Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil
Autor(a) principal: | |
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Data de Publicação: | 2011 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFBA |
Texto Completo: | http://repositorio.ufba.br/ri/handle/ri/14801 |
Resumo: | Texto completo: acesso restrito. p. 255-260 |
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Penna, Gerson de OliveiraMachado, Paulo Roberto LimaTalhari, SinésioTalhari, Anette ChrusciakDietze, ReynaldoTalhari, Carolina ChrusciakSilva, Roberto Moreira daYamashita, Ellen Priscila GadelhaMachado, Paulo Roberto LimaTalhari, SinésioPenna, Gerson de OliveiraMachado, Paulo Roberto LimaTalhari, SinésioTalhari, Anette ChrusciakDietze, ReynaldoTalhari, Carolina ChrusciakSilva, Roberto Moreira daYamashita, Ellen Priscila GadelhaMachado, Paulo Roberto LimaTalhari, Sinésio2014-04-08T13:38:23Z20110002-9637http://repositorio.ufba.br/ri/handle/ri/14801v. 84, n. 2Texto completo: acesso restrito. p. 255-260Miltefosine 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.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). 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dc.title.pt_BR.fl_str_mv |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil |
dc.title.alternative.pt_BR.fl_str_mv |
American Journal of Tropical Medicine and Hygiene |
title |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil |
spellingShingle |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil Penna, Gerson de Oliveira |
title_short |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil |
title_full |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil |
title_fullStr |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil |
title_full_unstemmed |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil |
title_sort |
Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil |
author |
Penna, Gerson de Oliveira |
author_facet |
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 |
author_role |
author |
author2 |
Machado, Paulo Roberto Lima Talhari, Sinésio Talhari, Anette Chrusciak Dietze, Reynaldo Talhari, Carolina Chrusciak Silva, Roberto Moreira da Yamashita, Ellen Priscila Gadelha |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
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 Machado, Paulo Roberto Lima Talhari, Sinésio 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 Machado, Paulo Roberto Lima Talhari, Sinésio |
description |
Texto completo: acesso restrito. p. 255-260 |
publishDate |
2011 |
dc.date.issued.fl_str_mv |
2011 |
dc.date.accessioned.fl_str_mv |
2014-04-08T13:38:23Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://repositorio.ufba.br/ri/handle/ri/14801 |
dc.identifier.issn.none.fl_str_mv |
0002-9637 |
dc.identifier.number.pt_BR.fl_str_mv |
v. 84, n. 2 |
identifier_str_mv |
0002-9637 v. 84, n. 2 |
url |
http://repositorio.ufba.br/ri/handle/ri/14801 |
dc.language.iso.fl_str_mv |
eng |
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eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
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http://dx.doi.org/ 10.4269/ajtmh.2011.10-0155 |
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reponame:Repositório Institucional da UFBA instname:Universidade Federal da Bahia (UFBA) instacron:UFBA |
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