[Clinical efficacy and tolerability of short course therapy with cefaclor compared with long-term therapy for treatment of acute otitis media in children].

Clinical efficacy and tolerability of two different regimens of cefaclor were studied in 410 paediatric patients affected by non-recurrent acute otitis media (AOM). 204 patients were randomly treated with cefaclor given at the dosage of 50 mg/kg/die in two doses for 5 days; 206 patients with 40 mg/kg/die in two doses for 10 days. Diagnosis of acute otitis media was based on the following signs and symptoms: otalgia, fever, possible otorrhea, alterations of tympanic membrane under otoscopic examination. At the end of the treatment 95.5% of patients were cured after short-term therapy and 94.8% after long-term therapy. At the follow-up (two months after the interruption of treatment) 19 and 17 patients respectively had a recurrence. Side effects were observed in 6.9% and 8.7% of patients respectively (not statistically significant); they were mild, never requiring interruption of the treatment. Cefaclor therapy is very effective for treating children aged 2-6 years affected by acute otitis media, with no significant difference related to treatment duration. Short-course treatments appear better in terms of compliance and tolerability.