Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.

摘要: Background Cutaneous leishmaniasis (CL) is treated with parenteral drugs for decades decreasing rate cures. Miltefosine an oral medication anti-leishmania activity and may increase the cure rates improve compliance. Methodology/principal findings This study a randomized, open-label, controlled clinical trial aimed to evaluate efficacy safety of miltefosine versus pentavalent antimony (Sb(v)) in treatment patients CL caused by Leishmania braziliensis Bahia, Brazil. A total 90 were enrolled trial; 60 assigned receive 30 Sb(v). Six months after treatment, intention-to-treat analyses, definitive was 53.3% Sb(v) group 75% (difference 21.7%, 95% CI 0.08% 42.7%, p = 0.04). more effective than age 13-65 years-old compared 2-12 (78.9% 45% 0.02; 68.2% 70% 1.0, respectively). The incidence adverse events similar groups (76.7% vs. 78.3%). Vomiting (41.7%), nausea (40%), abdominal pain (23.3%) significantly frequent while arthralgias (20.7%), mialgias (20.7%) fever group. Conclusions demonstrates that therapy standard safe Trial registration Clinicaltrials.gov Identifier NCT00600548.