Wudneh Feven, Assefa Ashenafi, Nega Desalegn, Mohammed Hussien, Solomon Hiwot, Kebede Tadesse, Woyessa Adugna, Assefa Yibeltal, Kebede Amha, Kassa Moges
Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa; Biomedical Department, College of Health Sciences and Medicine, Dilla University, Dilla.
Malaria and Other Parasitological and Entomological Research Team, Bacterial, Parasitic and Zoonotic Diseases Research Directorate, Ethiopian Public Health Institute.
Ther Clin Risk Manag. 2016 Aug 24;12:1293-300. doi: 10.2147/TCRM.S113603. eCollection 2016.
Following the increased Plasmodium falciparum resistance to chloroquine and sulfadoxine/pyrimethamine, Ethiopia adopted artemether/lumefantrine (AL) as the first-line treatment for uncomplicated P. falciparum in 2004. According to the recommendation of the World Health Organization, this study was carried out for regular monitoring of the efficacy of AL in treating the uncomplicated P. falciparum malaria in Metema district, Gondar Zone, Northwest Ethiopia.
This is a one-arm prospective 28-day in vivo therapeutic efficacy study among the uncomplicated P. falciparum malaria patients aged 6 months and older. The study was conducted from October 2014 to January 2015, based on the revised World Health Organization protocol of 2009 for surveillance of antimalarial drug therapeutic efficacy study. Standard six-dose regimen of AL was given twice daily for 3 days, and then the treatment outcomes were assessed on days 0, 1, 2, 3, 7, 14, 21, 28, and any other unscheduled day for emergency cases.
There were 91 study subjects enrolled in this study, of whom 80 study subjects completed the full follow-up schedules and showed adequate clinical and parasitological responses on day 28, with no major adverse event. Per protocol analysis, the unadjusted cure rate of Coartem(®) was 98.8% (95% confidence interval: 93.3%-100%) in the study area. Recurrence of one P. falciparum case was detected on day 28, with a late parasitological failure rate of 1.2%. No early treatment failure occurred. Complete parasite and fever clearance was observed on day 3. Gametocyte carriage was 4.4% at enrollment that cleared on day 21. Although the difference is statistically not significant, a slight increase in the level of mean hemoglobin from baseline to day 28 was observed.
The study showed high efficacy and tolerability of Coartem(®) against uncomplicated P. falciparum malaria, suggesting the continuation as a first-line drug in the study district. However, regular monitoring of the therapeutic efficacy of the drug, possibly with plasma drug-level measurement, is critical among the mobile border population.
随着恶性疟原虫对氯喹和磺胺多辛/乙胺嘧啶耐药性的增加，埃塞俄比亚于2004年采用蒿甲醚/本芴醇（AL）作为无并发症恶性疟原虫的一线治疗药物。根据世界卫生组织的建议，开展本研究以定期监测AL在埃塞俄比亚西北部贡德尔地区梅特马区治疗无并发症恶性疟原虫疟疾的疗效。
这是一项针对6个月及以上无并发症恶性疟原虫疟疾患者的单组前瞻性28天体内治疗疗效研究。该研究于2014年10月至2015年1月开展，依据2009年世界卫生组织修订的抗疟药物治疗疗效监测方案进行。采用标准的六剂量AL方案，每日给药两次，持续3天，然后在第0、1、2、3、7、14、21、28天以及紧急情况的任何其他非预定日期评估治疗结果。
本研究共纳入91名研究对象，其中80名研究对象完成了全部随访计划，在第28天显示出充分的临床和寄生虫学反应，且无重大不良事件。根据方案分析，在研究地区，Coartem（®）的未调整治愈率为98.8%（95%置信区间：93.3%-100%）。在第28天检测到1例恶性疟原虫病例复发，晚期寄生虫学失败率为1.2%。未发生早期治疗失败。在第3天观察到寄生虫和发热完全清除。入组时配子体携带率为4.4%，在第21天清除。尽管差异无统计学意义，但观察到从基线到第28天平均血红蛋白水平略有升高。
该研究表明Coartem（®）对无并发症恶性疟原虫疟疾具有高效和耐受性，表明在研究地区可继续作为一线药物使用。然而，对于流动的边境人群，定期监测该药物的治疗疗效，可能包括血浆药物水平测定，至关重要。
