Comparison of three treatment regimens with liposomal amphotericin B (AmBisome®) for visceral leishmaniasis in India: a randomized dose-finding study
- 1 May 1996
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in Transactions of the Royal Society of Tropical Medicine and Hygiene
- Vol. 90 (3) , 319-322
- https://doi.org/10.1016/s0035-9203(96)90271-0
Abstract
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 days 1, 5 and 10 (total dose 6 mg/kg). Clinical cure resulted in all patients by day 24. Haemoglobin, white blood cell count, body weight and serum albumin level improved on day 24 and became normal by day 180. No patient relapsed within 12 months of follow-up. 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.Keywords
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