Análise de reações adversas a antimicrobianos em crianças hospitalizadas

Detalhes bibliográficos
Ano de defesa: 2023
Autor(a) principal: Ramos, Sheila Feitosa
Orientador(a): Junior, Divaldo Pereira de Lyra
Banca de defesa: Não Informado pela instituição
Tipo de documento: Tese
Tipo de acesso: Acesso aberto
Idioma: por
Instituição de defesa: Não Informado pela instituição
Programa de Pós-Graduação: Pós-Graduação em Ciências da Saúde
Departamento: Não Informado pela instituição
País: Não Informado pela instituição
Palavras-chave em Português:
Palavras-chave em Inglês:
Link de acesso: https://ri.ufs.br/jspui/handle/riufs/23400
Resumo: Introduction. Adverse drug reactions (ADRs) especially affect hospitalized children and contribute to increased morbidity, mortality, length of stay, and costs for health systems. Antimicrobials are often involved in these reactions due to the frequency and consequences of their use. Thus, investigating ADRs related to antimicrobials in children can help to improve understanding of the factors involved, as well as help in the development of appropriate strategies to contribute to the safety of these patients. Aim. To analyze ADRs to antimicrobials in hospitalized children. Methods. The study was carried out in two stages. In step 01, a prospective multicenter cohort study was carried out in 5 public hospitals for 6 months. Children aged 0 to 11 years and 11 months who remained hospitalized for more than 48 hours and used prescribed antimicrobials for more than 24 hours were included. To analyze the causality and preventability of ADRs, the validated Portuguese versions of the Liverpool causality and preventability tools were used. This study was approved by the Human Research Ethics Committee (CEP: SE:2,801,684; CE:3,027,780; RJ:3,264,238; DF:4,273,903; RGS: 3,782,762). Results. In stage 01, a total of 1,020 patients met the inclusion criteria. Of these, 152 patients had 183 suspected ADRs. The majority of reactions were related to the gastrointestinal system (65.6%), followed by skin reactions (18.6%). Regarding causality, severity and preventability, the majority were classified as probable (58.5%), moderate (61.1%) and inevitable (56.2%), respectively. Our findings showed that ADRs were associated with increased length of stay (P < 0.001), increased time on therapy (P < 0.015), increased days of therapy (P = 0.038) and increased number of antimicrobials prescribed per patient (P < 0.001). In relation to stage 02, 30 articles met the inclusion criteria. Skin reactions were the main serious clinical manifestations presented in most articles 19/30, with emphasis on erythema multiforme (71 cases), Stevens-Johnson syndrome (72 cases) and toxic epidermal necrolysis (22 cases). The main classes of antimicrobials involved in moderate and severe ADRs were penicillins, cephalosporins and sulfonamides. Regarding the main outcomes found, 30% (9/30) of the articles mentioned at least one death and 46.7% (14/30) of the studies reported an increase in hospitalization time, the need for intensive therapy and/or transfer to another hospital. Regarding the main interventions, 10% (3/30) of the articles mentioned greater monitoring, suspension, medication replacement or prescription of specific medication for the symptomatology. Conclusion. The incidence of ADR in hospitalized children exposed to antimicrobials was 14.9%. Its occurrence was classified as probable, moderate in severity and inevitable. ADRs were significantly influenced by length of stay and the number of antimicrobials prescribed per patient. In the systematic review, the majority of moderate and severe ADRs were cutaneous reactions with an emphasis on erythema multiforme, Stevens- Johnson syndrome and toxic epidermal necrolysis. The main classes involved were penicillins, cephalosporins and sulfonamides, and in relation to antimicrobials, the highest number of ADRs was reported for vancomycin, amoxicillin and amoxicillin with clavulanate. 30% of articles reported at least one death related to a moderate or severe ADR caused by antimicrobials.
