Cissé Badara, Sokhna Cheikh, Boulanger Denis, Milet Jacqueline, Bâ El Hadj, Richardson Keshena, Hallett Rachel, Sutherland Colin, Simondon Kirsten, Simondon François, Alexander Neal, Gaye Oumar, Targett Geoffrey, Lines Jo, Greenwood Brian, Trape Jean-François
London School of Hygiene & Tropical Medicine, London, UK.
Lancet. 2006 Feb 25;367(9511):659-67. doi: 10.1016/S0140-6736(06)68264-0.
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 full dose of antimalarial treatment given at defined times without previous testing for malaria infection.
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 , number NCT00132561.
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.
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.
在非洲的萨赫勒和萨赫勒次区域，疟疾传播具有高度季节性。在疟疾传播高峰期的短时间内，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性预防治疗的效果——在特定时间给予全剂量抗疟治疗，无需事先检测疟疾感染情况。
我们在塞内加尔农村地区尼亚尔的三个医疗中心进行了一项随机、安慰剂对照、双盲试验，以研究间歇性预防治疗对疟疾发病率的影响。1136名年龄在2至59个月的儿童在疟疾传播季节分三次接受一剂青蒿琥酯加一剂磺胺多辛-乙胺嘧啶或两剂安慰剂。主要结局是通过主动或被动病例检测发现的首次或单次临床疟疾发作。主要分析采用意向性分析。本研究已在[具体注册号]注册，编号为NCT00132561。
在13周的随访期间，干预措施使疟疾临床发作次数减少了86%（95%置信区间80 - 90）。通过被动病例检测，对疟疾的保护效力为86%（77 - 92），通过主动检测时为86%（78 - 91）。接受活性药物治疗的儿童疟疾发病率为每1000人年风险期308次发作，而接受安慰剂治疗的儿童为每1000人年风险期2250次发作。13名儿童未纳入意向性分析，该分析仅限于接受第一剂抗疟药物或安慰剂治疗的儿童。接受活性药物治疗的儿童呕吐情况有所增加，但总体而言该干预措施耐受性良好。
间歇性预防治疗对于生活在季节性疟疾感染地区的5岁以下儿童预防疟疾可能非常有效。
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