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首页> 外文期刊>PLoS Medicine >Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial
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Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial

机译：计划性的间歇性筛查，包括快速诊断测试和二氢青蒿素-哌拉喹的治疗以及磺胺嘧啶-乙胺嘧啶在马拉维妊娠中的疟疾间歇性预防性治疗：一项开放标签的随机对照试验

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Background In Africa, most plasmodium infections during pregnancy remain asymptomatic, yet are associated with maternal anemia and low birthweight. WHO recommends intermittent preventive therapy in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP). However, sulfadoxine-pyrimethamine (SP) efficacy is threatened by high-level parasite resistance. We conducted a trial to evaluate the efficacy and safety of scheduled intermittent screening with malaria rapid diagnostic tests (RDTs) and treatment of RDT-positive women with dihydroartemisinin-piperaquine (DP) as an alternative strategy to IPTp-SP. Methods and Findings This was an open-label, two-arm individually randomized superiority trial among HIV-seronegative women at three sites in Malawi with high SP resistance. The intervention consisted of three or four scheduled visits in the second and third trimester, 4 to 6 wk apart. Women in the IPTp-SP arm received SP at each visit. Women in the intermittent screening and treatment in pregnancy with DP (ISTp-DP) arm were screened for malaria at every visit and treated with DP if RDT-positive. The primary outcomes were adverse live birth outcome (composite of small for gestational age, low birthweight [p = 0.625; paucigravidae: RR = 1.10 [95% CI 0.92–1.31], p = 0.282; multigravidae: RR = 0.92 [95% CI 0.71–1.20], p = 0.543). The prevalence of malaria at delivery was higher in the ISTp-DP arm (48.7% versus 40.8%; risk difference = 7.85%, [95% CI 3.07%–12.63%]; all women: RR = 1.19 [95% CI 1.07–1.33], p = 0.007; paucigravidae: RR = 1.16 [95% CI 1.04–1.31], p = 0.011; multigravidae: RR = 1.29 [95% CI 1.02–1.63], p = 0.037). Fetal loss was more common with ISTp-DP (2.6% versus 1.3%; RR = 2.06 [95% CI 1.01–4.21], p = 0.046) and highest among non-DP-recipients (3.1%) in the ISTp-DP arm. Limitations included the open-label design. Conclusions Scheduled screening for malaria parasites with the current generation of RDTs three to four times during pregnancy as part of focused antenatal care was not superior to IPTp-SP in this area with high malaria transmission and high SP resistance and was associated with higher fetal loss and more malaria at delivery. Trial Registration Pan African Clinical Trials Registry PACTR201103000280319 ; ISRCTN Registry ISRCTN69800930
机译：背景技术在非洲，怀孕期间大多数疟原虫感染仍无症状，但与孕妇贫血和低出生体重有关。世卫组织建议在妊娠期使用磺胺多辛-乙胺嘧啶（IPTp-SP）进行间歇性预防性治疗。然而，磺胺多辛-乙胺嘧啶（SP）的功效受到高水平的寄生虫抗性的威胁。我们进行了一项试验，以评估通过疟疾快速诊断测试（RDT）进行的间歇性筛查的有效性和安全性，以及用双氢青蒿素-哌喹（DP）作为IPTp-SP的替代策略来治疗RDT阳性女性。方法和研究结果这是一项在马拉维三个地点的具有高SP抗药性的HIV阴性女性中进行的开放标签，两臂单独随机优势试验。干预包括在中期和中期三个或四个预定的访视，相隔4至6周。 IPTp-SP部门的妇女每次访问都接受SP。每次接受间歇性筛查和妊娠DP（ISTp-DP）治疗的妇女均应进行疟疾筛查，如果RDT阳性，则应进行DP治疗。主要结局为活产不良结局（胎龄小，出生体重低的复合物[p = 0.625;足grav：RR = 1.10 [95％CI 0.92-1.31]，p = 0.282;多胎ida：RR = 0.92 [95％CI 0.71–1.20]，p = 0.543）。 ISTp-DP组的分娩疟疾患病率较高（48.7％比40.8％;风险差异= 7.85％，[95％CI 3.07％–12.63％];所有女性：RR = 1.19 [95％CI 1.07– 1.33]，p = 0.007;重凹科：RR = 1.16 [95％CI 1.04–1.31]，p = 0.011;多重力科：RR = 1.29 [95％CI 1.02-1.63]，p = 0.037）。 ISTp-DP的胎儿流失更为常见（2.6％对1.3％; RR = 2.06 [95％CI 1.01–4.21]，p = 0.046），在ISTp-DP组中，非DP接受者的胎儿丢失率最高（3.1％）。 。局限性包括开放标签设计。结论在有高疟疾传播和高SP抗性的这一地区，作为重点产前护理的一部分，在怀孕期间使用当前RDT进行三到四次定期疟疾寄生虫筛查并不优于IPTp-SP，并且与较高的胎儿流失率和分娩时更多的疟疾。审判注册泛非临床试验注册中心PACTR201103000280319; ISRCTN注册处ISRCTN69800930

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