CONCISE COMMUNICATIONS Randomized, Double-Blind Study of Stibogluconate Plus Human Granulocyte Macrophage Colony-Stimulating Factor versus Stibogluconate Alone

The response to recombinant human granulocyte macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis was evaluated. Twenty patients with cutaneous leishmaniasis who had lesions for 60 days were enrolled in a double-blind placebo trial of GM-CSF with standard parenteral sodium stibogluconate (20 mg/kg21/day21) for 20 days. Ten patients were randomized to receive intralesionally injected GM-CSF (200 mg) at enrollment and 1 week after, and 10 patients received saline as placebo. GM-CSF ± and an-timony-treated patients healed faster than patients who received antimony alone (49 5 32.8 vs. days,). Seven of 10 patients were healed of their lesions before 40 days110 5 61.6 P!.05 after therapy in the GM-CSF group, compared with only 1 of 10 patients in the placebo group (relative risk, 7; 95 % con®dence interval, 1.04±47.00). Thus, GM-CSF plus antimony signi®cantly increased the chance of lesion healing in 40 days. Cutaneous leishmaniasis (CL) caused by Leishmania species is a sand¯y-transmitted protozoal disease endemic in many tropical countries of the Americas, Africa, and Asia. World-wide, »400,000 new cases occur every year [1]. In infection