Associação do glucantime e G-CSF no tratamento da leishmaniose cutânea causada por leishmania (viannia) braziliensis

Abstract

Pentavalent Antimony Associated With G-Csf in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) Braziliensis: a pilot study

Objective: To compare the effectiveness of meglumine antimoniate (Sbv) (Glucantime™, 20mg/kg/day intravenously for 20 days) associated with G-CSF and the use of Sbv (same scheme) plus placebo in the treatment of cutaneous leishmaniasis (CL). Methods: Thirty-two patients aged between 18 and 50 years with localized ulcerated LC (up to 3 lesions) with positive PCR for L. braziliensis were included in the study. G-CSF or placebo (0.9% saline solution) was applied by intralesional infiltration of 0.1 mL at 4 equidistant points on the edge of the largest ulcer on day 0 and day 15. Cytokine levels (IL-1 β, TNF, IFN-γ and IL-10) were determined in culture supernatant of mononuclear cells stimulated with soluble Leishmania antigen at a concentration of 5 μg/ml.m. on days 0 and 15 (during treatment). Healing was defined as complete healing without elevation of the ulcer edges by day 90 after initiation of therapy. Failure was defined by the presence of an active ulcer or scar with raised edges at day 90. Results: Males predominated in the G-CSF group (59%), while the control group had a higher frequency of females (53.3%). Most of the lesions were located in the lower limbs. The study showed no differences in therapeutic outcome between the two groups. The cure rate in the G-CSF group was 53% and in the placebo group it was 47%, however at the final evaluation on day 180 there was an increase in cure in the G-CSF group compared to the placebo group (65% versus 47%), but it was not significant. Conclusion: The association of G-CSF and Sbv in the treatment of CL was not able to significantly change the cure rate when compared to the control group, probably due to insufficient sample size. The continuation of this study in a larger number of patients may be necessary to prove the effectiveness of the association of G-CSF in the treatment of CL.