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Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：尽管在2000年至2015年之间取得了令人瞩目的成就，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，疟疾控制和消除工作面临重大挑战。撒哈拉以南非洲的许多国家记录了对青蒿素的部分抗性的确认或潜在标记，治疗简单的恶性疟原虫疟疾的首选药物。世界卫生组织（WHO）建议定期监测青蒿素的治疗效果，以指导政策决定。
方法：本研究旨在评估蒿甲醚-本美特林（AL）的疗效，这是自2004年以来埃塞俄比亚无并发症的恶性疟原虫疟疾的一线治疗方法。使用单臂前瞻性评估设计，这项研究评估了Metehara健康中心无并发症的恶性疟原虫疟疾患者的临床和寄生虫反应，埃塞俄比亚中东部。在2332名疟疾嫌疑人中（1187名男性，1145名女性）筛选，80（50名男性，30名女性）报名参加，随访了28天,和73（44名男性，29名女性)完成了随访。根据2009年WHO疟疾治疗功效评估指南，通过采用符合方案和Kaplan-Meier分析进行研究并分析数据。
结果：结果表明寄生虫清除迅速，临床症状消退，所有患者在（D）3天之前从无性寄生虫血症和发烧中完全康复。配子细胞的患病率从D0的6.3％下降到D2，D3，D7的2.5％，并最终实现完全清除。
结论：AL治疗的总治愈率为100％，证明其有效消除患者疟疾寄生虫的高功效。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20年后，AL仍然是研究地点对无并发症的恶性疟原虫疟疾的高效治疗方法。
方法：本研究旨在评估蒿甲醚-本美特林（AL）的疗效，这是自2004年以来埃塞俄比亚无并发症的恶性疟原虫疟疾的一线治疗方法。使用单臂前瞻性评估设计，这项研究评估了Metehara健康中心无并发症的恶性疟原虫疟疾患者的临床和寄生虫反应，埃塞俄比亚中东部。在2332名疟疾嫌疑人中（1187名男性，1145名女性）筛选，80（50名男性，30名女性）报名参加，随访了28天,和73（44名男性，29名女性)完成了随访。根据2009年WHO疟疾治疗功效评估指南，通过采用符合方案和Kaplan-Meier分析进行研究并分析数据。
结果：结果表明寄生虫清除迅速，临床症状消退，所有患者在（D）3天之前从无性寄生虫血症和发烧中完全康复。配子细胞的患病率从D0的6.3％下降到D2，D3，D7的2.5％，并最终实现完全清除。
结论：AL治疗的总治愈率为100％，证明其有效消除患者疟疾寄生虫的高功效。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20年后，AL仍然是研究地点对无并发症的恶性疟原虫疟疾的高效治疗方法。
