum transaminase activity, and is contraindicated if pretreatment serum transaminase activity is more than twice the upper limit of normal. (7) Trials versus warfarin showed a higher risk of myocardial infarction in patients taking ximelagatran (0.7% versus 0.16%). (8) There are few data on the patient subgroups most likely to receive melagatran-ximelagatran, namely patients over 75, underweight and overweight patients, and patients with renal failure. (9) There is currently no clotting test that allows the melagatran-ximelagatran dose regimen to be adjusted in patients who have an increased risk of adverse effects due to overdosing.
  • Melagatran and ximelagatran must not be combined with other anticoagulants, thrombolytic agents or antiplatelet drugs because of a increased bleeding risk. (11) In practice, low-molecular-weight heparin remains the reference prophylactic treatment for venous thromboembolism after hip or knee replacement surgery.
  • [MeSH-major] Anticoagulants / therapeutic use. Azetidines / therapeutic use. Glycine / therapeutic use. Venous Thrombosis / prevention & control
  • [MeSH-minor] Arthroplasty, Replacement, Hip / rehabilitation. Arthroplasty, Replacement, Knee / rehabilitation. Fibrinolytic Agents / administration & dosage. Fibrinolytic Agents / adverse effects. Fibrinolytic Agents / therapeutic use. Heparin, Low-Molecular-Weight / administration & dosage. Heparin, Low-Molecular-Weight / adverse effects. Heparin, Low-Molecular-Weight / therapeutic use. Humans. Randomized Controlled Trials as Topic. Treatment Outcome

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  • (PMID = 16106594.001).
  • [ISSN] 1167-7422
  • [Journal-full-title] Prescrire international
  • [ISO-abbreviation] Prescrire Int
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] France
  • [Chemical-registry-number] 0 / Anticoagulants; 0 / Azetidines; 0 / Fibrinolytic Agents; 0 / Heparin, Low-Molecular-Weight; TE7660XO1C / Glycine
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90. de Boer NK, Mulder CJ, van Bodegraven AA: Myelotoxicity and hepatotoxicity during azathioprine therapy. Neth J Med; 2005 Dec;63(11):444-6
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  • [Title] Myelotoxicity and hepatotoxicity during azathioprine therapy.
  • We report the case of a 40-year-old man with Crohn's disease treated with azathioprine.
  • The 6-thioguaninenucleotide level was 738 picomoles/8 x 10(8) per red blood cell, which is well above the proposed upper limit of efficacy and associated with an increased risk of developing a myelodepression.
  • An upper endoscopy revealed oesophageal varices (grade 2 to 3).
  • Autoimmune and viral liver diseases were ruled out by laboratory parameters.
  • After cessation of therapy, all laboratory parameters normalised.
  • The role of 6-thioguaninenucleotide levels in inducing myelotoxicity and hepatotoxicity is discussed.
  • [MeSH-major] Azathioprine / adverse effects. Bone Marrow / drug effects. Immunosuppressive Agents / adverse effects. Liver Cirrhosis / chemically induced
  • [MeSH-minor] Adult. Biopsy. Blood Platelets / cytology. Crohn Disease / drug therapy. Guanine Nucleotides / blood. Humans. Leukocytes / cytology. Liver / pathology. Male. Thionucleotides / blood

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  • (PMID = 16397313.001).
  • [ISSN] 0300-2977
  • [Journal-full-title] The Netherlands journal of medicine
  • [ISO-abbreviation] Neth J Med
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Guanine Nucleotides; 0 / Immunosuppressive Agents; 0 / Thionucleotides; 15867-02-4 / 6-thioguanylic acid; MRK240IY2L / Azathioprine
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91. Idoko JA, Akinsete L, Abalaka AD, Keshinro LB, Dutse L, Onyenekwe B, Lhekwaba A, Njoku OS, Kehinde MO, Wambebe CO: A multicentre study to determine the efficacy and tolerability of a combination of nelfinavir (VIRACEPT), zalcitabine (HIVID) and zidovudine in the treatment of HIV infected Nigerian patients. West Afr J Med; 2002 Apr-Jun;21(2):83-6
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  • [Title] A multicentre study to determine the efficacy and tolerability of a combination of nelfinavir (VIRACEPT), zalcitabine (HIVID) and zidovudine in the treatment of HIV infected Nigerian patients.
