The treatment of kala-azar in the Sudan with sodium stibogluconate: a randomized trial of three dosage regimens.
In a randomized study in the Sudan, 3 different regimens of sodium stibogluconate were compared in patients with parasitologically confirmed kala-azar (visceral leishmaniasis): 10 mg/kg for 30 d (38 patients), 20 mg/kg for 30 d (29 patients), and 20 mg/kg for 15 d (37 patients). Treatment failures were defined as death, partial response, relapse, or the development of post-kala-azar dermal leishmaniasis. The hazard ratio for failure of 20 mg/kg for 30 d vs. 10 mg/kg for 30 d 2.1 (95% confidence interval [CI] = 0.6, 7.6) and for 20 mg/kg for 15 d vs. 10 mg/kg for 30 d it was 1.7 (95% CI = 0.5, 6.1). No significant difference was detected between the 3 regimens in the rate of return to normal of haematological criteria, regression of spleen size, or weight gain. After 15 d treatment parasite clearance with 20 mg/kg for 30 d and 20 mg/kg for 15 d was more profound than with 10 mg/kg for 30 d (P < 0.05), but the difference was no longer present at the end of treatment. Further investigation of the effectiveness of short, intensive treatment regimens in the treatment of kala-azar is warranted.
Zijlstra
E E
EE
Leishmania Research Group, Medical Research Council, Sudan.
Siddig Ali
M
M
el-Hassan
A M
AM
Hofland
H W
HW
el-Toum
I
I
Satti
M
M
Ghalib
H W
HW
D000293:Adolescent; D000328:Adult; D000818:Animals; D000967:Antimony Sodium Gluconate / Q000009:adverse effects / Q000627:therapeutic use*; D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007893:Leishmania donovani / Q000302:isolation & purification; D007898:Leishmaniasis, Visceral / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D013154:Spleen / Q000469:parasitology; D016896:Treatment Outcome
D000967:Antimony Sodium Gluconate