Epidemic visceral leishmaniasis in Sudan: a randomized trial of aminosidine plus sodium stibogluconate versus sodium stibogluconate alone.
In a comparative trial of treatment in southern Sudan, visceral leishmaniasis was diagnosed by the following symptoms: fever for > 1 month, splenomegaly, and antileishmanial direct agglutination test (DAT) titer of > or = 1:25,600. Patients (200) were randomized to receive sodium stibogluconate (Sbv) at 20 mg/kg/day for 30 days (groups S, n = 99) or Sbv at 20 mg/kg/day plus aminosidine at 15 mg/kg/day for 17 days (group AS, n = 101). Of 192 patients who had spleens or lymph nodes aspirated at entry, 134 (70%) were positive for parasites. During treatment, 7% in group S and 4% in group AS died. All 184 patients who completed treatment were clinically cured. At days 15-17, microscopy of aspirates showed that 57 (95%) of 60 in group AS were negative for parasites compared with 47 (81%) of 58 in group S (P = .018). At day 30, 57 (93.4%) of 61 group S aspirates were negative.
Seaman
J
J
Medecins Sans Frontieres-Holland, Amsterdam.
Pryce
D
D
Sondorp
H E
HE
Moody
A
A
Bryceson
A D
AD
Davidson
R N
RN
D000293:Adolescent; D000328:Adult; D000967:Antimony Sodium Gluconate / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004196:Disease Outbreaks; D004359:Drug Therapy, Combination; D005260:Female; D005873:Giardiasis / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007898:Leishmaniasis, Visceral / Q000150:complications / Q000188:drug therapy*; D008288:Malaria / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009748:Nutrition Disorders / Q000150:complications; D010303:Paromomycin / Q000627:therapeutic use*; D011247:Pregnancy; D013397:Sudan / Q000453:epidemiology; D015431:Weight Loss
D010303:Paromomycin; D000967:Antimony Sodium Gluconate