Center for International Health (CIH), Ludwig-Maximilians-Universität (LMU), Leopoldstraße 7, 80802, Munich, Germany.
Department of Public Health, College of Medical Sciences, University of Calabar, Calabar, Nigeria.
Malar J. 2018 Jul 6;17(1):251. doi: 10.1186/s12936-018-2394-2.
The spread of SP resistance may compromise the effectiveness of intermittent preventive treatment of malaria in pregnancy (MiP) with sulfadoxine-pyrimethamine (IPTp-SP) across Africa. However, there is no recommended alternative medicine for IPTp or alternative strategy for prevention of MiP. This poses problems for the prevention of MiP. This study investigated, whether screening with a rapid diagnostic test for malaria at routine antenatal clinic attendances and treatment of only those who are positive (intermittent screening and treatment) with artemether-lumefantrine is as effective and safe as IPTp-SP in pregnant women.
During antenatal clinic sessions at the General Hospital Calabar, Nigeria, held between October 2013 and November 2014, 459 pregnant women were randomized into either the current standard IPTp-SP or intermittent screening and treatment with artemether-lumefantrine (ISTp-AL). All women received a long-lasting insecticide-treated net at enrolment. Study women had a maximum of four scheduled visits following enrolment. Haemoglobin concentration and peripheral parasitaemia were assessed in the third trimester (36-40 weeks of gestation). Birth weight was documented at delivery or within a week for babies delivered at home.
In the third trimester, the overall prevalence of severe anaemia (Hb < 8 g/dl) and moderate (8-10.9 g/dl) anaemia was 0.8 and 27.7%, respectively, and was similar in both treatment groups (p = 0.204). The risk of third-trimester severe anaemia did not differ significantly between both treatment arms (risk difference - 1.75% [95% CI - 4.16 to 0.66]) although the sample was underpowered for this outcome due to several participants being unavailable to give a blood sample. The risk of third-trimester maternal parasitaemia was significantly lower in the ISTp-AL arm (RD - 3.96% [95% CI - 7.76 to - 0.16]). The risk of low birthweight was significantly lower in the ISTp-AL arm after controlling for maternal age, gravidity and baseline parasitaemia (risk difference - 1.53% [95% CI - 1.54 to - 1.15]). Women in the ISTp-AL arm complained of fever more frequently compared to women in the IPTp-SP arm (p = 0.022).
The trial results suggest that in an area of high malaria transmission with moderate sulfadoxine-pyrimethamine resistance, ISTp with artemether-lumefantrine may be an effective strategy for controlling malaria in pregnancy. Trial registration PACTR, PACTR201308000543272. Registered 29 April 2013, http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201308000543272.
随着对间日疟原虫的药物抗性在非洲的蔓延，采用磺胺多辛-乙胺嘧啶（IPTp-SP）间歇性预防治疗妊娠疟疾（MiP）的有效性可能受到影响。然而，目前还没有推荐用于 IPTp 的替代药物或预防 MiP 的替代策略。这给 MiP 的预防带来了问题。本研究旨在探讨，在尼日利亚卡拉巴尔综合医院的常规产前就诊期间，采用快速疟疾诊断检测进行间歇性筛查并对阳性者（间歇性筛查和治疗）采用青蒿琥酯-咯萘啶进行治疗，与采用磺胺多辛-乙胺嘧啶（IPTp-SP）治疗相比，在孕妇中是否同样有效和安全。
在 2013 年 10 月至 2014 年 11 月期间，共有 459 名孕妇参加了本研究，她们被随机分配到现行标准的 IPTp-SP 或青蒿琥酯-咯萘啶间歇性筛查和治疗（ISTp-AL）组。所有女性在入组时均获得长效驱虫蚊帐。研究女性在入组后最多可进行四次预约。在妊娠晚期（36-40 周）评估血红蛋白浓度和外周寄生虫血症。分娩时或在家中分娩的婴儿在一周内记录出生体重。
在妊娠晚期，严重贫血（Hb<8g/dl）和中度贫血（8-10.9g/dl）的总患病率分别为 0.8%和 27.7%，两组之间相似（p=0.204）。两种治疗方法之间，第三孕期严重贫血的风险无显著差异（风险差异-1.75%[95%CI-4.16 至 0.66]），尽管由于一些参与者无法提供血液样本，本研究的样本量不足以得出这一结果。ISTp-AL 组的第三孕期母体寄生虫血症风险显著降低（RD-3.96%[95%CI-7.76 至-0.16]）。在控制了母亲年龄、孕次和基线寄生虫血症后，ISTp-AL 组的低出生体重风险显著降低（风险差异-1.53%[95%CI-1.54 至-1.15]）。与 IPTp-SP 组相比，ISTp-AL 组的女性更频繁地抱怨发热（p=0.022）。
试验结果表明，在疟疾传播率较高且磺胺多辛-乙胺嘧啶耐药率中等的地区，采用青蒿琥酯-咯萘啶的 ISTp 可能是控制妊娠疟疾的有效策略。试验注册 PACTR，PACTR201308000543272。于 2013 年 4 月 29 日注册，http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201308000543272。
