Daily versus alternate-day regimen of amphotericin B in the treatment of kala-azar: a randomized comparison

Bull World Health Organ. 1994;72(6):931-6.

Abstract

Using a randomized study, we compared a daily and an alternate-day regimen of amphotericin B for the treatment of kala-azar, with respect to efficacy, adverse reactions, cost-effectiveness, and tolerance. The study subjects were 80 kala-azar patients, drawn from the first four decades of life and matched by age, sex, and parasite load. The patients were randomly allocated to treatment groups A and B (40 patients per group). Patients in group A received a daily regimen of amphotericin B, starting with an escalating dose of 0.05 mg/kg body weight per day until a daily dose of 1 mg/kg was reached; the latter dose was then given daily till a total dose of 20 mg/kg body weight had been administered. The patients in group B also started with an escalating dose of 0.05 mg/kg but when 1 mg/kg was reached the drug was given on alternate days. All 80 patients using the two treatment regimens were cured, no patient relapsed in either group in 6 months of follow-up, and their bone-marrow aspirates were free of amastigotes. Treatment of kala-azar patients with the daily regimen of amphotericin B at a dose 1 mg/kg body weight was as effective, not more toxic, equally well tolerated, and much more cost-effective than the alternate-day regimen and should be adopted for treatment of this condition.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Amphotericin B / administration & dosage*
  • Amphotericin B / adverse effects
  • Animals
  • Child
  • Cost-Benefit Analysis
  • Drug Administration Schedule
  • Humans
  • Leishmania donovani / isolation & purification
  • Leishmaniasis, Visceral / drug therapy*
  • Leishmaniasis, Visceral / economics
  • Leishmaniasis, Visceral / parasitology
  • Spleen / parasitology

Substances

  • Amphotericin B