Nifurtimox-Eflornithine Combination Therapy for Second-Stage Gambiense Human African Trypanosomiasis: Medecins Sans Frontieres Experience in the Democratic Republic of the Congo
Nifurtimox-Eflornithine Combination Therapy for Second-Stage Gambiense Human African Trypanosomiasis: Medecins Sans Frontieres Experience in the Democratic Republic of the Congo
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DOI：
10.1093/cid/cis886
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发表时间：
2013-01-15
影响因子：
11.8
通讯作者：
Chappuis, Francois
中科院分区：
文献类型：
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作者：
Alirol, Emilie;Schrumpf, David;Chappuis, Francois
背景。非洲人类锥虫病的现有诊断和治疗工具有限。硝呋替莫-依氟鸟氨酸联合治疗（NECT）的最新进展为第二阶段患者带来了新的希望。虽然NECT已在大多数流行国家推广，但安全性数据很少，而且仅来自临床试验。世界卫生组织（世卫组织）协调了一项药物警戒规划，以收集有关NECT安全性和有效性的更多数据。我们在此报告无国界医生组织在刚果民主共和国（DRC）的治疗中心18个月NECT使用经验的结果。该队列研究包括2010年1月至2011年6月期间在刚果民主共和国东北部多鲁玛和丁吉拉医院接受NECT治疗的684例二期HAT患者（包括120名儿童）。所有治疗中出现的不良事件（ae）均按照不良事件通用术语标准3.0版进行记录和评分。安全性和有效性数据从世卫组织药物警戒表和项目监测数据库Epitryps中检索。86%的患者在治疗期间经历了至少1次AE。平均而言，儿童经历的不良反应少于成人。大多数ae为轻度（37.9%）或中度（54.7%）。严重ae包括呕吐（n = 32）、头晕（n = 16）、头痛（n = 11）和抽搐（n = 11）。住院病死率低（0.15%），复发率低（n = 14）。与以前的治疗方法相比，NECT在刚果民主共和国的非试验环境中有效、安全且耐受性良好，这进一步支持了将NECT作为第二阶段布氏冈比亚锥虫HAT的一线治疗方法的推广。儿童的耐受性特别好。
Background. Existing diagnostic and treatment tools for human African trypanosomiasis (HAT) are limited. The recent development of nifurtimox-eflornithine combination therapy (NECT) has brought new hopes for patients in the second stage. While NECT has been rolled out in most endemic countries, safety data are scarce and derive only from clinical trials. The World Health Organization (WHO) coordinates a pharmacovigilance program to collect additional data on NECT safety and efficacy. We report here the results of 18 months of experience of NECT use in treatment centers run by Medecins Sans Frontieres in the Democratic Republic of the Congo (DRC).Methods. This cohort study included 684 second-stage HAT patients (including 120 children) treated with NECT in Doruma and Dingila hospitals, northeastern DRC, between January 2010 and June 2011. All treatment-emergent adverse events (AEs) were recorded and graded according to the Common Terminology Criteria for Adverse Events version 3.0. Safety and efficacy data were retrieved from the WHO pharmacovigilance forms and from Epitryps, a program monitoring database.Results. Eighty-six percent of the patients experienced at least 1 AE during treatment. On average, children experienced fewer AEs than adults. Most AEs were mild (37.9%) or moderate (54.7%). Severe AEs included vomiting (n = 32), dizziness (n = 16), headache (n = 11), and convulsions (n = 11). The in-hospital case fatality rate was low (0.15%) and relapses were rare (n = 14).Conclusions. In comparison with previous treatments, NECT was effective, safe, and well tolerated in nontrial settings in DRC, further supporting the roll-out of NECT as first-line treatment in second-stage Trypanosoma brucei gambiense HAT. Tolerance was particularly good in children.