Randomized, double-blind study of stibogluconate plus human granulocyte macrophage colony-stimulating factor versus stibogluconate alone in the treatment of cutaneous leishmaniasis
R. Almeida et al., Randomized, double-blind study of stibogluconate plus human granulocyte macrophage colony-stimulating factor versus stibogluconate alone in the treatment of cutaneous leishmaniasis, J INFEC DIS, 180(5), 1999, pp. 1735-1737
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 w
ere enrolled in a double-blind placebo trial of GM-CSF with standard parent
eral sodium stibogluconate (20 mg/kg(-1)/day(-1)) for 20 days. Ten patients
were randomized to receive intralesionally injected GM-CSF (200 mu g) at e
nrollment and 1 week after, and 10 patients received saline as placebo. GM-
CSF- and antimony-treated patients healed faster than patients who received
antimony alone (49 +/- 32.8 vs. 110 +/- 61.6 days, P<.05). Seven of 10 pat
ients were healed of their lesions before 40 days after therapy in the GM-C
SF group, compared with only 1 of 10 patients in the placebo group (relativ
e risk, 7; 95% confidence interval, 1.04-47.00), Thus, GM-CSF plus antimony
significantly increased the chance of lesion healing in 40 days.