Tesfaye Mahelet, Assefa Ashenafi, Hailgiorgis Henok, Gidey Bokretsion, Mohammed Hussein, Tollera Getachew, Tasew Geremew, Assefa Gudissa, Bekele Worku, Mamo Hassen
Department of Microbial, Cellular and Molecular Biology, College of Natural and Computational Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
Malar J. 2024 Jun 12;23(1):184. doi: 10.1186/s12936-024-04991-2.
Malaria remains a major global health problem although there was a remarkable achievement between 2000 and 2015. Malaria drug resistance, along with several other factors, presents a significant challenge to malaria control and elimination efforts. Numerous countries in sub-Saharan Africa have documented the presence of confirmed or potential markers of partial resistance against artemisinin, the drug of choice for the treatment of uncomplicated Plasmodium falciparum malaria. The World Health Organization (WHO) recommends regular surveillance of artemisinin therapeutic efficacy to inform policy decisions.
This study aimed to evaluate the therapeutic efficacy of artemether-lumefantrine (AL), which is the first-line treatment for uncomplicated P. falciparum malaria in Ethiopia since 2004. Using a single-arm prospective evaluation design, the study assessed the clinical and parasitological responses of patients with uncomplicated P. falciparum malaria in Metehara Health Centre, central-east Ethiopia. Out of 2332 malaria suspects (1187 males, 1145 females) screened, 80 (50 males, 30 females) were enrolled, followed up for 28 days, and 73 (44 males, 29 females) completed the follow up. The study was conducted and data was analysed by employing the per-protocol and Kaplan-Meier analyses following the WHO Malaria Therapeutic Efficacy Evaluation Guidelines 2009.
The results indicated rapid parasite clearance and resolution of clinical symptoms, with all patients achieving complete recovery from asexual parasitaemia and fever by day (D) 3. The prevalence of gametocytes decreased from 6.3% on D0 to 2.5% on D2, D3, D7, and ultimately achieving complete clearance afterward.
The overall cure rate for AL treatment was 100%, demonstrating its high efficacy in effectively eliminating malaria parasites in patients. No serious adverse events related to AL treatment were reported during the study, suggesting its safety and tolerability among the participants. These findings confirm that AL remains a highly efficacious treatment for uncomplicated P. falciparum malaria in the study site after 20 years of its introduction in Ethiopia.
尽管2000年至2015年间取得了显著成就，但疟疾仍然是一个主要的全球健康问题。疟疾耐药性以及其他几个因素，给疟疾控制和消除工作带来了重大挑战。撒哈拉以南非洲的许多国家都记录了对青蒿素（治疗非复杂性恶性疟原虫疟疾的首选药物）存在部分耐药的确诊或潜在标志物。世界卫生组织（WHO）建议定期监测青蒿素的治疗效果，为政策决策提供依据。
本研究旨在评估蒿甲醚-本芴醇（AL）的治疗效果，自2004年以来，AL一直是埃塞俄比亚治疗非复杂性恶性疟原虫疟疾的一线药物。该研究采用单臂前瞻性评估设计，在埃塞俄比亚中东部的梅特哈拉健康中心评估了非复杂性恶性疟原虫疟疾患者的临床和寄生虫学反应。在筛查的2332名疟疾疑似患者（1187名男性，1145名女性）中，80名（50名男性，30名女性）被纳入研究，随访28天，73名（44名男性，29名女性）完成了随访。该研究按照2009年WHO疟疾治疗效果评估指南进行，并采用符合方案分析和Kaplan-Meier分析对数据进行分析。
结果表明寄生虫清除迅速，临床症状得到缓解，所有患者在第3天均实现了无性疟原虫血症和发热的完全恢复。配子体的患病率从第0天的6.3%降至第2天、第3天、第7天的2.5%，最终在此后实现完全清除。
AL治疗的总体治愈率为100%，表明其在有效消除患者体内疟原虫方面具有高效性。研究期间未报告与AL治疗相关的严重不良事件，表明其在参与者中的安全性和耐受性。这些发现证实，在埃塞俄比亚引入AL 20年后，它在研究地点仍然是治疗非复杂性恶性疟原虫疟疾的高效药物。
