دورية أكاديمية
Equivalence trial of melarsoprol and nifurtimox monotherapy and combination therapy for the treatment of second-stage Trypanosoma brucei gambiense sleeping sickness.
| العنوان: | Equivalence trial of melarsoprol and nifurtimox monotherapy and combination therapy for the treatment of second-stage Trypanosoma brucei gambiense sleeping sickness. |
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| المؤلفون: | Bisser S; Institute of Tropical Medicine, Department of Parasitology, Antwerp, B-2000 Antwerp, Belgium., N'Siesi FX, Lejon V, Preux PM, Van Nieuwenhove S, Miaka Mia Bilenge C, Būscher P |
| المصدر: | The Journal of infectious diseases [J Infect Dis] 2007 Feb 01; Vol. 195 (3), pp. 322-9. Date of Electronic Publication: 2006 Dec 21. |
| نوع المنشور: | Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 0413675 Publication Model: Print-Electronic Cited Medium: Print ISSN: 0022-1899 (Print) Linking ISSN: 00221899 NLM ISO Abbreviation: J Infect Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Jan. 2011- : Oxford : Oxford University Press Original Publication: 1904-2010 : Chicago, IL : University of Chicago Press |
| مواضيع طبية MeSH: | Trypanosoma brucei gambiense*, Melarsoprol/*therapeutic use , Nifurtimox/*therapeutic use , Trypanocidal Agents/*therapeutic use , Trypanosomiasis, African/*drug therapy, Administration, Oral ; Adult ; Animals ; Brain Diseases/chemically induced ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Humans ; Injections, Intravenous ; Male ; Melarsoprol/administration & dosage ; Melarsoprol/adverse effects ; Recurrence ; Treatment Outcome |
| مستخلص: | Background: Treatment of second-stage sleeping sickness relies mainly on melarsoprol. Nifurtimox has been successfully used to cure melarsoprol-refractory sleeping sickness caused by Trypanosoma brucei gambiense infection. Methods: An open, randomized trial was conducted to test for equivalence between the standard melarsoprol regimen and 3 other regimens, as follows: standard melarsoprol therapy (3 series of 3.6 mg/kg/day intravenously [iv] for 3 days, with 7-day breaks between the series); 10-day incremental-dose melarsoprol therapy (0.6 mg/kg iv on day 1, 1.2 mg/kg iv on day 2, and 1.8 mg/kg iv on days 3-10); nifurtimox monotherapy for 14 days (5 mg/kg orally 3 times per day); and consecutive 10-day melarsoprol-nifurtimox combination therapy (0.6 mg/kg iv melarsoprol on day 1, 1.2 mg/kg iv melarsoprol on day 2, and 1.2 mg/kg/day iv melarsoprol combined with oral 7.5 mg/kg nifurtimox twice a day on days 3-10). Primary outcomes were relapse, severe adverse events, and death attributed to treatment. Results: A total of 278 patients were randomized. The frequency of adverse events was similar between the standard melarsoprol regimen and the other regimens. Encephalopathic syndromes occurred in all groups and caused all deaths that were likely due to treatment. Relapses (n=48) were observed only with the 3 monotherapy regimens. Conclusion: A consecutive 10-day low-dose melarsoprol-nifurtimox combination is more effective than the standard melarsoprol regimen. |
| التعليقات: | Comment in: J Infect Dis. 2007 Feb 1;195(3):311-3. (PMID: 17205466) Comment in: J Infect Dis. 2007 Aug 15;196(4):650-1. (PMID: 17624857) |
| سلسلة جزيئية: | ISRCTN ISRCTN36877262 |
| المشرفين على المادة: | 0 (Trypanocidal Agents) M84I3K7C2O (Nifurtimox) ZF3786Q2E8 (Melarsoprol) |
| تواريخ الأحداث: | Date Created: 20070106 Date Completed: 20070228 Latest Revision: 20131121 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1086/510534 |
| PMID: | 17205469 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 0022-1899 |
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| DOI: | 10.1086/510534 |