Kala-azar Medical Research Center, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005, India.
Trans R Soc Trop Med Hyg. 2011 Feb;105(2):115-7. doi: 10.1016/j.trstmh.2010.10.008. Epub 2010 Dec 3.
The combination of one intravenous administration of 5mg/kg Ambisome and oral administration of miltefosine, 2.5mg/kg/day for 14 days, was evaluated in 135 Indian patients with kala-azar. The Intent-to-Treat cure rate at 6 months was 124 of the 135 enrolled patients (91.9%: 95% CI = 86-96%), and the per protocol cure rate was 124 of 127 evaluable patients (97.6%: 95% CI = 93-100%). Side effects could be attributed to each drug separately: fevers, rigors and back pain due to Ambisome; gastrointestinal side effects due to miltefosine. This combination is attractive for reasons of efficacy, tolerance, and feasibility of administration, although the gastrointestinal side effects of miltefosine require medical vigilance. Clinical Trials.gov identification number: NCT00371995.
在 135 例印度黑热病患者中评估了 1 次静脉注射 5mg/kg 两性霉素 B 脂质体和口服米替福新，2.5mg/kg/天，疗程 14 天。意向治疗 6 个月的治愈率为 135 例入组患者中的 124 例（91.9%：95%CI=86-96%），符合方案的治愈率为 127 例可评价患者中的 124 例（97.6%：95%CI=93-100%）。不良反应可归因于每种药物：两性霉素 B 脂质体引起发热、寒战和背痛；米替福新引起胃肠道副作用。该联合用药具有疗效好、耐受性好、给药可行性强的优点，尽管米替福新的胃肠道副作用需要密切关注。临床试验.gov 注册号：NCT00371995。
