Transactions of the Royal Society of Tropical Medicine and Hygiene
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Trans. R. Soc. Trop. Med. Hyg. · May 1996
Randomized Controlled Trial Clinical TrialComparison of three treatment regimens with liposomal amphotericin B (AmBisome) for visceral leishmaniasis in India: a randomized dose-finding study.
The efficacy and safety of 3 regimens of liposomal amphotericin B (AmBisome) in the treatment of Indian visceral leishmaniasis were compared in a prospective open randomized trial. Thirty parasitologically confirmed patients were randomly divided into 3 equal treatment groups; group 1 received AmBisome 2mg/kg on days 1, 2, 3, 4, 5, 6, and 10 (total dose 14 mg/kg); group 2 received AmBisome 2 mg/kg on days 1, 2, 3, 4, and 10 (total dose 10 mg/kg); group 3 received the same dosage on 1, 5 and 10 (total dose 6 mg/kg). Clinical cure resulted in all patients by day 24. ⋯ Side effects were minimal. One patient in group 2 died after 2 months from an unrelated disease. Liposomal amphotericin B is a promising new drug which is highly efficacious in the treatment of Indian kala-azar and produces minimal toxicity.