METHODS: A single-arm in vivo prospective therapeutic efficacy study was conducted to assess the clinical and parasitological response to the first-line treatment of P. vivax in Ethiopia, chloroquine plus 14 days low dose of (0.25 mg/kg/day) primaquine between December 2022 and March 2023 at Hamusit Health Centre using the standard World Health Organization (WHO) protocol. A total of 100 study participants with P. vivax mono-infection who were over 6 months old were enrolled and monitored for adequate clinical and parasitological responses for 42 days. The WHO double-entry Excel sheet and SPSS v.25 software were used for Kaplan-Meier survival analysis, and a paired t-test was used for analysis of haemoglobin improvements between follow up days.
RESULTS: A total of 100 patients were enrolled among those, 96% cases were rural residents, 93% had previous malaria exposure, and predominant age group was 5-15 years (61%). 92.6% (95% CI 85.1-96.4%) of enrolled patients were adequate clinical and parasitological response, and 7.4% (95% CI 3.6-14.9%) recurrences were observed among treated patients. The fever and parasite clearance rate on day 3 were 98% and 94%, respectively. The baseline haemoglobin levels improved significantly compared to those days 14 and 42 (p < 0.001). No serious adverse event was observed during the study period.
CONCLUSIONS: In this study, co-administration of chloroquine with primaquine was efficacious and well-tolerated with fast resolution of fever and high parasites clearance rate. However, the 7.4% failure is reported is alarming that warrant further monitoring of the therapeutic efficacy study of P. vivax.
方法:进行了一项单臂体内前瞻性疗效研究,以评估埃塞俄比亚对间日疟原虫一线治疗的临床和寄生虫反应,在2022年12月至2023年3月期间,在Hamusit卫生中心使用标准世界卫生组织(WHO)协议,氯喹加14天低剂量(0.25mg/kg/天)伯氨喹。共纳入100名超过6个月大的间日疟原虫单感染研究参与者,并监测42天的临床和寄生虫反应。采用WHO双条目Excel表和SPSSv.25软件进行Kaplan-Meier生存分析,使用配对t检验分析随访日之间的血红蛋白改善情况.
结果:共纳入100名患者,96%为农村居民,93%以前曾接触过疟疾,主要年龄组为5-15岁(61%)。92.6%(95%CI85.1-96.4%)的入组患者有足够的临床和寄生虫反应,在接受治疗的患者中观察到7.4%(95%CI3.6-14.9%)的复发。第3天发热和寄生虫清除率分别为98%和94%,分别。与第14天和第42天相比,基线血红蛋白水平显著改善(p<0.001)。在研究期间未观察到严重不良事件。
结论:在这项研究中,氯喹与伯氨喹联合给药有效且耐受性良好,发热消退快,寄生虫清除率高.然而,据报道,7.4%的失败令人震惊,需要进一步监测间日疟原虫的疗效研究.