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1. Gopal AK, Gooley TA, Maloney DG, Petersdorf SH, Eary JF, Rajendran JG, Bush SA, Durack LD, Golden J, Martin PJ, Matthews DC, Appelbaum FR, Bernstein ID, Press OW: High-dose radioimmunotherapy versus conventional high-dose therapy and autologous hematopoietic stem cell transplantation for relapsed follicular non-Hodgkin lymphoma: a multivariable cohort analysis. Blood; 2003 Oct 1;102(7):2351-7
The Lens. Cited by Patents in .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] High-dose radioimmunotherapy versus conventional high-dose therapy and autologous hematopoietic stem cell transplantation for relapsed follicular non-Hodgkin lymphoma: a multivariable cohort analysis.
  • We performed a multivariable comparison of 125 consecutive patients with follicular lymphoma (FL) treated at our centers with either high-dose radioimmunotherapy (HD-RIT) using 131I-anti-CD20 (n = 27) or conventional high-dose therapy (C-HDT) (n = 98) and autologous hematopoietic stem cell transplantation.
  • The groups were similar, although more patients treated with HD-RIT had an elevated pretransplantation level of lactate dehydrogenase (41% versus 20%, P =.03) and elevated international prognostic score (41% versus 19%, P =.02).
  • Patients treated with HD-RIT received individualized therapeutic doses of 131I-tositumomab (median, 19.7 GBq [531 mCi]) to deliver 17 to 31 Gy (median, 27 Gy) to critical organs.
  • Patients treated with C-HDT received total body irradiation plus chemotherapy (70%) or chemotherapy alone (30%).
  • Patients treated with HD-RIT experienced improved overall survival (OS) (unadjusted hazard ratio [HR] for death = 0.4 [95% confidence interval (95% CI), 0.2-0.9], P =.02; adjusted HR, 0.3, P =.004) and progression-free survival (PFS) (unadjusted HR =.6 [95% C.I., 0.3-1.0], P =.06; adjusted HR, 0.5, P =.03) versus patients treated with C-HDT.
  • The estimated 5-year OS and PFS were 67% and 48%, respectively, for HD-RIT and 53% and 29%, respectively, for C-HDT.
  • One hundred-day treatment-related mortality was 3.7% in the HD-RIT group and 11% in the C-HDT group.
  • The probability of secondary myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) was estimated to be.076 at 8 years in the HD-RIT group and.086 at 7 years in the C-HDT group.
  • HD-RIT may improve outcomes versus C-HDT in patients with relapsed FL.
  • [MeSH-major] Antigens, CD20 / immunology. Hematopoietic Stem Cell Transplantation. Iodine Radioisotopes / therapeutic use. Lymphoma, Follicular / radiotherapy. Lymphoma, Non-Hodgkin / radiotherapy. Radioimmunotherapy / methods
  • [MeSH-minor] Adult. Cohort Studies. Combined Modality Therapy. Disease Progression. Dose-Response Relationship, Radiation. Female. Humans. Male. Middle Aged. Multivariate Analysis. Neoplasm Recurrence, Local / mortality. Neoplasm Recurrence, Local / radiotherapy. Survival Rate. Treatment Outcome


2. Raoul JL, Van Laethem JL, Peeters M, Brezault C, Husseini F, Cals L, Nippgen J, Loos AH, Rougier P: Cetuximab in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) in the initial treatment of metastatic colorectal cancer: a multicentre two-part phase I/II study. BMC Cancer; 2009;9:112
NCI CPTC Antibody Characterization Program. NCI CPTC Antibody Characterization Program .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cetuximab in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) in the initial treatment of metastatic colorectal cancer: a multicentre two-part phase I/II study.
  • BACKGROUND: This study was designed to investigate the efficacy and safety of the epidermal growth factor receptor (EGFR) inhibitor cetuximab combined with irinotecan, folinic acid (FA) and two different doses of infusional 5-fluorouracil (5-FU) in the first-line treatment of EGFR-detectable metastatic colorectal cancer.
  • Patients received cetuximab (400 mg/m2 initial dose and 250 mg/m2/week thereafter) and every 2 weeks irinotecan (180 mg/m2), FA (400 mg/m2) and 5-FU (either low dose [LD], 300 mg/m2 bolus plus 2,000 mg/m2 46-hour infusion, n = 7; or, high-dose [HD], 400 mg/m2 bolus plus 2,400 mg/m2; n = 45).
  • RESULTS: Only two DLTs occurred in the HD group, and HD 5-FU was selected for use in part II.
  • Treatment facilitated the resection of initially unresectable metastases in fourteen patients (27%): of these, 10 patients (71%) had no residual tumour after surgery, and these resections hindered the estimation of PFS.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal / adverse effects. Antibodies, Monoclonal, Humanized. Camptothecin / administration & dosage. Camptothecin / adverse effects. Camptothecin / analogs & derivatives. Cetuximab. Diarrhea / chemically induced. Disease Progression. Dose-Response Relationship, Drug. Drug Administration Schedule. Exanthema / chemically induced. Female. Fluorouracil / administration & dosage. Fluorouracil / adverse effects. Follow-Up Studies. Humans. Infusions, Intravenous. Leucovorin / administration & dosage. Leucovorin / adverse effects. Leukopenia / chemically induced. Male. Middle Aged. Neoplasm Metastasis. Survival Analysis. Treatment Outcome. Vomiting / chemically induced

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  • (PMID = 19366444.001).
  • [ISSN] 1471-2407
  • [Journal-full-title] BMC cancer
  • [ISO-abbreviation] BMC Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 7673326042 / irinotecan; PQX0D8J21J / Cetuximab; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil; XT3Z54Z28A / Camptothecin
  • [Other-IDs] NLM/ PMC2678147
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3. Lötvall J, Ankerst J: Long duration of airway but not systemic effects of inhaled formoterol in asthmatic patients. Respir Med; 2008 Mar;102(3):449-56
Hazardous Substances Data Bank. ALBUTEROL .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • RATIONALE: Formoterol is approved as asthma rescue medication in many countries.
  • The exact duration of the airway vs. systemic effects of formoterol compared with another rescue medication, salbutamol, has not been evaluated.
  • LD) and 6x9 microg (higher dose; HD), salbutamol (VentolinDiskhaler) 3x400 microg (LD) and 9x400 microg (HD), and placebo in a randomized, double-blind, crossover trial.
  • Time with clinically relevant bronchodilation (FEV1 increase 12%) without clinically relevant markers of systemic effects (serum potassium suppression 0.2 mmol/L, QTc-prolongation 20 ms, or heart rate increase 8 beats per minute) was evaluated.
  • Thus, the time with clinically relevant bronchodilation without systemic effects is substantially longer after formoterol than after salbutamol.
  • [MeSH-major] Albuterol / administration & dosage. Asthma / drug therapy. Bronchodilator Agents / administration & dosage. Ethanolamines / administration & dosage
  • [MeSH-minor] Administration, Inhalation. Adult. Aged. Bronchi / drug effects. Bronchi / physiopathology. Cross-Over Studies. Double-Blind Method. Female. Forced Expiratory Volume. Formoterol Fumarate. Humans. Male. Middle Aged. Time Factors. Treatment Outcome

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  • (PMID = 18023335.001).
  • [ISSN] 0954-6111
  • [Journal-full-title] Respiratory medicine
  • [ISO-abbreviation] Respir Med
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Bronchodilator Agents; 0 / Ethanolamines; QF8SVZ843E / Albuterol; W34SHF8J2K / Formoterol Fumarate
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4. Kim JH, Park BL, Cheong HS, Bae JS, Park JS, Jang AS, Uh ST, Choi JS, Kim YH, Kim MK, Choi IS, Cho SH, Choi BW, Park CS, Shin HD: Genome-wide and follow-up studies identify CEP68 gene variants associated with risk of aspirin-intolerant asthma. PLoS One; 2010;5(11):e13818
Hazardous Substances Data Bank. ACETYLSALICYLIC ACID .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Aspirin-intolerant asthma (AIA) is a rare condition that is characterized by the development of bronchoconstriction in asthmatic patients after ingestion of non-steroidal anti-inflammatory drugs including aspirin.
  • All seven SNPs of the CEP68 gene showed linkage disequilibrium (LD), and the haplotype of CEP68_ht4 (T-G-A-A-A-C-G) showed a highly significant association with aspirin intolerance (OR= 2.63; 95% CI= 1.64-4.21; P = 6.0×10(-5)).
  • [MeSH-major] Aspirin / adverse effects. Drug Hypersensitivity / genetics. Microtubule-Associated Proteins / genetics. Polymorphism, Single Nucleotide
  • [MeSH-minor] Adolescent. Adult. Aged. Anti-Inflammatory Agents, Non-Steroidal / adverse effects. Anti-Inflammatory Agents, Non-Steroidal / therapeutic use. Asthma / drug therapy. Asthma / physiopathology. Chromosome Mapping. Female. Follow-Up Studies. Forced Expiratory Volume / drug effects. Gene Frequency. Genetic Predisposition to Disease / genetics. Genome-Wide Association Study. Genotype. Humans. Linkage Disequilibrium. Male. Middle Aged. Risk Factors. Young Adult

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  • (PMID = 21072201.001).
  • [ISSN] 1932-6203
  • [Journal-full-title] PloS one
  • [ISO-abbreviation] PLoS ONE
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anti-Inflammatory Agents, Non-Steroidal; 0 / CEP68 protein, human; 0 / Microtubule-Associated Proteins; R16CO5Y76E / Aspirin
  • [Other-IDs] NLM/ PMC2972220
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5. Ma XR, Chen YX, Liu J, Zhang WG, Cao XM, He AL, Yang Y: [Efficacy of different thalidomide regimens for patients with multiple myeloma and its relationship with TNF-alpha level]. Zhongguo Shi Yan Xue Ye Xue Za Zhi; 2008 Dec;16(6):1312-5
Hazardous Substances Data Bank. THALIDOMIDE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The study was aimed to investigate the clinical efficacy and adverse reactions of different thalidomide regimens in the treatment of multiple myeloma (MM), and to explore the relationship between efficacy of thalidomide and serum level of TNF-alpha in MM patients.
  • These 5 groups were following: group with the high dose (HD-T), group with thalidomide+VAD chemotherapy (T-VAD), group with thalidomide+MP chemotherapy (T-MP), group with thalidomide plus dexamethasone (TD), and group with low dose of thalidomide (LD-T).
  • Except 5 groups mentioned above, the group with conventional VAD chemotherapy was served as the control.
  • Clinical effects, adverse reactions, treatment-related mortality were observed.
  • At the same time, serum levels of TNF-alpha in 30 cases of MM treated with thalidomide (15 cases effective and 15 cases ineffective) before and after treatment were detected by double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) and were compared with the clinical efficacy.
  • The results showed that the efficient rate of HD-T, T-VAD, T-MP, TD, LD-T groups were 25.0%, 80.0%, 71.4%, 33.3%, 27.3% respectively; the efficacy of T-VAD, T-MP groups were significantly higher (p<0.05) than that of other groups and conventional VAD chemotherapy group.
  • The treatment-related mortality was 0%.
  • At the same time, it was found that the serum levels of TNF-alpha in ineffective group treated with thalidomide were 44.7+/-5.7 pg/ml and 46.3+/-4.0 pg/ml before and after thalidomide treatment, and there was no significant difference (p>0.05).
  • The serum levels of TNF-alpha (27.3+/-6.4) pg/ml in the effective group after treatment was significantly lower than that before treatment (49.2+/-7.3) pg/ml (p<0.05).
  • It is concluded that compared with conventional chemotherapy, thalidomide is a effective drug for treating MM patients.
  • Thalidomide in combination with chemotherapy (T-VAD, T-MP) may be one better therapeutic regimen with high efficiency and milder adverse reactions.

