Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
Texto Completo: | https://www.arca.fiocruz.br/handle/icict/33745 |
Resumo: | Fundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, Brasil. |
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Ramalho, Dario BrockSilva, Rosiana Estéfane daSenna, Maria Camilo Ribeiro deMoreira, Hugo Silva AssisPedras, Mariana JunqueiraAvelar, Daniel Moreira deSaraiva, LaraRabello, Ana Lucia TelesCota, Gláucia Fernandes2019-07-01T13:13:56Z2019-07-01T13:13:56Z2018RAMALHO, Dario Brock et al. Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 9, p. 1-8, 2018.0074-0276https://www.arca.fiocruz.br/handle/icict/3374510.1590/0074-02760180200engFundação Oswaldo CruzInfiltração intralesionalAntimoniato de megluminaLeishmaniose cutâneaTerapiaIntralesional infiltrationMeglumine antimoniateCutaneous leishmaniasisTherapyMeglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.BACKGROUND: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES: The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS: It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS: A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83082https://www.arca.fiocruz.br/bitstream/icict/33745/1/license.txt9193a7c197bc67acd023525e72a03240MD51ORIGINALMeglumine antimoniate intralesional .pdfMeglumine antimoniate intralesional .pdfapplication/pdf7105635https://www.arca.fiocruz.br/bitstream/icict/33745/2/Meglumine%20antimoniate%20intralesional%20.pdf52176217c690d2e39394b1e5ab2c0a57MD52TEXTMeglumine antimoniate intralesional .pdf.txtMeglumine antimoniate intralesional .pdf.txtExtracted texttext/plain104https://www.arca.fiocruz.br/bitstream/icict/33745/3/Meglumine%20antimoniate%20intralesional%20.pdf.txt4bd5918ab5fa4779e698b5951024cc60MD53icict/337452019-07-03 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dc.title.pt_BR.fl_str_mv |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
title |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
spellingShingle |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial Ramalho, Dario Brock Infiltração intralesional Antimoniato de meglumina Leishmaniose cutânea Terapia Intralesional infiltration Meglumine antimoniate Cutaneous leishmaniasis Therapy |
title_short |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
title_full |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
title_fullStr |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
title_full_unstemmed |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
title_sort |
Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
author |
Ramalho, Dario Brock |
author_facet |
Ramalho, Dario Brock Silva, Rosiana Estéfane da Senna, Maria Camilo Ribeiro de Moreira, Hugo Silva Assis Pedras, Mariana Junqueira Avelar, Daniel Moreira de Saraiva, Lara Rabello, Ana Lucia Teles Cota, Gláucia Fernandes |
author_role |
author |
author2 |
Silva, Rosiana Estéfane da Senna, Maria Camilo Ribeiro de Moreira, Hugo Silva Assis Pedras, Mariana Junqueira Avelar, Daniel Moreira de Saraiva, Lara Rabello, Ana Lucia Teles Cota, Gláucia Fernandes |
author2_role |
author author author author author author author author |
dc.contributor.author.fl_str_mv |
Ramalho, Dario Brock Silva, Rosiana Estéfane da Senna, Maria Camilo Ribeiro de Moreira, Hugo Silva Assis Pedras, Mariana Junqueira Avelar, Daniel Moreira de Saraiva, Lara Rabello, Ana Lucia Teles Cota, Gláucia Fernandes |
dc.subject.other.pt_BR.fl_str_mv |
Infiltração intralesional Antimoniato de meglumina Leishmaniose cutânea Terapia |
topic |
Infiltração intralesional Antimoniato de meglumina Leishmaniose cutânea Terapia Intralesional infiltration Meglumine antimoniate Cutaneous leishmaniasis Therapy |
dc.subject.en.pt_BR.fl_str_mv |
Intralesional infiltration Meglumine antimoniate Cutaneous leishmaniasis Therapy |
description |
Fundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, Brasil. |
publishDate |
2018 |
dc.date.issued.fl_str_mv |
2018 |
dc.date.accessioned.fl_str_mv |
2019-07-01T13:13:56Z |
dc.date.available.fl_str_mv |
2019-07-01T13:13:56Z |
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.citation.fl_str_mv |
RAMALHO, Dario Brock et al. Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 9, p. 1-8, 2018. |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/33745 |
dc.identifier.issn.pt_BR.fl_str_mv |
0074-0276 |
dc.identifier.doi.none.fl_str_mv |
10.1590/0074-02760180200 |
identifier_str_mv |
RAMALHO, Dario Brock et al. Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 9, p. 1-8, 2018. 0074-0276 10.1590/0074-02760180200 |
url |
https://www.arca.fiocruz.br/handle/icict/33745 |
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eng |
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eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
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Fundação Oswaldo Cruz |
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Fundação Oswaldo Cruz |
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