Background Artemether-lumefantrine (AL) is the first-line antimalarial drug for the treatment of uncomplicated malaria in Tanzania. The World Health Organization (WHO) recommends regular efficacy monitoring of antimalarial drugs to inform case management policy decisions. This study assessed the safety and efficacy of AL for treating uncomplicated Plasmodium falciparum malaria in Tanzania in 2022. Methods Children aged 6 months to 10 years with uncomplicated P falciparum malaria were recruited from 4 sentinel sites and treated with the standard 6-dose, 3-day regimen for AL. Clinical and parasitological responses were monitored for 28 days using the WHO standard protocol. Genotyping based on msp1, msp2, and glurp was used to distinguish recrudescence from reinfection. Sanger sequencing was used to detect K13 mutations. Results Three hundred fifty-two participants, 88 per site, were enrolled. Four withdrew and 55 experienced parasite recurrence. The polymerase chain reaction (PCR)–corrected Kaplan-Meier efficacies were 89.9% in Pwani, 95.0% in Kigoma, 94.4% in Tanga, and 98.9% in Morogoro. No K13 mutations were found. Conclusions Artemether-lumefantrine remains highly efficacious in 3 regions of Tanzania, but the PCR-corrected efficacy in Pwani fell below the WHO-defined 90% threshold at which policy change is recommended. Implementing strategies to diversify artemisinin-based combination therapies to ensure effective case management in Tanzania is critical.

中文翻译：

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2022 年坦桑尼亚蒿甲醚-苯蒽醌对单纯性恶性疟疾感染的疗效和安全性：一项单臂临床试验


背景 蒿甲醚-苯芴醇 （AL） 是坦桑尼亚治疗单纯性疟疾的一线抗疟药。世界卫生组织 （WHO） 建议定期监测抗疟药物的疗效，以便为病例管理政策决策提供信息。本研究于 2022 年评估了 AL 治疗坦桑尼亚单纯性恶性疟原虫疟疾的安全性和有效性。方法 从 4 个哨点招募 6 个月至 10 岁的无并发症恶性疟原虫疟疾儿童，并接受标准的 6 剂、3 天的 AL 治疗方案。使用 WHO 标准方案监测临床和寄生虫学反应 28 天。基于 msp1 、 msp2 和 glurp 的基因分型用于区分复发和再感染。使用 Sanger 测序检测 K13 突变。结果 共纳入 352 名参与者，每个中心 88 名。4 例退出，55 例出现寄生虫复发。聚合酶链反应 （PCR） 校正的 Kaplan-Meier 疗效在 Pwani 中为 89.9%，在 Kigoma 中为 95.0%，在 Tanga 中为 94.4%，在 Morogoro 中为 98.9%。未发现 K13 突变。结论 蒿甲醚-苯芴醇在坦桑尼亚的 3 个地区仍然非常有效，但 Pwani 的 PCR 校正疗效低于 WHO 定义的建议改变政策的 90% 阈值。实施策略，使基于青蒿素的联合疗法多样化，以确保在坦桑尼亚进行有效的病例管理，这一点至关重要。