化膿性中耳炎 (急性, 慢性の急性増悪, 慢性) に対するDL-8280の薬効評価

Pipemidic acidとの二重盲検試験法による比較検討

抄録

In order to evaluate the clinical efficacy and safety of DL-8280 on acute suppurative otitis media, acute exacerbation of chronic suppurative otitis media and chronic otitis media, a double-blind trial was carried out in comparison with pipemidic acid (PPA). Six hundred (600) mg of DL-8280 or 2000mg of PPA was administered daily for seven days and the following results were obtained. Clinical efficacy: 1) The clinical efficacy was able to be evaluated in 136 cases of DL-8280 group and 138 cases of PPA group. 2) When judged by the committee members, the overall efficacy rate (cases of excellent and good responses) was 57.3% in DL-8280 group and 49.3% in PPA group. A trend of higher efficacy rate was observed in DL-8280 group (P<0.10). The efficacy rate of DL-8280 group (80.5%) was superior to that of PPA group (60.7%) on the treatment of acute suppurative otitis media (P<0.05). 3) The clinical efficacy judged by the doctors in charge was similar to the evaluation by the committee members, however, no significant difference was observed between two groups. 4) Concerning the symptoms, the property of otorrhea was much improved by the treatment of DL-8280 (improvement rate 79.1%) than by the treatment with PPA (65.5%) on the last day of treatment (P<0.05). Bacteriological efficacy: The causative organisms isolated from the patients were eradicated in a higher rate in DL-8280 group (67.5%) than in PPA group (56.3%) in total patients (P<0.10). For the acute suppurative otitis media, the ratios of eradication were 87.5% and 64.3%, in DL-8280 group and PPA group, respectively (P<0.05). Of the strains isolated, S. aureus and P. aeruginosa were particularly well responded to DL-8280 treatment. Safety: Side effects were observed in 8 of 145 cases (5.5%) in DL-8280 group and in 8 of 146 cases (5.5%) in PPA group. No serious side effects were observed. From these results, it was concluded that DL-8280 is a safe and useful drug which is able to provide a higher clinical efficacy as PPA, at a dose level of only one-third of PPA.