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spelling Ramos, Sheila FeitosaJunior, Divaldo Pereira de LyraLima, Elisângela Costa2025-10-09T13:28:37Z2025-10-09T13:28:37Z2023RAMOS, Sheila Feitosa. Análise de reações adversas a antimicrobianos em crianças hospitalizadas. 2023. 193f. Tese (Doutorado em Ciências da Saúde) – Universidade Federal de Sergipe, Aracaju, 2023.https://ri.ufs.br/jspui/handle/riufs/23400Introduction. Adverse drug reactions (ADRs) especially affect hospitalized children and contribute to increased morbidity, mortality, length of stay, and costs for health systems. Antimicrobials are often involved in these reactions due to the frequency and consequences of their use. Thus, investigating ADRs related to antimicrobials in children can help to improve understanding of the factors involved, as well as help in the development of appropriate strategies to contribute to the safety of these patients. Aim. To analyze ADRs to antimicrobials in hospitalized children. Methods. The study was carried out in two stages. In step 01, a prospective multicenter cohort study was carried out in 5 public hospitals for 6 months. Children aged 0 to 11 years and 11 months who remained hospitalized for more than 48 hours and used prescribed antimicrobials for more than 24 hours were included. To analyze the causality and preventability of ADRs, the validated Portuguese versions of the Liverpool causality and preventability tools were used. This study was approved by the Human Research Ethics Committee (CEP: SE:2,801,684; CE:3,027,780; RJ:3,264,238; DF:4,273,903; RGS: 3,782,762). Results. In stage 01, a total of 1,020 patients met the inclusion criteria. Of these, 152 patients had 183 suspected ADRs. The majority of reactions were related to the gastrointestinal system (65.6%), followed by skin reactions (18.6%). Regarding causality, severity and preventability, the majority were classified as probable (58.5%), moderate (61.1%) and inevitable (56.2%), respectively. Our findings showed that ADRs were associated with increased length of stay (P < 0.001), increased time on therapy (P < 0.015), increased days of therapy (P = 0.038) and increased number of antimicrobials prescribed per patient (P < 0.001). In relation to stage 02, 30 articles met the inclusion criteria. Skin reactions were the main serious clinical manifestations presented in most articles 19/30, with emphasis on erythema multiforme (71 cases), Stevens-Johnson syndrome (72 cases) and toxic epidermal necrolysis (22 cases). The main classes of antimicrobials involved in moderate and severe ADRs were penicillins, cephalosporins and sulfonamides. Regarding the main outcomes found, 30% (9/30) of the articles mentioned at least one death and 46.7% (14/30) of the studies reported an increase in hospitalization time, the need for intensive therapy and/or transfer to another hospital. Regarding the main interventions, 10% (3/30) of the articles mentioned greater monitoring, suspension, medication replacement or prescription of specific medication for the symptomatology. Conclusion. The incidence of ADR in hospitalized children exposed to antimicrobials was 14.9%. Its occurrence was classified as probable, moderate in severity and inevitable. ADRs were significantly influenced by length of stay and the number of antimicrobials prescribed per patient. In the systematic review, the majority of moderate and severe ADRs were cutaneous reactions with an emphasis on erythema multiforme, Stevens- Johnson syndrome and toxic epidermal necrolysis. The main classes involved were penicillins, cephalosporins and sulfonamides, and in relation to antimicrobials, the highest number of ADRs was reported for vancomycin, amoxicillin and amoxicillin with clavulanate. 30% of articles reported at least one death related to a moderate or severe ADR caused by antimicrobials.Introdução. As reações adversas medicamentosas (RAM) afetam especialmente as crianças hospitalizadas e contribuem para o aumento morbidade, mortalidade, tempo de internação e custos para os sistemas de saúde. Os antimicrobianos são frequentemente envolvidos nessas reações devido à frequência e às consequências de seu uso. Desse modo, investigar as RAM relacionadas aos antimicrobianos em crianças pode contribuir para melhorar o entendimento sobre os fatores envolvidos, bem como auxiliar na elaboração de estratégias apropriadas para contribuir com a segurança desses pacientes. Objetivo. Analisar RAM a antimicrobianos em crianças hospitalizadas. Métodos. O estudo foi realizado em duas etapas. Na etapa 01 foi realizado um estudo de coorte multicêntrico prospectivo em 5 hospitais públicos durante 6 meses. Crianças de 0 a 11 anos e 11 meses que permaneceram internados por mais de 48 