Liposomal amphotericin B (AmBisome) in the treatment of complicated kala-azar under field conditions.
An open trial of liposomal amphotericin B (AmBisome [L-AmB]; Vestar, San Dimas, CA) for treatment of complicated visceral leishmaniasis was performed in Sudan. Forty-nine patients were treated, and there were six deaths (12% mortality); these were not attributed to therapy. Thirty-seven patients were selected for the trial because of (1) relapse after treatment with a combination of pentavalent antimony (Sbv) and aminosidine, (2) incomplete parasitological response to Sbv and aminosidine, or (3) severe illness. Drug regimen 1 (3 doses of 3-5 mg/kg, on days 0, 3, and 10) cured 8 (50%) of 16 patients; regimen 2 (6 doses of 3-5 mg/kg, on days 0, 3, 6, 8, 10, and 13) cured 14 (88%) of 16. For four of 10 partial responders, "rescue" therapy with L-AmB alone (3 mg/kg daily for 10 days) resulted in cure. Twelve less-unwell patients received regimen 3 (4 doses of 4-5 mg/kg, on days 0, 2, 5, and 7); seven of 11 patients evaluated (64%) were cured. The optimal regimen of L-AmB in these circumstances is administration of 4 mg/kg on days 0, 3, 6, 8, 10, and 13.
Seaman
J
J
Medecins Sans Frontieres Holland, The Netherlands.
Boer
C
C
Wilkinson
R
R
de Jong
J
J
de Wilde
E
E
Sondorp
E
E
Davidson
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000563:Amebicides / Q000627:therapeutic use; D000666:Amphotericin B / Q000008:administration & dosage* / Q000009:adverse effects; D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000965:Antimony / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004337:Drug Carriers; D005260:Female; D006801:Humans; D007223:Infant; D007893:Leishmania donovani / Q000302:isolation & purification; D018314:Leishmania infantum / Q000302:isolation & purification; D007898:Leishmaniasis, Visceral / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D008081:Liposomes; D008198:Lymph Nodes / Q000469:parasitology; D008297:Male; D008875:Middle Aged; D010303:Paromomycin / Q000627:therapeutic use; D012008:Recurrence; D013154:Spleen / Q000469:parasitology; D013397:Sudan
D000563:Amebicides; D000900:Anti-Bacterial Agents; D004337:Drug Carriers; D008081:Liposomes; D010303:Paromomycin; D000666:Amphotericin B; D000965:Antimony