Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria
Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria
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DOI：
10.1186/s12936-018-2394-2
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发表时间：
2018-07-06
期刊：
影响因子：
3
通讯作者：
Meremikwu, Martin
中科院分区：
文献类型：
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作者：
Esu, Ekpereonne;Berens-Riha, Nicole;Meremikwu, Martin
背景：磺胺多辛-乙胺嘧啶（IPTp-SP）对妊娠期疟疾（MiP）间歇性预防性治疗在非洲的传播可能会受到影响。然而，目前尚无推荐的IPTp替代药物或预防MiP的替代策略。这就给预防MiP带来了问题。这项研究调查了在常规产前门诊就诊时使用疟疾快速诊断试验进行筛查，并仅对阳性的孕妇使用蒿甲醚-氨苯三嗪进行治疗（间歇性筛查和治疗）是否与IPTp-SP一样有效和安全。方法：在2013年10月至2014年11月在尼日利亚卡拉巴尔总医院举行的产前门诊期间，459名孕妇被随机分为目前标准的IPTp-SP或间歇性筛查和使用青蒿素- lumemantrine （ISTp-AL）治疗。所有妇女在登记时都获得了一顶长效驱虫蚊帐。研究妇女在入组后最多有四次预定的访问。在妊娠晚期（妊娠36-40周）评估血红蛋白浓度和外周寄生虫血症。在分娩时或在家分娩的婴儿一周内记录出生体重。结果：在妊娠晚期，重度贫血（Hb < 8 g/dl）和中度贫血（8-10.9 g/dl）的总患病率分别为0.8%和27.7%，两组差异无统计学意义（p = 0.204）。妊娠晚期严重贫血的风险在两个治疗组之间没有显著差异（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，该样本对这一结果的支持不足。ISTp-AL组妊娠晚期母体寄生虫病的风险显著降低（RD -3.96% [95% CI -7.76 ~ -0.16]）。在控制了母亲年龄、妊娠和基线寄生虫血症后，ISTp-AL组低出生体重的风险显著降低（风险差为-1.53% [95% CI -1.54至-1.15]）。ISTp-AL组的女性比IPTp-SP组的女性更频繁地抱怨发烧（p = 0.022）。结论：在疟疾高传播、磺胺多辛-乙胺嘧啶耐药性中等的地区，青蒿素-氨苯曲明联合ISTp可能是一种有效的妊娠期疟疾控制策略。
Background: 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.Methods: 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.Results: 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).Conclusions: 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.