Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised 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/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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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 |
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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 |
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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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Blackwell Science |
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Blackwell Science |
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