Department of Health System Information, National Directorate of Health, University of Bamako, Bamako, Mali.
Clin Infect Dis. 2011 Aug 1;53(3):215-23. doi: 10.1093/cid/cir374.
In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW).
We conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints.
Among the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32-0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32-0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19-0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed.
Adding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance.
ISRCTN 74189211.
2003 年，马里引入了磺胺多辛-乙胺嘧啶（SP）间歇性预防疗法（ITPp），以控制妊娠疟疾，包括在妊娠第 2 和第 3 个三个月给予 2 剂 SP。这种广泛使用的方案虽然非常有效，但在妊娠的最后 4-8 周期间仍有许多妇女无法免受疟疾的侵害，这是胎儿体重增加的关键时期。本研究的目的是比较 3 剂与 2 剂 IPTp-SP 预防胎盘疟疾和相关低出生体重（LBW）的疗效和安全性。
我们进行了一项平行组、开放标签、个体随机对照优效性试验，纳入了 2006 年 4 月至 2008 年 3 月期间所有妊娠的 814 名妇女。所有妇女均至少接受了 3 次检查，并接受了 2 剂（n=401）或 3 剂（n=413）IPTp-SP。主要终点是胎盘疟疾，LBW、早产和产妇贫血是次要终点，严重产妇皮肤反应和新生儿黄疸是安全性终点。
在 96%的随访至分娩的研究对象中，3 剂组胎盘疟疾的患病率（8.0%）是 2 剂组（16.7%）的两倍低；调整后的患病率比（APR）为 0.48（95%置信区间[CI]，0.32-0.71）。LBW 和早产也有所减少；3 剂组 LBW 的患病率为 6.6%，2 剂组为 13.3%（APR，0.50；95%CI，0.32-0.79），早产的患病率为 3.2%，2 剂组为 8.9%（APR，0.37；95%CI，0.19-0.71）。未观察到产妇贫血的显著减少或安全性终点的差异。
与标准的 2 剂方案相比，在季节性传播水平低、磺胺多辛耐药率低的地区，所有妊娠妇女中，添加 3 剂 ITPp-SP 可将胎盘疟疾、LBW 和早产的风险降低一半。
ISRCTN 74189211。
