PDF(Pubmed)
Abstract：
BACKGROUND: Plasmodium vivax malaria is still an important public health problem in Ethiopia. Unlike Plasmodium falciparum, P. vivax has a dormant liver stage (hypnozoite) that can be a risk of recurrent vivax malaria unless treated by radical cure with primaquine. Drug resistance to chloroquine is threatening malaria control and elimination efforts. This study assessed the therapeutic efficacy and safety of chloroquine plus 14 days of primaquine on P. vivax infection based on parasitological, clinical, and haematological parameters.
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.
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.
摘要：
背景：间日疟原虫疟疾在埃塞俄比亚仍然是一个重要的公共卫生问题。与恶性疟原虫不同,间日疟原虫具有休眠的肝脏阶段（hypnozoite），除非用伯氨喹进行彻底治疗，否则可能有复发性间日疟原虫疟疾的风险。对氯喹的耐药性正威胁着疟疾的控制和消除工作。这项研究评估了氯喹加14天伯氨喹对间日疟原虫感染的治疗效果和安全性。临床,和血液学参数。
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.
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.
