Author | Machado, Paulo Roberto Lima | |
Author | Ampuero, Julia | |
Author | Guimarães, Luiz Henrique Santos | |
Author | Villasboas, Leonardo | |
Author | Rocha, Ana T. | |
Author | Schriefer, Albert | |
Author | Sousa, Rosana S. | |
Author | Talhari, Anette Chursciack | |
Author | Penna, Gerson Oliveira | |
Author | Carvalho, Edgar Marcelino | |
Access date | 2020-05-28T15:19:29Z | |
Available date | 2020-05-28T15:19:29Z | |
Document date | 2010 | |
Citation | MACHADO, Paulo R. et al. Miltefosine in the treatment of Cutaneous Leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. Plos Neglected Tropical Diseases, [San Francisco], v. 12, n. 4, p.1-6, Dec. 2010. | pt_BR |
ISSN | 1935-2727 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/41434 | |
Description | Gerson Oliveira Penna - Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento do vinculo com a unidade da Fiocruz Brasília. | pt_BR |
Language | eng | pt_BR |
Publisher | Public Library of Science | pt_BR |
Rights | open access | pt_BR |
MeSH | Abdominal Pain | pt_BR |
MeSH | Administration, Oral | pt_BR |
MeSH | Antimony | pt_BR |
MeSH | Antiprotozoal Agents | pt_BR |
MeSH | Leishmania braziliensis | pt_BR |
MeSH | Leishmaniasis, Cutaneous | pt_BR |
MeSH | Phosphorylcholine | pt_BR |
MeSH | Prevalence | pt_BR |
MeSH | Treatment Outcome | pt_BR |
MeSH | Vomiting | pt_BR |
MeSH | Nausea | pt_BR |
MeSH | Brazil | pt_BR |
Title | Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial | pt_BR |
Type | Article | pt_BR |
DOI | 10.1371/journal.pntd.0000912 | |
Abstract | Background: 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. | pt_BR |
Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
Affilliation | Universidade de Brasília. Faculdade de Medicina. Núcleo de Medicina Tropical. Brasília, DF, Brasil. | pt_BR |
Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical do Amazonas, Manaus, AM, Brasil. | pt_BR |
Affilliation | Universidade de Brasília. Faculdade de Medicina. Núcleo de Medicina Tropical. Brasília, DF, Brasil. | pt_BR |
Affilliation | Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Salvador, BA, Brasil. | pt_BR |
Subject | Leishmaniasis | pt_BR |
Subject | Cutaneous Leishmaniasis | pt_BR |
Subject | Drug therapy | pt_BR |
Subject | Miltefosine | pt_BR |
Subject | Antiprotozoal agents | pt_BR |
Subject | Treatment outcome | pt_BR |
DeCS | Leishmaniose Cutânea | pt_BR |
DeCS | Leishmania braziliensis | pt_BR |
DeCS | Resultado do Tratamento | pt_BR |
DeCS | Antiprotozoários | pt_BR |
DeCS | Antimônio | pt_BR |
DeCS | Sensibilidade Colateral a Medicamentos | pt_BR |