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  • (PMID = 19099634.001).
  • [ISSN] 1009-2137
  • [Journal-full-title] Zhongguo shi yan xue ye xue za zhi
  • [ISO-abbreviation] Zhongguo Shi Yan Xue Ye Xue Za Zhi
  • [Language] CHI
  • [Publication-type] Comparative Study; Controlled Clinical Trial; English Abstract; Journal Article
  • [Publication-country] China
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Tumor Necrosis Factor-alpha; 4Z8R6ORS6L / Thalidomide
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6. Gaedigk A, Simon SD, Pearce RE, Bradford LD, Kennedy MJ, Leeder JS: The CYP2D6 activity score: translating genotype information into a qualitative measure of phenotype. Clin Pharmacol Ther; 2008 Feb;83(2):234-42
Hazardous Substances Data Bank. DEXTROMETHORPHAN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • This complexity poses a challenge in translational research where genotyping is being considered as a tool to personalize drug therapy.
  • [MeSH-minor] Adolescent. Adult. Child. Child, Preschool. Cluster Analysis. Cohort Studies. Dextromethorphan / metabolism. Dextromethorphan / urine. Gene Frequency. Genotype. Humans. Infant. Linear Models. Male. Middle Aged. Phenotype. Reproducibility of Results. Substrate Specificity. United States

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  • [CommentIn] Clin Pharmacol Ther. 2008 Feb;83(2):225-7 [18202689.001]
  • (PMID = 17971818.001).
  • [ISSN] 1532-6535
  • [Journal-full-title] Clinical pharmacology and therapeutics
  • [ISO-abbreviation] Clin. Pharmacol. Ther.
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / 1P20RR11104; United States / NIGMS NIH HHS / GM / R01GM58647; United States / NICHD NIH HHS / HD / R03 HD36783; United States / NICHD NIH HHS / HD / U10 HD031313
  • [Publication-type] Evaluation Studies; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 7355X3ROTS / Dextromethorphan; EC 1.14.14.1 / Cytochrome P-450 CYP2D6
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7. Angelopoulou MK, Vassilakopoulos TP, Siakantaris MP, Kontopidou FN, Boussiotis VA, Papavassiliou C, Kittas C, Pangalis GA: EBVD combination chemotherapy plus low dose involved field radiation is a highly effective treatment modality for early stage Hodgkin's disease. Leuk Lymphoma; 2000 Mar;37(1-2):131-43
Hazardous Substances Data Bank. VINBLASTINE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] EBVD combination chemotherapy plus low dose involved field radiation is a highly effective treatment modality for early stage Hodgkin's disease.
  • To evaluate the efficacy of EBVD combination chemotherapy followed by low dose (LD) involved field (IF) radiation therapy (RT) in patients with clinical stage (CS) I-IIA Hodgkin's disease (HD), we analyzed 148 patients treated in our Unit from March 1988 to November 1995.
  • All drugs were administered i.v. at days 1 and 15, every 4 weeks, for a total of 4-6 cycles.
  • LDIF RT (24-32 Gy) was scheduled for patients with complete response (CR) or >90% reduction of tumor load, after EBVD.
  • Patients with stable or progressive disease (SD, PD) after EBVDx3 or poor compliance to the regimen received mantle or inverted Y RT at standard dose.
  • Nine patients relapsed at a median of 7 months from the end of treatment.
  • Six patients have died so far; 5 of HD and one of stroke.
  • One patient developed a diffuse large cell lymphoma 48 months after the diagnosis of HD.
  • We conclude that EBVD followed by LDIF RT is a highly effective regimen for patients with CS I-IIA HD.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Hodgkin Disease / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Bleomycin / administration & dosage. Combined Modality Therapy. Dacarbazine / administration & dosage. Epirubicin / administration & dosage. Female. Humans. Male. Middle Aged. Neoplasm Staging. Radiotherapy Dosage. Remission Induction. Survival Analysis. Vinblastine / administration & dosage

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  • (PMID = 10721777.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] SWITZERLAND
  • [Chemical-registry-number] 11056-06-7 / Bleomycin; 3Z8479ZZ5X / Epirubicin; 5V9KLZ54CY / Vinblastine; 7GR28W0FJI / Dacarbazine; EBVD protocol
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8. Nelles G, Schmitt L, Humbert T, Becker V, Sandow P, Bornhoevd K, Fritzsche D, Schäuble B, TOPMATMIG-0001 investigators: Prevention of episodic migraines with topiramate: results from a non-interventional study in a general practice setting. J Headache Pain; 2010 Feb;11(1):33-44
Hazardous Substances Data Bank. TOPIRAMATE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The majority of patients with migraine headaches are treated in non-specialized institutions though data on treatment outcomes are largely derived from tertiary care centers.
  • Reasons for discontinuation included adverse events (2.1%), lost to follow-up (1.8%), other reasons (1.5%), and end of therapy (0.3%) though in the majority of patients who discontinued no reasons were listed.
  • [MeSH-major] Fructose / analogs & derivatives. Migraine Disorders / prevention & control. Neuroprotective Agents / therapeutic use
  • [MeSH-minor] Absenteeism. Adolescent. Adult. Aged. Analgesics, Opioid / therapeutic use. Drug Administration Schedule. Dysmenorrhea / drug therapy. Electronic Health Records. Family Practice. Female. Follow-Up Studies. Humans. Male. Middle Aged. Outcome Assessment (Health Care). Pain Measurement / methods. Prospective Studies. Quality of Life. Surveys and Questionnaires. Time Factors. Young Adult

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  • (PMID = 19894100.001).
  • [ISSN] 1129-2377
  • [Journal-full-title] The journal of headache and pain
  • [ISO-abbreviation] J Headache Pain
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Analgesics, Opioid; 0 / Neuroprotective Agents; 0H73WJJ391 / topiramate; 30237-26-4 / Fructose
  • [Other-IDs] NLM/ PMC3452185
  • [Investigator] Wegner T; Fischer HW; Wolfram B; Schindlbeck K; Peters S; Schax U; Dietz EM; Haas J; Föh M; Katholnigg D; Rauch G; Kühn M; Becker VU; Springer M; Auner GM; Hontzek K; Kaune HW; Schreibmüller V; Liadski S; Wiedeking B; Rengeling M; Henning V; Walaschewski B; Schätzl RJ; Steinbrück B; Reineke H; Rönnebeck S; Armbruster T; Schätzl RJ; Tiedt A; Hördt T; Eisenkrätzer F; Waldmann R; Sandow P; Metzger B; Eckert A; Kayali N; Lang M; Klein H; Böneke H; Schiel C; Eyck M; Gross HD; Beck A; Spengruber B; Schulz-Meentzen M; Gruber A; Rubbel-Ehle A; Porrmann B; Unger M; Schaps KP; Stienker-Fisse H; Meyer G; Matuschke A; Eckardt H; Jansen U; Klook K; Witteborn M; Roidl T; Farke-Rämer K; Dietlein M; Möller P; Hofmann W; Lederle S; Wiedemann F; Rieser U; Wimmer ML; Enderle C; Gottesbüren D; Weber T; Oberling M; Flöhl W; Martinovic N; Köller W; Jersch B; Adam H; Carstensen O; Franke K; Martini N; Schneider-Nutz H; Bek E; Magnus-Ellenbroek B; Kukowski B; Jorns U; Kelch T; Endrass G; Katzfuss R; Schmitt L; Kühn F; Schietsch HJ; Diery HD; Wiese-Junginger D; Guse-Grosse F; Thonack J; Franz P; Dauwe R; Gerbaulet U; Koller S; Freitag E; Krug R; Jonas B; Linke A; Ulmer A; Jakob S; Gillwald V; Tomm M; Ampatziadis N; Udosic J; Kossler-Wiesweg C; Brose KO; Westfal HP; Noveanu RD; Jacob C; Fuchs V; Althen A; Lang A; Lebmeier R; Beykirch KF; Müller S; Krehan G; Ivancic R; Eichhorn A; Lion F; Misera A; Nowack C; Wagner A; Böger M; Ries S; Hachenberg K; Pickert P; Lang M; Strick V; Lüdtke A; Siemer M; Setiawan S; Feuerstack G; Müller A; Kim-Giesemann S; Noack D; Unsorg B; Busch R; Weischer K; Stenzel C; Albrecht C; Assmann U; Wegner M; Hufnagel H; Loddo M; Lohse LD; Derissen W; Junge B; Seidel F; Bannies H; Hanoldt I; Bachus R; Burger-Deinerth E; Ha-Phuoc H; Gülbeyaz M; Brauer G; Leps W; Ahrari F; Lode S; Brandt C; Zimmermann R; Böhme A; Bruckhaus-Walter M; Phillipp U; Loel U; Bruch M; Schulze K; Kohl SC; Lakony R; Nesimi M; Zug HD; Scarel S; Schultheiss UG; Berdermann-Welz S; Freudenstein W; Schmitt R; Christopher A; Patzelt U; Augustin-Reuss D; Sigel KO
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9. Borget I, Aupérin A, Pignon JP, Abbas M, Bouché O, Mousseau M, Raoul JL, Bedenne L, Cassan P, Clavero-Fabri MC, Stremsdoerfer N, Nasca S, Queuniet AM, Ducreux M, Fédération Francophone de Cancérologie Digestive: Cost-effectiveness analysis of first-line chemotherapies in metastatic colorectal cancer. Results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 randomized trial. Oncology; 2006;71(1-2):40-8
Hazardous Substances Data Bank. LEUCOVORIN .

