Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará

Detalhes bibliográficos
Ano de defesa: 2004
Autor(a) principal: Sousa, Mariana de Oliveira Brizeno de
Orientador(a): Fonteles , Marta Maria de França
Banca de defesa: Não Informado pela instituição
Tipo de documento: Dissertação
Tipo de acesso: Acesso aberto
Idioma: por
Instituição de defesa: Não Informado pela instituição
Programa de Pós-Graduação: Não Informado pela instituição
Departamento: Não Informado pela instituição
País: Não Informado pela instituição
Palavras-chave em Português:
Link de acesso: http://www.repositorio.ufc.br/handle/riufc/4237
Resumo: The large use of oxacillin in Brazilian hospitals and the ausence of scientific data confirming its safety, justify the necessity of carrying out well –structured studies, identifying the existence of possible triggering factors of the reactions. AIM: To study the use of oxacillin and the occurrence of adverse reactions in two different groups, identifying risk factors associated. METHODS: Children using oxacillin were monitorized from October 2000 to July 2001 in the Universitary Hospital Walter Cantídio (HUWC), as well as ones under treatment with oxacillin of block D from Children’s Hospital Albert Sabin in the period of July 2001 and March 2002 (FIRST STUDY). Also, patients under treatment with oxacillin from HUWC, during the period of July until October 2003, were followed up (SECOND STUDY). The follow-up was done through daily visits in the infirmary and analysis of medical records and prescriptions, being observed the clinical history, prescribed drugs, laboratorial exams, oxacillin use, adverse reaction reports related to oxacillin (AROx) and procedures done due to these AROx. The reactions were reported and classified according to causality and gravity (both studies) and hypersensitivity type (in the SECOND STUDY). Statistical tests were used promptly. RESULTS: FIRST STUDY: In 130 children monitorized were observed both a large oxacillin exposure in the masculine sex, being used the oxacillin average dose of 216,3mg/kg/day. The accumulative incidence (AI) of AROx was equal to 20,8%, of the total of 3352 patients-day monitorized (incidence density/ ID = 0,8). Of the 43 reactions reports, the most frequent reactions were fever (50%) and cutaneous rash (35,7%). The procedure more used in the case of occurrence of AROx was the suspension of oxacillin use (51,9%). The most of reactions presented causality and gravity as Probable (55,6%) and Moderate (92,6%), respectively. In addition, the average of exposure time to oxacillin and hospitalization time were significantly different between the groups of patients that presented AROx or no. The relative risk (RR) of oxacillin exposure by more than 14 days was 5,46 to AROx occurrence. SECOND STUDY: Of the 76 patients, 36,8% ones related to allergic antecedents. Of these, 72,5% were associated to use of drugs. Oxacillin was considered as first choice drug for treatment of 75% of patients. The association oxacillin plus ceftazidima was the most used (22%) during treatments. The average dose of oxacillin prescribed was 206mg/kg/day. The average time of treatment with oxacillin was 15 days. The ineffective therapeutic (21,1%) and occurrence of adverse reaction (15,8%) caused the suspension of this antibiotic. The permanence time in the hospital of patients was 32,4% (patients-day total: 2463; ID = 0,97). The most frequent reactions were the increase of transaminases (22,1%), fever (17%) and cutaneous rash (13,6%). The majority of reactions showed causality, gravity and hypersensitivity as Probable (44,1%), Moderate (66,1%) and type B (86,4%). The presence of AROx was frequent between patients with age equal or under 14 years old (P = 0,0159)/ RR = 2,22). The incidence of adverse reactions to other medicaments was higher in the AROx patient group (P = 0,0036)/ RR = 2,66). 34% of followed patients presented at least one drug related problem involving oxacillin (DRPOx). A total of 71 DRPOx was identified. Of these DRPOx, the detection of adverse reactions was predominant (33,8%). CONCLUSION: The careful use of oxacillin is recommended in paediatrics, with duration of treatment established promptly. The empirical and prolonged exposure of this drug should be avoided.
