A Comparative Double Blind Study of 56472 (Prolonged Action Preparation of Cefaclor) with Cefaclor in Acute Suppurative Otitis Media and Acute Exacerbation of Chronic Suppurative Otitis Media

Abstract

The efficacy, safety and utility of S6472 750mg/day (in 2 divided doses) were compared with those of Cefaclor (CCL) 750mg/day (in 3 divided doses) in a double-blind. study in the treatment of 242 patients with acute suppurative otitis media or acute exacerbation of chronic suppurative otitis media. 1. In the evaluation of clinical efficacy by the doctors in charge, the efficacy rate was 58.9% for the S6472 group and 55.4% for the CCL group. In evaluation on the basis of the criteria set by the committee, the efficacy rate was 56.1% for the S6472 group and 59.4% for the CCL group. In neither evaluation, was there a significant difference between the two groups. 2. The bacteriological response (elimination rate) was 71.3% in the S6472 group and 60.2% in the CCL group. There was no significant difference between the two groups. 3. Side effects occurred in 4 (3.4%) of 116 cases in the S6472 group and 1 (0.9%) of 115 cases in the CCL group. Drug related aggravation of the laboratory test were observed in 1 case in the S6472 group and 2 cases in the CCL group. There was no significant difference between the two groups. 4. In utility evaluation, the acceptability rate covering “satisfactory” and “very satisfactory” was 58.9% for the S6472 group and 53.9% for the CCL group. There was no significant difference between the two groups. These results indicate 750 mg/day of S6472 in 2 divided doses has the same effectiveness, safety and utility as 750 mg/day of CCL in 3 divided doses for the treatment of suppurative otitis media.