RESUMO
INTRODUCTION: Acute respiratory infections are the second leading cause of morbidity in children under 18 years. Several drugs have been used with variable efficacy and safety, trying to reduce the associated symptoms and improve quality of life. OBJECTIVE: To evaluate the efficacy and safety of buphenine, aminophenazone and diphenylpyraline hydrochloride when compared with placebo for the control of symptoms associated with common cold in children 6-24 months of age. MATERIAL AND METHODS: Randomized clinical trial, double blind, placebo controlled, in 100 children < 24 months of any gender, with symptoms associated to common cold. They received the drug under study vs. placebo for seven days. Both groups received acetaminophen. The change on common cold related symptoms were evaluated. Statistic analysis was made with STATA 11.0 for Mac. RESULTS: Fifty-three children were randomized to study drug and forty-seven to placebo. Age of children in each group was similar (12.2 +/- 5.8 months vs. 12.7 +/- 5.8 months, p NS). There were significant differences between groups in relation to rhinorrea and sneezing resolution, with better results in Flumil group and no adverse events observed. CONCLUSIONS: The results in this study indicates that Flumil is a safe and effective drug for control of symptoms present in the common cold in children aged 6-24 months.
Assuntos
Aminopirina/uso terapêutico , Resfriado Comum/tratamento farmacológico , Nilidrina/uso terapêutico , Piperidinas/uso terapêutico , Acetaminofen/administração & dosagem , Acetaminofen/uso terapêutico , Aminopirina/administração & dosagem , Pré-Escolar , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Lactente , Masculino , Mucosa Nasal/metabolismo , Nilidrina/administração & dosagem , Piperidinas/administração & dosagem , Espirro/efeitos dos fármacosRESUMO
The aim of this randomized study was to compare the neonatal outcome in infants who have been exposed in utero to indomethacin with that in infants exposed to a beta-adrenergic agonist, nylidrin hydrochloride. Eighty pregnant women threatened with preterm labor between 24 and 34 weeks of gestation were enrolled in the study. An intravenous infusion of nylidrin or enterally administered indomethacin was given for a maximum of 72 hours. If preterm labor recurred, all parturient patients were treated with nylidrin. Indomethacin prolonged gestation significantly more than the beta-adrenergic agonist (6.6 weeks vs 4.5 weeks; p = 0.04). Ten of the forty-two infants exposed to indomethacin and 2 of the 45 infants exposed to nylidrin had bronchopulmonary dysplasia (24% vs 5%; p = 0.02). Among the 28 infants delivered within 120 hours after the start of treatment, the incidences of respiratory distress syndrome (82% vs 29%; p = 0.02), bronchopulmonary dysplasia (73% vs 6%; p = 0.0006), and necrotizing enterocolitis or focal intestinal perforation (27% vs 0%; p = 0.03) were higher among those exposed to indomethacin than among those exposed to nylidrin. We infer that administration of indomethacin to pregnant women threatened with premature labor is associated with an increased risk of bronchopulmonary dysplasia in their infants if delivery occurs early.