Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study.
In this randomized, double-blind, dose-ranging, multicenter trial, 84 patients with visceral leishmaniasis refractory to antimony therapy were administered liposomal amphotericin B (AmBisome) at cumulative doses of 3.75, 7.5, and 15.0 mg/kg for 5 consecutive days. Posttreatment apparent cure and definite cure were assessed at 2 weeks and 6 months after the end of therapy, respectively. Mild to moderate infusion-related fever and rigors were seen in 29 and 44% of patients, respectively. One patient each in the 3.75- and 7.5-mg groups had detectable parasites on splenic smear at posttreatment evaluation. At 6 months' follow-up, however, 2, 1, and 1 patients relapsed in the 3.75-, 7.5-, and 15.0-mg groups, resulting in definite cure rates of 89, 93, and 97%, respectively. There was no significant difference in the cure rates of the 3 groups. Low-dose liposomal amphotericin B given for 5 days can cure most patients with Indian kala-azar.
Kala-azar Medical Research Center, Banaras Hindu University, Varanasi, India. shyam_vns@satyam.net.in
S
S
Sundar
T K
TK
Jha
C P
CP
Thakur
M
M
Mishra
V R
VR
Singh
R
R
Buffels
D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage / Q000627:therapeutic use*; D000965:Antimony / Q000627:therapeutic use; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008297:Male; D016896:Treatment Outcome
D000981:Antiprotozoal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B; D000965:Antimony