Comparison of the clinical efficiacy of azithromycin and cerufoxime axetile in the treatment of patients with acute otitis media

Abstract

This study was prospectively planned to compare the efficiacy of azithromycin which is a new antibacterial agent and cefuroxine axetile which is commonly used second-generation cephalosporin for the treatment of acute otitis media. Patients diagnosed with acute otitis media received three days of azithromycin (10 mg/kg/day in children, 500 mg/day in adults in single daily dose) or ten days of cefuroxime axetile (40 mg/kg/day in children, 500 mg/day in two divided doses). Clinical efficiacy was evaluated at the beginning and on days 4-6, 10-14 and 30 of the treatment. Microbiologic assessments were performed in patients provided informed consent. Fifty-six patients were enrolled in the study. Thirty-one patients received azithromycin and twenty-five cefuroxime axetile. There were no significant differences in symptoms and signs between the patient groups with acute otitis media (p>0.05). Microbiologic assessments were performed in thirty- seven ear samples and the primary pathogen was found to be Streptococcus pneumoniae. Four patients in azithromycin-treated group and three patients in cefuroxime axetile-treated group were excluded for lack of efficiacy. Moreover, nine patients in each group were excluded for inadequate follow- up; thus, the study which was started with fifty-six patients could be finished with thirty patients. Satisfactory clinical outcome observed in 82% of azithromycin-treated group and in 81% of cefuroxime axetile-treated group. The gastrointestinal complaints were the most common side effects. No patient discontinued treatment because of adverse events. Statistically significant difference between clinical responses in azithromycin-treated and in cefuroxime axetile-treated groups was not found. Compliance was better in azithromycin-treated patients than in cefuroxime axetile-treated patients.