A randomized controlled trial of extended intermittent preventive antimalarial treatment in infants
A randomized controlled trial of extended intermittent preventive antimalarial treatment in infants
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DOI：
10.1086/518575
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发表时间：
2007-07-01
影响因子：
11.8
通讯作者：
May, Juergen
中科院分区：
文献类型：
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作者：
Kobbe, Robin;Kreuzberg, Christina;May, Juergen
背景用磺胺嘧啶-乙胺嘧啶进行的婴儿间歇性预防性抗疟治疗（IPTi）可减少恶性疟和贫血，但尚未在常年疟疾传播严重的地区进行评估。目前尚不清楚是否在生命的第二年额外的治疗保护。一项随机、双盲、安慰剂对照试验，在加纳疟疾完全流行的地区，对1070名儿童在3、9和15个月龄时给予磺胺嘧啶-乙胺嘧啶治疗。参与者在招募后通过主动随访和被动病例检测进行了21个月的监测。主要终点是疟疾发病率，其他结局指标包括贫血、门诊就诊、住院和死亡率。每次治疗后6个月进行分层分析。对疟疾发作的保护效力为20%（95%置信区间[ CI]，11%-29%）。前2次应用周效磺胺-乙胺嘧啶后，疟疾发作频率降低（第一剂后保护功效为23% [95%CI，6%-36%]，第二剂后为17% [95%CI，1%-30%]）。然而，在第15个月的第三次治疗后，没有实现保护。对首次或单次贫血发作的保护作用仅在首次IPTi给药后显著（保护效力，30%; 95% CI，5%-49%）。最后一次IPTi剂量后贫血发作次数增加（保护效力，-24%; 95% CI，-50%至-2%）。在一个密集的常年疟疾传播的地区，磺胺嘧啶-乙胺嘧啶为基础的IPTi提供了相当低的保护比报告中的疾病是中度或季节性流行的地区。保护功效是年龄依赖性的，IPTi延长到生命的第二年并不提供任何益处。
Background. Intermittent preventive antimalarial treatment in infants ( IPTi) with sulfadoxine-pyrimethamine reduces falciparum malaria and anemia but has not been evaluated in areas with intense perennial malaria transmission. It is unknown whether an additional treatment in the second year of life prolongs protection.Methods. A randomized, double-blinded, placebo-controlled trial with administration of sulfadoxine-pyrimethamine therapy at 3, 9, and 15 months of age was conducted with 1070 children in an area in Ghana where malaria is holoendemic. Participants were monitored for 21 months after recruitment through active follow-up visits and passive case detection. The primary end point was malaria incidence, and additional outcome measures were anemia, outpatient visits, hospital admissions, and mortality. Stratified analyses for 6-month periods after each treatment were performed.Results. Protective efficacy against malaria episodes was 20% ( 95% confidence interval [ CI], 11%-29%). The frequency of malaria episodes was reduced after the first 2 sulfadoxine-pyrimethamine applications ( protective efficacy, 23% [ 95% CI, 6%-36%] after the first dose and 17% [ 95% CI, 1%-30%] after the second dose). After the third treatment at month 15, however, no protection was achieved. Protection against the first or single anemia episode was only significant after the first IPTi dose ( protective efficacy, 30%; 95% CI, 5%-49%). The number of anemia episodes increased after the last IPTi dose ( protective efficacy, -24%; 95% CI, -50% to -2%).Conclusion. In an area of intense perennial malaria transmission, sulfadoxine-pyrimethamine-based IPTi conferred considerably lower protection than reported in areas where the disease is moderately or seasonally endemic. Protective efficacy is age-dependent, and extension of IPTi into the second year of life does not provide any benefit.