Evaluation of Sodium Stibogluconate (Pentostam) and Ketoconazole in the Treatment of American Cutaneous Leishmaniasis.

摘要

Guatemalans with parasitologically proven cutaneous leishmaniasis were randomly and equally divided into 3 treatment groups: those receiving sodium stibogluconate (Pentostam), 20 mg antimony/kg/day iv for 20 days; those receiving ketoconazole (600 mg/day po for 28 days; and those receiving placebo treatment. All patients tolerated the treatments well with the exception of 2 patients in the ketoconazole group who prematurely stopped their medication; 1 developed abdominal pain and nausea and the other developed a generalized erythematous papular rash. Thirteen weeks after beginning treatment, the number of patients from each group with completely healed and parasitologically negative lesions were as follows: sodium stibogluconate, 33 (83%); ketoconazole, 14 (37%); and placebo, 10 (25%). The response rates for those with infections due to Leishmania braziliensis braziliensis were: sodium stibogluconate, 17 (94%); ketoconazole, 6 (32%); and placebo, 1(7%). The response rates for those with infections due to Leishmania mexicana mexicana were: sodium stibogluconate, 4 (50%); ketoconazole 8 (80%); and placebo, 6 (38%). High dose sodium stibogluconate appears to be well tolerated and effective against infections caused by L. b. braziliensis but less so against infections caused by L. m. mexicana, and ketoconazole appears to be effective against infections caused by L. m. mexicana but less so for infections caused by L. b. braziliensis. (jes)