Medical Research Council Laboratories, Banjul, The Gambia.
PLoS One. 2010 Jun 21;5(6):e11227. doi: 10.1371/journal.pone.0011227.
In malaria endemic countries, children who have experienced an episode of severe anaemia are at increased risk of a recurrence of anaemia. There is a need to find ways of protecting these at risk children from malaria and chemoprevention offers a potential way of achieving this objective.
During the 2003 and 2004 malaria transmission seasons, 1200 Gambian children with moderate or severe anaemia (Hb concentration <7 g/dL) were randomised to receive either monthly sulfadoxine-pyrimethamine (SP) or placebo until the end of the malaria transmission season in which they were enrolled, in a double-blind trial. All study subjects were treated with oral iron for 28 days and morbidity was monitored through surveillance at health centres. The primary endpoint was the proportion of children with moderate or severe anaemia at the end of the transmission season. Secondary endpoints included the incidence of clinical episodes of malaria during the surveillance period, outpatient attendances, the prevalence of parasitaemia and splenomegaly, nutritional status at the end of the malaria transmission season and compliance with the treatment regimen.
The proportions of children with a Hb concentration of <7 g/dL at the end of the malaria transmission season were similar in the two study groups, 14/464 (3.0%) in children who received at least one dose of SP and 16/471 (3.4%) in those who received placebo, prevalence ratio 0.89 (0.44,1.8) P = 0.742. The protective efficacy of SP against episodes of clinical malaria was 53% (95% CI 37%, 65%). Treatment with SP was safe and well tolerated; no serious adverse events related to SP administration were observed. Mortality following discharge from hospital was low among children who received SP or placebo (6 in the SP group and 9 in the placebo group respectively).
Intermittent treatment with SP did not reduce the proportion of previously anaemic children with moderate or severe anaemia at the end of the malaria season, although it prevented malaria. The combination of appropriate antimalarial treatment plus one month of iron supplementation and good access to healthcare during follow-up proved effective in restoring haemoglobin to an acceptable level in the Gambian setting.
ClinicalTrials.gov NCT00131716.
在疟疾流行的国家，经历过严重贫血发作的儿童再次发生贫血的风险增加。需要寻找保护这些处于危险中的儿童免受疟疾侵害的方法，化学预防提供了实现这一目标的潜在途径。
在 2003 年和 2004 年疟疾传播季节期间，1200 名患有中度或重度贫血（Hb 浓度 <7 g/dL）的冈比亚儿童被随机分配接受每月磺胺多辛-乙胺嘧啶（SP）或安慰剂治疗，直至他们入组的疟疾传播季节结束，这是一项双盲试验。所有研究对象均接受口服铁剂治疗 28 天，并通过在卫生中心进行监测来监测发病率。主要终点是传播季节结束时中度或重度贫血儿童的比例。次要终点包括监测期间临床疟疾发作的发生率、门诊就诊次数、寄生虫血症和脾肿大的患病率、疟疾传播季节结束时的营养状况以及治疗方案的依从性。
两个研究组在疟疾传播季节结束时 Hb 浓度 <7 g/dL 的儿童比例相似，接受至少一剂 SP 的儿童中有 14/464（3.0%），接受安慰剂的儿童中有 16/471（3.4%），流行率比为 0.89（0.44,1.8），P = 0.742。SP 对临床疟疾发作的保护效果为 53%（95%CI 37%，65%）。SP 治疗安全且耐受性良好；未观察到与 SP 给药相关的严重不良事件。接受 SP 或安慰剂的儿童出院后的死亡率均较低（SP 组 6 例，安慰剂组 9 例）。
间歇性使用 SP 治疗并没有降低疟疾季节结束时中度或重度贫血儿童再次发生贫血的比例，尽管它预防了疟疾。在冈比亚，适当的抗疟治疗加上一个月的铁补充剂和良好的随访期间获得医疗保健相结合，在将血红蛋白恢复到可接受水平方面证明是有效的。
ClinicalTrials.gov NCT00131716。
