Abstract
Leishmaniasis is a group of diseases with a large spectrum, cosmopolitan, but with broad and signifiant 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 effiacy of Fluconazole® with high-dose treatment of ACL in patients from an endemic area in the Southern State of Ceara, 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 coeffiient (r) was used. The time healing of each group had its evaluation by Kaplan-Meier method. In all tests the hypothesis α was considered signifiant when less than 5% (p <0.05). The therapeutic effiacy (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 prevalence of females. The results showed therapeutic effiacy of 38.7%. The cure was related to the size of the lesion, relevant factor in the statistical p <0.0001. The lesions smaller than 30 mm (alone or sum of multiple lesions) responded promptly to Fluconazole®
Highlights
The American tegumentary leishmaniasis (ATL) is an infectious disease of the skin and mucosa, whose etiological agent is a protozoan of the gender Leishmania sp
This is a prospective, randomized study to evaluate the therapeutic efficacy of Fluconazol®, orally, in high doses, in patients with cutaneous leishmaniasis determined by Leishmania (V.) braziliensis
One case of tegumentary leishmaniasis in a young man of 20 lesions did not respond to conventional treatment, responding promptly to amphotericin B in 20 days, with a final cure after 40 days of clinical follow-up without recurrence. This randomized study, performed in a population of 120 patients, to evaluate the therapeutic efficacy of Fluconazol® in high doses in the treatment of tegumentary leishmaniasis was justified and is justified in light of the risks related to the use of first-line drugs, in general, in elderly patients, especially in cardiac, hepatopathic and nephropathic patients, to the exclusive use of these injectable, to complications at the application site, among other discomforts and contraindications
Summary
The American tegumentary leishmaniasis (ATL) is an infectious disease of the skin and mucosa, whose etiological agent is a protozoan of the gender Leishmania sp. Definitive diagnosis involves the demonstration of the parasite, obtained by various parasitological techniques of direct and indirect research. The simplest technique is the direct detection of parasites in material obtained by scarification, aspiration or biopsy of the edge of the lesion, using Romanowsky colorings (Furtado, 1994). The polymerase chain reaction (PCR) is a method endowed with high sensitivity, capable of detecting trace quantities as small as a fentogram from the DNA of a leishmania, equivalent to 1/10 of the parasite (Brujin; Barker, 1992), Brazil has a sensitivity of 98.41% and specificity of 95.59% (Gontijo, 1997). The MIDR detects the presence of delayed-type hypersensitivity, since, from the immunological point of view, LT is characterized by a cellular response during and after the cure of the infection, either spontaneously or after treatment (Carvalho et al, 1995). Demonstrates sensitivity greater than 60% in cutaneous forms, 100% in the LCM and negative in the LCD (KAR, 1995; Mendonca et al, 1988)
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