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  • BACKGROUND: The De Gramont regimen (or high-dose LV5FU2, HD-LV5FU2) is considered a standard treatment for metastatic colorectal cancer.
  • The aim of the study was to evaluate the efficacy and the costs of three regimens as compared to HD-LV5FU2: raltitrexed (R), LV5FU2 with a lower dose of folinic acid (LD-LV5FU2), and weekly infusional 5FU (WI-FU).
  • METHODS: An economic analysis was performed prospectively as part of a randomized trial comparing first-line chemotherapy regimens in 294 patients with unresectable metastatic colorectal cancer.
  • RESULTS: None of the three regimens improved EFS as compared to HD-LV5FU2.
  • The mean total cost per patient was euro 15,970 for HD-LV5FU2.
  • The cost of R (10,687 euro) was lower than that of HD-LV5FU2 (p = 0.008).
  • The cost of LD-LV5FU2 (14,888 euro) and of WI-FU (13,760 euro) was not significantly different from that of HD-LV5FU2.
  • The HD-LV5FU2 protocol remains a better treatment.
  • LD-LV5FU2 appeared a good alternative regimen because it reduced costs without jeopardizing its efficacy.
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols. Cost of Illness. Cost-Benefit Analysis. Disease-Free Survival. Female. France. Humans. Leucovorin / administration & dosage. Male. Middle Aged. Neoplasm Staging. Quinazolines / administration & dosage. Survival Rate. Thiophenes / administration & dosage. Treatment Outcome

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  • (PMID = 17344670.001).
  • [ISSN] 0030-2414
  • [Journal-full-title] Oncology
  • [ISO-abbreviation] Oncology
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Quinazolines; 0 / Thiophenes; FCB9EGG971 / raltitrexed; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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10. Chihara K, Fujieda K, Shimatsu A, Miki T, Tachibana K: Dose-dependent changes in body composition during growth hormone (GH) treatment in Japanese patients with adult GH deficiency: a randomized, placebo-controlled trial. Growth Horm IGF Res; 2010 Jun;20(3):205-11
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Dose-dependent changes in body composition during growth hormone (GH) treatment in Japanese patients with adult GH deficiency: a randomized, placebo-controlled trial.
  • OBJECTIVE: A clinical study was carried out to investigate the efficacy and safety of two doses of GH treatment on adult growth hormone deficiency (AGHD) patients in Japan.
  • Mean changes in IGF-I SDS were 3.63+/-1.67, 1.97+/-1.27, and -0.13+/-0.55 in high-dose (HD) group (0.012 mg/kg/day), low-dose (LD) group (0.006 mg/kg/day), and placebo group, respectively.
  • Trunk fat mass decreased significantly (p<0.001) in HD group and LD group but not in placebo group (mean changes in percent trunk fat mass were -4.6+/-2.6%, -3.0+/-2.5% and 0.2+/-2.1% in HD group, LD group and placebo group, respectively).
  • Serum LDL-cholesterol decreased in both GH treated groups but significantly only in HD group.
  • CONCLUSIONS: GH treatment significantly improved serum levels of IGF-I and body composition in a dose-responsive manner in Japanese AGHD patients.
  • GH treatment was safe and generally well tolerated.
  • [MeSH-major] Body Composition / drug effects. Growth Disorders / drug therapy. Human Growth Hormone / administration & dosage. Human Growth Hormone / pharmacology
  • [MeSH-minor] Adolescent. Adult. Asian Continental Ancestry Group. Dose-Response Relationship, Drug. Double-Blind Method. Female. Humans. Male. Middle Aged. Placebos. Treatment Outcome. Young Adult

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  • [Copyright] Copyright 2010 Elsevier Ltd. All rights reserved.
  • (PMID = 20176498.001).
  • [ISSN] 1532-2238
  • [Journal-full-title] Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society
  • [ISO-abbreviation] Growth Horm. IGF Res.
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Scotland
  • [Chemical-registry-number] 0 / Placebos; 12629-01-5 / Human Growth Hormone
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11. Clark AD, Douglas KW, Mitchell LD, McQuaker IG, Parker AN, Tansey PJ, Franklin IM, Cook G: Dose escalation therapy in previously untreated patients with multiple myeloma following Z-Dex induction treatment. Br J Haematol; 2002 Jun;117(3):605-12
Hazardous Substances Data Bank. BUSULFAN .

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  • [Title] Dose escalation therapy in previously untreated patients with multiple myeloma following Z-Dex induction treatment.
  • A phase I-II study of high-dose (HD) alkylating agents in newly diagnosed patients with multiple myeloma after maximum response to Z-Dex (idarubicin, dexamethasone) therapy and DHAP (cisplatin, HD cytosine arabinoside, dexamethasone), stem cell mobilization is reported.
  • Twenty-six patients, median age 56 years (range 42-66), completed Z-Dex chemotherapy and peripheral blood stem cells (PBSC) were mobilized with DHAP.
  • Patients then preceded to cyclophosphamide (HD Cy: 6 g/m(2)) with granulocyte colony-stimulating factor followed by busulphan-melphalan-conditioned PBSC autograft.
  • Interferon alpha was introduced at 3 months post transplant as maintenance therapy.
  • Median time from diagnosis to transplantation was 8 months (range 6-12).
  • Median time from DHAP to HD-Cy was 6 weeks (range 4-12) and from HD-Cy to transplant was 8 weeks (range 6-12).
  • On an intent-to-treat basis, the response rates were three complete response (CR, 12%), 21 partial response (PR, 80%) and two stable disease (SD, 8%) post Z-Dex, five CR (19%) and 21 PR (81%) post HD-Cy, and 14 CR (54%) and 12 PR (46%) post transplant.
  • The treatment-related mortality (TRM) was 4% (1 patient).
  • DHAP produces effective PBSC mobilization and sequential HD therapy, including autologous PBSCT, in patients who received Z-Dex; this offers significant durable disease response rates with acceptable TRM.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Cyclophosphamide / administration & dosage. Multiple Myeloma / drug therapy
  • [MeSH-minor] Adult. Aged. Busulfan / administration & dosage. Cisplatin / administration & dosage. Cytarabine / administration & dosage. Dexamethasone / administration & dosage. Disease-Free Survival. Drug Administration Schedule. Female. Granulocyte Colony-Stimulating Factor / therapeutic use. Hematopoietic Stem Cell Mobilization / methods. Hematopoietic Stem Cell Transplantation. Humans. Idarubicin / administration & dosage. Interferon-alpha / administration & dosage. Male. Melphalan / administration & dosage. Middle Aged. Recombinant Proteins. Survival Rate. Treatment Outcome

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  • [ErratumIn] Br J Haematol 2002 Sep;118(4):1201
  • (PMID = 12028028.001).
  • [ISSN] 0007-1048
  • [Journal-full-title] British journal of haematology
  • [ISO-abbreviation] Br. J. Haematol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Recombinant Proteins; 04079A1RDZ / Cytarabine; 143011-72-7 / Granulocyte Colony-Stimulating Factor; 7S5I7G3JQL / Dexamethasone; 8N3DW7272P / Cyclophosphamide; 99210-65-8 / interferon alfa-2b; G1LN9045DK / Busulfan; Q20Q21Q62J / Cisplatin; Q41OR9510P / Melphalan; ZRP63D75JW / Idarubicin; DHAP protocol
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12. Cerfolio RJ, Bryant AS, Spencer SA, Bartolucci AA: Pulmonary resection after high-dose and low-dose chest irradiation. Ann Thorac Surg; 2005 Oct;80(4):1224-30; discussion 1230
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • BACKGROUND: The purpose of this study is to assess the safety and efficacy of pulmonary resection after low and high dose neoadjuvant radiotherapy with concurrent chemotherapy.
  • All patients had N2, stage IIIa, nonsmall cell lung cancer, and received neoadjuvant carboplatinum-based chemotherapy with similar doses.
  • In addition, some patients received high-dose chest radiation (HD) equal to or greater than 60 Gy and were compared with those who received low-dose radiation (LD) less than 60 Gy.
  • RESULTS: There were 104 patients, 50 in the LD group and 54 patients in the HD group.
  • Median dose of radiation was 45 Gy (range 35-50.4) in the LD group and 60 Gy (range 60-66.7) in the HD group.
  • Complete pathologic response rate was 10% compared to 28% favoring the HD group (p = 0.04).
  • CONCLUSIONS: Pulmonary resection after preoperative chest radiation is safe even after 60 Gy or higher.
  • However, if pneumonectomy is known to be required we prefer to avoid neoadjuvant radiotherapy and use chemotherapy alone.
  • [MeSH-major] Carcinoma, Non-Small-Cell Lung / radiotherapy. Carcinoma, Non-Small-Cell Lung / surgery. Lung Neoplasms / radiotherapy. Lung Neoplasms / surgery. Neoadjuvant Therapy / methods
  • [MeSH-minor] Adult. Aged. Antineoplastic Agents / administration & dosage. Cohort Studies. Dose-Response Relationship, Radiation. Female. Humans. Male. Middle Aged. Neoplasm Staging. Pneumonectomy. Radiotherapy Dosage. Retrospective Studies. Survival Analysis. Treatment Outcome

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  • (PMID = 16181844.001).
  • [ISSN] 1552-6259
  • [Journal-full-title] The Annals of thoracic surgery
  • [ISO-abbreviation] Ann. Thorac. Surg.
  • [Language] eng
  • [Publication-type] Comparative Study; Evaluation Studies; Journal Article
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Antineoplastic Agents
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13. Nassar AH, Abu-Musa AA, Awwad J, Khalil A, Tabbara J, Usta IM: Two dose regimens of nifedipine for management of preterm labor: a randomized controlled trial. Am J Perinatol; 2009 Sep;26(8):575-81
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  • Women with singleton pregnancies admitted in preterm labor (24 to 34 weeks) were randomized to high-dose (HD) nifedipine ( N = 49; 20 mg loading dose, repeated in 30 minutes, daily 120 to 160 mg slow-release nifedipine for 48 hours followed by 80 to 120 mg daily until 36 weeks) or low-dose (LD) nifedipine ( N = 53; 10 mg, up to four doses every 15 minutes, daily 60 to 80 mg slow-release nifedipine for 48 hours followed by 60 mg daily until 36 weeks).
  • Gestational age at delivery was higher in HD (36.0 +/- 2.8 versus 34.7 +/- 3.7 weeks, P = 0.049).
  • Rescue treatment was needed more in LD (24.5 versus 50.9%, odds ratio = 0.3; 95% confidence interval 0.1 to 0.7).
  • However, neonatal mechanical ventilation was needed less and nursery stay was shorter in HD.
  • HD nifedipine does not seem to have an advantage over LD in achieving uterine quiescence at 48 hours.
  • [MeSH-major] Nifedipine / administration & dosage. Obstetric Labor, Premature / drug therapy. Tocolytic Agents / administration & dosage
  • [MeSH-minor] Adult. Female. Humans. Pregnancy. Uterine Contraction / drug effects

