title: [Comparative assessment of the efficacy and toxicity of N-methyl-glucamine and BP88 sodium stibogluconate in the treatment of localized cutaneous leishmaniasis].
abstract: This randomized, single blind clinical trial was performed to compare the efficacy and toxicity of BP88 Sodium Stibogluconate (SS) to Glucantime(R) (N-methyl-glucamine), (GL). Sixty-three patients were randomly assigned to one of two groups: 32 patients were treated with GL and 3l patients were treated with SS. Both groups received 15mg Sb+5/kg/day for 20 days. Toxicity was evaluated through EKG, urea, creatinine, AST, ALT, alkaline phosphatase, amylase, and lipase, assessed before treatment, on day 10 and day 20 of treatment and 90 days after treatment. In the group treated with GL, 81% (26/32) of patients were cured compared to 77% (24/31) in the SS group. Five (16%) patients relapsed in the GL group compared to 6 (19%) in the SS group. One patient in each group did not respond to treatment. AST, ALT, amylase, and lipase were more elevated in the SS group (p < 0.05). In conclusion, the efficacy of both treatments was similar although there was more toxicity in the ES group.
authors.affiliation: Departamento de Cínica Médica, Escola de Medicina, Santa Casa de Misericórdia, Vitória, ES, Brazil. patddeps@escelsa.com.br
authors.forename: P D
authors.initials: PD
authors.lastname: Deps
authors.forename: M C
authors.initials: MC
authors.lastname: Viana
authors.forename: A
authors.initials: A
authors.lastname: Falqueto
authors.forename: R
authors.initials: R
authors.lastname: Dietze
mesh_terms: D000293:Adolescent; D000328:Adult; D000967:Antimony Sodium Gluconate / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D002648:Child; D005260:Female; D006801:Humans; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008536:Meglumine / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*; D016037:Single-Blind Method
chemical_list: D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000967:Antimony Sodium Gluconate