Efetividade e segurança da budesonida nebulizada no controle da crise aguda de sibilância em crianças menores de três anos não responsivas ao fenoterol
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Data
2007-04-25
Autores
Silva, Margarete Lopes da [UNESP]
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Universidade Estadual Paulista (Unesp)
Resumo
Objetivos: Investigar a eficácia e segurança da budesonida comparada à prednisona na crise aguda de sibilância. Métodos: Estudo prospectivo, duplo-cego, randomizado comparou a budesonida nebulizada (2mg diários com redução gradual para 0,5mg, n=30, grupo A) com a prednisona (n= 30, grupo B) e placebo (n=15, grupo C) durante sete dias, envolvendo crianças de 40 dias a 36 meses em Santo André, SP, Brasil. Os critérios de inclusão foram: crianças nutridas, sem uso de corticosteróide, hospitalizadas por crise aguda grave de sibilância. Escore clínico foi mensurado nos períodos: 20, 40, 60 e 90 minutos, 2,4,6,12,24 horas e, após diariamente por uma semana. A função adrenal foi avaliada por dosagem de cortisol salivar nos dias de acompanhamento 3,5,7,10 e 15. Saliva foi coletada pela manhã e tarde. Cortisol foi dosado por radioimunoensaio com anticorpo anticortisol- 3-oxima albumina bovina. Resultados: Budesonida proporcionou melhora clínica mais rápida do que prednisona ou placebo nas primeiras 24h do tratamento (A 56 e B 282, p= 0,0000, Mann Whitney) (C 434 minutos). O percentil de interrupção por piora clínica foi: A: 3,3, B: 43, C: 40. Todos os grupos exibiram concentração de cortisol salivar mais alta de manhã do que tarde. Grupo A mostrou diminuição da dosagem vespertina no 10º dia de acompanhamento (p< 0,0001). Conclusão: Budesonida nebulizada proporcionou efeitos benéficos mais precocemente (1h) em exacerbações graves de broncoespasmo, sem alterar o ritmo circadaino.
Background: Inhaled steroids are an effective and recommended prophylactic treatment for moderate to severe asthma, but in acute exacerbations are not advocated as conventional therapy. Objectives: To investigate the efficacy of budesonide as compared to prednisone in severe acute wheezing.Methods: In prospective, double-blind, randomized study nebulized budesonide (2mg with gradual reduce to 0,5mg, n= 30, group A) was compared with oral prednisone (n= 30, group B) and placebo (n= 15, group C) during seven days, enrolling children aged 40 days to 36 months in Santo André, SP, Brazil. Inclusion criteria were: well-nourished, free from corticosteroid use and hospitalized for severe acute wheezing. Index score clinical was measured in the periods: 20, 40, 60 and 90 minutes; 2,4,6,12,24 h and then daily for a week. The adrenal function was availably for cortisol salivary dosage in the 3,5,7,10 and 15 days of treatment. Saliva was collected in the morning and afternoon. Cortisol was radioimmunoassayed with cortisol 3- oxime-bovine albumin antiserum. Results: Budesonide displayed a faster clinical improvement compared with prednisone or placebo into 24h of treatment (A 56 and B 282 minutes, p < 0,0000). The percentile of interruption by worse clinical was: A 3.3; B 43; C 40. All groups exhibited higher cortisol concentration during the morning than afternoon (p < 0.0001). Group A showed lower afternoon value in the 10th day (p < 0,001). Conclusion: nebulized budesonide brings early beneficial effects (1h) in severe acute exacerbations of wheezing without adrenal suppression, without changing the circadian rhythm.
Background: Inhaled steroids are an effective and recommended prophylactic treatment for moderate to severe asthma, but in acute exacerbations are not advocated as conventional therapy. Objectives: To investigate the efficacy of budesonide as compared to prednisone in severe acute wheezing.Methods: In prospective, double-blind, randomized study nebulized budesonide (2mg with gradual reduce to 0,5mg, n= 30, group A) was compared with oral prednisone (n= 30, group B) and placebo (n= 15, group C) during seven days, enrolling children aged 40 days to 36 months in Santo André, SP, Brazil. Inclusion criteria were: well-nourished, free from corticosteroid use and hospitalized for severe acute wheezing. Index score clinical was measured in the periods: 20, 40, 60 and 90 minutes; 2,4,6,12,24 h and then daily for a week. The adrenal function was availably for cortisol salivary dosage in the 3,5,7,10 and 15 days of treatment. Saliva was collected in the morning and afternoon. Cortisol was radioimmunoassayed with cortisol 3- oxime-bovine albumin antiserum. Results: Budesonide displayed a faster clinical improvement compared with prednisone or placebo into 24h of treatment (A 56 and B 282 minutes, p < 0,0000). The percentile of interruption by worse clinical was: A 3.3; B 43; C 40. All groups exhibited higher cortisol concentration during the morning than afternoon (p < 0.0001). Group A showed lower afternoon value in the 10th day (p < 0,001). Conclusion: nebulized budesonide brings early beneficial effects (1h) in severe acute exacerbations of wheezing without adrenal suppression, without changing the circadian rhythm.
Descrição
Palavras-chave
Asma em crianças - Tratamento, Esteroides - Efeitos fisiológicos, Budesonide, Status asmhaticus
Como citar
SILVA, Margarete Lopes da. Efetividade e segurança da budesonida nebulizada no controle da crise aguda de sibilância em crianças menores de três anos não responsivas ao fenoterol. 2007. 152 f. Tese (doutorado) - Universidade Estadual Paulista, Faculdade de Medicina de Botucatu, 2007.