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  • [Copyright] Thieme Medical Publishers.
  • (PMID = 19399705.001).
  • [ISSN] 1098-8785
  • [Journal-full-title] American journal of perinatology
  • [ISO-abbreviation] Am J Perinatol
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Tocolytic Agents; I9ZF7L6G2L / Nifedipine
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14. Nickelsen T, Samel A, Vejvoda M, Wenzel J, Smith B, Gerzer R: Chronobiotic effects of the melatonin agonist LY 156735 following a simulated 9h time shift: results of a placebo-controlled trial. Chronobiol Int; 2002 Sep;19(5):915-36
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  • [Title] Chronobiotic effects of the melatonin agonist LY 156735 following a simulated 9h time shift: results of a placebo-controlled trial.
  • INTRODUCTION: The melatonin agonist LY 156735 (LY) is a new investigational drug under development to treat circadian rhythm disorders.
  • The present study assessed the efficacy of LY to alleviate the symptoms of shift lag and to enhance readaptation of desynchronized circadian rhythms to a new time zone.
  • A high dose (HD) of 5 mg and a low dose (LD) of 0.5 mg of LY and placebo (PL) were administered double-blinded in a three-period cross-over design.
  • The time shift was performed at 23:00h of day 6 by advancing the laboratory time to 08:00h of day 7.
  • Double-blind study medication was administered at 14:30h on day 6, and at 22:30h on days 7-10.
  • RESULTS: HD but not LD enhanced the readaptation speed of all physiological rhythms investigated, as demonstrated by a significantly faster movement of acrophases towards the post-shift target time.
  • HD (p = 0.05) significantly blunted the post-shift deterioration of performance in those tests that were sensitive to shift lag.
  • [MeSH-major] Circadian Rhythm / drug effects. Indoles / pharmacology. Jet Lag Syndrome / drug therapy. Melatonin / agonists
  • [MeSH-minor] Adaptation, Physiological. Adult. Body Temperature / drug effects. Cross-Over Studies. Double-Blind Method. Humans. Hydrocortisone / urine. Male. Motor Activity / drug effects. Psychomotor Performance / drug effects

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  • (PMID = 12405554.001).
  • [ISSN] 0742-0528
  • [Journal-full-title] Chronobiology international
  • [ISO-abbreviation] Chronobiol. Int.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Indoles; 0 / LY 156735; JL5DK93RCL / Melatonin; WI4X0X7BPJ / Hydrocortisone
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15. Ohno S, Rai Y, Iwata H, Yamamoto N, Yoshida M, Iwase H, Masuda N, Nakamura S, Taniguchi H, Kamigaki S, Noguchi S: Three dose regimens of fulvestrant in postmenopausal Japanese women with advanced breast cancer: results from a double-blind, phase II comparative study (FINDER1). Ann Oncol; 2010 Dec;21(12):2342-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • BACKGROUND: FINDER1 compared efficacy, tolerability and pharmacokinetics (PK) of three fulvestrant dose regimens in postmenopausal Japanese women with estrogen receptor (ER)-positive locally advanced/metastatic breast cancer recurring or progressing after prior endocrine therapy.
  • PATIENTS AND METHODS: The primary end point of this randomised, multicentre, phase II study was objective response rate (ORR) and the secondary end points included time to progression (TTP), clinical benefit rate (CBR), PK profiles and tolerability.
  • Postmenopausal women with ER-positive advanced breast cancer were randomised to 28-day cycles of fulvestrant approved dose (AD), loading dose (LD) or high dose (HD) until disease progression.
  • RESULTS: Hundred and forty-three patients (median age 61 years) received fulvestrant AD (n = 45), LD (n = 51) or HD (n = 47).
  • ORR was similar across dose regimens: 11.1%, 17.6% and 10.6% for AD, LD and HD, respectively, with overlapping confidence intervals.
  • TTP and CBR were also similar between groups (median TTP: 6.0, 7.5 and 6.0 months, respectively; CBR: 42.2%, 54.9% and 46.8% for AD, LD and HD, respectively).
  • C(max) and area under the plasma concentration-time curve were dose proportional and PK steady state was reached earlier with LD and HD than with AD.
  • CONCLUSION: Fulvestrant AD, LD and HD had similar efficacy and tolerability profiles in postmenopausal Japanese women with ER-positive advanced breast cancer.

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  • (PMID = 20494961.001).
  • [ISSN] 1569-8041
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 22X328QOC4 / fulvestrant; 4TI98Z838E / Estradiol
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16. Dressler D, Adib Saberi F, Benecke R: Botulinum toxin type B for treatment of axillar hyperhidrosis. J Neurol; 2002 Dec;249(12):1729-32

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  • [Title] Botulinum toxin type B for treatment of axillar hyperhidrosis.
  • Recently, botulinum toxin type B (BT-B) became commercially available for treatment of cervical dystonia.
  • It is the aim of this study to explore its use for treatment of bilateral axillar hyperhydrosis (HH).
  • For this we directly compared the antihyperhydrotic effect of BT-B (NeuroBloc)/MyoBloc) with that of botulinum toxin type A (BT-A) (Botox).
  • 9 patients (HD group) received BT-A 100MU unilaterally and BT-B 4000MU contralaterally.
  • 10 patients (LD group) received BT-A 100MU and BT-B 2000MU.
  • The duration of HH improvement until first recurrence in the HD group was 16.0 +/-4.3 weeks in the BT-A treated axillar and 16.4 +/-4.5 weeks in the BT-B treated axillae (Wilcoxon rank-sum test, p = 0.336).
  • In the LD group it was 16.4 +/-5.3 weeks in the BT-B treated axillae and 17.1 +/-5.7 weeks in the BT-A treated axillae (Wilcoxon rank-sum test, p = 0.059).
  • 5 out of 9 patients in the HD group (chi-square test, p = 0.025) and 7 out of 10 patients in the LD group (chi-square test, p = 0.008) reported more application discomfort in the BT-B treated axillae.
  • In 6 out of 9 patients in the HD group (chi-square test, p = 0.014) and in 6 out of 10 patients in the LD group (chi-square test, p = 0.014) the onset of HH improvement appeared earlier in the BT-B treated axillae.
  • One patient in the HD group reported dryness of the mouth and eyes and accomodation difficulties.BT-B is a safe and efficient treatment for axillar HH.
  • [MeSH-major] Botulinum Toxins / administration & dosage. Hyperhidrosis / drug therapy
  • [MeSH-minor] Adult. Axilla. Botulinum Toxins, Type A. Chi-Square Distribution. Female. Humans. Male. Statistics, Nonparametric

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  • (PMID = 12529798.001).
  • [ISSN] 0340-5354
  • [Journal-full-title] Journal of neurology
  • [ISO-abbreviation] J. Neurol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0Y70779M1F / rimabotulinumtoxinB; EC 3.4.24.69 / Botulinum Toxins; EC 3.4.24.69 / Botulinum Toxins, Type A
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17. Comella P, Massidda B, Filippelli G, Palmeri S, Natale D, Farris A, De Vita F, Buzzi F, Tafuto S, Maiorino L, Mancarella S, Leo S, Lorusso V, De Lucia L, Roselli M: Oxaliplatin plus high-dose folinic acid and 5-fluorouracil i.v. bolus (OXAFAFU) versus irinotecan plus high-dose folinic acid and 5-fluorouracil i.v. bolus (IRIFAFU) in patients with metastatic colorectal carcinoma: a Southern Italy Cooperative Oncology Group phase III trial. Ann Oncol; 2005 Jun;16(6):878-86
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  • PATIENTS AND METHODS: Patients with measurable metastatic colorectal carcinoma were randomly allocated to receive: IRI 200 mg/m(2) on day 1, l-FA 250 mg/m(2) intravenously plus 5-FU 850 mg/m(2) on day 2 (IRIFAFU); or OXA 100 mg/m(2) on day 1, l-FA 250 mg/m(2) plus 5-FU 1050 mg/m(2) on day 2 [OXAFAFU high dose (hd)].
  • After a planned interim analysis, OXA was reduced to 85 mg/m(2) and 5-FU to 850 mg/m(2) [OXAFAFU low dose (ld)].
  • CONCLUSIONS: OXAFAFU was more active and less toxic than IRIFAFU, and it should be preferred in the first-line treatment of advanced colorectal cancer patients.

