当前位置：
X-MOL 学术
›
J. Vector Borne Dis.
›
论文详情
Our official English website, www.x-mol.net, welcomes your
feedback! (Note: you will need to create a separate account there.)
Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate in comparison with chloroquine phosphate in children with acute uncomplicated Plasmodium vivax malaria: A phase III, randomised, multicentric study
Journal of Vector Borne Diseases ( IF 0.8 ) Pub Date : 2020-07-01 , DOI: 10.4103/0972-9062.311781 Neena Valecha 1 , Vimal Kant Goyal 2 , Deo Nidhi Mishra 3 , Rashmi Ranjan Das 4 , Neeraj Jauhri 5 , Alok Chandra Bhardwaj 6 , Omesh Khurana 7 , Reena Choudhury 8 , Madhukar Pandey 9 , Bantwal Shantharam Baliga 10 , Susanta Kumar Ghosh 11 , Bina Srivastava 1 , Santhosh T Soans 12 , Raj Kamal Bahl 13 , Ajay Punj 14 , Arjun Roy 15 , Sanjay K Sharma 15 , Amit Nasa 15 , Rajinder K Jalali 15 , Anupkumar R Anvikar 1
Journal of Vector Borne Diseases ( IF 0.8 ) Pub Date : 2020-07-01 , DOI: 10.4103/0972-9062.311781 Neena Valecha 1 , Vimal Kant Goyal 2 , Deo Nidhi Mishra 3 , Rashmi Ranjan Das 4 , Neeraj Jauhri 5 , Alok Chandra Bhardwaj 6 , Omesh Khurana 7 , Reena Choudhury 8 , Madhukar Pandey 9 , Bantwal Shantharam Baliga 10 , Susanta Kumar Ghosh 11 , Bina Srivastava 1 , Santhosh T Soans 12 , Raj Kamal Bahl 13 , Ajay Punj 14 , Arjun Roy 15 , Sanjay K Sharma 15 , Amit Nasa 15 , Rajinder K Jalali 15 , Anupkumar R Anvikar 1
Affiliation
Background & objectives: In India, the burden of Plasmodium vivax malaria has been projected to be highest in some areas. This study investigated the efficacy and safety of fixed dose combination (FDC) of arterolane maleate (AM) 37.5 mg and piperaquine phosphate 187.5 mg (PQP) dispersible tablets and (not with) chloroquine in the treatment of uncomplicated vivax malaria in pediatric patients.
Methods: This multicentric, open-label trial was carried out at 12 sites in India. A total of 164 patients aged 6 months to 12 years with P. vivax malaria were randomized in a ratio of 2:1 to AM-PQP (111 patients) or chloroquine (53 patients) arms. The duration of follow up was 42 days.
Results: At 72 hours, the proportion of a parasitaemic and afebrile patients was 100% in both treatment arms in per protocol (PP) population, and 98.2% and 100% [95% CI: -1.8 (-6.33 to 5.08)] in AM-PQP and chloroquine arms, respectively, in intent to treat (ITT) population. The efficacy and safety of AM-PQP was found to be comparable to chloroquine in the treatment of uncomplicated P. vivax malaria in pediatric patients. Overall, the cure rate at Day 28 and 42 was >95% for both AM-PQP or CQ. The commonly reported clinical adverse event was vomiting. No patient was discontinued for any QTc abnormality.
Interpretation & conclusion: The efficacy and safety of FDC of arterolane maleate and piperaquine phosphate was found to be comparable to chloroquine for treatment of uncomplicated P. vivax malaria in pediatric patients.
