Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster-randomised, double-blind, placebo-controlled trial
Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster-randomised, double-blind, placebo-controlled trial
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DOI：
10.1016/s0140-6736(08)61034-x
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发表时间：
2008-07-12
期刊：
影响因子：
168.9
通讯作者：
Brooker, Simon
中科院分区：
文献类型：
--
作者：
Clarke, Sian E.;Jukes, Matthew C. H.;Brooker, Simon
背景疟疾是幼儿期发病和死亡的主要原因，但其对学龄期健康和教育的影响仍知之甚少。我们研究了间歇性预防性治疗（IPT）在减少贫血和提高课堂注意力和教育成就的半免疫学童在一个地区的高常年transmission.Methods分层，随机分组，双盲，安慰剂对照试验IPT在肯尼亚西部的30所小学。通过使用计算机生成的列表，学校被随机分配到治疗组（磺胺嘧啶-乙胺嘧啶与阿莫地喹或双重安慰剂组合）。5-18岁的儿童每隔4个月接受3次治疗（IPT n=3535，安慰剂n=3223）。主要终点是贫血的患病率，定义为血红蛋白浓度低于110 g/L。通过干预后12个月的横断面调查评估了这一结果。通过意向治疗（排除缺失数据的儿童）和符合方案进行分析。该研究注册于ClinicalTrials.gov，编号NCT 00142246。结果IPT组2604名儿童和安慰剂组2302名儿童被纳入主要结局的意向治疗分析;排除的主要原因是失访。12个月时，IPT组平均贫血患病率为6.3%，安慰剂组为12.6%（校正风险比为0。52，95% Cl 0。29-0.93; p=0。028）。在两项基于班级的持续注意力测试中也观察到显著改善，代码传输测试得分平均增加6.05（95% CI 2.83-9.27; p=0 . 05）。0007）和计数声音测试得分为1。80（0 . 19-3.41; p=0.03），与对照组相比。对注意力不集中或过度活跃的强迫行为或教育成就没有影响。符合方案分析得出了相似的结果。在任何治疗的28天内报告了23起严重的不良事件（IPT组19起，安慰剂组4起）;主要副作用是治疗后不久出现的平衡问题，头晕，头晕，恶心和/或呕吐。为盖茨疟疾伙伴关系、挪威教育信托基金和世界银行多捐助方教育发展方案基金、DBL卫生研究与发展中心和惠康信托基金提供资金。
Background Malaria is a major cause of morbidity and mortality in early childhood, yet its consequences for health and education during the school-age years remain poorly understood. We examined the effect of intermittent preventive treatment (IPT) in reducing anaemia and improving classroom attention and educational achievement in semi-immune schoolchildren in an area of high perennial transmission.Methods A stratified, cluster-randomised, double-blind, placebo-controlled trial of IPT was done in 30 primary schools in western Kenya. Schools were randomly assigned to treatment (sulfadoxine-pyrimethamine in combination with amodiaquine or dual placebo) by use of a computer-generated list. Children aged 5-18 years received three treatments at 4-month intervals (IPT n=3535, placebo n=3223). The primary endpoint was the prevalence of anaemia, defined as a haemoglobin concentration below 110 g/L. This outcome was assessed through cross-sectional surveys 12 months post-intervention. Analysis was by both intention to treat, excluding children with missing data, and per protocol. This study is registered with ClinicalTrials.gov, number NCT00142246.Findings 2604 children in the IPT group and 2302 in the placebo group were included in the intention-to-treat analysis of the primary outcome; the main reason for exclusion was loss to follow-up. Prevalence of anaemia at 12 months averaged 6.3% in the IPT group and 12.6% in the placebo group (adjusted risk ratio 0 . 52, 95% Cl 0 . 29-0.93; p=0 . 028). Significant improvements were also seen in two of the class-based tests of sustained attention, with a mean increase in code transmission test score of 6.05 (95% Cl 2.83-9.27; p=0 . 0007) and counting sounds test score of 1 . 80 (0 . 19-3.41; p=0.03), compared with controls. No effect was shown for inattentive or hyperactive-compulsive behaviours or on educational achievement. The per-protocol analysis yielded similar results. 23 serious adverse events were reported within 28 days of any treatment (19 in the IPT group and four in the placebo group); the main side-effects were problems of balance, dizziness, feeling faint, nausea, and/or vomiting shortly after treatment.Interpretation IPT of malaria improves the health and cognitive ability of semi-immune schoolchildren. Effective malaria interventions could be a valuable addition to school health programmes.Funding Gates Malaria Partnership, the Norwegian Education Trust Fund and multidonor Education Development Programme Fund of the World Bank, DBL Centre for Health Research and Development, and the Wellcome Trust.