Por favor, use este identificador para citar o enlazar este ítem:
Tipo
ArtículoDerechos de autor
Acceso abierto
Colecciones
Metadatos
Mostrar el registro completo del ítem
A DOUBLE-BIND AND RANDOMIZED TRIAL TO EVALUATE MILTEFOSINE AND TOPICAL GM-CSF IN THE TREATMENT OF CUTANEOUS LEISHMANIASIS CAUSED BY LEISHMANIA BRAZILIENSIS IN BRAZIL
Miltefosine
GM-CSF
Pentavalent antimony
Leishmania (V.) braziliensis
https://www.arca.fiocruz.br/handle/icict/44288
Autor
Afiliación
Resumen en ingles
Background: The treatment of cutaneous leishmaniasis (CL) in Brazil using pentavalent antimony (Sbv) is associated with a high rate of failure. Miltefosine has proven efficacy for CL caused by L. braziliensis, with a cure rate (CR) of 75%. A combined treatment with granulocyte macrophage colony-stimulating factor (GM-CSF) and miltefosine could increase CR and decrease healing time. Methods: A randomized, double-blind clinical trial to evaluate the efficacy of miltefosine combined with topical GM-CSF (M +GM) vs miltefosine and placebo (M + P) vs Sbv in 133 patients with CL caused by L. braziliensis in Bahia, Brazil. Results: The final CR at 180 days after the initiation of treatment was 44.4% in the Sbv group, 76.6% in the M + P group (P = .003 vs Sbv), and 75.6% in the M + GM group (P = .004 vs Sbv). The median healing time for cure was 102 days for the Sbv group and 60 days for both miltefosine groups (P = .0009). During the 6-month follow-up period, 4 relapses were documented: 1 in the Sbv group, 1 in the M + P group, and 2 in the M + GM group. Mild adverse events occurred in 65% of patients from the Sbv group, 76% and 79% from the M + P and M + GM groups respectively. Conclusions: Miltefosine is more effective than Sbv for the treatment of CL caused by L. braziliensis in Brazil and accelerates the healing time. Association with GM-CSF does not improve therapeutic outcome.
Palabras clave en ingles
Cutaneous leishmaniasisMiltefosine
GM-CSF
Pentavalent antimony
Leishmania (V.) braziliensis
Compartir