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西非科特迪瓦六个哨点地区一线疟疾治疗药物青蒿琥酯-阿莫地喹和青蒿琥酯-氨酚喹啉的疗效和安全性。

Efficacy and safety of artesuante-amodiaquine and artemether lumefantrine, the first line malaria treatment in six sentinel's sites of Côte d'Ivoire, West Africa.

机构信息

Malariology Department, Institut Pasteur of Côte d'Ivoire, Boulevard Universite, Abidjan 01, Côte d'Ivoire.

Parasitology Unit, Pierre Richet Institute/National Malaria Control Program, Boulevard CHU, Bouake 1500, Côte d'Ivoire.

出版信息

Ann Parasitol. 2020;66(4):561-571. doi: 10.17420/ap6604.299.

DOI:10.17420/ap6604.299
PMID:33789028
Abstract

The purpose of this study was to update efficacy data of Artesunate-Amodiaquine (AS+AQ) and Artemether-Lumefantrine (AL) used as first-line malaria treatment in Côte d'Ivoire since 2005. This was an open-label, randomized trial conducted in patients older than 6 months with uncomplicated P. falciparum malaria at six sentinel sites. The WHO 2009 protocol on surveillance of anti-malaria drug efficacy was used with primary outcomes as ACPR corrected by PCR at day 42. Secondary endpoints were parasite and fever clearance times and safety. From January to July 2016, 712 patients were included in the trial. 353 and 359 patients were randomly assigned respectively to the AS+AQ and AL arm. Day 42 PCR-adjusted ACPR in the per-protocol analysis was 99.4% and 98.8% in AS+AQ and AL arm respectively. Delayed parasite clearance was observed in six patients at Abidjan and Yamousssoukro sites. Both ACTs were well tolerated. Both ACTs remain efficacious for uncomplicated P. falciparum malaria treatment in Côte d'Ivoire. But regarding delayed parasite clearance observed in this study, a close monitoring and supervision for ACT resistance are essential for future malaria treatment and control strategies in Côte d'Ivoire.

摘要

本研究旨在更新自 2005 年以来在科特迪瓦用作一线疟疾治疗的青蒿琥酯-阿莫地喹(AS+AQ)和青蒿琥酯-甲氟喹(AL)的疗效数据。这是一项在六个哨点进行的开放性、随机试验,纳入了年龄大于 6 个月的、患有无并发症恶性疟原虫疟疾的患者。采用世卫组织 2009 年关于抗疟药疗效监测的方案,主要终点为第 42 天 PCR 校正后的临床有效率(ACPR)。次要终点为寄生虫和发热清除时间及安全性。2016 年 1 月至 7 月,共有 712 例患者入组本研究。353 例和 359 例患者分别被随机分配到 AS+AQ 和 AL 组。意向治疗人群分析中,第 42 天 PCR 校正后的 ACPR 在 AS+AQ 和 AL 组中分别为 99.4%和 98.8%。在阿比让和亚穆苏克罗两个地点观察到 6 例寄生虫清除延迟。两种 ACT 均具有良好的耐受性。两种 ACT 均对科特迪瓦无并发症恶性疟原虫疟疾的治疗有效。但鉴于本研究中观察到的寄生虫清除延迟,对于未来科特迪瓦的疟疾治疗和控制策略,需要对 ACT 耐药性进行密切监测和监督。

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