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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 (PREPRINT)
Fator Estimulador de Colônias de Granulócitos e Macrófagos
Antimônio pentavalente
Leishmania braziliensis
Miltefosine
GM-CSF
Pentavalent antimony
Leishmania (V.) braziliensis
https://www.arca.fiocruz.br/handle/icict/45507
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Abstract
The treatment of cutaneous leishmaniasis (CL) in Brazil by pentavalent antimony (Sbv) is associated with a high rate of failure. Oral miltefosine in monotherapy has proven high efficacy in CL caused by L. braziliensis with a cure rate of 75%. A combined treatment with GM-CSF and miltefosine was tested to increase the cure rate and decrease the healing time. Methods: This is a randomized and double-blind clinical trial to evaluate the efficacy of miltefosine combined with topical GM-CSF (M+GM) versus miltefosine and placebo (M+P) versus standard Sbv in the treatment of 133 patients with CL caused by L. braziliensis in Bahia, Brazil. Results: The final cure rate at 180 days after the initiation of treatment was 44.4% in the Sbv group, 76.6% in the M+P group (P= 0.003 versus Sbv), and 75.6% in the M+GM group (P= 0.004 versus Sbv). By survival curve analysis median healing time for cure was 102 for Sbv group and 60 days for both miltefosine groups (P= 0.0009). During the 6 months follow-up period, four relapses were documented, one in the Sbv group (2%), one in the M+P group (2%) and two in the M+GM group (5%). Adverse events were documented in 65% of subjects from Sbv group, 79% of M+GM group and 76% of M+P group. Conclusions: Miltefosine is more effective than standard Sbv for the treatment of CL caused by L. braziliensis in Brazil and accelerate the healing time of CL. The association of Miltefosine with GM-CSF do not improve therapeutic outcome. (Clinicaltrials.gov Identifier NCT03023111).
Keywords in Portuguese
Leishmaniose cutâneaFator Estimulador de Colônias de Granulócitos e Macrófagos
Antimônio pentavalente
Leishmania braziliensis
Keywords
Cutaneous LeishmaniasisMiltefosine
GM-CSF
Pentavalent antimony
Leishmania (V.) braziliensis
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