  • Summary Forty (40) HIV positive patients with CD4 cell counts between 100 - 500 cellh/mm3 were recruited from 8 different centres in Nigeria including a research centre and specialist and teaching hospitaLs They were enrolled into an open, non-comparative study of a triple combination regimen containing the Protease Inhibitor (PI), Nelfinavir and two Reverse Transcriptase Inhibitors (RTIs), Zakitabine (Hivid) and Zidovudine for a period of 24 weeks.
  • Two of these because of Adverse Events (AE), 2 others because they developed tuberculosis and had to withdraw because of rifampicin therapy.
  • In 2 patients (8%), plasma viral load was reduced below the level of detection.
  • The viral load increased over the treatment period in five patients (21%).
  • Similarly 22 out of the 26 patients (85%) experienced increase in the level of their CD4 lymphocyte counts at the end of the study.
  • The average CD4 counts of all 26 patients rose from 272.94 +/- 137.71/dl to 414 +/- 243.71/ul over 24 weeks (p<0.05).
  • None of these adverse events was severe enough to warrant withdrawal from therapy.
  • [MeSH-major] Anti-HIV Agents / therapeutic use. Antiretroviral Therapy, Highly Active / methods. HIV Infections / drug therapy. HIV Protease Inhibitors / therapeutic use. Nelfinavir / therapeutic use. Reverse Transcriptase Inhibitors / therapeutic use. Zalcitabine / therapeutic use. Zidovudine / therapeutic use
  • [MeSH-minor] CD4 Lymphocyte Count. Diarrhea / chemically induced. Double-Blind Method. Drug Resistance, Microbial. Female. Humans. Male. Nigeria. Peripheral Nervous System Diseases / chemically induced. Quality of Life. Treatment Outcome. Viral Load. Weight Gain / drug effects


92. Markman M, Markman J, Webster K, Zanotti K, Kulp B, Peterson G, Belinson J: Duration of response to second-line, platinum-based chemotherapy for ovarian cancer: implications for patient management and clinical trial design. J Clin Oncol; 2004 Aug 1;22(15):3120-5
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  • [Title] Duration of response to second-line, platinum-based chemotherapy for ovarian cancer: implications for patient management and clinical trial design.
  • PURPOSE: Limited information is available regarding the influence of the duration of a prior response on the length of a subsequent response to platinum chemotherapy in recurrent ovarian cancer.
  • Patients were considered to have responded to second-line therapy if they satisfied specific criteria, including favorable effects on both measurable or assessable disease.
  • RESULTS: A total of 211 platinum-based regimens were administered to 176 women with recurrent ovarian cancer during this time period, with a response being observed in 125 treatment episodes (59%).
  • In three of these four cases, the platinum-based regimen used in the second-line approach included a drug that had not been used in that patient's primary chemotherapy program.
  • CONCLUSION: The length of a prior response to platinum-based therapy in ovarian cancer is highly predictive of the upper limit of the duration of response to a subsequent platinum program, assuming the same or similar drugs are used.
  • [MeSH-major] Ovarian Neoplasms / drug therapy. Platinum / administration & dosage
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Clinical Trials as Topic / methods. Drug Administration Schedule. Female. Humans. Middle Aged. Neoplasm Recurrence, Local. Research Design. Retrospective Studies. Time Factors

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  • [Copyright] Copyright 2004 American Society of Clinical Onocology
  • (PMID = 15284263.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 49DFR088MY / Platinum
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93. Arribas JR, Delgado R, Arranz A, Muñoz R, Portilla J, Pasquau J, Pérez-Elias MJ, Iribarren JA, Rubio R, Ocampo A, Sánchez-Conde M, Knobel H, Arazo P, Sanz J, López-Aldeguer J, Montes ML, Pulido F, OK04 Study Group: Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr; 2009 Jun 1;51(2):147-52
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis.
