Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial
Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial
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DOI：
10.1016/s0140-6736(09)61117-x
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发表时间：
2009-07-04
期刊：
影响因子：
168.9
通讯作者：
Kande, Victor
中科院分区：
文献类型：
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作者：
Priotto, Gerardo;Kasparion, Serena;Kande, Victor
背景由布氏冈比亚锥虫引起的非洲人类锥虫病（HAT，昏睡病）是一种致命疾病。目前对第二阶段疾病患者的治疗方案是有毒的、无效的或不切实际的。与标准依氟鸟氨酸方案相比，我们评估了尼福替莫-依氟鸟氨酸联合治疗（NECT）治疗二期疾病的有效性和安全性。方法在刚果共和国和刚果民主共和国的四个HAT治疗中心进行了一项多中心、随机、开放标签、主动对照、III期非劣效性试验。通过计算机生成的随机化序列随机分配确诊的15岁及以上二期冈比亚型结核感染患者，接受静脉注射依氟鸟氨酸（400 mg/kg /天，每6小时；n=144），持续14天，或静脉注射依氟鸟氨酸（400 mg/kg /天，每12小时），持续7天，口服硝呋替莫（15 mg/kg /天，每8小时），持续10天（NECT, n=143）。主要终点是治愈（定义为体液中没有锥虫和白细胞计数）
Background Human African trypanosomiasis (HAT, sleeping sickness) caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are toxic, ineffective, or impractical. We assessed the efficacy and safety of nifurtimox-eflornithine combination therapy (NECT) for second-stage disease compared with the standard eflornithine regimen.Methods A multicentre, randomised, open-label, active control, phase III, non-inferiority trial was done at four HAT treatment centres in the Republic of the Congo and the Democratic Republic of the Congo. Patients aged 15 years or older with confirmed second-stage T b gambiense infection were randomly assigned by computer-generated randomisation sequence to receive intravenous eflornithine (400 mg/kg per day, every 6 h; n=144) for 14 days or intravenous eflornithine (400 mg/kg per day, every 12 h) for 7 days with oral nifurtimox (15 mg/kg per day, every 8 h) for 10 days (NECT, n=143). The primary endpoint was cure (defined as absence of trypanosomes in body fluids and a leucocyte count