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  • [CommentIn] Ann Oncol. 2005 Jun;16(6):845-6 [15890668.001]
  • (PMID = 15837702.001).
  • [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] Clinical Trial; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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18. Jang IG, Yang JK, Lee HJ, Yi JY, Kim HO, Kim CW, Kim TY: Clinical improvement and immunohistochemical findings in severe atopic dermatitis treated with interferon gamma. J Am Acad Dermatol; 2000 Jun;42(6):1033-40
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • BACKGROUND: Several clinical studies have focused on the therapeutic effects of interferon gamma (IFN-gamma) in patients with severe atopic dermatitis (AD), although the dosage of recombinant IFN-gamma (rIFN-gamma), therapeutic schedule, and the degree of clinical improvement were different among studies.
  • Although the exact mechanism of action of IFN-gamma therapy in AD is not clear, the beneficial effects of IFN-gamma have been attributed mainly to an immunomodulating effect on the expression of certain immunologic markers.
  • OBJECTIVE: Our purpose was to study the therapeutic effect of two different dosages of rIFN-gamma on AD and to investigate the change of lesional expression of infiltrating inflammatory cell markers associated with rIFN-gamma therapeutic efficacy.
  • Twenty patients were treated with 0.5 x 10(6) IU/m(2) of rIFN-gamma (low-dose [LD] group); 21 patients received 1.5 x 10(6) IU/m(2) of rIFN-gamma (high-dose [HD] group); and 10 patients received placebo.
  • The patients were injected subcutaneously 3 times a week for 12 weeks.
  • Immunohistochemical study was performed in 20 patients of the HD group in the initial visit and after completion of rIFN-gamma therapy with a panel of 14 monoclonal antibodies as markers of inflammatory cells and cytokines.
  • RESULTS: The disease severity of the 2 groups treated with rIFN-gamma was reduced significantly at the end of treatment compared with that of the placebo group (P<.05).
  • More rapid clinical improvement and more effective treatment outcome were seen in the HD group than in the LD group for the initial 6-week treatment period; however, the clinical improvement in both of the treated groups was stable and maintained after week 8 of treatment.
  • Immunohistochemical findings showed statistically significant reduction in the lesional expression of CD25 and EG2 cells that infiltrated into skin after rIFN-gamma therapy.
  • CONCLUSION: This study demonstrated that rIFN-gamma therapy for AD is safe and effective.
  • In the early phase of therapy, a higher dosage of rIFN-gamma is more effective; and for the maintenance of clinical improvement, a lower dosage of rIFN-gamma is recommended when high cost and effectiveness of rIFN-gamma are considered.
  • The therapeutic efficacy of rIFN-gamma in AD might be in part related to the decreased number of CD25(+) and EG2(+) inflammatory cells infiltrated into skin.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Dermatitis, Atopic / drug therapy. Interferon-gamma / therapeutic use
  • [MeSH-minor] Adolescent. Adult. Biomarkers / analysis. Cost-Benefit Analysis. Cytokines / analysis. Dose-Response Relationship, Drug. Female. Humans. Immunohistochemistry. Lymphocytes / immunology. Male. Receptors, Interleukin-2 / analysis. Treatment Outcome

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  • (PMID = 10827410.001).
  • [ISSN] 0190-9622
  • [Journal-full-title] Journal of the American Academy of Dermatology
  • [ISO-abbreviation] J. Am. Acad. Dermatol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Comparative Study; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Biomarkers; 0 / Cytokines; 0 / Receptors, Interleukin-2; 82115-62-6 / Interferon-gamma
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19. Schild SE, Bonner JA, Shanahan TG, Brooks BJ, Marks RS, Geyer SM, Hillman SL, Farr GH Jr, Tazelaar HD, Krook JE, Geoffroy FJ, Salim M, Arusell RM, Mailliard JA, Schaefer PL, Jett JR: Long-term results of a phase III trial comparing once-daily radiotherapy with twice-daily radiotherapy in limited-stage small-cell lung cancer. Int J Radiat Oncol Biol Phys; 2004 Jul 15;59(4):943-51
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  • ) RT for patients with limited-stage small-cell lung cancer (LD-SCLC).
  • METHODS AND MATERIALS: A total of 310 patients with LD-SCLC initially received three cycles of etoposide and cisplatin.
  • RT (50.4 Gy in 28 fractions) or split-course b.i.d.
  • RT (24 Gy in 16 fractions, a 2.5-week break, and 24 Gy in 16 fractions) to the chest.
  • No statistically significant differences were found in the rates of progression (p = 0.68), intrathoracic failure (p = 0.45), in-field failure (p = 0.62), or distant failure (p = 0.82) between the two treatment arms.
  • RT, the long-term survival was favorable, likely reflecting the positive influences of concurrent combined modality therapy and prophylactic cranial RT.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Small Cell / drug therapy. Carcinoma, Small Cell / radiotherapy. Lung Neoplasms / drug therapy. Lung Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Cisplatin / administration & dosage. Combined Modality Therapy. Cranial Irradiation. Dose Fractionation. Etoposide / administration & dosage. Female. Humans. Male. Middle Aged. Radiotherapy / adverse effects. Survival Analysis

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  • [CommentIn] Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):925-7 [15234025.001]
  • (PMID = 15234027.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 15083; United States / NCI NIH HHS / CA / CA 25224; United States / NCI NIH HHS / CA / CA 35101; United States / NCI NIH HHS / CA / CA 35103; United States / NCI NIH HHS / CA / CA 35113; United States / NCI NIH HHS / CA / CA 35195; United States / NCI NIH HHS / CA / CA 35269; United States / NCI NIH HHS / CA / CA 35272; United States / NCI NIH HHS / CA / CA 35415; United States / NCI NIH HHS / CA / CA 35448; United States / NCI NIH HHS / CA / CA 37404; United States / NCI NIH HHS / CA / CA 37417; United States / NCI NIH HHS / CA / CA 52352; United States / NCI NIH HHS / CA / CA 60276; United States / NCI NIH HHS / CA / CA 63826; United States / NCI NIH HHS / CA / CA 63848; United States / NCI NIH HHS / CA / CA 63849
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 6PLQ3CP4P3 / Etoposide; Q20Q21Q62J / Cisplatin
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20. Wexberg P, Sperker W, Morgenthaler NG, Heinzl H, Adlbrecht C, Plass C, Glogar HD, Lang IM, Neunteufl T: Inhomogeneous vasomotor effects of moderate selective and non-selective endothelin-receptor blockade in stable coronary artery disease. Heart; 2009 Aug;95(15):1258-64
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  • [Title] Inhomogeneous vasomotor effects of moderate selective and non-selective endothelin-receptor blockade in stable coronary artery disease.
  • OBJECTIVE: To explore the morphological and functional effect of selective and non-selective endothelin (ET)-receptor blockade in coronary artery disease (CAD).
  • MAIN OUTCOME MEASURES: Fractional flow reserve (FFR), coronary flow reserve (CFR) and intramyocardial resistance (IMR) by PressureWire, mean arterial blood pressure (MAP), minimal lumen diameter (MLD) and average angiographic lumen diameter (mean LD) of the target vessel before and after intracoronary infusion of ET antagonists.
  • RESULTS: Mean MLD, mean LD, FFR, CFR, IMR and MAP remained unaffected by ET-receptor blockade in both groups; their changes were comparable.
  • Prolonged infusion time may be needed to cause a more distinct vasomotor response.
  • [MeSH-major] Antihypertensive Agents / therapeutic use. Coronary Artery Disease / drug therapy. Endothelin Receptor Antagonists. Oligopeptides / therapeutic use. Peptides, Cyclic / therapeutic use. Piperidines / therapeutic use
  • [MeSH-minor] Adult. Aged. Angina Pectoris / drug therapy. Angina Pectoris / physiopathology. Coronary Angiography. Endothelin-1 / blood. Female. Fractional Flow Reserve, Myocardial / drug effects. Humans. Male. Middle Aged. Myocardial Ischemia / drug therapy. Myocardial Ischemia / physiopathology. Prospective Studies. Protein Precursors / blood. Young Adult

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  • (PMID = 19414437.001).
  • [ISSN] 1468-201X
  • [Journal-full-title] Heart (British Cardiac Society)
  • [ISO-abbreviation] Heart
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00427232
  • [Publication-type] Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antihypertensive Agents; 0 / BQ 788; 0 / Endothelin Receptor Antagonists; 0 / Endothelin-1; 0 / Oligopeptides; 0 / Peptides, Cyclic; 0 / Piperidines; 0 / Protein Precursors; 0 / proendothelin 1; 136553-81-6 / cyclo(Trp-Asp-Pro-Val-Leu)
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21. Oreskovich MR, Saxon AJ, Ellis ML, Malte CA, Reoux JP, Knox PC: A double-blind, double-dummy, randomized, prospective pilot study of the partial mu opiate agonist, buprenorphine, for acute detoxification from heroin. Drug Alcohol Depend; 2005 Jan 7;77(1):71-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Heroin users (N = 30) who met DSM-IV criteria for opioid dependence and achieved a Clinical Opiate Withdrawal Scale (COWS) score of 13 (moderate withdrawal), were randomized to receive higher dose buprenorphine (HD, 8-8-8-4-2 mg/day on days 1-5), lower dose buprenorphine (LD, 2-4-8-4-2 mg/day on days 1-5), or clonidine (C, 0.2-0.3-0.3-0.2-0.1 mg QID on days 1-5).
  • Twenty-four hours after randomization, the percentages of subjects who achieved suppression of withdrawal, as defined by four consecutive COWS scores <12, were: C = 11%, LD = 40%, and HD = 60%.
  • Generalized estimating equation regression models, controlling for baseline COWS and time, indicated that COWS scores over the course of 5 days were lower in both LD and HD compared to C (chi(2)(2) = 13.28, P = 0.001).
  • Similar analyses examining scores over time on the Adjective Rating Scale for Withdrawal (ARSW) and on a Visual Analog Scale of Opiate Craving (VAS) indicated an overall treatment effect on the VAS accounted for by a significant difference between HD and C, but no overall treatment effect on the ARSW.
  • There were no discontinuations due to treatment-related adverse events.
  • Both HD and LD regimens are safe and efficacious treatment for opioid detoxification, but HD demonstrated superiority to C on a greater number of measures.
  • [MeSH-major] Analgesics, Opioid / therapeutic use. Buprenorphine / therapeutic use. Heroin Dependence / drug therapy. Receptors, Opioid, mu / agonists
  • [MeSH-minor] Adult. Analysis of Variance. Clonidine / pharmacology. Clonidine / therapeutic use. Double-Blind Method. Female. Follow-Up Studies. Humans. Male. Middle Aged. Pilot Projects. Prospective Studies. Time Factors

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  • (PMID = 15607843.001).
  • [ISSN] 0376-8716
  • [Journal-full-title] Drug and alcohol dependence
  • [ISO-abbreviation] Drug Alcohol Depend
  • [Language] eng
  • [Publication-type] Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Analgesics, Opioid; 0 / Receptors, Opioid, mu; 40D3SCR4GZ / Buprenorphine; MN3L5RMN02 / Clonidine
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22. Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P: Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat; 2010 Sep;123(2):453-61
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • FINDER2 enrolled Western postmenopausal women recurring or progressing after prior endocrine therapy.
  • Primary endpoint: objective response rate (ORR); secondary endpoints: time to progression (TTP), clinical benefit rate (CBR), tolerability, and PK parameters.
  • Patients were randomized to receive fulvestrant: 250 mg/month (approved dose [AD]); 250 mg plus loading dose (loading dose [LD]; 500 mg on day 0, 250 mg on days 14, 28, and monthly thereafter); or 500 mg (high dose [HD]; 500 mg/month plus 500 mg on day 14 of Month 1).
  • Treatment continued until disease progression or discontinuation.
  • 144 patients were randomized: fulvestrant AD (n = 47); LD (n = 51); HD (n = 46).
  • ORRs were: 8.5% (95% confidence interval [CI]: 2.4, 20.4%), 5.9% (1.2, 16.2%), and 15.2% (6.3, 28.9%) in the AD, LD, and HD arms, respectively.
  • CBRs were: 31.9% (95% CI: 19.1, 47.1%), 47.1% (32.9, 61.5%), and 47.8% (32.9, 63.1%) for the AD, LD, and HD arms, respectively.
  • Median TTP (months) was numerically longer for HD (6.0) and LD (6.1) versus AD (3.1).
  • Steady-state plasma fulvestrant concentrations were predictable and achieved earlier with LD and HD.
  • While there appeared to be a trend toward improved efficacy with HD and LD versus AD, no significant differences could be shown.
  • [MeSH-major] Breast Neoplasms / drug therapy. Estradiol / analogs & derivatives. Estrogen Antagonists / administration & dosage. Receptors, Estrogen / drug effects
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Canada. Disease Progression. Double-Blind Method. Europe. Female. Humans. Kaplan-Meier Estimate. Middle Aged. Postmenopause. Time Factors. Treatment Outcome

