A phase IV, prospective, observational study of the clinical safety of snake antivenoms

Detalhes bibliográficos
Autor(a) principal: Nogueira, Denise Christie Souto
Data de Publicação: 2021
Outros Autores: Calil, Iara Pinheiro, Santos, Roberta Márcia Marques Dos, Andrade Filho, Adebal de, Cota, Gláucia Fernandes
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/53463
Resumo: Fundação Ezequiel Dias. Divisão de Produção Farmacêutica. Belo Horizonte, MG, Brazil.
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spelling Nogueira, Denise Christie SoutoCalil, Iara PinheiroSantos, Roberta Márcia Marques DosAndrade Filho, Adebal deCota, Gláucia Fernandes2022-06-24T13:00:15Z2022-06-24T13:00:15Z2021NOGUEIRA, Denise Christie Souto et al. A phase IV, prospective, observational study of the clinical safety of snake antivenoms. Rev Inst Med Trop Sao Paulo, v. 63, e79, 2021. doi: 10.1590/S1678-9946202163079.0036-4665https://www.arca.fiocruz.br/handle/icict/5346310.1590/S1678-9946202163079engInstituto de Medicina Tropical de São PauloA phase IV, prospective, observational study of the clinical safety of snake antivenomsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Ezequiel Dias. Divisão de Produção Farmacêutica. Belo Horizonte, MG, Brazil.Fundação Oswaldo Cruz. Instituto René Rachou. Departamento de Pesquisa Clínica e Políticas Públicas de Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brazil.Fundação Ezequiel Dias. Divisão de Desenvolvimento de Medicamentos. Belo Horizonte, MG, Brazil.Fundação Hospitalar do Estado de Minas Gerais. Hospital João XXIII. Centro de Toxicologia. Belo Horizonte, MG, Brazil.Fundação Oswaldo Cruz. Instituto René Rachou. Departamento de Pesquisa Clínica e Políticas Públicas de Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brazil.Snake envenoming is a neglected tropical disease that affects more than 2.7 million people worldwide. The treatment is based on the administration of antivenom composed of heterologous immunoglobulins, species-specific therapy involving the possibility of adverse reactions due to activation of the immune system. Considering the scarcity of prospective studies evaluating the safety of snake antivenoms, this study aimed to describe and characterize adverse events after antivenom infusion in an observational, prospective, single-centre investigation conducted in a referral centre in Brazil. A total of 47 victims of snake envenoming were included in the study, who were mostly men (75%), with ages ranging from 2 to 83 years. Twenty-two participants (47%) presented manifestations compatible with infusion-related reactions (IRRs) during or up to two hours after F(ab')2 heterologous immunoglobulin infusion. The most common clinical manifestation related to the infusion was a diffuse cutaneous rash (82%), followed by respiratory manifestations (46%) and facial swelling (23%). In four cases (9%), IRR were considered serious adverse events (SAE), characterized by haemodynamic instability, airway obstruction or hypoxia. Only one patient developed symptoms compatible with serum sickness. Although almost half of the patients treated with antivenom sera experienced IRRs, the SAE rate was 9%; in all cases, the adverse reaction was reversible by using supportive treatment, and there were no deaths. The results have shown that there is much to improve in the antivenom production process to obtain a more purified and specific product. Even so, a timely antivenom serum administration managed by well-trained health teams is safe and prevents complications after snake-related accidents.neglected diseasePublic Healthinfo: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/53463/1/license.txt9193a7c197bc67acd023525e72a03240MD51ORIGINALA phase IV, prospective, observational study of the clinical safety of snake antivenoms.pdfA phase IV, prospective, observational study of the clinical safety of snake antivenoms.pdfapplication/pdf611509https://www.arca.fiocruz.br/bitstream/icict/53463/2/A%20phase%20IV%2c%20prospective%2c%20observational%20study%20of%20the%20clinical%20safety%20of%20snake%20antivenoms.pdfbb10f91966639172e722ac349680104cMD52icict/534632022-06-24 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dc.title.pt_BR.fl_str_mv A phase IV, prospective, observational study of the clinical safety of snake antivenoms
title A phase IV, prospective, observational study of the clinical safety of snake antivenoms
spellingShingle A phase IV, prospective, observational study of the clinical safety of snake antivenoms
Nogueira, Denise Christie Souto
neglected disease
Public Health
title_short A phase IV, prospective, observational study of the clinical safety of snake antivenoms
title_full A phase IV, prospective, observational study of the clinical safety of snake antivenoms
title_fullStr A phase IV, prospective, observational study of the clinical safety of snake antivenoms
title_full_unstemmed A phase IV, prospective, observational study of the clinical safety of snake antivenoms
title_sort A phase IV, prospective, observational study of the clinical safety of snake antivenoms
author Nogueira, Denise Christie Souto
author_facet Nogueira, Denise Christie Souto
Calil, Iara Pinheiro
Santos, Roberta Márcia Marques Dos
Andrade Filho, Adebal de
Cota, Gláucia Fernandes
author_role author
author2 Calil, Iara Pinheiro
Santos, Roberta Márcia Marques Dos
Andrade Filho, Adebal de
Cota, Gláucia Fernandes
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Nogueira, Denise Christie Souto
Calil, Iara Pinheiro
Santos, Roberta Márcia Marques Dos
Andrade Filho, Adebal de
Cota, Gláucia Fernandes
dc.subject.en.pt_BR.fl_str_mv neglected disease
Public Health
topic neglected disease
Public Health
description Fundação Ezequiel Dias. Divisão de Produção Farmacêutica. Belo Horizonte, MG, Brazil.
publishDate 2021
dc.date.issued.fl_str_mv 2021
dc.date.accessioned.fl_str_mv 2022-06-24T13:00:15Z
dc.date.available.fl_str_mv 2022-06-24T13:00:15Z
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 NOGUEIRA, Denise Christie Souto et al. A phase IV, prospective, observational study of the clinical safety of snake antivenoms. Rev Inst Med Trop Sao Paulo, v. 63, e79, 2021. doi: 10.1590/S1678-9946202163079.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/53463
dc.identifier.issn.pt_BR.fl_str_mv 0036-4665
dc.identifier.doi.none.fl_str_mv 10.1590/S1678-9946202163079
identifier_str_mv NOGUEIRA, Denise Christie Souto et al. A phase IV, prospective, observational study of the clinical safety of snake antivenoms. Rev Inst Med Trop Sao Paulo, v. 63, e79, 2021. doi: 10.1590/S1678-9946202163079.
0036-4665
10.1590/S1678-9946202163079
url https://www.arca.fiocruz.br/handle/icict/53463
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 Instituto de Medicina Tropical de São Paulo
publisher.none.fl_str_mv Instituto de Medicina Tropical de São Paulo
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/53463/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/53463/2/A%20phase%20IV%2c%20prospective%2c%20observational%20study%20of%20the%20clinical%20safety%20of%20snake%20antivenoms.pdf
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
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