Artemisinin combination therapies for treatment of uncomplicated malaria in Uganda
Artemisinin combination therapies for treatment of uncomplicated malaria in Uganda
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DOI：
10.1371/journal.pctr.0010007
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发表时间：
2006-05-19
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影响因子：
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通讯作者：
Staedke, Sarah G.
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作者：
Bukirwa, Hasifa;Yeka, Adoke;Staedke, Sarah G.
目的：比较青蒿素联合疗法治疗乌干达无并发症恶性疟疾的疗效和安全性。设计：随机单盲对照试验。环境：乌干达托罗罗，疟疾高水平传播地区。参与者：确诊无并发症恶性疟原虫疟疾的1至10岁儿童。干预措施：阿莫地喹+青蒿琥酯或蒿甲醚-甲苯胺。结果指标：28天复发性症状性疟疾和复发性寄生虫病的风险，未调整和通过基因分型调整以区分复发和新感染。结果：入组的408名参与者中，有403名未调整的疗效结果被纳入每方案分析。两种治疗方案都非常有效；用阿莫地喹+青蒿琥酯治疗的患者无复发，而用蒿甲醚-氨苯曲明治疗的患者仅有2例复发。然而，由于新感染而复发的疟疾很常见。接受蒿甲醚-氨苯曲明治疗的受试者复发症状性疟疾的未调整风险显著低于接受阿莫地喹+青蒿琥酯治疗的受试者（27%对42%，风险差异15%，95% CI 5.9% - 24.2%）。在寄生虫病复发风险方面也观察到类似的结果（蒿甲醚-氨苯曲明组为51%，阿莫地喹+青蒿琥酯组为66%，风险差异为16%，95% CI 6.2% - 25.2%）。阿莫地喹+青蒿琥酯和蒿甲醚-氨苯曲明均耐受良好。两种方案均未发生严重不良事件。结论：阿莫地喹+青蒿琥酯和蒿甲醚-氨苯曲明治疗无并发症疟疾均有较好的疗效。然而，在这个全流行地区，尽管两种方案在疗效方面表现出色，但许多患者由于新感染而复发寄生虫病。蒿甲醚-氨苯曲明预防新发感染的效果优于阿莫地喹+青蒿琥酯。为了在非洲最大限度地发挥青蒿素联合疗法的效益，治疗应与预防疟疾传播的战略结合起来。应进一步研究频繁重复治疗对新青蒿素方案的疗效、安全性和成本效益的影响。
Objectives: To compare the efficacy and safety of artemisinin combination therapies for the treatment of uncomplicated falciparum malaria in Uganda.Design: Randomized single-blind controlled trial.Setting: Tororo, Uganda, an area of high-level malaria transmission.Participants: Children aged one to ten years with confirmed uncomplicated P. falciparum malaria.Interventions: Amodiaquine + artesunate or artemether - lumefantrine.Outcome Measures: Risks of recurrent symptomatic malaria and recurrent parasitemia at 28 days, unadjusted and adjusted by genotyping to distinguish recrudescences and new infections.Results: Of 408 participants enrolled, 403 with unadjusted efficacy outcomes were included in the per-protocol analysis. Both treatment regimens were highly efficacious; no recrudescences occurred in patients treated with amodiaquine + artesunate, and only two occurred in those treated with artemether - lumefantrine. However, recurrent malaria due to new infections was common. The unadjusted risk of recurrent symptomatic malaria was significantly lower for participants treated with artemether - lumefantrine than for those treated with amodiaquine + artesunate (27% versus 42%, risk difference 15%, 95% CI 5.9% - 24.2%). Similar results were seen for the risk of recurrent parasitemia (51% artemether - lumefantrine versus 66% amodiaquine+ artesunate, risk difference 16%, 95% CI 6.2% - 25.2%). Amodiaquine + artesunate and artemether - lumefantrine were both well-tolerated. Serious adverse events were uncommon with both regimens.Conclusions: Amodiaquine + artesunate and artemether - lumefantrine were both highly efficacious for treatment of uncomplicated malaria. However, in this holoendemic area, despite the excellent performance of both regimens in terms of efficacy, many patients experienced recurrent parasitemia due to new infections. Artemether - lumefantrine was superior to amodiaquine + artesunate for prevention of new infections. To maximize the benefit of artemisinin combination therapy in Africa, treatment should be integrated with strategies to prevent malaria transmission. The impact of frequent repeated therapy on the efficacy, safety, and cost-effectiveness of new artemisinin regimens should be further investigated.