European and Developing Countries Clinical Trials Partnership, Cape Town, South Africa.
Am J Trop Med Hyg. 2011 Nov;85(5):793-804. doi: 10.4269/ajtmh.2011.11-0069.
Randomized trials have confirmed the efficacy and safety of artemether-lumefantrine (AL) for treatment of uncomplicated Plasmodium falciparum malaria. Data from seven studies supported by Novartis (1996-2007), including 647 adults (> 16 years of age, 83.3% completed the study) and 1,332 children (≤ 16 years of age, 89.3% completed the study) with microscopically confirmed uncomplicated P. falciparum malaria and treated with the recommended regimen of AL, were pooled. The 28-day polymerase chain reaction-corrected parasitologic cure rate (primary efficacy endpoint) was 97.1% (495 of 510) in adults and 97.3% (792 of 814) in children (evaluable population). Gametocytemia prevalence after day was 4.2% (23 of 554) in adults and 0.9% (8 of 846) in children. No noteworthy safety signals were observed. Serious adverse events occurred in 1.4% of the adults and 1.3% of the children. This study is the largest data set to date assessing AL therapy for treatment of acute uncomplicated P. falciparum malaria. Artemether-lumefantrine showed high cure rates and rapid resolution of parasitemia, fever, and gametocytemia in adults and children, and showed an excellent safety and tolerability profile.
随机试验已经证实了青蒿琥酯-咯萘啶（AL）治疗无并发症恶性疟原虫疟疾的疗效和安全性。诺华公司（1996-2007 年）支持的 7 项研究的数据，包括 647 名成年人（>16 岁，83.3%完成了研究）和 1332 名儿童（≤16 岁，89.3%完成了研究），他们均患有经显微镜确认的无并发症恶性疟原虫疟疾，并接受了 AL 的推荐方案治疗。28 天聚合酶链反应校正的寄生虫学治愈率（主要疗效终点）在成年患者中为 97.1%（510 例中有 495 例），在儿童患者中为 97.3%（814 例中有 792 例）（可评估人群）。成人在第 28 天的配子体血症发生率为 4.2%（554 例中有 23 例），儿童为 0.9%（814 例中有 8 例）。未观察到明显的安全信号。成年人中 1.4%和儿童中 1.3%发生严重不良事件。本研究是迄今为止评估 AL 治疗急性无并发症恶性疟原虫疟疾的最大数据集。青蒿琥酯-咯萘啶在成年和儿童中显示出高治愈率和寄生虫血症、发热和配子体血症的快速消退，并且具有极好的安全性和耐受性。
