RESUMEN
OBJETIVO: Comparar os efeitos cardiovasculares e midriáticos da fenilefrina tópica nas concentrações de 2,5 e 10,0 por cento. MÉTODOS: Ensaio clínico do tipo caso controle, randomizado, com auto-emparelhamento. Foram monitoradas a freqüência cardíaca (FC), a pressão arterial (PA) e a midríase em voluntários sadios, com idade entre 18 e 45 anos, após a instilação da fenilefrina a 2,5 e a 10,0 por cento em duas ocasiões diferentes. RESULTADOS: A amostra foi constituída de 28 voluntários, sendo 17 do sexo masculino e 11 do sexo feminino, com a idade média de 26,5 anos. Não foi verificado nenhum padrão de mudanças com relação à freqüência cardíaca e à pressão arterial sistólica. Com relação à pressão arterial diastólica média dos indivíduos, não foi encontrada variação significativa após a instilação da fenilefrina a 2,5 por cento nos tempos de um, cinco, dez e 30 minutos, o que se revelou bem diferente quando do uso da fenilefrina a 10,0 por cento, com a qual houve aumento da pressão arterial diastólica média após cinco e dez minutos, e subseqüente queda após 30 minutos, porém sem significância estatística. A midríase foi maior com a fenilefrina a 10,0 por cento nos dois olhos, sendo a diferença estatisticamente significativa. CONCLUSÕES: Observou-se maior efeito midriático da fenilefrina a 10,0 por cento, quando comparada a 2,5 por cento, com significância estatística. Já com relação aos efeitos cardiovasculares não houve diferença estatística entre as duas concentrações.
PURPOSE: To compare the cardiovascular and mydriatic effects of 2.5 percent and 10.0 percent phenylephrine. METHODS: A case-control, randomized, crossover clinical trial study. We monitored heart rate (HR), blood pressure (BP) and mydriasis in healthy volunteers aged 18-45 years after the instillation of 2.5 percent and 10.0 percent phenylephrine in two different occasions. RESULTS: The sample comprised 28 healthy volunteers, 17 male and 11 female, with a mean age of 26.5 years. No changes in heart rate and systolic blood pressure were observed. No significant variation of the mean diastolic blood pressure was found after 1, 5, 10 and 30- minute instillation of 2.5 percent phenylephrine. However, with 10.0 percent phenylephrine, there was an increase in mean diastolic blood pressure after five and ten minutes, followed by a drop after 30 minutes, which was not statistically significant. Mydriasis was more marked in both eyes with a statistically significant difference after instillation of 10.0 percent phenylephrine. CONCLUSIONS: The mydriatic effect was greater with 10.0 percent phenylephrine than with 2.5 percent phenylephrine and the difference was statistically significant. No statistically significant difference was found in relation to cardiovascular effects in both phenylephrine concentrations.
Asunto(s)
Adolescente , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Frecuencia Cardíaca/efectos de los fármacos , Midriáticos/administración & dosificación , Fenilefrina/administración & dosificación , Pupila/efectos de los fármacos , Presión Sanguínea/efectos de los fármacos , Midriáticos/química , Midriáticos/farmacología , Estudios Prospectivos , Fenilefrina/química , Fenilefrina/farmacología , Pupila/fisiología , Estadísticas no Paramétricas , Factores de TiempoRESUMEN
PURPOSE: To compare the cardiovascular and mydriatic effects of 2.5% and 10.0% phenylephrine. METHODS: A case-control, randomized, crossover clinical trial study. We monitored heart rate (HR), blood pressure (BP) and mydriasis in healthy volunteers aged 18-45 years after the instillation of 2.5% and 10.0% phenylephrine in two different occasions. RESULTS: The sample comprised 28 healthy volunteers, 17 male and 11 female, with a mean age of 26.5 years. No changes in heart rate and systolic blood pressure were observed. No significant variation of the mean diastolic blood pressure was found after 1, 5, 10 and 30- minute instillation of 2.5% phenylephrine. However, with 10.0% phenylephrine, there was an increase in mean diastolic blood pressure after five and ten minutes, followed by a drop after 30 minutes, which was not statistically significant. Mydriasis was more marked in both eyes with a statistically significant difference after instillation of 10.0% phenylephrine. CONCLUSIONS: The mydriatic effect was greater with 10.0% phenylephrine than with 2.5% phenylephrine and the difference was statistically significant. No statistically significant difference was found in relation to cardiovascular effects in both phenylephrine concentrations.