  • BACKGROUND: The OK04 trial has shown that 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy with 2 nucleosides and lopinavir-ritonavir in patients with prior stable suppression.
  • METHODS: Patients entered this noninferiority trial (upper limit 95% confidence interval: +12%) with no history of virological failure while receiving a protease inhibitor and receiving 2 nucleosides plus lopinavir/ritonavir, with HIV RNA <50 copies per milliliter for more than 6 months.
  • Primary end point was percent of patients without therapeutic failure, defined as confirmed HIV RNA >500 copies per milliliter with exclusion of monotherapy patients who resuppressed to <50 copies per milliliter after resuming baseline nucleosides, or loss to follow-up, or change of randomized therapy other than reinduction.
  • RESULTS: Through 96 weeks, percentage of patient without therapeutic failure was 87% (monotherapy, n = 100) vs. 78% (triple therapy, n = 98; 95% confidence interval: -20% to +1.2%).
  • Percentage with HIV RNA <50 copies per milliliter (intention to treat, missing = failure, reinduction = failure): 77% (monotherapy) vs. 78% (triple therapy).
  • Low-level viral rebound was more frequent in the monotherapy group.
  • Discontinuations due to adverse events were significantly more frequent in the triple therapy group (8%) than in the monotherapy group (0%); P = 0.003.
  • CONCLUSIONS: At 96-week lopinavir/ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy.
  • Incidence of adverse events leading to treatment discontinuation was significantly lower with monotherapy. (ClinicalTrials.gov number, NCT00114933).
  • [MeSH-major] Anti-HIV Agents / therapeutic use. HIV Infections / drug therapy. Nucleosides / therapeutic use. Pyrimidinones / therapeutic use. Ritonavir / therapeutic use
  • [MeSH-minor] Drug Resistance, Viral. Drug Therapy, Combination. Humans. Lopinavir. Middle Aged

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  • [CommentIn] J Acquir Immune Defic Syndr. 2010 Apr;53(5):669; author reply 670 [20335746.001]
  • (PMID = 19349870.001).
  • [ISSN] 1525-4135
  • [Journal-full-title] Journal of acquired immune deficiency syndromes (1999)
  • [ISO-abbreviation] J. Acquir. Immune Defic. Syndr.
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00114933
  • [Publication-type] Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anti-HIV Agents; 0 / Nucleosides; 0 / Pyrimidinones; 2494G1JF75 / Lopinavir; O3J8G9O825 / Ritonavir
  • [Investigator] Fiorante S; Cepeda C; Moreno V; Hernando A; Costa JR; González-Garciá J; Perez Valero N; Gaya F; Dronda F; Antela A; Moreno S; Sanz J; De Miguel J; Casas E; Boix V; Merino E; Reus S; López M; Camino X; von Wichmann MA; Arrizabalaga J; Rodriguez-Arrondo FJ; López A; Miralles C; Vázquez P; Miralles P; Berenguer J; López JC; Cosín J; Vallecillo G; Carrillo R; Santos I; Salavert M; Lacruz J; Blanes M; Navarro V; Aguirre JM; Pascual MA; Górgolas M; Goyeneche A; Sirvent JL; Alemán R; López AM; Alonso MM; Santamaría JM; Teira R; Ferrero O; Zubero Z; Muñoz J; Baraiaetxaburu J; Lozano F; Gómez J; Pineda JA; Corzo J; León EM; Sebastián G; Domingo P; Gutiérrez M; Mateo G; Fuster M; Sambeat MA; Cadafalch J; Gurgí M; Clotet B; Tuldrá A; Ballesteros A; Moltó J; Santos JR; Bonjoch A; Podzamczer D; Robres P; Ferrerr E; Olmo M; Gatell JM; Milinkovic A; Mallolas J; Martínez E; Estrada V; Fuster M; Téllez MJ; Vergas J; Gutiérrez F; Masía M; Padilla S; Bernal E; García G; Galindo MJ; Francés A; Muniaín MA; Gálvez J; Orbea L; Rodríguez J; Domínguez A; Morales D; Ollero G; Abril V; Ortega E; Martín A
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94. Lee SS, Sherman M: Pilot study of interferon-alpha and ribavirin treatment in patients with chronic hepatitis C and normal transaminase values. J Viral Hepat; 2001 May;8(3):202-5
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pilot study of interferon-alpha and ribavirin treatment in patients with chronic hepatitis C and normal transaminase values.
