Comparison of two dosage schedules of sodium stibogluconate in the treatment of visceral leishmaniasis in Kenya.
The efficacy and safety of a single daily dose of sodium stibogluconate, 20 mg/kg body weight, given by deep intramuscular injection was compared with the conventional dose of 10 mg Sb/kg body weight in a randomised trial in Kenyan children and adults with visceral leishmaniasis. Splenic aspiration proved a safe and simple method for assessing parasitological response to treatment. In children the higher dose was associated with a faster clinical and parasitological response, and 100% were cured within 4 weeks, compared with 60% receiving the lower dosage. This difference is statistically significant by life-table analysis (x2 = 4.41, p less than 0.05). The superiority of the higher dose was not, however, seen in adults. In both children and adults the higher dose given daily for 2--4 weeks and in one patient for up to 7 weeks was found to be safe and well tolerated. It is likely, but not proven, that the use of sodium stibogluconate in a dose of 20 mg/kg bw daily for 4 weeks will reduce the relapse-rate in Kenyan children with visceral leishmaniasis.
D000328:Adult; D000967:Antimony Sodium Gluconate / Q000008:administration & dosage*; D002648:Child; D002986:Clinical Trials as Topic; D004196:Disease Outbreaks / Q000453:epidemiology; D005260:Female; D005942:Gluconates / Q000008:administration & dosage*; D006801:Humans; D007273:Injections, Intramuscular / Q000379:methods; D007630:Kenya; D007891:Leishmania; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008297:Male; D011897:Random Allocation; D013154:Spleen / Q000469:parasitology
D005942:Gluconates; D000967:Antimony Sodium Gluconate