Department of International Health, University of Tampere Medical School, Tampere, Finland.
PLoS One. 2012;7(7):e41123. doi: 10.1371/journal.pone.0041123. Epub 2012 Jul 19.
New regimens for intermittent preventive treatment in pregnancy (IPTp) against malaria are needed as the effectiveness of the standard two-dose sulfadoxine-pyrimethamine (SP) regimen is under threat. Previous trials have shown that IPTp with monthly SP benefits HIV-positive primi- and secundigravidae, but there is no conclusive evidence of the possible benefits of this regimen to HIV-negative women, or to a population comprising of both HIV-positive and -negative women of different gravidities.
This study analyzed 484 samples collected at delivery as part of a randomized, partially placebo controlled clinical trial, conducted in rural Malawi between 2003 and 2007. The study included pregnant women regardless of their gravidity or HIV-infection status. The participants received SP twice (controls), monthly SP, or monthly SP and two doses of azithromycin (AZI-SP). The main outcome was the prevalence of peripheral Plasmodium falciparum malaria at delivery diagnosed with a real-time polymerase chain reaction (PCR) assay.
Overall prevalence of PCR-diagnosed peripheral P. falciparum malaria at delivery was 10.5%. Compared with the controls, participants in the monthly SP group had a risk ratio (95% CI) of 0.33 (0.17 to 0.64, P<0.001) and those in the AZI-SP group 0.23 (0.11 to 0.48, P<0.001) for malaria at delivery. When only HIV-negative participants were analyzed, the corresponding figures were 0.26 (0.12 to 0.57, P<0.001) for women in the monthly SP group, and 0.24 (0.11 to 0.53, P<0.001) for those in the AZI-SP group.
Our results suggest that increasing the frequency of SP administration during pregnancy improves the efficacy against malaria at delivery among HIV-negative women, as well as a population consisting of both HIV-positive and -negative pregnant women of all gravidities, in a setting of relatively low but holoendemic malaria transmission, frequent use of bed nets and high SP resistance.
新的间歇性预防治疗方案（IPTp）在妊娠期间（针对疟疾）需要不断完善，因为标准的两剂磺胺多辛-乙胺嘧啶（SP）方案的有效性受到了威胁。先前的试验表明，每月给予 SP 的 IPTp 对 HIV 阳性的初产妇和经产妇有益，但尚无确凿证据表明该方案对 HIV 阴性妇女或包括 HIV 阳性和阴性不同孕次的妇女具有可能的益处。
本研究分析了 2003 年至 2007 年在马拉维农村进行的一项随机、部分安慰剂对照临床试验中分娩时采集的 484 份样本。该研究纳入了无论其孕次或 HIV 感染状况如何的孕妇。参与者接受了两次 SP（对照组）、每月 SP、或每月 SP 和两剂阿奇霉素（AZI-SP）。主要结局是通过实时聚合酶链反应（PCR）检测诊断分娩时外周血疟原虫感染的患病率。
总体而言，分娩时 PCR 诊断的外周性疟疾病例的患病率为 10.5%。与对照组相比，每月 SP 组的参与者的风险比（95%置信区间）为 0.33（0.17 至 0.64，P<0.001），AZI-SP 组为 0.23（0.11 至 0.48，P<0.001）。当仅分析 HIV 阴性参与者时，每月 SP 组的相应数字为 0.26（0.12 至 0.57，P<0.001），AZI-SP 组为 0.24（0.11 至 0.53，P<0.001）。
我们的结果表明，在妊娠期间增加 SP 的给药频率可提高在相对低但全疟疾传播、频繁使用蚊帐和高 SP 耐药性的环境中，HIV 阴性妇女以及包括 HIV 阳性和阴性不同孕次的孕妇分娩时的疟疾疗效。
