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

Detalhes bibliográficos
Autor(a) principal: Mendes, Luciana
Data de Publicação: 2021
Outros Autores: 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.
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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spelling 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
format article
status_str 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
url https://www.arca.fiocruz.br/handle/icict/46333
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 Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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