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spelling Sousa, Mariana de Oliveira Brizeno deFonteles , Marta Maria de França2012-12-20T12:47:55Z2012-12-20T12:47:55Z2004SOUZA, M. O. B. Monitorização intensiva de reaões adversas a oxacilina em pacientes hospitalizados em Fortaleza-Ceará. 2004. 161 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal do Ceará. Faculdade de Farmácia, Odontologia e Enfermagem, Fortaleza, 2004.http://www.repositorio.ufc.br/handle/riufc/4237The large use of oxacillin in Brazilian hospitals and the ausence of scientific data confirming its safety, justify the necessity of carrying out well –structured studies, identifying the existence of possible triggering factors of the reactions. AIM: To study the use of oxacillin and the occurrence of adverse reactions in two different groups, identifying risk factors associated. METHODS: Children using oxacillin were monitorized from October 2000 to July 2001 in the Universitary Hospital Walter Cantídio (HUWC), as well as ones under treatment with oxacillin of block D from Children’s Hospital Albert Sabin in the period of July 2001 and March 2002 (FIRST STUDY). Also, patients under treatment with oxacillin from HUWC, during the period of July until October 2003, were followed up (SECOND STUDY). The follow-up was done through daily visits in the infirmary and analysis of medical records and prescriptions, being observed the clinical history, prescribed drugs, laboratorial exams, oxacillin use, adverse reaction reports related to oxacillin (AROx) and procedures done due to these AROx. The reactions were reported and classified according to causality and gravity (both studies) and hypersensitivity type (in the SECOND STUDY). Statistical tests were used promptly. RESULTS: FIRST STUDY: In 130 children monitorized were observed both a large oxacillin exposure in the masculine sex, being used the oxacillin average dose of 216,3mg/kg/day. The accumulative incidence (AI) of AROx was equal to 20,8%, of the total of 3352 patients-day monitorized (incidence density/ ID = 0,8). Of the 43 reactions reports, the most frequent reactions were fever (50%) and cutaneous rash (35,7%). The procedure more used in the case of occurrence of AROx was the suspension of oxacillin use (51,9%). The most of reactions presented causality and gravity as Probable (55,6%) and Moderate (92,6%), respectively. In addition, the average of exposure time to oxacillin and hospitalization time were significantly different between the groups of patients that presented AROx or no. The relative risk (RR) of oxacillin exposure by more than 14 days was 5,46 to AROx occurrence. SECOND STUDY: Of the 76 patients, 36,8% ones related to allergic antecedents. Of these, 72,5% were associated to use of drugs. Oxacillin was considered as first choice drug for treatment of 75% of patients. The association oxacillin plus ceftazidima was the most used (22%) during treatments. The average dose of oxacillin prescribed was 206mg/kg/day. The average time of treatment with oxacillin was 15 days. The ineffective therapeutic (21,1%) and occurrence of adverse reaction (15,8%) caused the suspension of this antibiotic. The permanence time in the hospital of patients was 32,4% (patients-day total: 2463; ID = 0,97). The most frequent reactions were the increase of transaminases (22,1%), fever (17%) and cutaneous rash (13,6%). The majority of reactions showed causality, gravity and hypersensitivity as Probable (44,1%), Moderate (66,1%) and type B (86,4%). The presence of AROx was frequent between patients with age equal or under 14 years old (P = 0,0159)/ RR = 2,22). The incidence of adverse reactions to other medicaments was higher in the AROx patient group (P = 0,0036)/ RR = 2,66). 34% of followed patients presented at least one drug related problem involving oxacillin (DRPOx). A total of 71 DRPOx was identified. Of these DRPOx, the detection of adverse reactions was predominant (33,8%). CONCLUSION: The careful use of oxacillin is recommended in paediatrics, with duration of treatment established promptly. The empirical and prolonged exposure of this drug should be avoided.O elevado grau de utilização da oxacilina nos hospitais do Brasil e a inexistência de dados científicos que comprovem sua segurança justificam a necessidade da realização de estudos bem planejados que visem testar a existência de fatores desencadeantes das reações. OBJETIVOS: Estudar a utilização da oxacilina e a ocorrência de reações adversas em duas populações distintas, apontando fatores de risco associados. METODOLOGIA: Foram acompanhadas crianças expostas à oxacilina no Hospital Universitário Walter Cantídio (HUWC), entre outubro/2000 e julho/2001, e no bloco D do Hospital Infantil Albert Sabin, entre julho/2001 e março/2002 (PRIMEIRO ESTUDO); e também, os pacientes adultos e as crianças expostos à oxacilina no HUWC, no período de julho a outubro de 2003 (SEGUNDO ESTUDO). O seguimento de pacientes foi feito