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  • (PMID = 20632084.001).
  • [ISSN] 1573-7217
  • [Journal-full-title] Breast cancer research and treatment
  • [ISO-abbreviation] Breast Cancer Res. Treat.
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00313170
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Estrogen Antagonists; 0 / Receptors, Estrogen; 22X328QOC4 / fulvestrant; 4TI98Z838E / Estradiol
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23. Lehmann KA, Paral F, Sabatowski R: [Postoperative pain therapy with hydromorphone and metamizole. A prospective randomized study in intravenous patient-controlled analgesia (PCA)]. Anaesthesist; 2001 Oct;50(10):750-6
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  • [Title] [Postoperative pain therapy with hydromorphone and metamizole. A prospective randomized study in intravenous patient-controlled analgesia (PCA)].
  • [Transliterated title] Postoperative Schmerztherapie mit Hydromorphon und Metamizol. Eine prospektiv randomisierte Untersuchung im Rahmen der intravenösen patientenkontrollierten Analgesie (PCA).
  • A total of 120 patients recovering from elective abdominal or orthopaedic surgery, performed under standardised general anaesthesia, were randomised into 3 double-blind treatment groups to receive intravenous PCA demand doses of hydromorphone 283 micrograms (low dose, LD), 566 micrograms (high dose, HD) or a combination of hydromorphone 283 micrograms and metamizole 50 mg (low dose hydromorphone + metamizole, LM).
  • Lockout times were set to 2 min.
  • After an average observation time of 24.5 +/- 2.6 h (mean, SD) since start of PCA, cumulative PCA hydromorphone doses in groups LD, HD and LM were 7.8 +/- 3.3, 12.1 +/- 4.8 and 7.5 +/- 2.0 mg, respectively, with the well known large inter-individual variability in all groups.
  • Although hydromorphone consumption was significantly higher in group HD, self-reported pain intensities (VAS, retrospective pain scores) were quite comparable between the groups.
  • Side-effects were typical for potent postoperative opioids, but never required special treatment; haemodynamic or respiratory complications were not observed in any patient.
  • It can be concluded by comparison with other PCA opioid investigations performed under the same study protocol that hydromorphone is about 3-4 times as potent an analgesic as morphine under the conditions of intravenous postoperative PCA.
  • Due to a favourable patient acceptance, hydromorphone can be recommended as a suitable alternative to other opioids for the treatment of postoperative pain.
  • [MeSH-major] Analgesia, Patient-Controlled. Analgesics, Opioid / therapeutic use. Anti-Inflammatory Agents, Non-Steroidal / therapeutic use. Dipyrone / therapeutic use. Hydromorphone / therapeutic use. Pain, Postoperative / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Double-Blind Method. Drug Therapy, Combination. Female. Humans. Male. Middle Aged. Prospective Studies

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  • (PMID = 11702324.001).
  • [ISSN] 0003-2417
  • [Journal-full-title] Der Anaesthesist
  • [ISO-abbreviation] Anaesthesist
  • [Language] ger
  • [Publication-type] Clinical Trial; English Abstract; Journal Article; Randomized Controlled Trial
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Analgesics, Opioid; 0 / Anti-Inflammatory Agents, Non-Steroidal; 6429L0L52Y / Dipyrone; Q812464R06 / Hydromorphone
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24. Park J, Chang JW, Lee JS, Chung HC, Yang WS, Lee SK, Park SK, Park JS: Efficacy of low-dose i.v. iron therapy in haemodialysis patients. Nephrology (Carlton); 2009 Dec;14(8):716-21
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  • [Title] Efficacy of low-dose i.v. iron therapy in haemodialysis patients.
  • AIM: i.v. iron therapy is more effective in maintaining adequate iron status in haemodialysis (HD) patients than oral iron therapy (OIT).
  • However, data on lower doses of i.v. iron therapy are insufficient.
  • METHODS: A non-randomized, open-label study was performed to compare the efficacy of low-dose (<or=50 mg/week of iron sucrose) i.v. iron therapy (LD-IVIT) with OIT in HD patients with 100-800 microg/L serum ferritin levels over 4 months.
  • RESULTS: Eighty-nine patients in the LD-IVIT group (40 men, 49 women; aged 61 +/- 13 years) and 30 patients in the oral iron therapy group (17 men, 13 women; aged 59 +/- 7 years) were evaluated.
  • After 4 months of each treatment, serum ferritin levels increased from 398 +/- 137 to 529 +/- 234 microg/L in the LD-IVIT group (P < 0.01) but decreased from 351 +/- 190 to 294 +/- 175 microg/L in the OIT group (P < 0.01).
  • In the LD-IVIT group, transferrin saturation (from 28% +/- 11% to 30% +/- 14%, P = 0.49), weekly doses of recombinant human erythropoietin (from 5822 +/- 2354 to 5636 +/- 2306 IU/week, P = 0.48) and haemoglobin (from 101 +/- 9 to 103 +/- 9 g/L, P = 0.15) levels remained stable.
  • CONCLUSION: LD-IVIT may be one of the regimens that may be considered for maintaining iron status in HD patients.
  • However, efficacy of LD-IVIT should be verified by further randomized study.
  • [MeSH-major] Anemia / drug therapy. Iron / administration & dosage. Renal Dialysis / adverse effects
  • [MeSH-minor] Adult. Aged. Erythropoietin / therapeutic use. Female. Ferritins / blood. Humans. Injections, Intravenous. Male. Middle Aged. Recombinant Proteins

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  • (PMID = 20025679.001).
  • [ISSN] 1440-1797
  • [Journal-full-title] Nephrology (Carlton, Vic.)
  • [ISO-abbreviation] Nephrology (Carlton)
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Australia
  • [Chemical-registry-number] 0 / Recombinant Proteins; 11096-26-7 / Erythropoietin; 9007-73-2 / Ferritins; E1UOL152H7 / Iron
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25. Olivares JM, Rodriguez-Morales A, Diels J, Povey M, Jacobs A, Zhao Z, Lam A, Villalobos Vega JC, Cuéllar JA, de Castro FJ, Quintero CM, Martíin JF, Domínguez P, Ojeda JL, Cortés SS, Cala FI, Marín CG, Castro LM, Duaso MA, Albarracín JR, Vergara GN, Benítez AF, Cleries FM, Pérez-Brian JM, Aragón AB, Navarro JC, Biedma JA, de Pedro RB, González JF, López ME, Moreno HD, López JA, Rodríguez EO, de Hoyos CM, Sacristán MP, Martín MD, Ballesteros EM, Rodríguez PA, Menéndez LF, Rivas RS, del Pino Cuadrado P, Lauffer JC, Solano JJ, Martínez JM, Solano FG, Rodríguez PG, Rodríguez JA, Cano TR, Fortacin MD, Lobeiras JM, Sampedro JM, Bravo AP, Pellicer AF, López MD, Liste JF, Fernández MR, Losada AC, Mendez RV, Romero SA, Blanco JJ, Bonaselt IT, Mahia MC, del Valle EF, Yañez PQ, Camarasa MG, Alonso JA, Mendez GF, Feliz FD, Lamela MA, Piñero MV, Alvarado PF, Gómez IL, Martín PF, Gómez JL, López AG, Jiménez AR, Nafs AE, Barquero NC, Ortiz RF, Noguera JL, Carrasco PR, Muñoz JM, Palma MM, Hortelano CM, Bonome LS, Sevilla JS, Juan JM, Ramos JM, Muñoz JL, Guisasola JE, Vazquez LS, Guerras FC, Nebot FJ, Fernández FJ, Nicolau AL, Subirats RC, Kidias MM, Navarro VF, García BF, del Rosal FM, de Vicente Muñoz T, Ballester JA, Lieb PM, Martel AD, Bea ER, Joaquim IG, Enjuanes FB, Piñol MB, Carbonell EF, Muñoz RM, Giribets CA, Sans LA, Blanco AS, Felipe MA, Muñoz PG, Villanueva AP, Arroyo MB, Borri RC, Fallada SM, Merola MC, Rodon EP, Palmes JR, Martínez EP, Catala JM, Coca AS, Ferrandiz FP, Paya EF, Caballero GI, Bonet AF, Figueras JF, Pagador PM, Garibo MM, Camo VP, Carrillo CS, Valero CP, Rebollo FJ, García Campayo J, Sala Ayma JM, Roig MM, de Uña Mateos MA, Bertolin RG, García AM, Mazo FJ, Velasco JL, Pérez LS, Casado CJ, Barba JJ, Diaz MC, Rubio JP, Mandoli AS, Herrero AU, Martínez AR, Serrano PS, Rodríguez EN, Montesinos JS, Macia JF, Mateos Marcos AM, Soto JV, Dumont MV, Pagan JP, Martínez VB, Santiuste de Pablos M, Delgado CE, Quiles MD, López FJ, Navarro PP, Torres AM, Ingles FJ, Arias-Camison JM, Manzano JC, Peña RV, Guitarte GP, Fontecilla HB, Romero JB, Gil RS, Lozano JM, Adanez LD, Zarranz Herrera-Oria I, Jiménez JP, Vaz FC, García OS, Anton CC, Casula RR, Hernandez MC, Escabias FT, Torresano JR, Pérez-Villamil AH, Estevez L, Figuero MA, Muñoz de Morales A, Calvin JL, Criado MD, Rodríguez VM, Ambrosolio EB, Madera PM, Alfaro GP, Vidal MM, Valtuille AG, Ruiz O, Cabornero GL, Echevarria Martínez de Bujo M, Mallen MJ, Puigros JS, Martorell AL, Forteza AC, Arrebola ER, Rodríguez de la Torre M, Saiz CG, Bardolet I Casas C, Linde ER, De Arce Cordon R, Molina EM, Carazo FJ, Romero JJ, Cano DV, Dorado MS, Velazquez SC, Sánchez AJ, Leon SO, Sánchez KP, Benitez MH, Zugarramurai AI, Contreras MA, De la Varga González M, Marín PB, Robina FG, García MS, Pérez FJ, Bros PC, Gómez AC, de Dios Molina Martín J, Perera JL, Averbach MC, Perera JL, Palancares EG, Gallego de Dios MT, Rojo CF, Iglesias SS, Merino MI, Mestre NP, Urdaniz AP, Sánchez JM, Seco RG, Muñoz JF, Agut MM, Lozano ML, Herguedas FM, Pena AT, García JV, Martínez AV, Sanz Granado OS, Fernández MA, Canseco JM, López PA, Martín MA, Barrio JA, Ubago JG, Bennassar MR, Díez JM, Fleta JL, Fortes FP, López CA, Medina O, Alvarez DF, Roca JM, Valladolid GR, Tavera JA, García-Castrillon Sales JA, Llordes IB, Melgarejo CA, Cañas de la Paz F, Callol VV, García MB, García JB, Leal FJ, Corrales EC, Iglesias ES, Gómez MA, Serrano GG, Chillarón EG, Aguado FJ, Castillo JJ, González AG, Vázquez JG, Peralvarez MB, Diaz MR, Mesa MY, Artiles FJ, Chao MA, Mesa MY, del Rosario Santana P, Escudero MA, Berenguer MM, Llacer JM, Berna JA, Ortiz JB, Pardell LT, Hernández-Alvarez de Sotomayor C, Méndez MR, Garate RC, Múgica BD, González MC, Domingo JP, Navarro CS, Vera GS, Cuquerella MA, Monzo JL, Boada PC, Pérez MF, Parrado EC, Sánchez JJ, Fernández JC, e-STAR Spanish Study Group: Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR). Eur Psychiatry; 2009 Jun;24(5):287-96
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  • [Title] Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR).
  • BACKGROUND: The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is a prospective, observational study of patients with schizophrenia designed to evaluate long-term treatment outcomes in routine clinical practice.
  • Hospitalization prior to therapy was assessed by a retrospective chart review.
  • RESULTS: At 24 months, treatment retention (81.8% for RLAI versus 63.4% for oral APs, p<0.0001) and reduction in Clinical Global Impression Severity scores (-1.14 for RLAI versus -0.94 for APs, p=0.0165) were significantly higher with RLAI.
  • CONCLUSIONS: This 2 year, prospective, observational study showed that, compared to oral antipsychotics, RLAI was associated with better treatment retention, greater improvement in clinical symptoms and functioning, and greater reduction in hospital stays and days in hospital in patients with schizophrenia.
  • Improved treatment adherence, increased efficacy and reduced hospitalization with RLAI offer the opportunity of substantial therapeutic improvement in schizophrenia.
  • [MeSH-major] Antipsychotic Agents / administration & dosage. Medication Adherence. Risperidone / administration & dosage. Schizophrenia / drug therapy. Schizophrenic Psychology
  • [MeSH-minor] Administration, Oral. Adult. Benzodiazepines / administration & dosage. Benzodiazepines / adverse effects. Delayed-Action Preparations. Drug Therapy, Combination. Female. Follow-Up Studies. Humans. Injections, Intramuscular. Long-Term Care. Male. Middle Aged. Patient Readmission / statistics & numerical data. Prospective Studies. Psychiatric Status Rating Scales. Registries