  • Combination interferon-alpha (IFN-alpha) and ribavirin treatment has become standard therapy for patients with chronic hepatitis C and elevated transaminase levels (> 1.5 x upper limit of normal).
  • No previous study has specifically examined the efficacy of this treatment in patients with normal transaminase values.
  • Nine of the 19 (47%) showed sustained virological response, defined as undetectable HCV-RNA at 24 weeks after the end of treatment.
  • We conclude that combination induction IFN-alpha and ribavirin therapy may be effective in patients with normal-ALT, and appears not to induce flares of ALT activity.
  • Controlled trials of this treatment in this subgroup of patients with hepatitis C are warranted.
  • [MeSH-major] Alanine Transaminase / blood. Antiviral Agents / therapeutic use. Hepacivirus. Hepatitis C, Chronic / drug therapy. Interferon-alpha / therapeutic use. Ribavirin / therapeutic use
  • [MeSH-minor] Adolescent. Adult. Biopsy. Dose-Response Relationship, Drug. Drug Therapy, Combination. Female. Humans. Liver / pathology. Male. Middle Aged. Pilot Projects. Polymerase Chain Reaction. RNA, Viral / blood. RNA, Viral / isolation & purification. Viral Load

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  • (PMID = 11380798.001).
  • [ISSN] 1352-0504
  • [Journal-full-title] Journal of viral hepatitis
  • [ISO-abbreviation] J. Viral Hepat.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antiviral Agents; 0 / Interferon-alpha; 0 / RNA, Viral; 49717AWG6K / Ribavirin; EC 2.6.1.2 / Alanine Transaminase
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95. Chen CI, Nanji S, Prabhu A, Beheshti R, Yi QL, Sutton D, Stewart AK: Sequential, cycling maintenance therapy for post transplant multiple myeloma. Bone Marrow Transplant; 2006 Jan;37(1):89-94
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  • [Title] Sequential, cycling maintenance therapy for post transplant multiple myeloma.
  • High-dose chemotherapy with autologous stem cell transplantation in patients with newly diagnosed multiple myeloma can prolong survival but is not curative.
  • Maintenance therapy post transplant may prolong the disease-free interval and impact overall survival.
  • We have conducted a phase II pilot study of 28 post transplant myeloma patients treated with a sequential, cycling maintenance regimen.
  • The 12-month cycling schedule included dexamethasone (months 1-3); melphalan and prednisone (months 4, 5); cyclophosphamide and prednisone (months 6, 7); alpha-interferon (months 8-10); followed by a drug holiday (months 11, 12).
  • There was one toxic death on study due to non-neutropenic pneumonia and sepsis.
