Pandey Krishna, Pal Biplab, Siddiqui Niyamat Ali, Rabi Das Vidya Nand, Murti Krishna, Lal Chandra Shekhar, Verma Neena, Babu Rajendra, Ali Vahab, Kumar Rakesh, Das Pradeep
Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian, Council of Medical Research), Patna, Bihar, India.
Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India.
Am J Trop Med Hyg. 2017 Nov;97(5):1498-1502. doi: 10.4269/ajtmh.17-0094. Epub 2017 Oct 10.
Liposomal amphotericin B is being used increasingly to reduce the burden of kala-azar from the Indian subcontinent. There are studies which have evaluated efficacy and safety of liposomal amphotericin B for visceral leishmaniasis in all age groups. However, the only study that specifically addressed treatment of childhood visceral leishmaniasis did not include all ages or document renal and liver function. We, therefore, felt it was important to reassess the efficacy and safety of single dose liposomal amphotericin B in children and adolescents. A total of 100 parasitologically confirmed visceral leishmaniasis patients aged < 15 years were included in this study. Participants consisted of 65 males and 35 females. All of them had come from the endemic region of Bihar. They were administered one dose intravenous infusion of liposomal amphptericin B at 10 mg/kg body weight. Efficacy was assessed as initial and final cure at 1 and 6 months, respectively, and safety of all participants who were recruited in the study. The initial and final cure rate by per protocol analysis was 100% and 97.9%, respectively. Chills and rigors were the most commonly occurring adverse events (AEs). All the AEs were mild in intensity, and none of the patients experienced any serious AEs. No patients developed nephrotoxicity. Our finding indicates that liposomal amphotericin B at 10 mg/kg body weight is safe and effective in children. Results of our study support the use of single dose liposomal amphotericin B in all age group populations for elimination of kala-azar from the Indian subcontinent.
脂质体两性霉素B越来越多地被用于减轻印度次大陆黑热病的负担。有研究评估了脂质体两性霉素B对所有年龄组内脏利什曼病的疗效和安全性。然而，唯一一项专门针对儿童内脏利什曼病治疗的研究并未涵盖所有年龄段，也未记录肾功能和肝功能。因此，我们认为重新评估单剂量脂质体两性霉素B在儿童和青少年中的疗效和安全性很重要。本研究共纳入100例年龄小于15岁、经寄生虫学确诊的内脏利什曼病患者。参与者包括65名男性和35名女性。他们均来自比哈尔邦的流行地区。给他们静脉输注一剂10mg/kg体重的脂质体两性霉素B。分别在1个月和6个月时评估疗效，即初始治愈和最终治愈情况，并评估本研究中所有招募参与者的安全性。根据方案分析，初始治愈率和最终治愈率分别为100%和97.9%。寒战和发冷是最常见的不良事件。所有不良事件的严重程度均为轻度，没有患者经历任何严重的不良事件。没有患者出现肾毒性。我们的研究结果表明，10mg/kg体重的脂质体两性霉素B在儿童中是安全有效的。我们的研究结果支持在所有年龄组人群中使用单剂量脂质体两性霉素B来消除印度次大陆的黑热病。
