Avaliation the therapeutic efficacy of Fluconazol on Human Tegumentary Leishmaniasis

Abstract

Leishmaniasis is a group of diseases with a large spectrum, cosmopolitan, but with broad and significant impact in the tropical zone. Leishmaniasis presents itself in two forms, one visceral involving hemolinfopoietic system structures, other with skin and/or mucosa involvement, often without visceralizing. The latter, known as American Cutaneous Leishmaniasis (ACL) is the aim of this study. One of the major problems in the ACL is treatment procedure using injectable formulations, with risk for complications from the injection and the risk of damage to the liver and kidney function and cardiac complications. Several tests have demonstrated satisfactory results using Fluconazole ®. In order to consolidate the results described in the literature, this study sought to demonstrate the therapeutic efficacy of Fluconazole ® with high-dose treatment of ACL in patients from an endemic area in the Southern State of Ceará, Brazil, City of Barbalha. It's conducted a prospective randomized study with two groups of patients. Sixty of the Group I: they were treated with 300mg or 450mg of Fluconazole ® for six weeks. Sixty Group II: they were treated with Glucantime 20mg/kg/ day for 20 consecutive days. The diagnosis of ACL was performed with Imprint, culture, biopsy and histopathological stain with Giemsa and immunohistochemistry. Montenegro's Intradermoreaction was also performed. All patients were evaluated clinically and followed up for ninety days. Continuous variables were evaluated by Student's t test, and for the correlation of variables the Pearson correlation coefficient (r) was used. The time healing of each group had its evaluation by Kaplan-Meier method. In all tests the hypothesis α was considered significant when less than 5% (p <0.05). The therapeutic efficacy (TE) was calculated based on the reduction of relative risk. The study population was predominantly made up of individuals between 30 and 40 years, brown skin color, peasants, rural people, with a slight pre