Placebo-Controlled Clinical Trial of Sodium Stibogluconate (Pentostam) vs.Ketoconazole for Treating Cutaneous Leishmaniasis in Guatemala

摘要

To determine the relative efficacy and toxicity of stibogluconate andketoconazole for the treatment of cutaneous leishmaniasis, we conducted a comparative trial in which 120 Guatemalan men with parasitologically proven cutaneous leishmaniasis were randomly divided into three treatment groups: sodium stibogluconate (20 mg of antimony per kg per day intravenously for 20 days); ketoconazole (600 mg per day orally for 28 days); and placebo. Stibogluconate was associated with occasional moderate but manageable adverse effects, including abnormal electrocardiograms and elevated transaminase values. Treatment outcome was influenced by species. Among patients infected with Leishmania braziliensis, 24 (96%) of 25 in the stibogluconate group responded. Among L. mexicana-infected patients, only four (57%) of seven in the stibogluconate group but eight (89%) of nine in the ketoconazole group responded. These differences emphasize the importance of specification in the treatment of leishmaniasis.