através de visitas diárias às enfermarias, análise de prontuários e prescrições, sendo observada a história clinica, medicamentos prescritos, resultados de exames laboratoriais, perfil de utilização da oxacilina, ocorrência de reação adversa à oxacilina (RAOx) e procedimentos adotados devido à RAOx. Os casos foram notificados e classificados quanto à causalidade e gravidade (nos dois estudos) e quanto ao tipo de hipersensibilidade (no segundo estudo), sendo realizados testes estatísticos pertinentes. RESULTADOS: PRIMEIRO ESTUDO: A amostra foi composta por 130 crianças, sendo observada uma maior exposição do sexo masculino (56,9%) e uma dose média de oxacilina utilizada, equivalente a 216,3 mg/kg/dia. A incidência acumulada (IA) de RAOx foi igual a 20,8%, para um total de 3352 pacientes/dia acompanhados (densidade de incidência/ DI = 0,8). De 43 reações relatadas, as mais freqüentes foram febre (50%) e rash cutâneo (35,7%), A conduta mais utilizada na ocorrência de RAOx foi a suspensão do uso da oxacilina (51,9%). A maioria das reações tiveram causalidade Provável (55,6%) e gravidade Moderada (92,6%). As médias do tempo de exposição à oxacilina e do tempo de internamento, diferiram significantemente entre os grupos de pacientes com e sem RAOx. O risco relativo (RR) da exposição à oxacilina por mais de 14 dias foi de 5,46 para a ocorrência de RAOx. SEGUNDO ESTUDO: Dos 76 pacientes monitorizados, 36,8% referiram antecedentes alérgicos, dos quais 72,5% foram atribuídos ao uso de medicamentos. A oxacilina foi primeira escolha para o tratamento de 75% dos pacientes monitorizados e a ceftazidima, a associação mais utilizada (22%). A dose média prescrita de oxacilina foi de 206mg/kg/dia e o tempo médio de exposição, igual a 15 dias. A ineficácia terapêutica e a ocorrência de reação adversa, foram os causadores da suspensão do tratamento com oxacilina em 21,1% e 15,8% dos casos, respectivamente. O tempo de internação dos pacientes foi em média 32,4 dias. Observou-se uma IA de RAOx igual a 31,6%, para um total de 2463 pacientes-dia monitorizados (DI = 0,97). As reações mais freqüentes foram: aumento de transaminases (22,1%), febre (17,0%) e rash cutâneo (13,6%). A maioria das reações foi considerada de causalidade Provável (44,1%), gravidade Moderada (66,1%) e hipersensibilidade do tipo B (86,4%). A ocorrência de RAOx foi mais freqüente entre os pacientes com idade igual ou menor que 14 anos (P = 0,0159/ RR = 2,22) e a incidência de reação adversa a outros medicamentos, foi maior no grupo de pacientes com RAOx (P = 0,0036/ RR = 2,66). Cerca de 34% dos pacientes monitorizados apresentaram pelo menos 01 problema relacionado com medicamento envolvendo a oxacilina (PRMOx), sendo identificado um total de 71 PRMOx, dos quais a ocorrência de reação adversa foi o mais freqüente (33,8%). CONCLUSÃO: Recomenda-se a administração cautelosa de oxacilina em crianças, com duração do tratamento estabelecida, evitando-se tratamento empírico e uso prolongado.Monitorização FisiológicaFarmacoepidemiologiaOxacilinaMonitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-CearáIntensive Monitoring of Adverse Reaction Related to Oxacillin in Patients Hospitalized in Fortaleza - Cearáinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisporreponame:Repositório Institucional da Universidade Federal do Ceará (UFC)instname:Universidade Federal do Ceará (UFC)instacron:UFCinfo:eu-repo/semantics/openAccessLICENSElicense.txtlicense.txttext/plain; charset=utf-81748http://repositorio.ufc.br/bitstream/riufc/4237/2/license.txt8a4605be74aa9ea9d79846c1fba20a33MD52ORIGINAL2004_dis_mobsousa.pdf2004_dis_mobsousa.pdfapplication/pdf363720http://repositorio.ufc.br/bitstream/riufc/4237/1/2004_dis_mobsousa.pdf051a8cfa505d122c21965b85f62527eaMD51riufc/42372021-06-28 10:21:14.808oai:repositorio.ufc.br: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Repositório InstitucionalPUBhttp://www.repositorio.ufc.br/ri-oai/requestbu@ufc.br || repositorio@ufc.bropendoar:2021-06-28T13:21:14Repositório Institucional da Universidade Federal do Ceará (UFC) - Universidade Federal do Ceará (UFC)false
dc.title.pt_BR.fl_str_mv Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
dc.title.en.pt_BR.fl_str_mv Intensive Monitoring of Adverse Reaction Related to Oxacillin in Patients Hospitalized in Fortaleza - Ceará
title Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
spellingShingle Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
Sousa, Mariana de Oliveira Brizeno de
Monitorização Fisiológica
Farmacoepidemiologia
Oxacilina
title_short Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
title_full Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
title_fullStr Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
title_full_unstemmed Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
title_sort Monitorização intensiva de reação adversa a medicamentos em pacientes hospitalizadas em Fortaleza-Ceará
author Sousa, Mariana de Oliveira Brizeno de