horas e usavam antimicrobianos prescritos por mais de 24 horas foram incluídas. Para analisar a causalidade e evitabilidade das RAM foram utilizadas as versões validadas para o português das ferramentas de causalidade e evitabilidade de Liverpool. Este estudo foi aprovado pelo comitê de ética e pesquisa com seres humanos (CEP: SE:2.801.684; CE:3.027.780; RJ:3.264.238; DF:4.273.903; RGS: 3.782.762). Na etapa 02 foi realizada uma revisão sistemática da literatura para identificar o perfil das RAM moderadas e graves aos antimicrobianos em crianças hospitalizadas. A estratégia de busca foi realizada nas bases Pubmed, Cochrane, Embase, Web of Science, Scopus, Lilacs e Cinahl em abril de 2023. Resultados. Na etapa 01, um total de 1.020 pacientes preencheram os critérios de inclusão. Destes, 152 pacientes tiveram 183 suspeitas de RAM. A maioria das reações foram relacionados ao sistema gastrointestinal (65,6%), seguido de reações cutâneas (18,6%). Em relação a causalidade, gravidade e evitabilidade, a maioria foi classificada como provável (58,5%), moderada (61,1%) e inevitável (56,2%), respectivamente. Nossos achados mostraram que as RAM foram associadas com aumento do tempo de internação (P < 0,001), aumento do tempo de terapia (P < 0,015), aumento dos dias de terapia (P = 0,038) e aumento do número de antimicrobianos prescritos por paciente (P < 0,001). Em relação a etapa 02, 30 artigos atenderam aos critérios de inclusão. As reações cutâneas foram as principais manifestações clínicas graves apresentadas na maioria dos artigos 19/30, com destaque para o eritema multiforme (71 casos), síndrome de Stevens-Johnson (72 casos) e necrólise epidérmica tóxica (22 casos). As principais classes de antimicrobianos envolvidas em RAM moderadas e graves foram penicilinas, cefalosporinas e sulfonamidas. Quanto aos principais desfechos encontrados, 30% (9/30) dos artigos mencionaram pelo menos um óbito e 46,7% (14/30) dos estudos relataram aumento do tempo de internação, necessidade de terapia intensiva e/ou transferência para outro hospital. Em relação às principais intervenções, 10% (3/30) dos artigos mencionaram maior monitoramento, suspensão, substituição medicamentosa ou prescrição de medicamento específico para a sintomatologia. Conclusão. A incidência de RAM em crianças hospitalizadas expostas a antimicrobianos foi de 14,9%. Sua ocorrência foi classificada como prováveis, de gravidade moderada e inevitáveis. As RAM foram significativamente influenciadas pelo tempo de internação e o número de antimicrobianos prescritos por paciente. Na revisão sistemática, a maioria das RAM moderadas e graves foram reações cutâneas com ênfase para eritema multiforme, síndrome de Stevens-Johnson e necrólise epidérmica tóxica. As principais classes envolvidas foram as penicilinas, cefalosporinas e sulfonamidas, e em relação aos antimicrobianos o maior número de RAM foi reportada para vancomicina, amoxicilina e amoxicilina com clavulanato. 30% dos artigos reportaram pelo menos uma morte relacionada a uma RAM moderada ou grave causada por antimicrobianos.AracajuporReação adversa a medicamentoAntimicrobianoCriançasHospitalAdverse drug reactionAntimicrobialChildrenHospitalAnálise de reações adversas a antimicrobianos em crianças hospitalizadasinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisPós-Graduação em Ciências da SaúdeUniversidade Federal de Sergipereponame:Repositório Institucional da UFSinstname:Universidade Federal de Sergipe (UFS)instacron:UFSinfo:eu-repo/semantics/openAccessLICENSElicense.txtlicense.txttext/plain; charset=utf-81475https://ri.ufs.br/jspui/bitstream/riufs/23400/1/license.txt098cbbf65c2c15e1fb2e49c5d306a44cMD51ORIGINALTese_Sheila_Feitosa_Ramos.pdfTese_Sheila_Feitosa_Ramos.pdfapplication/pdf3778127https://ri.ufs.br/jspui/bitstream/riufs/23400/2/Tese_Sheila_Feitosa_Ramos.pdfe4ecfc0c277e90cc0623233a8aed9865MD52riufs/234002025-10-09 10:28:42.262oai:oai:ri.ufs.br:repo_01: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Repositório InstitucionalPUBhttps://ri.ufs.br/oai/requestrepositorio@academico.ufs.bropendoar:2025-10-09T13:28:42Repositório Institucional da UFS - Universidade Federal de Sergipe (UFS)false
dc.title.pt_BR.fl_str_mv Análise de reações adversas a antimicrobianos em crianças hospitalizadas
title Análise de reações adversas a antimicrobianos em crianças hospitalizadas
spellingShingle Análise de reações adversas a antimicrobianos em crianças hospitalizadas
Ramos, Sheila Feitosa
Reação adversa a medicamento
Antimicrobiano
Crianças
Hospital
Adverse drug reaction
Antimicrobial
Children
Hospital
title_short Análise de reações adversas a antimicrobianos em crianças hospitalizadas
title_full Análise de reações adversas a antimicrobianos em crianças hospitalizadas
