扒哥吃瓜

Abstract

Background: Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second鈥恠tage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the nifurtimox鈥恊flornithine drug combination with the standard eflornithine regimen for the treatment of second鈥恠tage disease. Methods: A randomized, open鈥恖abel, active鈥恈ontrol, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by M茅decins Sans Fronti猫res, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. Results: A total of 103 patients with second鈥恠tage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the nifurtimox鈥恊flornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the nifurtimox鈥恊flornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the nifurtimox鈥恊flornithine arm. Conclusions: The nifurtimox鈥恊flornithine combination appears to be a promising first鈥恖ine therapy for second鈥恠tage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new nifurtimox鈥恊flornithine combination therapy will mark a major and multifaceted advance over current therapies.

Citation

Clinical Infectious Diseases (2007) 45 (11) 1435鈥�1442 [DOI: 10.1086/522982]

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