吡喹酮-青蒿琥酯（Pyramax）治疗埃塞俄比亚西北部无并发症间日疟原虫疟疾的疗效和安全性。
Efficacy and safety of pyronaridine-artesunate (Pyramax) for the treatment of uncomplicated Plasmodium vivax malaria in Northwest Ethiopia.
机构信息
Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
Department of Medical Laboratory Sciences, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.
出版信息
Malar J. 2022 Dec 31;21(1):401. doi: 10.1186/s12936-022-04422-0.
BACKGROUND
Declining efficacy of chloroquine for the treatment Plasmodium vivax malaria has been reported in different endemic settings in Ethiopia. This highlights the need to assess alternative options for P. vivax treatment with artemisinin-based combination therapy, such as pyronaridine-artesunate. This treatment regimen has shown high efficacy for uncomplicated malaria in both Africa and Asia. However, limited data are available from Ethiopia. This study was conducted to assess the efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated P. vivax malaria in Northwest Ethiopia.
METHODS
A single arm prospective efficacy study was conducted in the Hamusite area, Northwest Ethiopia. Fifty-one febrile adult patients with uncomplicated P. vivax malaria were enrolled between March and July 2021. Patients were treated with pyronaridine-artesunate once daily for three days. Clinical and parasitological parameters were monitored over a 42-day follow-up period using the standard World Health Organization protocol for therapeutic efficacy studies.
RESULTS
A total of 4372 febrile patients were screened with 51 patients enrolled and 49 completing the 42-day follow-up period. The PCR-uncorrected adequate clinical and parasitological response (ACPR) was 95.9% (47/49; 95% CI 84.9-99.0) on day 42. Two patients had recurrences [4.0% (2/49); 95% CI 0.7-12.1] on days 35 and 42. The parasite clearance rate was rapid with fast resolution of clinical symptoms; 100% of participants had cleared parasitaemia on day 1 and fever on day 2. All 16 (31.4%) patients with gametocyte carriage on day 0 had cleared by day 1. There were no serious adverse events.
CONCLUSION
In this small study, pyronaridine-artesunate was efficacious and well-tolerated for the treatment of uncomplicated P. vivax malaria. In adults in the study setting, it would be a suitable alternative option for case management.
背景
在埃塞俄比亚不同流行地区，氯喹治疗间日疟原虫疟疾的疗效已下降。这凸显了评估青蒿素为基础的联合疗法（如咯萘啶-青蒿琥酯）治疗间日疟原虫的替代方案的必要性。这种治疗方案在非洲和亚洲的无并发症疟疾中均显示出较高的疗效。然而，来自埃塞俄比亚的数据有限。本研究旨在评估咯萘啶-青蒿琥酯治疗西北埃塞俄比亚无并发症间日疟原虫疟疾的疗效和安全性。
方法
在埃塞俄比亚西北部的哈穆斯泰特地区进行了一项单臂前瞻性疗效研究。2021 年 3 月至 7 月期间，共招募了 51 名患有无并发症间日疟原虫疟疾的发热成年患者。患者每天服用咯萘啶-青蒿琥酯一次，共三天。采用标准的世界卫生组织治疗疗效研究方案，在 42 天的随访期间监测临床和寄生虫学参数。
结果
共对 4372 名发热患者进行了筛查，其中 51 名患者入选并完成了 42 天的随访期。PCR 未校正的完全临床和寄生虫学反应（ACPR）在第 42 天为 95.9%（47/49；95%CI 84.9-99.0）。2 名患者在第 35 天和第 42 天复发[4.0%（2/49）；95%CI 0.7-12.1]。寄生虫清除率很快，临床症状迅速缓解；所有患者在第 1 天清除了寄生虫血症，在第 2 天清除了发热。所有 16 名（31.4%）在第 0 天有配子体携带的患者在第 1 天清除了配子体。无严重不良事件。
结论
在这项小型研究中，咯萘啶-青蒿琥酯治疗无并发症间日疟原虫疟疾的疗效好且耐受性良好。在研究环境中，对于成人病例管理来说，它将是一种合适的替代方案。
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