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  • (PMID = 19195847.001).
  • [ISSN] 0924-9338
  • [Journal-full-title] European psychiatry : the journal of the Association of European Psychiatrists
  • [ISO-abbreviation] Eur. Psychiatry
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] France
  • [Chemical-registry-number] 0 / Antipsychotic Agents; 0 / Delayed-Action Preparations; 12794-10-4 / Benzodiazepines; 132539-06-1 / olanzapine; L6UH7ZF8HC / Risperidone
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26. Nachmany I, Subhi A, Meller I, Gutman M, Lahat G, Merimsky O, Klausner JM: Efficacy of high vs low dose TNF-isolated limb perfusion for locally advanced soft tissue sarcoma. Eur J Surg Oncol; 2009 Feb;35(2):209-14
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  • [Title] Efficacy of high vs low dose TNF-isolated limb perfusion for locally advanced soft tissue sarcoma.
  • Reports that a low dose of TNF (1mg) is as effective, led to the adoption of the low dose regimen as the treatment of choice.
  • METHODS: Retrospective study of 41 patients who underwent ILP, with "high dose" (HD) and "low dose" (LD) TNF.
  • ILP/TNF was performed on candidates to either amputation or significantly mutilating surgery without this treatment.
  • In both groups, all patients, with the exception of three in each group, underwent resection of the residual tumor or tumor bed or limb 8-12 weeks after the procedure.
  • RESULTS: In the HD group, marked tumor softening occurred within 48 h, and in tumors protruding through the skin, hemorrhagic necrosis was evident within 24h.
  • In eight patients, only minimal regression was observed (stabilization of disease).
  • In the LD group, the overall response rate was 30.7%.
  • [MeSH-major] Chemotherapy, Cancer, Regional Perfusion. Sarcoma / drug therapy. Tumor Necrosis Factor-alpha / administration & dosage
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Arm. Dose-Response Relationship, Drug. Female. Follow-Up Studies. Humans. Leg. Male. Middle Aged. Retrospective Studies. Treatment Outcome. Young Adult

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  • (PMID = 18295442.001).
  • [ISSN] 1532-2157
  • [Journal-full-title] European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology
  • [ISO-abbreviation] Eur J Surg Oncol
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Tumor Necrosis Factor-alpha
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27. Sabry A, Abo-Zenah H, Medhat T, Sheashaa H, Mahmoud K, El-Huseini A: A comparative study of two intensified pulse cyclophosphamide remission-inducing regimens for diffuse proliferative lupus nephritis: an Egyptian experience. Int Urol Nephrol; 2009;41(1):153-61
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  • PATIENTS AND METHODS: In this single center, prospective clinical trial, we assigned 46 SLE patients with diffuse proliferative glomerulonephritis to either a high-dose (a maximum of 1 g/dose) of IV CYC (HD-CYC) for six monthly pulses followed by two quarterly pulses or a fixed low-dose (500 mg/dose) of IV CYC (LD-CYC) for six fortnightly pulses with a cumulative dose of 3 g.
  • THE OBJECTIVE: To compare between efficacy, potential toxicity and outcome of parenteral LD-CYC versus HD-CYC therapy for severe LN.
  • RESULTS: Twenty patients (2 male and 18 female) received fortnightly fixed LD-CYC while 26 (5 male and 21 female) received monthly HD-CYC therapy.
  • At the end of the study (1 year after starting therapy), there was no difference either in patients' or in renal survival in both groups.
  • Significant improvement of disease activity (SLE disease activity index) as well as rise of serum albumin was noticed with both regimens.
  • Renal relapse was observed in 11.5% of HD-CYC patients and in none of the LD-CYC therapy patients.
  • Treatment failure was seen in 5% and 3.4% (P = NS) of LD-CYC and HD-CYC patients, respectively.
  • Infection (pneumonia and cellulitis) occurred in five patients in the LD-CYC group and four patients of HD-CYC; again this difference was not statistically significant.
  • CONCLUSION: A remission-inducing regimen of LD-CYC (cumulative dose 3 g) followed by AZA for SLE patients with proliferative LN achieves clinical results comparable to those obtained with HD-CYC without serious infection in both regimens.
  • [MeSH-major] Cyclophosphamide / administration & dosage. Immunosuppressive Agents / administration & dosage. Lupus Nephritis / drug therapy
  • [MeSH-minor] Adult. Egypt. Female. Humans. Male. Prospective Studies. Pulse Therapy, Drug. Remission Induction

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  • (PMID = 18214709.001).
  • [ISSN] 1573-2584
  • [Journal-full-title] International urology and nephrology
  • [ISO-abbreviation] Int Urol Nephrol
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Randomized Controlled Trial
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Immunosuppressive Agents; 8N3DW7272P / Cyclophosphamide
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28. Daminov BT, Raimkulova NP: [Effects of simvastatin therapy on the lipid blood spectrum and nitric oxide in patients with chronic glomerulonephritis]. Lik Sprava; 2008 Oct-Dec;(7-8):57-60
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  • [Title] [Effects of simvastatin therapy on the lipid blood spectrum and nitric oxide in patients with chronic glomerulonephritis].
  • 100 patients with different types of glomerular disease were divided in two groups depending on the treatment scheme: Group B received the traditional therapy, Group A patients received traditional therapy + 20 mg Simvastatin per day.
  • Nitric oxide radicals, NADPF-diaphorase, nitrate reductase, acetylcholinesterase enzymes, as well as total cholesterol, triglycerides, HD, LD, VLD lipoproteins concentration were assessed initially and after three month treatment.
  • It was revealed that the treatment with statins taking into account types of dislipidemia could have an additional renoprotective effect in the patients with different types of chronic glomerular disease.

