Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial
Autor(a) principal: | |
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Data de Publicação: | 2021 |
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/46333 |
Resumo: | Ethics Committee of the Tropical Medicine Foundation Dr. Heitor Vieira Dourado (CAAE 80862417.3.0000.0005). |
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Mendes, LucianaGuerra, Jorge OliveiraCosta, BlenoSilva, Aríneia Soares daGuerra, Maria das Graças BarbosaOrtiza, JéssicaDoria, Susan SmithSilva, George Villarouco daJesus, Denison Vital deBarral Netto, ManoelPenna, GersonCarvalho, Edgar Marcelino deMachado, Paulo R.L.2021-03-11T12:10:15Z2021-03-11T12:10:15Z2021MENDES, Luciana et al. Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial. International Journal of Infectious Diseases, v. 103, p. 358–363 2021.1201-9712https://www.arca.fiocruz.br/handle/icict/4633310.1016/j.ijid.2020.11.183Ethics Committee of the Tropical Medicine Foundation Dr. Heitor Vieira Dourado (CAAE 80862417.3.0000.0005).Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil / Universidade Federal do Amazonas. Manaus, AM, Brasil.Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil.Universidade Federal do Amazonas. Manaus, AM, Brasil.Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil.Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil.Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil.Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil.Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil.Universidade do Estado do Amazonas. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Programa de Pós graduação em Medicina Tropical. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Bahia, Brasil.Fundação Oswaldo Cruz. Universidade de Brasília. Núcleo de Medicina Tropical. Escola Fiocruz de Governo, Brasília, DF, Brasil.Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Bahia, Brasil / Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Ministério da Ciência, Tecnologia, Inovações e Comunicações. Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Brasília, DF, Brasil.Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Bahia, Brasil / Universidade Federal da Bahia. Hospital Universitário Prof. Edgard Santos. Serviço de Imunologia. Salvador, BA, Brasil / Ministério da Ciência, Tecnologia, Inovações e Comunicações. Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Brasília, DF, Brasil.To compare topical granulocyte and macrophage colony-stimulating factor (GM-CSF) and miltefosine (G + M) versus placebo and miltefosine (P + M) or parenteral meglumine antimoniate (MA) in the treatment of 150 patients with cutaneous leishmaniasis (CL) caused by Leishmania guyanensis in the Amazon. Design: A randomized and double-blinded clinical trial. Results: At 90 days after the initiation of therapy, the cure rates were 66%, 58%, and 52% for the groups P + M, G + M, and MA, respectively (p > 0.05). Cure rates at 180 days did not differ. Healing time was similar in the 3 groups, but faster in the MA group as compared to the G + M group (p = 0.04). Mild and transitory systemic adverse events were frequent in all groups (above 85%). Nausea (85%) and vomiting (39%) predominated in the miltefosine groups and arthralgia (51%) and myalgia (48%) in the MA group. One patient (group MA) stopped treatment after presenting with fever, exanthema, and severe arthralgia. Conclusions: Miltefosine did not present a higher cure rate than MA, and the association of GM-CSF did not improve the therapeutic response. Nevertheless, because of its less toxicity, easier administration, and a similar cure rate when compared with MA, miltefosine should remain as one of the main drugs for treating CL due to L. guyanensis.engElsevierLeishmaniose cutâneaGranulócitosAntimoniato de MegluminaLeishmania guyanensisCutaneous leishmaniasisGM-CSFMiltefosine Meglumine antimoniateL. guyanensisAssociation of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled 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; charset=utf-83097https://www.arca.fiocruz.br/bitstream/icict/46333/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALMendes Luciana Association.pdfMendes Luciana Association.pdfapplication/pdf473669https://www.arca.fiocruz.br/bitstream/icict/46333/2/Mendes%20Luciana%20Association.pdfafb85daeadd6114655e7fa42d45264c4MD52TEXTMendes Luciana Association.pdf.txtMendes Luciana Association.pdf.txtExtracted texttext/plain33874https://www.arca.fiocruz.br/bitstream/icict/46333/3/Mendes%20Luciana%20Association.pdf.txta102dca0531d9a2addc6851381454f75MD53icict/463332023-03-15 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dc.title.pt_BR.fl_str_mv |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial |
title |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial |
spellingShingle |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial Mendes, Luciana Leishmaniose cutânea Granulócitos Antimoniato de Meglumina Leishmania guyanensis Cutaneous leishmaniasis GM-CSF Miltefosine Meglumine antimoniate L. guyanensis |
title_short |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial |
title_full |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial |
title_fullStr |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial |
title_full_unstemmed |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial |
title_sort |
Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial |
author |
Mendes, Luciana |
author_facet |
Mendes, Luciana Guerra, Jorge Oliveira Costa, Bleno Silva, Aríneia Soares da Guerra, Maria das Graças Barbosa Ortiza, Jéssica Doria, Susan Smith Silva, George Villarouco da Jesus, Denison Vital de Barral Netto, Manoel Penna, Gerson Carvalho, Edgar Marcelino de Machado, Paulo R.L. |
author_role |
author |
author2 |
Guerra, Jorge Oliveira Costa, Bleno Silva, Aríneia Soares da Guerra, Maria das Graças Barbosa Ortiza, Jéssica Doria, Susan Smith Silva, George Villarouco da Jesus, Denison Vital de Barral Netto, Manoel Penna, Gerson Carvalho, Edgar Marcelino de Machado, Paulo R.L. |
author2_role |
author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Mendes, Luciana Guerra, Jorge Oliveira Costa, Bleno Silva, Aríneia Soares da Guerra, Maria das Graças Barbosa Ortiza, Jéssica Doria, Susan Smith Silva, George Villarouco da Jesus, Denison Vital de Barral Netto, Manoel Penna, Gerson Carvalho, Edgar Marcelino de Machado, Paulo R.L. |
dc.subject.other.pt_BR.fl_str_mv |
Leishmaniose cutânea Granulócitos Antimoniato de Meglumina Leishmania guyanensis |
topic |
Leishmaniose cutânea Granulócitos Antimoniato de Meglumina Leishmania guyanensis Cutaneous leishmaniasis GM-CSF Miltefosine Meglumine antimoniate L. guyanensis |
dc.subject.en.pt_BR.fl_str_mv |
Cutaneous leishmaniasis GM-CSF Miltefosine Meglumine antimoniate L. guyanensis |
description |
Ethics Committee of the Tropical Medicine Foundation Dr. Heitor Vieira Dourado (CAAE 80862417.3.0000.0005). |
publishDate |
2021 |
dc.date.accessioned.fl_str_mv |
2021-03-11T12:10:15Z |
dc.date.available.fl_str_mv |
2021-03-11T12:10:15Z |
dc.date.issued.fl_str_mv |
2021 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
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article |
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publishedVersion |
dc.identifier.citation.fl_str_mv |
MENDES, Luciana et al. Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial. International Journal of Infectious Diseases, v. 103, p. 358–363 2021. |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/46333 |
dc.identifier.issn.pt_BR.fl_str_mv |
1201-9712 |
dc.identifier.doi.none.fl_str_mv |
10.1016/j.ijid.2020.11.183 |
identifier_str_mv |
MENDES, Luciana et al. Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial. International Journal of Infectious Diseases, v. 103, p. 358–363 2021. 1201-9712 10.1016/j.ijid.2020.11.183 |
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https://www.arca.fiocruz.br/handle/icict/46333 |
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eng |
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Elsevier |
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Elsevier |
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