Efficacy and toxicity of sodium stibogluconate for mucosal leishmaniasis.
OBJECTIVE
To determine the efficacy and toxicity of the World Health Organization's (WHO) recommended treatment for mucosal leishmaniasis: antimony, 20 mg/kg body weight per day for 28 days.


METHODS
Open trial with 12-month follow-up.


METHODS
Inpatient unit of a regional referral hospital in a developing country.


METHODS
Twenty-nine consecutive eligible patients with culture-confirmed infection of the mucosa with Leishmania species who were otherwise healthy. Eight patients (28%) had mild to moderate disease (confined to the nasal mucosa). Twenty-one patients (72%) had severe disease (including the oropharynx as well as the nasal mucosa).


METHODS
Antimony, 20 mg/kg body weight intravenously every day for 28 days. Patients received antimony in the form of sodium stibogluconate.


RESULTS
Initial results of therapy were as follows: 63 of 72 lesions (88%) healed or markedly improved; all lesions were culture-negative for parasites; and 18 of 29 patients (62%) showed complete clinical and parasitologic cure of all lesions. By the 12-month follow-up examinations, however, 37 lesions had recurred, 8 new lesions had appeared, and only 8 patients (30%) showed clinical cure of all lesions. Of the 8 patients with mild to moderate disease, 6 were cured compared with only 2 of the 21 patients with severe disease. Side effects of this treatment regimen included T-wave inversion on electrocardiogram (4 patients), abnormal liver function tests (10 patients), and musculoskeletal pain (24 patients). No side effects occurred during week 1 of therapy.


CONCLUSIONS
The only recommended treatment for mucosal leishmaniasis is ineffective in patients with severe disease. The acceptable toxicity of the regimen suggests that longer courses of therapy with antimony, or that trials with other antileishmanial agents alone or combined with antimony be evaluated as initial therapy for this disease.
Franke
E D
ED
Naval Medical Research Institute Detachment-Peru, Lima.
Wignall
F S
FS
Cruz
M E
ME
Rosales
E
E
Tovar
A A
AA
Lucas
C M
CM
Llanos-Cuentas
A
A
Berman
J D
JD
D000328:Adult; D000967:Antimony Sodium Gluconate / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000187:drug effects; D001769:Blood / Q000187:drug effects; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007897:Leishmaniasis, Mucocutaneous / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010568:Peru; D012008:Recurrence
D001219:Aspartate Aminotransferases; D000967:Antimony Sodium Gluconate