RESUMO
OBJECTIVE: To assess the optimum duration of topical ofloxacin therapy for chronic otitis media and to compare the response between patients with chronic suppurative otitis media (CSOM) and acute exacerbation of chronic otitis media (AE). STUDY DESIGN: Prospective observational study. SETTING: Five university hospitals and 30 affiliated institutions. PATIENTS: A total of 294 patients who presented to the participating institutions with CSOM were enrolled. Among them, 268 patients were evaluable for safety and 237 were evaluable for efficacy (64 with CSOM and 173 with AE . INTERVENTION: Ofloxacin otic solution was administered for as long as 4 weeks. MAIN OUTCOME MEASURES: Clinical and bacteriologic assessment was done weekly during the treatment period. The clinical response was assessed on the basis of the symptom scores. RESULTS: There were no differences between CSOM and AE patients with respect to sex, age, and severity. The most common bacterial isolate from middle ear discharge was Staphylococcus aureus. The clinical response rates in patients with CSOM and AE were 39.1% and 61.3% after 2 weeks of treatment and 57.8% and 75.1% after 4 weeks, respectively, and the bacterial eradication rate was 91.0% at 2 weeks and 94.6% at 4 weeks. Detection of new fungal infection did not increase as the duration of therapy was prolonged. No serious adverse events were reported. CONCLUSIONS: The duration of treatment was shorter and the clinical response was higher in AE patients than in CSOM patients. The standard topical ofloxacin regimen for chronic otitis media should consist of a 2-week course from the aspect of bacteriologic efficacy, although patients showing insufficient symptomatic improvement after 2 weeks may benefit from another 1 or 2 weeks of therapy. Administration of this drug for as long as 4 weeks can increase the clinical efficacy without causing safety problems.