Ambisome plus miltefosine for Indian patients with kala-azar

作者:Sundar Shyam; Sinha Prabhat Kumar; Verma Deepak K; Kumar Nawin; Alam Shahnawaj; Pandey Krishna; Kumari Poonam; Ravidas Vidyanand; Chakravarty Jaya; Verma Neena; Berman Jonathan*; Ghalib Hashim; Arana Byron
来源:Transactions of the Royal Society of Tropical Medicine and Hygiene, 2011, 105(2): 115-117.
DOI:10.1016/j.trstmh.2010.10.008

摘要

The combination of one intravenous administration of 5 mg/kg Ambisome and oral administration of miltefosine, 2.5 mg/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.