Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial

Detalhes bibliográficos
Autor(a) principal: Machado, Paulo Roberto Lima
Data de Publicação: 2018
Outros Autores: Ribeiro, Camila S, Costa, Jaqueline França, Dourado, Mayra Elizabeth Ferreira, Trinconi, Cristiana de Melo, Yasunaka, Jenicer K U Yokoyama, Santos, Hayna Malta, Borges, Valéria de Matos, Carvalho Filho, Edgar Marcelino, Uliana, Silvia Reni Bortoloni
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/28149
Resumo: Fundação de Amparo a Pesquisa do Estado de São Paulo (FAPESP 2015/09080-2). SRBU is the recipient of a sênior researcher scholarship from CNPq
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spelling Machado, Paulo Roberto LimaRibeiro, Camila SCosta, Jaqueline FrançaDourado, Mayra Elizabeth FerreiraTrinconi, Cristiana de MeloYasunaka, Jenicer K U YokoyamaSantos, Hayna MaltaBorges, Valéria de MatosCarvalho Filho, Edgar MarcelinoUliana, Silvia Reni Bortoloni2018-08-15T16:34:59Z2018-08-15T16:34:59Z2018MACHADO, P. R. L. et al.Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial. Tropical Medicine and International Health, 2018.1360-2276https://www.arca.fiocruz.br/handle/icict/2814910.1111/tmi.13119Fundação de Amparo a Pesquisa do Estado de São Paulo (FAPESP 2015/09080-2). SRBU is the recipient of a sênior researcher scholarship from CNPqUniversidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, BrasilUniversidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, BrasilUniversidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, BrasilUniversidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, BrasilUniversidade de São Paulo. Departamento de Parasitologia. São Paulo, SP, BrasilUniversidade de São Paulo. Departamento de Parasitologia. São Paulo, SP, BrasilUniversidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, BrasilUniversidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, BrasilUniversidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, BrasilUniversidade de São Paulo. Departamento de Parasitologia. São Paulo, SP, BrasilThere is a clear need for new strategies of leishmaniasis treatment. This work was conducted to evaluate the efficacy of the co-administration of tamoxifen and meglumine antimoniate (SbV ) in a phase II pilot clinical trial in localised cutaneous leishmaniasis patients. methods A randomised controlled pilot clinical trial was conducted to evaluate the efficacy and safety of oral (40 mg/day for 20 days) or topical tamoxifen (0.1% tamoxifen citrate for 20 days) combined with meglumine antimoniate (20 mg SbV/kg/day for 20 days) vs. a standard SbV protocol (20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis. Primary outcome was complete epithelisation of the lesion 6 months after the end of treatment. Secondary outcomes were lesion healing 2 months after the end of treatment and frequency and severity of adverse events. results A total of 38 subjects were included in the trial, 15 were treated with standard SbV and 23 with the combination of tamoxifen and SbV. Of the patients treated with the co-administration scheme, 12 received tamoxifen orally and 11 were treated with topical tamoxifen. Tamoxifen administered by the oral or topical routes was well tolerated. Cure rates 6 months after the end of treatment per intention to treat were 40% in the group treated with the standard SbV scheme, and 36.4% and 58%, respectively, for groups treated with SbV plus topical or oral tamoxifen. conclusions In the doses and schemes used in this study, co-administration of oral tamoxifen and SbV resulted in higher cure rates in comparison with the standard scheme of treatment, although not to statistically significant levels.engBlackwell Scienceleishmaniose cutâneaTratamentoAntimonial pentavalenteTamoxifenoUso tópicoOralCutaneous leishmaniasisTreatmentPentavalent antimonialsTamoxifenTopicalOralTamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
title Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
spellingShingle Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
Machado, Paulo Roberto Lima
leishmaniose cutânea
Tratamento
Antimonial pentavalente
Tamoxifeno
Uso tópico
Oral
Cutaneous leishmaniasis
Treatment
Pentavalent antimonials
Tamoxifen
Topical
Oral
title_short Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
title_full Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
title_fullStr Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
title_full_unstemmed Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
title_sort Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
author Machado, Paulo Roberto Lima
author_facet Machado, Paulo Roberto Lima
Ribeiro, Camila S
Costa, Jaqueline França
Dourado, Mayra Elizabeth Ferreira
Trinconi, Cristiana de Melo
Yasunaka, Jenicer K U Yokoyama
Santos, Hayna Malta
Borges, Valéria de Matos
Carvalho Filho, Edgar Marcelino
Uliana, Silvia Reni Bortoloni
author_role author
author2 Ribeiro, Camila S
Costa, Jaqueline França
Dourado, Mayra Elizabeth Ferreira
Trinconi, Cristiana de Melo
Yasunaka, Jenicer K U Yokoyama
Santos, Hayna Malta
Borges, Valéria de Matos
Carvalho Filho, Edgar Marcelino
Uliana, Silvia Reni Bortoloni
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Machado, Paulo Roberto Lima
Ribeiro, Camila S
Costa, Jaqueline França
Dourado, Mayra Elizabeth Ferreira
Trinconi, Cristiana de Melo
Yasunaka, Jenicer K U Yokoyama
Santos, Hayna Malta
Borges, Valéria de Matos
Carvalho Filho, Edgar Marcelino
Uliana, Silvia Reni Bortoloni
dc.subject.other.pt_BR.fl_str_mv leishmaniose cutânea
Tratamento
Antimonial pentavalente
Tamoxifeno
Uso tópico
Oral
topic leishmaniose cutânea
Tratamento
Antimonial pentavalente
Tamoxifeno
Uso tópico
Oral
Cutaneous leishmaniasis
Treatment
Pentavalent antimonials
Tamoxifen
Topical
Oral
dc.subject.en.pt_BR.fl_str_mv Cutaneous leishmaniasis
Treatment
Pentavalent antimonials
Tamoxifen
Topical
Oral
description Fundação de Amparo a Pesquisa do Estado de São Paulo (FAPESP 2015/09080-2). SRBU is the recipient of a sênior researcher scholarship from CNPq
publishDate 2018
dc.date.accessioned.fl_str_mv 2018-08-15T16:34:59Z
dc.date.available.fl_str_mv 2018-08-15T16:34:59Z
dc.date.issued.fl_str_mv 2018
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 MACHADO, P. R. L. et al.Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial. Tropical Medicine and International Health, 2018.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/28149
dc.identifier.issn.pt_BR.fl_str_mv 1360-2276
dc.identifier.doi.none.fl_str_mv 10.1111/tmi.13119
identifier_str_mv MACHADO, P. R. L. et al.Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial. Tropical Medicine and International Health, 2018.
1360-2276
10.1111/tmi.13119
url https://www.arca.fiocruz.br/handle/icict/28149
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Blackwell Science
publisher.none.fl_str_mv Blackwell Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
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