  • Median event-free survival from transplant was 36.9 months (95% CI 23.6 - upper limit not yet reached) with median overall survival not yet reached at a median follow-up of 44 months.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Multiple Myeloma / prevention & control. Stem Cell Transplantation
  • [MeSH-minor] Anti-Inflammatory Agents / administration & dosage. Anti-Inflammatory Agents / adverse effects. Antineoplastic Agents, Alkylating / administration & dosage. Antineoplastic Agents, Alkylating / adverse effects. Combined Modality Therapy. Cyclophosphamide / administration & dosage. Cyclophosphamide / adverse effects. Dexamethasone / administration & dosage. Dexamethasone / adverse effects. Disease-Free Survival. Female. Follow-Up Studies. Humans. Interferon-alpha / administration & dosage. Interferon-alpha / adverse effects. Male. Melphalan / administration & dosage. Melphalan / adverse effects. Pilot Projects. Prednisone / administration & dosage. Prednisone / adverse effects. Recurrence. Transplantation, Autologous

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  • (PMID = 16247415.001).
  • [ISSN] 0268-3369
  • [Journal-full-title] Bone marrow transplantation
  • [ISO-abbreviation] Bone Marrow Transplant.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Anti-Inflammatory Agents; 0 / Antineoplastic Agents, Alkylating; 0 / Interferon-alpha; 7S5I7G3JQL / Dexamethasone; 8N3DW7272P / Cyclophosphamide; Q41OR9510P / Melphalan; VB0R961HZT / Prednisone
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96. Achach T, Rammeh S, Trabelsi A, Ltaief R, Ben Abdelkrim S, Mokni M, Korbi S: Clear cell adenocarcinoma arising from abdominal wall endometriosis. J Oncol; 2008;2008:478325
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  • Endometriosis is a frequent benign disorder.
  • A 49-year-old woman is presented with a large painful abdominal wall mass.
  • She underwent a myomectomy, 20 years before, for uterus leiomyoma.
  • Computed tomography suggested that this was a desmoid tumor and she underwent surgery.
  • Pelvic ultrasound, computed tomography, and endometrial curettage did not show any malignancy or endometriosis in the uterus and ovaries.
  • Adjuvant chemotherapy was recommended, but the patient was lost to follow up.
  • Six months later, she returned with a recurrence of the abdominal wall mass.
  • She was given chemotherapy and then she was reoperated.

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  • [Cites] Int J Gynaecol Obstet. 2005 Sep;90(3):218-22 [16040035.001]
  • [Cites] Int J Gynecol Cancer. 2006 Jan-Feb;16(1):432-5 [16445672.001]
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  • (PMID = 19266089.001).
  • [ISSN] 1687-8450
  • [Journal-full-title] Journal of oncology
  • [ISO-abbreviation] J Oncol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Egypt
  • [Other-IDs] NLM/ PMC2648644
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97. Langleben D, Cacoub P: A review of STRIDE-2 and STRIDE-2X: the case for selective endothelin receptor blockade. Eur J Clin Invest; 2009 Jun;39 Suppl 2:27-31
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • BACKGROUND: Pulmonary arterial hypertension remains incurable and has previously required difficult parenteral therapy.
  • The recent availability of oral therapies, including endothelin receptor antagonists, has improved ease of use for patients, but most patients remain symptomatic to a significant degree.
  • Pre-specified comparisons included time to discontinuation of monotherapy, time to clinical worsening, incidence of elevated hepatic transaminase levels > 3 x upper limit of normal and survival.
  • RESULTS: Sitaxsentan therapy showed significant benefit over bosentan with respect to discontinuation of monotherapy at 1 year (24% vs. 43%, P = 0.002), clinical worsening at 1 year (28% vs. 39%, P = 0.0425), elevated hepatic transaminases at 1 year (4% vs. 14%, P = 0.014) and 1-year survival (96% vs. 88%, P = 0.028).
  • [MeSH-major] Antihypertensive Agents / pharmacology. Endothelin A Receptor Antagonists. Endothelin B Receptor Antagonists. Hypertension, Pulmonary / drug therapy
  • [MeSH-minor] Adult. Aged. Female. Humans. Isoxazoles / adverse effects. Isoxazoles / pharmacology. Isoxazoles / therapeutic use. Liver / drug effects. Liver / enzymology. Male. Middle Aged. Randomized Controlled Trials as Topic. Sulfonamides / adverse effects. Sulfonamides / pharmacology. Sulfonamides / therapeutic use. Survival Analysis. Thiophenes / adverse effects. Thiophenes / pharmacology. Thiophenes / therapeutic use. Transaminases / metabolism. Treatment Outcome

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  • [ErratumIn] Eur J Clin Invest. 2009 Jul;39(7):630
  • (PMID = 19335744.001).
