American Journal of Tropical Medicine and Hygiene

Autor: Penna, Gerson de Oliveira, Machado, Paulo Roberto Lima, Talhari, Sinésio, Talhari, Anette Chrusciak, Dietze, Reynaldo, Talhari, Carolina Chrusciak, Silva, Roberto Moreira da, Yamashita, Ellen Priscila Gadelha
Jazyk: angličtina
Rok vydání: 2011
Zdroj: Repositório Institucional da UFBA
Universidade Federal da Bahia (UFBA)
instacron:UFBA
DOI: 10.4269/ajtmh.2011.10-0155
Popis: Texto completo: acesso restrito. p. 255-260 Submitted by Edileide Reis (leyde-landy@hotmail.com) on 2014-04-08T13:38:23Z No. of bitstreams: 1 Gerson de Oliveira Penna.pdf: 753950 bytes, checksum: 20958639833bc3e1c7140fef4aa8bf07 (MD5) Made available in DSpace on 2014-04-08T13:38:23Z (GMT). No. of bitstreams: 1 Gerson de Oliveira Penna.pdf: 753950 bytes, checksum: 20958639833bc3e1c7140fef4aa8bf07 (MD5) Previous issue date: 2011 Miltefosine has been used in the treatment of several new world cutaneous leishmaniasis (CL) species with variable efficacy. Our study is the first evidence on its clinical efficacy in Leishmania (Viannia) guyanensis. In this phase II/III randomized clinical trial, 90 CL patients were randomly allocated (2:1) to oral miltefosine (2.5 mg/kg/day/28 days) (N = 60) or parenteral antimony (15–20 mg/Sb/kg/day/20 days) (N = 30) according to age groups: 2–12 y/o and 13–65 y/o. Patients were human immunodeficiency virus (HIV) noninfected parasitological proven CL without previous treatment. Definitive cure was accessed at 6 months follow-up visit. No severe adverse events occurred. Vomiting was the most frequent adverse event (48.3%) followed by nausea (8.6%) and diarrhea (6.7%). Cure rates were 71.4% (95% confidence interval [CI] = 57.8–82.7) and 53.6% (95% CI = 33.9–72.5) (P = 0.05) for miltefosine and antimonial, respectively. There were no differences in cure rates between age groups within the same treatment arms. Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.
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