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在北苏门答腊使用双氢青蒿素哌喹或蒿甲醚本芴醇治疗单纯性疟疾后的复发情况。

Recurrence of and Following Treatment of Uncomplicated Malaria in North Sumatera With Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine.

作者信息

Lubis Inke Nadia D, Wijaya Hendri, Lubis Munar, Lubis Chairuddin P, Beshir Khalid B, Staedke Sarah G, Sutherland Colin J

机构信息

Department of Paediatrics, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.

Infection and Immunity Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.

出版信息

Open Forum Infect Dis. 2020 Apr 2;7(5):ofaa116. doi: 10.1093/ofid/ofaa116. eCollection 2020 May.

DOI:10.1093/ofid/ofaa116
PMID:32420402
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7216766/
Abstract

BACKGROUND

We assessed the efficacy of artemisinin-based combination therapies for treatment of uncomplicated malaria, with or without co-infecting spp., in Sumatera, Indonesia.

METHODS

Febrile patients aged >6 months with uncomplicated were randomized to receive dihydroartemisinin-piperaquine or artemether-lumefantrine, plus single-dose primaquine, and were followed for 42 days. Mixed infections were included; infections received 14 days of primaquine. We retrospectively restricted the analysis to cases with polymerase chain reaction (PCR)-confirmed parasitemia. Recurrent parasitemia in follow-up was identified by species-specific nested PCR.

RESULTS

Of the 3731 participants screened, 302 were enrolled and randomized. In the dihydroartemisinin-piperaquine arm, infections were confirmed by PCR in 59 participants, with mixed infections in 23 (39.0%). In the artemether-lumefantrine arm, infections were confirmed by PCR in 55 participants, with mixed infections in 16 (29.0%). Both regimens were well tolerated, and symptoms improved rapidly in all treated participants. In the dihydroartemisinin-piperaquine arm, 1 recurrence (on day 7) and 6 recurrences (1 had a mixed infection with ) were identified during days 3-42 of follow-up. In the artemether-lumefantrine arm, 1 recurrence occurred on day 35. Submicroscopic persistence occurred during follow-up in 21 (37%) of 57 receiving dihydroartemisinin-piperaquine and 20 (39%) of 51 receiving artemether-lumefantrine.

CONCLUSIONS

In Sumatera, both regimens effectively cleared initial parasitemia, but and persisted in some individuals. Molecular species detection should be deployed in antimalarial efficacy trials in Indonesia.

TRIAL REGISTRATION

NCT02325180.

摘要

背景

我们在印度尼西亚苏门答腊评估了以青蒿素为基础的联合疗法治疗无并发症疟疾(无论是否合并其他物种感染)的疗效。

方法

年龄大于6个月的无并发症发热患者被随机分配接受双氢青蒿素 - 哌喹或蒿甲醚 - 本芴醇,加单剂量伯氨喹,并随访42天。纳入混合感染;疟原虫感染患者接受14天伯氨喹治疗。我们回顾性地将分析限制在聚合酶链反应(PCR)确诊的寄生虫血症病例。通过物种特异性巢式PCR确定随访期间的复发性寄生虫血症。

结果

在3731名筛查参与者中,302名被纳入并随机分组。在双氢青蒿素 - 哌喹组中,59名参与者经PCR确诊为疟原虫感染,其中23名(39.0%)为混合感染。在蒿甲醚 - 本芴醇组中,55名参与者经PCR确诊为疟原虫感染,其中16名(29.0%)为混合感染。两种方案耐受性良好,所有接受治疗的参与者症状迅速改善。在双氢青蒿素 - 哌喹组中,随访第3 - 42天期间发现1例复发(第7天)和6例疟原虫复发(1例为与其他物种的混合感染)。在蒿甲醚 - 本芴醇组中,第35天出现1例疟原虫复发。接受双氢青蒿素 - 哌喹的57名患者中有21名(37%)以及接受蒿甲醚 - 本芴醇的51名患者中有20名(39%)在随访期间出现亚显微水平的持续性感染。

结论

在苏门答腊,两种方案均有效清除初始寄生虫血症,但部分个体中疟原虫和其他物种仍持续存在。在印度尼西亚的抗疟疗效试验中应采用分子物种检测。

试验注册号

NCT02325180。

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