[Efficacy and safety of cefprozil versus cefaclor in the treatment of acute otitis media in pediatric patients]

OBJECTIVE: To evaluate the efficacy and safety of two oral cephalosporins, cefprozil and cefaclor, in the treatment of acute otitis media in children.METHODS: Forty children with clinical diagnosis of acute otitis media were randomized in two groups. Twenty-one children were given cefprozil at the dose of 30/mg/kg/day, in two equally divided doses every twelve hours, for ten days. Nineteen children were given cefaclor at the dose of 40/mg/kg/day in three divided doses every eight hours, for ten days. Efficacy evaluation of the antibiotic was analyzed by the presence or absence of symptoms, fever and otoscopic abnormalities while the safety and tolerability were evaluated by spontaneous information for possible adverse events.RESULTS: There was a significant decrease in the number of observed alterations between days 3 and 5 of treatment among those of the cefprozil group in comparison to the cefaclor group, while between days 10 and 14 of treatment the observed cure rate was clinically similar in both groups. Both medications presented adequate safety profiles. Only three children receiving cefprozil presented mild adverse events, such as nausea and vomit, none of which required treatment interruption.CONCLUSIONS: The clinical efficacy of both cephalosporins was similar although a more rapid activity was observed for cefprozil between days 3 and 5 of treatment. The favorable clinical results, the low incidence of adverse events and the twice a day dose regimen suggest that cefprozil is one more antimicrobial of choice for the treatment of acute otitis media in children, when this therapeutic is indicated.