title_fullStr Análise de reações adversas a antimicrobianos em crianças hospitalizadas
title_full_unstemmed Análise de reações adversas a antimicrobianos em crianças hospitalizadas
title_sort Análise de reações adversas a antimicrobianos em crianças hospitalizadas
author Ramos, Sheila Feitosa
author_facet Ramos, Sheila Feitosa
author_role author
dc.contributor.author.fl_str_mv Ramos, Sheila Feitosa
dc.contributor.advisor1.fl_str_mv Junior, Divaldo Pereira de Lyra
dc.contributor.advisor-co1.fl_str_mv Lima, Elisângela Costa
contributor_str_mv Junior, Divaldo Pereira de Lyra
Lima, Elisângela Costa
dc.subject.por.fl_str_mv Reação adversa a medicamento
Antimicrobiano
Crianças
Hospital
topic Reação adversa a medicamento
Antimicrobiano
Crianças
Hospital
Adverse drug reaction
Antimicrobial
Children
Hospital
dc.subject.eng.fl_str_mv Adverse drug reaction
Antimicrobial
Children
Hospital
description Introduction. Adverse drug reactions (ADRs) especially affect hospitalized children and contribute to increased morbidity, mortality, length of stay, and costs for health systems. Antimicrobials are often involved in these reactions due to the frequency and consequences of their use. Thus, investigating ADRs related to antimicrobials in children can help to improve understanding of the factors involved, as well as help in the development of appropriate strategies to contribute to the safety of these patients. Aim. To analyze ADRs to antimicrobials in hospitalized children. Methods. The study was carried out in two stages. In step 01, a prospective multicenter cohort study was carried out in 5 public hospitals for 6 months. Children aged 0 to 11 years and 11 months who remained hospitalized for more than 48 hours and used prescribed antimicrobials for more than 24 hours were included. To analyze the causality and preventability of ADRs, the validated Portuguese versions of the Liverpool causality and preventability tools were used. This study was approved by the Human Research Ethics Committee (CEP: SE:2,801,684; CE:3,027,780; RJ:3,264,238; DF:4,273,903; RGS: 3,782,762). Results. In stage 01, a total of 1,020 patients met the inclusion criteria. Of these, 152 patients had 183 suspected ADRs. The majority of reactions were related to the gastrointestinal system (65.6%), followed by skin reactions (18.6%). Regarding causality, severity and preventability, the majority were classified as probable (58.5%), moderate (61.1%) and inevitable (56.2%), respectively. Our findings showed that ADRs were associated with increased length of stay (P < 0.001), increased time on therapy (P < 0.015), increased days of therapy (P = 0.038) and increased number of antimicrobials prescribed per patient (P < 0.001). In relation to stage 02, 30 articles met the inclusion criteria. Skin reactions were the main serious clinical manifestations presented in most articles 19/30, with emphasis on erythema multiforme (71 cases), Stevens-Johnson syndrome (72 cases) and toxic epidermal necrolysis (22 cases). The main classes of antimicrobials involved in moderate and severe ADRs were penicillins, cephalosporins and sulfonamides. Regarding the main outcomes found, 30% (9/30) of the articles mentioned at least one death and 46.7% (14/30) of the studies reported an increase in hospitalization time, the need for intensive therapy and/or transfer to another hospital. Regarding the main interventions, 10% (3/30) of the articles mentioned greater monitoring, suspension, medication replacement or prescription of specific medication for the symptomatology. Conclusion. The incidence of ADR in hospitalized children exposed to antimicrobials was 14.9%. Its occurrence was classified as probable, moderate in severity and inevitable. ADRs were significantly influenced by length of stay and the number of antimicrobials prescribed per patient. In the systematic review, the majority of moderate and severe ADRs were cutaneous reactions with an emphasis on erythema multiforme, Stevens- Johnson syndrome and toxic epidermal necrolysis. The main classes involved were penicillins, cephalosporins and sulfonamides, and in relation to antimicrobials, the highest number of ADRs was reported for vancomycin, amoxicillin and amoxicillin with clavulanate. 30% of articles reported at least one death related to a moderate or severe ADR caused by antimicrobials.
publishDate 2023
dc.date.issued.fl_str_mv 2023
dc.date.accessioned.fl_str_mv 2025-10-09T13:28:37Z
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identifier_str_mv RAMOS, Sheila Feitosa. Análise de reações adversas a antimicrobianos em crianças hospitalizadas. 2023. 193f. Tese (Doutorado em Ciências da Saúde) – Universidade Federal de Sergipe, Aracaju, 2023.
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