Background. Mucosal leishmaniasis is associated with intense tissue damage and high tumor necrosis factor-α production. Therapeutic failure occurs in up to 42% of cases; patients who experience treatment failure will require >1 pentavalent antimony (Sbv) course or alternative drugs to achieve a cure. We previously showed that an inhibitor of tumor necrosis factor-α (pentoxifylline) combined with Sbv cured 90% patients refractory to monotherapy with Sbv. Methods. A double-blind, placebo-controlled trial involving 23 patients with mucosal leishmaniasis evaluated the efficacy of pentoxifylline when administered in association with Sbv, compared with Sbv treatment alone. Eleven patients were randomized to receive Sbv plus oral pentoxifylline for 30 days, and 12 patients received Sbv plus oral placebo. The criterion for cure was a complete healing of lesions. Results. All patients in the pentoxifylline group experienced a cure with 1 course of Sbv, whereas 5 (41.6%) of 12 patients in the placebo group required a second course of Sbv (P = .037). The healing time ± standard deviation in the pentoxifylline group was 83 ± 36 days, compared with 145 ± 99 days in the placebo group (P = .049). No relapses were documented in either group at the 2-year follow-up visit. Conclusions. The addition of pentoxifylline to Sbv in mucosal leishmaniasis reduces the healing time significantly and prevents the need for further courses of Sbv.
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