Article
Clinical trial with liposomal amphotericin B (AMBISOME®) for American Visceral Leisshmaniais (AVL)
Registro en:
VIANA, G. M. C. et al. Clinical trial with liposomal amphotericin B (AMBISOME®) for American Visceral Leishmaniais (AVL). Gazeta Médica da Bahia, v. 79, Supl 3, p. 156-162, 2009.
0016-545X
Autor
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
Resumen
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.