Seasonal intermittent preventive treatment with artesunate and sulfadoxine-pyrimethamine for prevention of malaria in Senegalese children:: a randomised, placebo-controlled, double-blind trial
Seasonal intermittent preventive treatment with artesunate and sulfadoxine-pyrimethamine for prevention of malaria in Senegalese children:: a randomised, placebo-controlled, double-blind trial
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DOI：
10.1016/s0140-6736(06)68264-0
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发表时间：
2006-02-25
期刊：
影响因子：
168.9
通讯作者：
Trape, JF
中科院分区：
文献类型：
--
作者：
Cissé, B;Sokhna, C;Trape, JF
背景在非洲的萨赫勒和萨赫勒以南地区，疟疾传播具有很强的季节性。在疟疾高度传播的短时期内，5岁以下儿童的死亡率和发病率很高。我们评估了季节性间歇预防治疗的有效性--在确定的时间给予的一种间歇剂量的抗疟疾治疗，而不是先前对疟疾感染的测试。方法我们在塞内加尔农村地区尼亚哈尔的三个卫生保健中心进行了一项随机、安慰剂对照的双盲试验，研究间歇预防治疗对疟疾发病率的影响。在疟疾传播季节，1136名2-59个月的儿童接受了一剂青蒿琥酯加一剂磺胺多辛乙胺或两种安慰剂的三次治疗。主要结果是通过主动或被动病例检测发现临床疟疾的第一次或单一发作。主要分析方法是意向治疗。这项研究在ClinicalTrials.gov注册，编号NCT00132561。在13周的随访中，干预导致疟疾临床发作的发生减少了86%(95%可信区间80-90)。被动发现疟疾保护率为86%(77~92)，主动发现疟疾保护率为86%(78~91)。服用活性药物的儿童疟疾发病率为每1000人年发病308例，而服用安慰剂的儿童疟疾发病率为每1000人年发病2250例。13名儿童未被纳入意向治疗分析，该分析仅限于接受第一剂抗疟药或安慰剂的儿童。接受活性药物治疗的儿童呕吐增加，但总体耐受性良好。解释间歇预防治疗对生活在季节性疟疾流行区的5岁以下儿童疟疾的预防是非常有效的。
Background In the Sahel and sub-Sahelian regions of Africa, malaria transmission is highly seasonal. During a short period of high malaria transmission, mortality and morbidity are high in children under age 5 years. We assessed the efficacy of seasonal intermittent preventive treatment-a lull dose of antimalarial treatment given at defined times without previous testing for malaria infection.Methods We did a randomised, placebo-controlled, double-blind trial of the effect of intermittent preventive treatment on morbidity from malaria in three health-care centres in Niakhar, a rural area of Senegal. 1136 children aged 2-59 months received either one dose of artesunate plus one dose of sulfadoxine-pyrimethamine or two placebos on three occasions during the malaria transmission season. The primary outcome was a first or single episode of clinical malaria detected through active or passive case detection. Primary analysis was by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00132561.Findings During 13 weeks of follow-up, the intervention led to an 86% (95% CI 80-90) reduction in the occurrence of clinical episodes of malaria. With passive case detection, protective efficacy against malaria was 86% (77-92), and when detected actively was 86% (78-91). The incidence of malaria in children on active drugs was 308 episodes per 1000 person-years at risk, whereas in those on placebo it was 2250 episodes per 1000 person-years at risk. 13 children were not included in the intention-to-treat analysis, which was restricted to children who received a first dose of antimalarial or placebo. There was an increase in vomiting in children who received the active drugs, but generally the intervention was well tolerated.Interpretation Intermittent preventive treatment could be highly effective for prevention of malaria in children under 5 years of age living in areas of seasonal malaria infection.