Mucosal leishmaniasis is characterized by an intense inflammatory reaction
and tissue damage with few parasites in the lesion. On the basis of previou
s observations that suggest a possible role of tumor necrosis factor alpha
(TNF-alpha) in the pathology of this disease, an open-label study was perfo
rmed to evaluate the efficacy of the treatment with an inhibitor of TNF-alp
ha (pentoxifylline) associated to antimony therapy in 10 patients with refr
actory mucosal leishmaniasis. Patients were treated with pentavalent antimo
ny (20 mg per kilogram of body weight per day) plus orally administered pen
toxifylline 400 mg 3 times daily for 30 days. Nine of 10 patients fulfilled
the criteria for cure: they experienced complete reepithelization of the m
ucosal tissue 90 days after therapy and displayed no evidence of relapse at
1 year of follow-up. The TNF-alpha levels before therapy (776 +/- 342 pg/m
L) fell to 94 +/- 57 pg/mL (P < 0.05) within 60 days after therapy. Our res
ults indicate that pentoxifylline plus antimony therapy should be considere
d in all patients with mucosal leishmaniasis that is refractory to treatmen
t.