Getnet Gebeyaw, Fola Abebe Alemu, Alemu Agersew, Getie Sisay, Fuehrer Hans-Peter, Noedl Harald
Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
School of Medicine, College of Health Sciences and Medicine, Wolaita Sodo University, Wolaita, Ethiopia.
Malar J. 2015 Jun 24;14:258. doi: 10.1186/s12936-015-0775-3.
Plasmodium falciparum accounts for approximately 60% of malaria cases in Ethiopia and artemether-lumefantrine has been used as a first-line treatment for uncomplicated P. falciparum malaria since 2004. The aim of this study was to assess the therapeutic efficacy of artemether-lumefantrine (AL) for the treatment of uncomplicated P. falciparum malaria in north-western Ethiopia.
A 28-day one-arm, prospective evaluation of the clinical and parasitological response to the first-line treatment for uncomplicated P. falciparum malaria was conducted in Enfranze Health Centre in accordance with the 2009 WHO efficacy study guidelines. Patients were treated with a 3-day course of AL and clinical and parasitological parameters were monitored over a 28-day follow-up. All data from recruited patients were imported into an electronic data base and Kaplan-Meier survival analysis was used for analysing primary [early treatment failures (ETF), late clinical failure (LCF), late parasitological failures (LPF), and adequate clinical and parasitological response (ACPR)] and secondary (PCT, GCT and FCT) outcomes.
Eighty patients were enrolled and all of them completed the 28-day follow-up period. The PCR-corrected cure rate was 95.0% (95% CI 87.0-98.4%) and there were two ETF, one LCF and three LPF. Two of the LPF were classified as re infections by PCR. Seventy three point seven five percent, 91.25 and 95% of patients had cleared their parasitaemia by days 1, 2, and 3, respectively, and 75, 91.25 and 96.25% of patients had cleared their fever by days 1, 2, and 3. All patients completely cleared their gametocytes by day 7.
The relatively high cure rate, low proportion of patients still positive on day 3 as well as parasite clearance times in this study would indicate no imminent threat of artemisinin resistance development in the region. However, the threat of spreading or de novo development of artemisinin resistance warrants regular monitoring of drug efficacy throughout the region.
恶性疟原虫导致了埃塞俄比亚约60%的疟疾病例，自2004年以来，蒿甲醚-本芴醇一直被用作非复杂性恶性疟原虫疟疾的一线治疗药物。本研究的目的是评估蒿甲醚-本芴醇（AL）治疗埃塞俄比亚西北部非复杂性恶性疟原虫疟疾的疗效。
根据2009年世界卫生组织疗效研究指南，在恩弗兰泽健康中心对非复杂性恶性疟原虫疟疾一线治疗的临床和寄生虫学反应进行了为期28天的单臂前瞻性评估。患者接受为期3天的AL疗程治疗，并在28天的随访期内监测临床和寄生虫学参数。将招募患者的所有数据导入电子数据库，并使用Kaplan-Meier生存分析来分析主要结局[早期治疗失败（ETF）、晚期临床失败（LCF）、晚期寄生虫学失败（LPF）以及充分的临床和寄生虫学反应（ACPR）]和次要结局（PCT、GCT和FCT）。
80名患者入组，所有患者均完成了28天的随访期。PCR校正治愈率为95.0%（95%CI 87.0-98.4%），有2例ETF、1例LCF和3例LPF。其中2例LPF经PCR分类为再感染。分别有73.75%、91.25%和95%的患者在第1天、第2天和第3天时疟原虫血症清除，分别有75%、91.25%和96.25%的患者在第1天、第2天和第3天时发热消退。所有患者在第7天时配子体均完全清除。
本研究中相对较高的治愈率、第3天时仍为阳性的患者比例较低以及寄生虫清除时间表明该地区不存在青蒿素耐药性发展的紧迫威胁。然而，青蒿素耐药性传播或新发的威胁使得有必要对该地区的药物疗效进行定期监测。
