Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.

Detalhes bibliográficos
Autor(a) principal: Machado, Paulo Roberto Lima
Data de Publicação: 2010
Outros Autores: Ampuero, Julia, Guimarães, Luiz H., Villasboas, Leonardo, Rocha, Ana T., Sousa, Rosana Santos, Carvalho Filho, Edgar Marcelino de
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFBA
Texto Completo: http://repositorio.ufba.br/ri/handle/ri/13843
Resumo: p.1-6
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spelling Machado, Paulo Roberto LimaAmpuero, JuliaGuimarães, Luiz H.Villasboas, LeonardoRocha, Ana T.Sousa, Rosana SantosCarvalho Filho, Edgar Marcelino deMachado, Paulo Roberto LimaAmpuero, JuliaGuimarães, Luiz H.Villasboas, LeonardoRocha, Ana T.Sousa, Rosana SantosCarvalho Filho, Edgar Marcelino de2013-11-22T12:07:52Z2013-11-22T12:07:52Z2010-121935-2727http://repositorio.ufba.br/ri/handle/ri/13843v. 4, n. 12p.1-6Background: Cutaneous leishmaniasis (CL) is treated with parenteral drugs for decades with decreasing rate cures. Miltefosine is an oral medication with anti-leishmania activity and may increase the cure rates and improve compliance. Methodology/Principal Findings: This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sbv) in the treatment of patients with CL caused by Leishmania braziliensis in Bahia, Brazil. A total of 90 patients were enrolled in the trial; 60 were assigned to receive miltefosine and 30 to receive Sbv. Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sbv group and 75% in the miltefosine group (difference of 21.7%, 95% CI 0.08% to 42.7%, p = 0.04). Miltefosine was more effective than Sbv in the age group of 13–65 years-old compared to 2–12 years-old group (78.9% versus 45% p = 0.02; 68.2% versus 70% p = 1.0, respectively). The incidence of adverse events was similar in the Sbv and miltefosine groups (76.7% vs. 78.3%). Vomiting (41.7%), nausea (40%), and abdominal pain (23.3%) were significantly more frequent in the miltefosine group while arthralgias (20.7%), mialgias (20.7%) and fever (23.3%) were significantly more frequent in the Sbv group. Conclusions: This study demonstrates that miltefosine therapy is more effective than standard Sbv and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil.Submitted by Suelen Reis (suziy.ellen@gmail.com) on 2013-06-25T17:02:51Z No. of bitstreams: 1 Paulo Machado.pdf: 352428 bytes, checksum: cfe1f635c04f20b83a6a736653504555 (MD5)Approved for entry into archive by Rodrigo Meirelles (rodrigomei@ufba.br) on 2013-11-22T12:07:52Z (GMT) No. of bitstreams: 1 Paulo Machado.pdf: 352428 bytes, checksum: cfe1f635c04f20b83a6a736653504555 (MD5)Made available in DSpace on 2013-11-22T12:07:52Z (GMT). No. of bitstreams: 1 Paulo Machado.pdf: 352428 bytes, checksum: cfe1f635c04f20b83a6a736653504555 (MD5) Previous issue date: 2010-12http://dx.doi.org/10.1371/journal.pntd.0000912.t003reponame:Repositório Institucional da UFBAinstname:Universidade Federal da Bahia (UFBA)instacron:UFBAMiltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.PLoS Neglected Tropical Diseasesinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleenginfo:eu-repo/semantics/openAccessORIGINALPaulo Machado.pdfPaulo Machado.pdfapplication/pdf352428https://repositorio.ufba.br/bitstream/ri/13843/1/Paulo%20Machado.pdfcfe1f635c04f20b83a6a736653504555MD51LICENSElicense.txtlicense.txttext/plain1762https://repositorio.ufba.br/bitstream/ri/13843/2/license.txt1b89a9a0548218172d7c829f87a0eab9MD52TEXTPaulo Machado.pdf.txtPaulo Machado.pdf.txtExtracted texttext/plain31141https://repositorio.ufba.br/bitstream/ri/13843/3/Paulo%20Machado.pdf.txt837ae4374b66f6a0e5f40d05fbd57f94MD53ri/138432022-07-05 14:03:43.718oai:repositorio.ufba.br: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Repositório InstitucionalPUBhttp://192.188.11.11:8080/oai/requestopendoar:19322022-07-05T17:03:43Repositório Institucional da UFBA - Universidade Federal da Bahia (UFBA)false
dc.title.pt_BR.fl_str_mv Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
dc.title.alternative.pt_BR.fl_str_mv PLoS Neglected Tropical Diseases
title Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
spellingShingle Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
Machado, Paulo Roberto Lima
title_short Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
title_full Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
title_fullStr Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
title_full_unstemmed Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
title_sort Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
author Machado, Paulo Roberto Lima
author_facet Machado, Paulo Roberto Lima
Ampuero, Julia
Guimarães, Luiz H.
Villasboas, Leonardo
Rocha, Ana T.
Sousa, Rosana Santos
Carvalho Filho, Edgar Marcelino de
author_role author
author2 Ampuero, Julia
Guimarães, Luiz H.
Villasboas, Leonardo
Rocha, Ana T.
Sousa, Rosana Santos
Carvalho Filho, Edgar Marcelino de
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Machado, Paulo Roberto Lima
Ampuero, Julia
Guimarães, Luiz H.
Villasboas, Leonardo
Rocha, Ana T.
Sousa, Rosana Santos
Carvalho Filho, Edgar Marcelino de
Machado, Paulo Roberto Lima
Ampuero, Julia
Guimarães, Luiz H.
Villasboas, Leonardo
Rocha, Ana T.
Sousa, Rosana Santos
Carvalho Filho, Edgar Marcelino de
description p.1-6
publishDate 2010
dc.date.issued.fl_str_mv 2010-12
dc.date.accessioned.fl_str_mv 2013-11-22T12:07:52Z
dc.date.available.fl_str_mv 2013-11-22T12:07:52Z
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dc.identifier.issn.none.fl_str_mv 1935-2727
dc.identifier.number.pt_BR.fl_str_mv v. 4, n. 12
identifier_str_mv 1935-2727
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