[Double-blind comparative trial of cefroxadine and cephalexin in the treatment of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media]

Abstract

A double-blind controlled trial of cefroxadine (CXD) 250 mg t.i.d. was undertaken to objectively evaluate its safety and effectiveness in the treatment of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media, using cephalexin (CEX) 250 mg q.i.d. as a control drug, and the following results were obtained. In the treatment of acute suppurative otitis media, the 2 drugs produced almost equal outcomes, showing no significant difference in assessments of both overall effects and usefulness. In the treatment of acute exacerbation of chronic suppurative otitis media, the 2 drugs exhibited no significant difference as well in overall effects by Wilcoxon's two-sample test. However, the CEX group had significantly more nonresponsive patients, i.e. 35.5% as compared with 9.7% of the CXD group (chi 2-test, P less than 0.05). In the assessment of clinical usefulness as well, no significant difference was observed between the 2 groups. In the assessment of overall effects based on the patients whose isolated organisms were sensitive to the drugs, CEX group had more patients not responding to the treatment of acute exacerbation of chronic suppurative otitis media (chi 2-test, P less than 0.05). Bacteriological effects were not significantly different between the 2 drugs in both acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media. Overall safety rating was not significantly different between the 2 drugs. Side effects occurred as the symptoms of digestive organ in 2 patients each in both groups (equally an incidence of 2.6%). As for the improvement of each symptom after treatment (assessed on day 3), CXD was superior in the improvement rate of otorrhea volume as the main symptom of acute exacerbation of chronic suppurative otitis media, while CEX was superior in that of otoobstruction feeling. From the above findings, it is presumed that CXD is a safe drug which can exhibit equal or superior therapeutic effects to CEX in the treatment of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media, at 3/4 of the CEX dose level.