A phase IV, prospective, observational study of the clinical safety of snake antivenoms
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) |
DOI: | 10.1590/S1678-9946202163079 |
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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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 |
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eng |
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eng |
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info:eu-repo/semantics/openAccess |
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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 |
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reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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