2022/23 年，在埃塞俄比亚西北部的泰达健康中心，使用蒿甲醚-本芴醇联合疗法治疗无并发症恶性疟原虫疟疾的疗效和安全性。

Therapeutic efficacy and safety of artemether-lumefantrine combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria at Teda Health Centre, Northwest Ethiopia, 2022/23.

机构信息

Department of Medical Laboratory Science, College of Medicine and Health Sciences, Wachemo University, Hossana, Ethiopia.

Department of Medical Parasitology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.

出版信息

Malar J. 2024 Aug 30;23(1):266. doi: 10.1186/s12936-024-05082-y.

DOI:10.1186/s12936-024-05082-y

PMID:39215366

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11363363/

Abstract

BACKGROUND

The emergence of Plasmodium falciparum drug resistance against artemisinin-based combination therapy has threatened malaria control efforts. Since malaria control and elimination plans are dependent on these drugs, they must remain efficacious. However, resistance to these drugs was detected in low-transmission settings and is predicted to emerge in high-transmission settings, including in unspecified areas of Ethiopia. Therefore, this study aimed to assess the therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria.

METHODS

A single-arm prospective observational study was conducted at Teda Health Centre, Northwest Ethiopia, by following the 2009 World Health Organization efficacy study guidelines from September 2022 to February 2023. Patients with uncomplicated falciparum malaria were conveniently selected and treated with a standard dose of artemether-lumefantrine, along with a single low dose of primaquine. Then clinical and parasitological responses and haemoglobin levels were assessed during the 28-day scheduled follow-up. Blood films were examined and asexual parasites were quantified; axillary temperature was measured; and drug adverse events were assessed throughout the follow-up. Finally, the drug efficacy (adequate clinical and parasitological response) was determined by Kaplan-Meier and per-protocol analyses. The data were analysed using the WHO Excel spreadsheet and SPSS version 25 software.

RESULTS

The success rates of PCR uncorrected and corrected Kaplan-Meier analysis on day 28 were 95.8% (95% CI 87.5-98.6) and 97.3% (95% CI 89.4-99.3), respectively. The per-protocol PCR uncorrected and corrected adequate clinical and parasitological responses were 95.5% (95% CI 87.5-99.1) and 97% (95% CI 89.5-99.6), respectively. On day-3, 97% of study participants were free of asexual parasitaemia, and all of them were fever-free on day-2. All of the gametocyte-positive patients at baseline were found to be negative for gametocytes on day-2. Moreover, the baseline mean hemoglobin of 13.10 g/dl increased slightly on day-14 to 13.27 g/dl but significantly on day-28 to 13.69 g/dl in a paired sample t test. All adverse events reported were mild.

CONCLUSION

Artemether-lumefantrine continued to be an efficacious and safe drug for the treatment of uncomplicated Plasmodium falciparum malaria at the Teda Health Centre.

TRIAL REGISTRATION

unique ID# PACTR202309773069812 at https://pactr.samrc.ac.za on September 1, 2023.

摘要

背景

疟原虫对青蒿素类复方疗法的耐药性的出现，威胁到了疟疾控制工作。由于疟疾控制和消除计划依赖于这些药物，因此它们必须保持有效。然而，在低传播地区已经检测到对这些药物的耐药性，预计在高传播地区也会出现耐药性，包括在埃塞俄比亚的未指定地区。因此，本研究旨在评估青蒿琥酯-咯萘啶治疗无并发症恶性疟原虫疟疾的疗效和安全性。

方法

本研究是一项在埃塞俄比亚西北部特达健康中心进行的单臂前瞻性观察性研究，遵循 2009 年世界卫生组织疗效研究指南，于 2022 年 9 月至 2023 年 2 月进行。方便选择患有无并发症恶性疟的患者，并给予青蒿琥酯-咯萘啶标准剂量治疗，同时给予单剂量低剂量的伯氨喹。然后在 28 天的预定随访期间评估临床和寄生虫学反应以及血红蛋白水平。在整个随访过程中检查血片并定量有性寄生虫；测量腋温；评估药物不良反应。最后，采用 Kaplan-Meier 和方案分析确定药物疗效（充分的临床和寄生虫学反应）。数据使用世界卫生组织 Excel 电子表格和 SPSS 版本 25 软件进行分析。

结果

PCR 未校正和校正的 Kaplan-Meier 分析在第 28 天的成功率分别为 95.8%（95%CI 87.5-98.6）和 97.3%（95%CI 89.4-99.3）。方案分析 PCR 未校正和校正的充分临床和寄生虫学反应率分别为 95.5%（95%CI 87.5-99.1）和 97%（95%CI 89.5-99.6）。在第 3 天，97%的研究参与者无无性寄生虫血症，所有参与者在第 2 天均无发热。所有基线时为阳性的配子体患者在第 2 天均为阴性。此外，配对样本 t 检验显示，基线时平均血红蛋白为 13.10 g/dl，在第 14 天略有增加至 13.27 g/dl，在第 28 天显著增加至 13.69 g/dl。报告的所有不良事件均为轻度。