Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial
Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial
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DOI：
10.1016/s0140-6736(00)04643-2
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发表时间：
2001-05-12
期刊：
影响因子：
168.9
通讯作者：
Alonso, P
中科院分区：
文献类型：
--
作者：
Schellenberg, D;Menendez, C;Alonso, P
临床疟疾和严重贫血是许多疟疾流行地区儿科住院和死亡的主要原因。在缺乏有效和负担得起的疫苗的情况下，控制方案继续依靠病例管理，同时试图大规模部署驱虫蚊帐。我们做了一个随机，安慰剂对照试验，以评估间歇性磺胺乙胺嘧啶治疗的有效性和安全性的疟疾和严重贫血的婴儿在农村地区的Tanzana.Methods我们随机分配701名儿童生活在Ifakara，坦桑尼亚南部，磺胺乙胺嘧啶或安慰剂在2，3和9个月的年龄。所有儿童在2至6个月大时都接受了铁补充剂。这项干预措施是与世卫组织扩大免疫计划（EPI）提供的常规疫苗接种一起进行的。主要结果指标是首次或唯一的临床疟疾发作，以及从招募到1岁期间的严重贫血。通过基于医院的被动病例检测系统进行的发病率监测得到了12个月和18个月大时横断面调查的补充。结果表示的保护效力（100 [1-风险比] %）和分析是由意向treat.Findings 40名儿童辍学（16人死亡，11迁移，12父母撤回同意，和其他原因）。间歇性磺胺嘧啶乙胺嘧啶治疗耐受性良好，没有记录药物引起的不良事件。在出生后的第一年，磺胺嘧啶-乙胺嘧啶组的临床疟疾发生率（每危险人年的事件数）为0.15，安慰剂组为0.36（保护效力为59% [95% CI 41-72]），磺胺嘧啶-乙胺嘧啶组的严重贫血发生率为0.06，安慰剂组为0.11（50% [8-73]）。对EPI疫苗的血清学反应没有受到干预的影响。解释这种新的疟疾控制方法通过现有的EPI系统提供可用且负担得起的药物，降低了临床疟疾和严重贫血的发病率。迫切需要数据来评估在疟疾流行模式不同的地区进行间歇性治疗的潜在成本效益。
Background Clinical malaria and severe anaemia are major causes of paediatric hospital admission and death in many malaria-endemic settings. In the absence of an effective and affordable vaccine, control programmes continue to rely on case management while attempting the large-scale deployment of insecticide-treated nets. We did a randomised, placebo-controlled trial to assess the efficacy and safety of intermittent sulphadoxine-pyrimethamine treatment on the rate of malaria and severe anaemia in infants in a rural area of Tanzania.Methods We randomly assigned 701 children living in Ifakara, southern Tanzania, sulphadoxine-pyrimethamine or placebo at 2, 3, and 9 months of age. All children received iron supplementation between 2 and 6 months of age. The intervention was given alongside routine Vaccinations delivered through WHO's Expanded Program on Immunisation (EPI). The primary outcome measures were first or only episode of clinical malaria, and severe anaemia in the period from recruitment to 1 year of age. Morbidity monitoring through a hospital-based passive case-detection system was complemented by cross-sectional surveys at 12 and 18 months of age. Results were expressed in terms of protective efficacy (100 [1-hazard ratio] %) and analysis was by intention to treat.Findings 40 children dropped out (16 died, 11 migrated, 12 parents withdrew consent, and one for other reasons). Intermittent sulphadoxine-pyrimethamine treatment was well tolerated and no drug-attributable adverse events were recorded. During the first year of life, the rate of clinical malaria (events per person-year at risk) was 0.15 in the sulphadoxine-pyrimethamine group versus 0.36 in the placebo group (protective efficacy 59% [95% CI 41-72]), and the rate of severe anaemia was 0.06 in the sulphadoxine-pyrimethamine group versus 0.11 in the placebo group (50% [8-73]). Serological responses to EPI vaccines were not affected by the intervention.Interpretation This new approach to malaria control reduced the rate of clinical malaria and severe anaemia by delivering an available and affordable drug through the existing EPI system. Data are urgently needed to assess the potential cost-effectiveness of intermittent treatment in areas with different patterns of malaria endemicity.