本文由小咖机器人翻译整理

期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-023-02719-4

摘要内容如下：

血吸虫病的治疗完全依赖于单一药物吡喹酮，这促使人们研究替代疗法。在此，我们在塞内加尔北部6个血吸虫病流行村的小学进行了一项概念验证、实用、开放标签、随机对照试验，评估了抗疟药物青蒿琥酯-甲氟喹联合治疗血吸虫病的疗效和安全性。如果通过显微镜检查在尿液和/或粪便中检测到血吸虫卵，则儿童（6-14岁）符合条件。总共有726名儿童按1:1的比例随机接受吡喹酮治疗（标准治疗：单次剂量40mgkg-1；N=364）或青蒿琥酯-甲氟喹（抗疟剂量：青蒿琥酯4mgkg-1和甲氟喹8mgkg-1，每日1次，连续3天；N=362）。8名不符合纳入标准的儿童被排除在疗效分析之外。其余718名参与者的中位年龄为9岁；男性399人（55.6%），女性319人（44.4%）；埃及血吸虫感染率为99.3%，曼氏血吸虫感染率为15.2%。主要结果是通过显微镜评估的治愈率，以及青蒿琥酯-甲氟喹与吡喹酮治疗4周后药物相关不良反应的频率。青蒿琥酯-甲氟喹组的治愈率为59.6%（208/349），而吡喹酮组为62.1%（211/340）。-2.5%的差异（95%置信区间（CI）-9.8至4.8）符合非劣效性的预定标准（界值设定为10%）。所有药物相关不良事件均为轻度或中度，在接受青蒿琥酯-甲氟喹治疗的361名儿童中有28名报告（7.8%；95%CI 5.4至11.0）对8/363（2.2%；95%CI 1.1-4.3）接受吡喹酮治疗（P<0.001）。抗疟剂量的青蒿琥酯-甲氟喹在治疗主要由埃及血吸虫引起的血吸虫病方面具有中等安全性，且不劣于标准治疗的吡喹酮。需要在不同人群和流行病学环境中进行多中心试验来证实这些发现。ClinicalTrials.gov标识符：NCT03893097。

英文原文如下：

Abstracts

Schistosomiasis treatment entirely relies on a single drug, praziquantel, prompting research into alternative therapeutics. Here we evaluated the efficacy and safety of the antimalarial combination artesunate-mefloquine for the treatment of schistosomiasis in a proof-of-concept, pragmatic, open-label, randomized controlled trial in primary schools of six villages endemic for schistosomiasis in northern Senegal. Children (6-14 years) were eligible if Schistosoma eggs were detected by microscopy in urine and/or stool. In total, 726 children were randomized 1:1 to praziquantel (standard care: 40 mg kg-1 single dose; n = 364) or to artesunate-mefloquine (antimalarial dosage: artesunate 4 mg kg-1 and mefloquine 8 mg kg-1 daily for three consecutive days; n = 362). Eight children not meeting the inclusion criteria were excluded from efficacy analysis. Median age of the remaining 718 participants was 9 years; 399 (55.6%) were male, and 319 (44.4%) female; 99.3% were infected with Schistosoma haematobium and 15.2% with S. mansoni. Primary outcomes were cure rate, assessed by microscopy, and frequency of drug-related adverse effects of artesunate-mefloquine versus praziquantel at 4 weeks after treatment. Cure rate was 59.6% (208/349) in the artesunate-mefloquine arm versus 62.1% (211/340) in the praziquantel arm. The difference of -2.5% (95% confidence interval (CI) -9.8 to 4.8) met the predefined criteria of noninferiority (margin set at 10%). All drug-related adverse events were mild or moderate, and reported in 28/361 children receiving artesunate-mefloquine (7.8%; 95% CI 5.4 to 11.0) versus 8/363 (2.2%; 95% CI 1.1 to 4.3) receiving praziquantel (P < 0.001). Artesunate-mefloquine at antimalarial dosage was moderately safe and noninferior to standard-care praziquantel for the treatment of schistosomiasis, predominantly due to S. haematobium. Multicentric trials in different populations and epidemiological settings are needed to confirm these findings. ClinicalTrials.gov identifier: NCT03893097 .

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