author_facet Sousa, Mariana de Oliveira Brizeno de
author_role author
dc.contributor.author.fl_str_mv Sousa, Mariana de Oliveira Brizeno de
dc.contributor.advisor1.fl_str_mv Fonteles , Marta Maria de França
contributor_str_mv Fonteles , Marta Maria de França
dc.subject.por.fl_str_mv Monitorização Fisiológica
Farmacoepidemiologia
Oxacilina
topic Monitorização Fisiológica
Farmacoepidemiologia
Oxacilina
description The large use of oxacillin in Brazilian hospitals and the ausence of scientific data confirming its safety, justify the necessity of carrying out well –structured studies, identifying the existence of possible triggering factors of the reactions. AIM: To study the use of oxacillin and the occurrence of adverse reactions in two different groups, identifying risk factors associated. METHODS: Children using oxacillin were monitorized from October 2000 to July 2001 in the Universitary Hospital Walter Cantídio (HUWC), as well as ones under treatment with oxacillin of block D from Children’s Hospital Albert Sabin in the period of July 2001 and March 2002 (FIRST STUDY). Also, patients under treatment with oxacillin from HUWC, during the period of July until October 2003, were followed up (SECOND STUDY). The follow-up was done through daily visits in the infirmary and analysis of medical records and prescriptions, being observed the clinical history, prescribed drugs, laboratorial exams, oxacillin use, adverse reaction reports related to oxacillin (AROx) and procedures done due to these AROx. The reactions were reported and classified according to causality and gravity (both studies) and hypersensitivity type (in the SECOND STUDY). Statistical tests were used promptly. RESULTS: FIRST STUDY: In 130 children monitorized were observed both a large oxacillin exposure in the masculine sex, being used the oxacillin average dose of 216,3mg/kg/day. The accumulative incidence (AI) of AROx was equal to 20,8%, of the total of 3352 patients-day monitorized (incidence density/ ID = 0,8). Of the 43 reactions reports, the most frequent reactions were fever (50%) and cutaneous rash (35,7%). The procedure more used in the case of occurrence of AROx was the suspension of oxacillin use (51,9%). The most of reactions presented causality and gravity as Probable (55,6%) and Moderate (92,6%), respectively. In addition, the average of exposure time to oxacillin and hospitalization time were significantly different between the groups of patients that presented AROx or no. The relative risk (RR) of oxacillin exposure by more than 14 days was 5,46 to AROx occurrence. SECOND STUDY: Of the 76 patients, 36,8% ones related to allergic antecedents. Of these, 72,5% were associated to use of drugs. Oxacillin was considered as first choice drug for treatment of 75% of patients. The association oxacillin plus ceftazidima was the most used (22%) during treatments. The average dose of oxacillin prescribed was 206mg/kg/day. The average time of treatment with oxacillin was 15 days. The ineffective therapeutic (21,1%) and occurrence of adverse reaction (15,8%) caused the suspension of this antibiotic. The permanence time in the hospital of patients was 32,4% (patients-day total: 2463; ID = 0,97). The most frequent reactions were the increase of transaminases (22,1%), fever (17%) and cutaneous rash (13,6%). The majority of reactions showed causality, gravity and hypersensitivity as Probable (44,1%), Moderate (66,1%) and type B (86,4%). The presence of AROx was frequent between patients with age equal or under 14 years old (P = 0,0159)/ RR = 2,22). The incidence of adverse reactions to other medicaments was higher in the AROx patient group (P = 0,0036)/ RR = 2,66). 34% of followed patients presented at least one drug related problem involving oxacillin (DRPOx). A total of 71 DRPOx was identified. Of these DRPOx, the detection of adverse reactions was predominant (33,8%). CONCLUSION: The careful use of oxacillin is recommended in paediatrics, with duration of treatment established promptly. The empirical and prolonged exposure of this drug should be avoided.
publishDate 2004
dc.date.issued.fl_str_mv 2004
dc.date.accessioned.fl_str_mv 2012-12-20T12:47:55Z
dc.date.available.fl_str_mv 2012-12-20T12:47:55Z
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dc.identifier.citation.fl_str_mv SOUZA, M. O. B. Monitorização intensiva de reaões adversas a oxacilina em pacientes hospitalizados em Fortaleza-Ceará. 2004. 161 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal do Ceará. Faculdade de Farmácia, Odontologia e Enfermagem, Fortaleza, 2004.
dc.identifier.uri.fl_str_mv http://www.repositorio.ufc.br/handle/riufc/4237
identifier_str_mv SOUZA, M. O. B. Monitorização intensiva de reaões adversas a oxacilina em pacientes hospitalizados em Fortaleza-Ceará. 2004. 161 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal do Ceará. Faculdade de Farmácia, Odontologia e Enfermagem, Fortaleza, 2004.
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