中文翻译：
与磷酸氯喹相比，固定剂量的马来酸阿特罗兰和磷酸哌喹联合用药在儿童急性无并发症间日疟原虫疟疾中的疗效和安全性：一项 III 期、随机、多中心研究
背景和目标：在印度，据预测，间日疟原虫疟疾在某些地区的负担最高。本研究调查了固定剂量组合 (FDC) 37.5 毫克的马来酸环戊酯 (AM) 和磷酸哌喹 187.5 毫克 (PQP) 分散片和（不与）氯喹治疗儿科患者的无并发症间日疟的疗效和安全性。
方法：这项多中心、开放标签的试验在印度的 12 个地点进行。共有 164 名 6 个月至 12 岁的间日疟患者以 2:1 的比例随机分配至 AM-PQP（111 名患者）或氯喹（53 名患者）组。随访时间为 42 天。
结果：在 72 小时时，在每个方案 (PP) 人群中，两个治疗组中寄生虫血症和无发热患者的比例均为 100%，而在 AM- 中分别为 98.2% 和 100% [95% CI：-1.8 (-6.33 至 5.08)] PQP 和氯喹分别用于治疗 (ITT) 人群。发现 AM-PQP 在治疗儿科患者的简单间日疟原虫疟疾方面的疗效和安全性与氯喹相当。总体而言，AM-PQP 或 CQ 在第 28 天和第 42 天的治愈率均 >95%。常见的临床不良事件是呕吐。没有患者因任何 QTc 异常而中断治疗。
解释和结论：发现马来酸阿特罗兰和磷酸哌喹的 FDC 治疗无并发症的疗效和安全性与氯喹相当。儿科患者的间日疟原虫。
更新日期：2020-07-01
Methods: This multicentric, open-label trial was carried out at 12 sites in India. A total of 164 patients aged 6 months to 12 years with P. vivax malaria were randomized in a ratio of 2:1 to AM-PQP (111 patients) or chloroquine (53 patients) arms. The duration of follow up was 42 days.
Results: At 72 hours, the proportion of a parasitaemic and afebrile patients was 100% in both treatment arms in per protocol (PP) population, and 98.2% and 100% [95% CI: -1.8 (-6.33 to 5.08)] in AM-PQP and chloroquine arms, respectively, in intent to treat (ITT) population. The efficacy and safety of AM-PQP was found to be comparable to chloroquine in the treatment of uncomplicated P. vivax malaria in pediatric patients. Overall, the cure rate at Day 28 and 42 was >95% for both AM-PQP or CQ. The commonly reported clinical adverse event was vomiting. No patient was discontinued for any QTc abnormality.
Interpretation & conclusion: The efficacy and safety of FDC of arterolane maleate and piperaquine phosphate was found to be comparable to chloroquine for treatment of uncomplicated P. vivax malaria in pediatric patients.
中文翻译：
与磷酸氯喹相比，固定剂量的马来酸阿特罗兰和磷酸哌喹联合用药在儿童急性无并发症间日疟原虫疟疾中的疗效和安全性：一项 III 期、随机、多中心研究
背景和目标：在印度，据预测，间日疟原虫疟疾在某些地区的负担最高。本研究调查了固定剂量组合 (FDC) 37.5 毫克的马来酸环戊酯 (AM) 和磷酸哌喹 187.5 毫克 (PQP) 分散片和（不与）氯喹治疗儿科患者的无并发症间日疟的疗效和安全性。
方法：这项多中心、开放标签的试验在印度的 12 个地点进行。共有 164 名 6 个月至 12 岁的间日疟患者以 2:1 的比例随机分配至 AM-PQP（111 名患者）或氯喹（53 名患者）组。随访时间为 42 天。
结果：在 72 小时时，在每个方案 (PP) 人群中，两个治疗组中寄生虫血症和无发热患者的比例均为 100%，而在 AM- 中分别为 98.2% 和 100% [95% CI：-1.8 (-6.33 至 5.08)] PQP 和氯喹分别用于治疗 (ITT) 人群。发现 AM-PQP 在治疗儿科患者的简单间日疟原虫疟疾方面的疗效和安全性与氯喹相当。总体而言，AM-PQP 或 CQ 在第 28 天和第 42 天的治愈率均 >95%。常见的临床不良事件是呕吐。没有患者因任何 QTc 异常而中断治疗。
解释和结论：发现马来酸阿特罗兰和磷酸哌喹的 FDC 治疗无并发症的疗效和安全性与氯喹相当。儿科患者的间日疟原虫。
京公网安备 11010802027423号