  • [ISSN] 1365-2362
  • [Journal-full-title] European journal of clinical investigation
  • [ISO-abbreviation] Eur. J. Clin. Invest.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antihypertensive Agents; 0 / Endothelin A Receptor Antagonists; 0 / Endothelin B Receptor Antagonists; 0 / Isoxazoles; 0 / Sulfonamides; 0 / Thiophenes; 0 / sitaxsentan; EC 2.6.1.- / Transaminases; Q326023R30 / bosentan
  • [General-notes] NLM/ Original DateCompleted: 20090407
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98. Schmilovitz-Weiss H, Melzer E, Tur-Kaspa R, Ben-Ari Z: Excellent outcome of Lamivudine treatment in patients with chronic renal failure and hepatitis B virus infection. J Clin Gastroenterol; 2003 Jul;37(1):64-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Excellent outcome of Lamivudine treatment in patients with chronic renal failure and hepatitis B virus infection.
  • We describe 4 patients with CRF on hemodialysis who showed a rapid and full response to 3TC, administered for a median of 10 months.
  • All patients had serum alanine transferase (ALT) levels 3 to 6 times the upper limit of normal prior to treatment, and different degrees of histologic inflammatory activity (Knodell score 4 to 8, median 6).
  • Within 4 to 8 weeks of initiation of therapy, HBV DNA became undetectable and serum ALT normalized.
  • Three patients also lost HBsAg with the evolution of a protective anti-HBsAb titer.
  • [MeSH-major] Hepatitis B / drug therapy. Kidney Failure, Chronic / drug therapy. Lamivudine / therapeutic use. Reverse Transcriptase Inhibitors / therapeutic use
  • [MeSH-minor] Adult. Hepatitis B Surface Antigens / drug effects. Hepatitis B e Antigens / drug effects. Hepatitis B virus / drug effects. Humans. Male. Middle Aged

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  • [CommentIn] J Clin Gastroenterol. 2003 Jul;37(1):9-11 [12811202.001]
  • (PMID = 12811212.001).
  • [ISSN] 0192-0790
  • [Journal-full-title] Journal of clinical gastroenterology
  • [ISO-abbreviation] J. Clin. Gastroenterol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hepatitis B Surface Antigens; 0 / Hepatitis B e Antigens; 0 / Reverse Transcriptase Inhibitors; 2T8Q726O95 / Lamivudine
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99. Sulkowski MS, Mehta SH, Chaisson RE, Thomas DL, Moore RD: Hepatotoxicity associated with protease inhibitor-based antiretroviral regimens with or without concurrent ritonavir. AIDS; 2004 Nov 19;18(17):2277-84
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • OBJECTIVE: To determine the incidence of significant liver enzyme elevations following the initiation of protease inhibitor (PI)-based antiretroviral therapy (ART) with or without pharmacokinetic boosting with ritonavir (RTV), and to define the role of chronic viral hepatitis in its development.
  • DESIGN: Prospective, cohort analysis of 1161 PI-naive, HIV-infected patients receiving RTV-boosted (lopinavir, indinavir and saquinavir) and unboosted PI-based ART (indinavir, nelfinavir) that had at least one liver enzyme measurement before and during therapy.
  • Severe hepatotoxicity was defined as an increase in serum liver enzyme >/= 5-times the upper limit of the normal range or 3.5-times an elevated baseline level.
  • CONCLUSIONS: Our data suggest that the lopinavir/RTV is not associated with a significantly increased risk of hepatotoxity among HCV-infected and uninfected patients compared with an alternative PI-based regimen, nelfinavir.
