title: Oral pentoxifylline combined with pentavalent antimony: a randomized trial for mucosal leishmaniasis.
abstract: BACKGROUND
  Mucosal leishmaniasis is associated with intense tissue damage and high tumor necrosis factor-alpha production. Therapeutic failure occurs in up to 42% of cases; patients who experience treatment failure will require >1 pentavalent antimony (Sb(v)) course or alternative drugs to achieve a cure. We previously showed that an inhibitor of tumor necrosis factor-alpha (pentoxifylline) combined with Sb(v) cured 90% patients refractory to monotherapy with Sb(v).
  
  
  METHODS
  A double-blind, placebo-controlled trial involving 23 patients with mucosal leishmaniasis evaluated the efficacy of pentoxifylline when administered in association with Sb(v), compared with Sb(v) treatment alone. Eleven patients were randomized to receive Sb(v) plus oral pentoxifylline for 30 days, and 12 patients received Sb(v) 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 Sb(v), whereas 5 (41.6%) of 12 patients in the placebo group required a second course of Sb(v) (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 Sb(v) in mucosal leishmaniasis reduces the healing time significantly and prevents the need for further courses of Sb(v).
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador-Bahia, Brazil.
authors.forename: Paulo R L
authors.initials: PR
authors.lastname: Machado
authors.forename: Hélio
authors.initials: H
authors.lastname: Lessa
authors.forename: Marcus
authors.initials: M
authors.lastname: Lessa
authors.forename: Luiz H
authors.initials: LH
authors.lastname: Guimarães
authors.forename: Heejung
authors.initials: H
authors.lastname: Bang
authors.forename: John L
authors.initials: JL
authors.lastname: Ho
authors.forename: Edgar M
authors.initials: EM
authors.lastname: Carvalho
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000965:Antimony / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007897:Leishmaniasis, Mucocutaneous / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010431:Pentoxifylline / Q000008:administration & dosage*; D012016:Reference Values; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000965:Antimony; D010431:Pentoxifylline