Safety, tolerability, and efficacy of repeated doses of dihydroartemisinin-piperaquine for prevention and treatment of malaria: a systematic review and meta-analysis.
Safety, tolerability, and efficacy of repeated doses of dihydroartemisinin-piperaquine for prevention and treatment of malaria: a systematic review and meta-analysis.
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重复剂量的二氢二甲素 - 二喹用于预防和治疗疟疾的安全性，耐受性和功效：系统评价和荟萃分析。
DOI：
10.1016/s1473-3099(16)30378-4
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发表时间：
2017-02
期刊：
影响因子：
--
通讯作者：
Ter Kuile FO
中科院分区：
文献类型：
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作者：
Gutman J;Kovacs S;Dorsey G;Stergachis A;Ter Kuile FO
疟疾的间歇性预防治疗（IPT）用于婴儿、儿童、成人和孕妇。双氢青蒿素-哌喹（DP）是一种有效、耐受性良好的青蒿素类联合治疗药物。哌喹的长半衰期使其对IPT具有吸引力。我们进行了系统回顾和荟萃分析，以确定DP重复治疗的疗效和安全性。根据PRISMA指南，我们于2016年9月1日检索了多个数据库，检索词为："人"和"双氢青蒿素-哌喹"或"DHA-PPQ"。如果研究是随机对照试验（RCT）或前瞻性队列研究，涉及在任何时间和任何地理位置重复暴露于标准的3天DP疗程，用于季节性疟疾化学预防、大规模药物给药或临床疟疾治疗，则符合条件。随机效应荟萃分析用于生成汇总的发生率比和相对风险或风险差异。纳入了11项研究：两项重复治疗研究（一项在5岁以下儿童中进行，一项在孕妇中进行）和九项IPT试验（五项在5岁以下儿童中进行，一项在学龄儿童中进行，一项在成人中进行，两项在孕妇中进行）。对照干预措施包括安慰剂、蒿甲醚-苯芴醇、磺胺甲基嘧啶-乙胺嘧啶（SP）、SP+阿莫地喹、SP+哌喹、SP+氯喹和复方新诺明。在14628名参与者中，3935人接受了多个DP课程（2 - 18）。 与安慰剂相比，每月一次的IPT-DP与显微镜测量的疟疾寄生虫血症发病率降低84%相关。与安慰剂、每日复方新诺明或每月SP相比，每月一次的IPT-DP与更少的严重不良事件相关。在56名具有心脏参数的IPT-DP接受者（26名儿童，30名孕妇）中，所有QTc间期均在正常范围内，随着DP疗程的增加，QTc间期延长无显著增加。每月一次DP对IPT耐受良好且有效。妊娠期需要更多数据，以进一步探索每月给药的心脏安全性。比尔和梅林达盖茨基金会和NIH。
Intermittent preventive treatment (IPT) for malaria is used in infants, children, adults, and pregnant women. Dihydroartemisinin-piperaquine (DP) is an effective, well tolerated artemisinin-based combination therapy. The long half-life of piperaquine makes it attractive for IPT. We conducted a systematic review and meta-analysis to establish the efficacy and safety of repeated treatment with DP. Following PRISMA guidelines, we searched multiple databases on Sept 1, 2016, with the terms: “human” AND “dihydroartemisinin-piperaquine” OR “DHA-PPQ”. Studies were eligible if they were randomised controlled trials (RCTs) or prospective cohort studies involving repeat exposures to standard 3-day courses of DP for either seasonal malaria chemoprevention, mass drug administration, or treatment of clinical malaria, conducted at any time and in any geographic location. Random-effects meta-analysis was used to generate pooled incidence rate ratios and relative risks, or risk differences. 11 studies were included: two repeat treatment studies (one in children younger than 5 years and one in pregnant women), and nine IPT trials (five in children younger than 5 years, one in schoolchildren, one in adults, two in pregnant women). Comparator interventions included placebo, artemether-lumefantrine, sulfadoxine-pyrimethamine (SP), SP+amodiaquine, SP+piperaquine, SP+chloroquine, and co-trimoxazole. Of 14 628 participants, 3935 received multiple DP courses (2–18). Monthly IPT-DP was associated with an 84% reduction in the incidence of malaria parasitaemia measured by microscopy compared with placebo. Monthly IPT-DP was associated with fewer serious adverse events than placebo, daily co-trimoxazole, or monthly SP. Among 56 IPT-DP recipients (26 children, 30 pregnant women) with cardiac parameters, all QTc intervals were within normal limits, with no significant increase in QTc prolongation with increasing courses of DP. Monthly DP appears well tolerated and effective for IPT. Additional data are needed in pregnancy and to further explore the cardiac safety with monthly dosing. Bill & Melinda Gates Foundation and NIH.