  • Accordingly, other medication-related factors (e.g, efficacy and non-hepatic toxicity) should guide individual treatment decisions.
  • [MeSH-major] Antiretroviral Therapy, Highly Active / methods. HIV Infections / drug therapy. HIV Protease Inhibitors / therapeutic use. Liver / enzymology. Ritonavir / therapeutic use
  • [MeSH-minor] AIDS-Related Opportunistic Infections / immunology. Adult. Chronic Disease. Drug Therapy, Combination. Female. Hepatitis / immunology. Humans. Indinavir / therapeutic use. Lopinavir. Male. Nelfinavir / therapeutic use. Prospective Studies. Pyrimidinones / therapeutic use. Reverse Transcriptase Inhibitors / therapeutic use. Risk Factors. Saquinavir / therapeutic use. Treatment Outcome

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  • (PMID = 15577540.001).
  • [ISSN] 0269-9370
  • [Journal-full-title] AIDS (London, England)
  • [ISO-abbreviation] AIDS
  • [Language] eng
  • [Grant] United States / NIAID NIH HHS / AI / AI 01637; United States / NIDA NIH HHS / DA / DA 00432; United States / NIDA NIH HHS / DA / DA 06007; United States / NIDA NIH HHS / DA / DA 11602; United States / NIDA NIH HHS / DA / DA 13806; United States / NIDA NIH HHS / DA / DA 16065; United States / AHRQ HHS / HS / HS 07-809
  • [Publication-type] Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] England
  • [Chemical-registry-number] 0 / HIV Protease Inhibitors; 0 / Pyrimidinones; 0 / Reverse Transcriptase Inhibitors; 2494G1JF75 / Lopinavir; 5W6YA9PKKH / Indinavir; HO3OGH5D7I / Nelfinavir; L3JE09KZ2F / Saquinavir; O3J8G9O825 / Ritonavir
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100. Joshi S, Cauch-Dudek K, Wanless IR, Lindor KD, Jorgensen R, Batts K, Heathcote EJ: Primary biliary cirrhosis with additional features of autoimmune hepatitis: response to therapy with ursodeoxycholic acid. Hepatology; 2002 Feb;35(2):409-13
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Primary biliary cirrhosis with additional features of autoimmune hepatitis: response to therapy with ursodeoxycholic acid.
  • 1) alanine transaminase (ALT) > 5 x the upper limit of normal (ULN);.
  • 2) immunoglobulin G (IgG) > 2 x ULN or positive anti-smooth muscle antibody (ASMA); and 3) moderate to severe lobular inflammation on pretreatment liver biopsy.
  • The median percent change in serum biochemistry and immunoglobulin values were similar in patients with PBC +/- features of AIH after 2 years of therapy with UDCA.
  • In conclusion, features of AIH in PBC may be transient and response to UDCA therapy similar to patients with PBC without features of AIH.
  • [MeSH-major] Cholagogues and Choleretics / therapeutic use. Hepatitis, Autoimmune / complications. Hepatitis, Autoimmune / drug therapy. Liver Cirrhosis, Biliary / complications. Liver Cirrhosis, Biliary / drug therapy. Ursodeoxycholic Acid / therapeutic use
  • [MeSH-minor] Adult. Antibodies, Antinuclear / analysis. Biopsy. Female. Humans. Liver / drug effects. Liver / pathology. Male. Middle Aged. Survival Analysis

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  • [CommentIn] Hepatology. 2002 Oct;36(4 Pt 1):1026-7; author reply 1027 [12297861.001]
  • (PMID = 11826416.001).
  • [ISSN] 0270-9139
  • [Journal-full-title] Hepatology (Baltimore, Md.)
  • [ISO-abbreviation] Hepatology
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Antinuclear; 0 / Cholagogues and Choleretics; 724L30Y2QR / Ursodeoxycholic Acid
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