Author(s): Viana, Graça Maria de Castro ; Saldanha, Ana Cristina Rodrigues ; Pinheiro, Clélia R ; Nascimento, Jeanne d’Arc de Lisboa ; Burattini, Marcelo Nascimento ; Costa, Jackson Mauricio Lopes
Date: 2015
Origin: Oasisbr
Subject(s): Leishmania chagasi; Visceral leishmaniasis; Liposomal amphotericin B; Northeastern of Brazil
Federal University of Maranhão. Nucleus of Tropical Pathology and Social Medicine. Department of Pathology. São Luis, MA, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Federal University of Maranhão. Nucleus of Tropical Pathology and Social Medicine. Department of Pathology. São Luis, MA, Brasil
Federal University of Maranhão. Nucleus of Tropical Pathology and Social Medicine. Department of Pathology. São Luis, MA, Brasil
Federal University of São Paulo. Department of Infectious Diseases. São Paulo, SP, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
A prospective, non-randomized study was conducted on 30 patients with American Visceral Leishmaniasis (AVL) aged 3 to 10 years from São Luis, Maranhão - Brazil, who were not previously submitted to treatment. After an informed consent form, was signed by the responsible person, all patients were submitted to anamnesis and physical examination and a standard chart was filled out. The patients were randomly divided into three cohorts of 10 patients each and submitted to the following treatment regimen with liposomal amphotericin B: cohort 1) 2 mg/kg/ day applied on days 1, 2, 3, 4, 5, 6 and 10, total dose of 14 mg/kg; cohort 2) 2 mg/kg/day applied on days 1, 2, 3, 4, and 10, total dose of 10 mg/kg; cohort 3) 2 mg/kg/day applied on days 1, 5, and 10, total dose of 6 mg/kg. An intra-hospital treatment regimen was used which consisted of intravenous administration of the drug over a period of 60 min. Efficacy was 70% in cohort 1, 90% cohort 2, and 80% in cohort 3. The patients were followed up for 6 months. No significant difference was observed between the three regimens in terms of toxicity, tolerability and effectiveness when evaluated by generalizations of the Gehan model and Wilcoxon test.
