2022-2023年利比里亚青蒿琥酯-阿莫地喹(ASAQ)和蒿甲醚-氨苯曲明(AL)治疗无并发症恶性疟原虫疟疾的疗效和安全性比较

IF 3 3区 医学 Q3 INFECTIOUS DISEASES
Victor S Koko, Laura Skrip, Odell Kumeh, Trokon Washington, Mamadou O Diallo, Jessica Kafuko, Uwem Inyang, Gabriel F Ponce de León, Zhiyong Zhou, Veronika R Laird, Jethro Zawolo, Birhanu Getahun, Wahdae-Mai Harmon-Gray, Mateusz Plucinski, Jonathan S Schultz
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引用次数: 0

摘要

背景:蒿甲醚-鲁美曲明(AL)目前是利比里亚治疗无并发症恶性疟原虫疟疾的一线药物。为了确保抗疟疾治疗的有效性,世界卫生组织(世卫组织)建议每两年利用疗效研究(TES)定期检测口服青蒿素联合疗法(ACT)治疗简单疟疾的疗效。2017年12月至2018年5月在利比里亚进行的最新TES报告称,经pcr校正的充分临床和寄生虫学反应(ACPR)在Bensonville为90.2%,在Saclepea为92.7%,在Kakata和Sinje为100%。由于这些发现,AL优先于ASAQ作为利比里亚的一线ACT。然而,ASAQ在利比里亚普遍可用,在其他西非国家仍然非常有效。方法:于2022年8月至2023年7月在利比里亚Saclepea和Sinje采用WHO标准TES方案评价AL和ASAQ的治疗效果。招募6 ~ 59月龄无并发症恶性疟原虫感染(无性寄生虫2000 ~ 20万/μL)的符合条件的患儿,在各部位应用AL或ASAQ治疗,临床和寄生虫学监测28 d。结果:共有1630名儿童被筛选为合格,305名儿童入组。在纳入的儿童中,152人接受AL治疗(Sacleapea组78人,Sinje组74人),153人接受ASAQ治疗(Sacleapea组77人,Sinje组76人)。在纳入的儿童中,299名(98%)达到了研究终点或完成了28天的随访。在研究期间,AL或ASAQ均未报告不良事件。ASAQ组在随访第3天出现寄生虫血症的比例为1.3% (2/153),AL组为0%(0/151)。第28天pcr校正的ACPR在Saclepea组为100%,在Sinje组为95.9% (95CI 88.0%-98.7%),在Saclepea组为100%,在Sinje组为94.4% (95CI 85.9%-97.9%)。结论:经pcr校正的ACPR疗效大于90% WHO阈值,第3天载玻片阳性率表明AL和ASAQ均是利比里亚无并发症疟疾的有效治疗方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ) for the treatment of uncomplicated Plasmodium falciparum malaria in Liberia, 2022-2023.

Background: Artemether-lumefantrine (AL) is currently the first-line treatment for uncomplicated Plasmodium falciparum malaria in Liberia. To ensure antimalarial treatments are effective, the World Health Organization (WHO) recommends routinely testing the efficacy of oral artemisinin-based combination therapy (ACT) for uncomplicated malaria using therapeutic efficacy studies (TES) every two years. The most recent TES in Liberia conducted from December 2017 to May 2018 reported a PCR-corrected adequate clinical and parasitological response (ACPR) of 90.2% in Bensonville and 92.7% in Saclepea for artesunate-amodiaquine (ASAQ), and 100% in Kakata and Sinje for AL. Due to these findings AL was prioritized over ASAQ as the first-line ACT in Liberia. However, ASAQ is commonly available in Liberia and remains highly efficacious in other West African countries.

Methods: The therapeutic efficacy of AL and ASAQ were evaluated using the standard WHO TES protocol in Saclepea and Sinje, Liberia, from August 2022 to July 2023. Eligible children aged 6 - 59 months with uncomplicated P. falciparum malaria infection (2,000-200,000 asexual parasites/μL) were recruited, treated with AL or ASAQ at each site, and monitored clinically and parasitologically for 28 days.

Results: A total of 1,630 children were screened for eligibility and 305 were enrolled. Among enrolled children, 152 were treated with AL (78 in Sacleapea and 74 in Sinje) and 153 were treated with ASAQ (77 in Sacleapea and 76 in Sinje). Of the enrolled children, 299 (98%) reached a study endpoint or completed the 28 days of follow up. No adverse events were reported for either AL or ASAQ during the study period. The proportion of participants with parasitaemia on day 3 of follow up was 1.3% (2/153) for ASAQ, and 0% (0/151) treated with AL. The PCR-corrected ACPR at day 28 was 100% in Saclepea and 95.9% (95CI 88.0%-98.7%) in Sinje for AL, and 100% in Saclepea and 94.4% (95CI 85.9%-97.9%) in Sinje for ASAQ.

Conclusion: The PCR-corrected ACPR efficacy greater than the 90% WHO threshold, and day 3 slide positivity rate demonstrate that AL and ASAQ are both effective treatments for uncomplicated malaria in Liberia.

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来源期刊
Malaria Journal
Malaria Journal 医学-寄生虫学
CiteScore
5.10
自引率
23.30%
发文量
334
审稿时长
2-4 weeks
期刊介绍: Malaria Journal is aimed at the scientific community interested in malaria in its broadest sense. It is the only journal that publishes exclusively articles on malaria and, as such, it aims to bring together knowledge from the different specialities involved in this very broad discipline, from the bench to the bedside and to the field.
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