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  • (PMID = 19663018.001).
  • [ISSN] 1019-5297
  • [Journal-full-title] Likars'ka sprava
  • [ISO-abbreviation] Lik. Sprava
  • [Language] RUS
  • [Publication-type] Clinical Trial; English Abstract; Journal Article
  • [Publication-country] Ukraine
  • [Chemical-registry-number] 0 / Hypolipidemic Agents; 0 / Lipids; 31C4KY9ESH / Nitric Oxide; AGG2FN16EV / Simvastatin
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29. McNamara DR, Nafziger AN, Menhinick AM, Bertino JS Jr: A dose-ranging study of gentamicin pharmacokinetics: implications for extended interval aminoglycoside therapy. J Clin Pharmacol; 2001 Apr;41(4):374-7
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  • [Title] A dose-ranging study of gentamicin pharmacokinetics: implications for extended interval aminoglycoside therapy.
  • Prolonged distribution time has been noted for high-dose (7 mg/kg) gentamicin.
  • Higher doses are used for extended-interval aminoglycoside therapy (EIA).
  • The authors investigated whether the increase in distribution time was proportional to the dose of gentamicin.
  • Twelve healthy volunteers were given low (LD, 2 mg/kg), medium (MD, 4.5 mg/kg), and high (HD, 7 mg/kg) doses of gentamicin in a randomized, crossover fashion.
  • Distribution half-life for HD (31.1 +/- 5.7 min) differed significantly (p < 0.05) from LD (22.4 +/- 6.1 min) and MD (23.8 +/- 5.1 min) with no significant difference being seen between LD and MD.
  • This study verifies that when using EIA dosing with HD gentamicin, sampling within 90 minutes after the beginning of the infusion provides information that leads to overestimation of peak serum concentration/minimum inhibitory concentration and inaccurate calculation of pharmacokinetic parameters.
  • [MeSH-major] Anti-Bacterial Agents / pharmacokinetics. Anti-Bacterial Agents / therapeutic use. Gentamicins / pharmacokinetics
  • [MeSH-minor] Adolescent. Adult. Area Under Curve. Creatinine / blood. Cross-Over Studies. Dose-Response Relationship, Drug. Female. Half-Life. Humans. Immunoassay. Infusions, Intravenous. Male. Metabolic Clearance Rate. Middle Aged. Time Factors. Urinalysis

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  • (PMID = 11304893.001).
  • [ISSN] 0091-2700
  • [Journal-full-title] Journal of clinical pharmacology
  • [ISO-abbreviation] J Clin Pharmacol
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anti-Bacterial Agents; 0 / Gentamicins; AYI8EX34EU / Creatinine
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30. Kaneda Y, Fujii A: Effects of chronic neuroleptic administration on the hypothalamo-pituitary-gonadal axis of male schizophrenics. Prog Neuropsychopharmacol Biol Psychiatry; 2000 Feb;24(2):251-8
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  • Based on the dosages of neuroleptics, the subjects were classified into two age-matched groups: those with lower dosages (LD) and those with higher dosages (HD).
  • 3. (1) The mean level of the blood testosterone (T) in the LD group was significantly lower than that in the normal group, although the level was within normal range.
  • There was no significant difference in the mean level of the blood T for the HD and the normal groups, or for the HD and the LD groups. (2) There was no significant difference in the mean levels of the blood luteinizing hormone between all groups. (3) Also, there was no significant difference in the mean levels of the blood follicle-stimulating hormone between the groups. (4) The mean levels of the blood prolactin in both the LD and HD groups were significantly higher than that in the normal subjects, but there was no significant difference between the LD and HD schizophrenics.
  • 4. Overall, these results seem to indicate that (i) in male patients with chronic schizophrenia, HPG function is impaired, and (ii) chronic neuroleptic medication stimulates the HPG axis in schizophrenic patients with impaired HPG function.
  • [MeSH-major] Antipsychotic Agents / adverse effects. Hypothalamo-Hypophyseal System / drug effects. Pituitary-Adrenal System / drug effects. Schizophrenia / drug therapy. Testis / drug effects
  • [MeSH-minor] Adult. Aged. Case-Control Studies. Chronic Disease. Dose-Response Relationship, Drug. Follicle Stimulating Hormone / blood. Humans. Luteinizing Hormone / blood. Male. Middle Aged. Testosterone / blood

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  • (PMID = 10800748.001).
  • [ISSN] 0278-5846
  • [Journal-full-title] Progress in neuro-psychopharmacology & biological psychiatry
  • [ISO-abbreviation] Prog. Neuropsychopharmacol. Biol. Psychiatry
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] ENGLAND
  • [Chemical-registry-number] 0 / Antipsychotic Agents; 3XMK78S47O / Testosterone; 9002-67-9 / Luteinizing Hormone; 9002-68-0 / Follicle Stimulating Hormone
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31. Davis ME, Pemberton CJ, Yandle TG, Fisher SF, Lainchbury JG, Frampton CM, Rademaker MT, Richards M: Urocortin 2 infusion in human heart failure. Eur Heart J; 2007 Nov;28(21):2589-97
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  • METHODS AND RESULTS: Eight male patients with HF [left ventricular ejection fraction (LVEF) < 40%, NYHA class II-III] received placebo and 25 [low dose (LD)] and 100 microg [high dose (HD)] of UCN2 intravenously over 1 h in a single-blind, placebo-controlled, dose-escalation design.
  • UCN2 increased cardiac output (CO) (mean peak increments +/- SEM; placebo 0.3 +/- 0.1; LD 1.0 +/- 0.3; HD 2.0 +/- 0.2 L/min; P < 0.001) and LVEF (0.0 +/- 1.5; LD 5.9 +/- 2.1; HD 14.1 +/- 2.7%; P = 0.001) and decreased mean arterial pressure (placebo 6.7 +/- 1.3; LD 11.4 +/- 1.7; HD 19.4 +/- 3.3 mmHg; P = 0.001), systemic vascular resistance (SVR) (placebo 104 +/- 37; LD 281 +/- 64; HD 476 +/- 79 dynes s/cm(5); P < 0.003), and cardiac work (CW) (placebo 48 +/- 12; LD 66 +/- 22; HD 94 +/- 13 mmHg/L/min; P < 0.001).
  • The role of UCN2 in circulatory regulation and its potential therapeutic application in heart disease warrant further investigation.
  • [MeSH-major] Cardiotonic Agents / pharmacology. Heart Failure / drug therapy. Urocortins / pharmacology
  • [MeSH-minor] Adult. Aged. Dose-Response Relationship, Drug. Hemodynamics / drug effects. Humans. Kidney / drug effects. Male. Middle Aged. Single-Blind Method

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  • [CommentIn] Eur Heart J. 2007 Nov;28(21):2561-2 [17905792.001]
  • (PMID = 17720993.001).
  • [ISSN] 0195-668X
  • [Journal-full-title] European heart journal
  • [ISO-abbreviation] Eur. Heart J.
  • [Language] eng
  • [Publication-type] Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Cardiotonic Agents; 0 / Urocortins
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32. Murphy JA, Savage CM, Alpard SK, Deyo DJ, Jayroe JB, Zwischenberger JB: Low-dose versus high-dose heparinization during arteriovenous carbon dioxide removal. Perfusion; 2001 Nov;16(6):460-8
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  • The purpose of this study was to compare low-dose (LD) and high-dose (HD) systemic heparinization in a prospective randomized study of arteriovenous carbon dioxide removal (AVCO2R) during acute respiratory distress syndrome, using a commercially available heparin-coated oxygenator.
  • Adult sheep (n = 13) received an LD50 smoke inhalation and 40% TBSA third degree cutaneous flame burn injury.
  • At 40-48 h post-injury, animals underwent cannulation of the carotid artery and jugular vein and were then randomized to HD heparin (activated clotting time, ACT > 300s, n = 6) and LD heparin (ACT < 200s, n =7) and placed on AVCO2R for approximately 72 h using an oxygenator with the Trillium Bio-Passive Surface.
  • Mean ACTs were significantly different, as expected (HD: 446 +/- 26s, LD: 213 +/- 12s, p < 0.05).
  • AVCO2R shunt flow averaged approximately 13% of cardiac output with mean CO2 removal similar in HD and LD, p = NS.
  • In conclusion, LD systemic heparin (ACT < 200s) with a heparin-coated oxygenator does not increase thrombogenicity during AVCO2R for smoke/burn-induced severe lung injury in sheep.
  • [MeSH-minor] Acute Disease. Animals. Arteriovenous Shunt, Surgical / methods. Arteriovenous Shunt, Surgical / standards. Blood Flow Velocity / drug effects. Coated Materials, Biocompatible. Disease Models, Animal. Dose-Response Relationship, Drug. Female. Fibrinogen / drug effects. Fibrinogen / metabolism. Oxygenators, Membrane / standards. Platelet Count. Respiratory Insufficiency / complications. Respiratory Insufficiency / therapy. Sheep. Treatment Outcome. Whole Blood Coagulation Time

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  • (PMID = 11761085.001).
  • [ISSN] 0267-6591
  • [Journal-full-title] Perfusion
  • [ISO-abbreviation] Perfusion
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Coated Materials, Biocompatible; 142M471B3J / Carbon Dioxide; 9001-32-5 / Fibrinogen; 9005-49-6 / Heparin
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33. Houssiau FA, Vasconcelos C, D'Cruz D, Sebastiani GD, de Ramon Garrido E, Danieli MG, Abramovicz D, Blockmans D, Cauli A, Direskeneli H, Galeazzi M, Gül A, Levy Y, Petera P, Popovic R, Petrovic R, Sinico RA, Cattaneo R, Font J, Depresseux G, Cosyns JP, Cervera R: The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide. Ann Rheum Dis; 2010 Jan;69(1):61-4
Hazardous Substances Data Bank. CYCLOPHOSPHAMIDE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • OBJECTIVE: To update the follow-up of the Euro-Lupus Nephritis Trial (ELNT), a randomised prospective trial comparing low-dose (LD) and high-dose (HD) intravenous (IV) cyclophosphamide (CY) followed by azathioprine (AZA) as treatment for proliferative lupus nephritis.
  • RESULTS: Death, sustained doubling of serum creatinine and end-stage renal disease rates did not differ between the LD and HD group (5/44 (11%) vs 2/46 (4%), 6/44 (14%) vs 5/46 (11%) and 2/44 (5%) vs 4/46 (9%), respectively) nor did mean serum creatinine, 24 h proteinuria and damage score at last follow-up.
  • Most patients in both groups were still treated with glucocorticoids, other immunosuppressant agents and blood pressure lowering drugs.
  • After 10 years of follow-up, the positive predictive value for a good outcome of an early drop in proteinuria in response to initial immunosuppressive therapy was confirmed.
  • CONCLUSION: The data confirm that a LD IVCY regimen followed by AZA-the "Euro-Lupus regimen"-achieves good clinical results in the very long term.
  • [MeSH-major] Cyclophosphamide / administration & dosage. Immunosuppressive Agents / administration & dosage. Lupus Nephritis / drug therapy
  • [MeSH-minor] Adolescent. Adult. Azathioprine / therapeutic use. Dose-Response Relationship, Drug. Drug Therapy, Combination. Epidemiologic Methods. Female. Humans. Injections, Intravenous. Kidney Function Tests. Male. Middle Aged. Proteinuria / drug therapy. Treatment Outcome. Young Adult

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  • (PMID = 19155235.001).
  • [ISSN] 1468-2060
  • [Journal-full-title] Annals of the rheumatic diseases
  • [ISO-abbreviation] Ann. Rheum. Dis.
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Immunosuppressive Agents; 8N3DW7272P / Cyclophosphamide; MRK240IY2L / Azathioprine
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