化膿性中耳炎に対するCS-807の臨床評価

Cefaclorを対照とする二重盲検群間比較試験

抄録

To evaluate the effectiveness and safety of the new drug oral cephem CS-807 for suppurative otitis media, a double-blind comparative study was carried out in 229 adult patients, using cefaclor (CCL) as a control drug. CS-807 and CCL were administered in a daily dose of 100 mg b. i. d. and of 250 mg t. i. d., respectively. 1. Improvement rates in clinical efficacy judged by physicians in charge were 71.2% for CS-807 and 65.5% for CCL; there was no significant difference between the two groups. 2. As for bacteriological efficacy. the elmination rate in acute exacerbation of chronic suppurative otitis media was found to be significantly higher in the CS-807 group (80.8%) than in CCL (58.3%). 3. As for causative organisms, clinical efficacy for cases isolating S. aureus was found in 71.4% for CS-807 and in 70.6% for CCL, and the overall efficacy rate was 67.4% for CS-807 and 70.3% for CCL. 4. As for improvement of symptoms, otorrhea was significantly decreased in CS-807 at day 7 ; swelling of the tympanic membrane at day 7 tended to be more reduced in CS-807 than CCL. 5. Side effects were observed in 6 cases each in the CS-807 and CCL groups. Abnormal laboratory findings were noted in one case in the CS-807 group. These results indicate that CS-807 100 mg b. i. d. is useful oral antibiotic for the treatment of suppurative otitis media.