化膿性中耳炎に対するCiprofloxadn (BAYo9867) とPipemidicacidの薬効比較試験

抄録

The clinical effectiveness, safety and utility of Ciprofloxacin (CPFX) in the treatment of patients with suppurative otitis media were compared with patients treated with Pipemidic acid (PPA) in a double-blind study. Patients of 15 years of age or over with acute suppurative otitis media, acute exacerbation of chronic suppurative otitis media, and chronic suppurative otitis media were administered either 600 mg of CPFX or 2g of PPA orally for 7 days. PPA is not indicated for gram positive infection. The following results were obtained. 1. The clinical efficacy rate according to doctors in charge of the cases was 63.8 % (83/130) in the CPFX group and 56.6 % (69/122) in the PPA group. A higher efficacy rate was observed in the CPFX group (p<0.1). In the patients with monomicrobial infec- tions, the CPFX group showed a higher efficacy rate (p<0.1), while in the patients with polymicrobial infections, there was no significant difference between the two groups. The clinical efficacy rate in the CPFX group was higher than that of the PPA group in patients with polymicrobial infections of gram positive bacteria (GPB)(p<0.05). In the patients with polymicrobial infections with GPB plus gram negative bacteria (GNB), the rate for the PPA group was higher than that of CPFX group (p<0.05). In the patients with monomicrobial infections with GPB or GNB or polymicrobial infections with GNB, there was no significant difference between the two groups. 2. On the basis of a committee judgement, the clinical efficacy rates in all the cases were 60.3 % (79/131) in the CPFX group and 50.8 % (62/122) in the PPA group. The difference between the two groups was not significant. In patients with polymicrobial infections with GPB, the efficacy rate in the CPFX group was higher than that in the PPA group (p<0.05). A higher rate of the cases with excellent effects was observed in the PPA group in polymicrobial infections with GPB plus GNB (p<0.1). No difference was seen in monomicrobial infections with GPB or GNB or polymicrobial infections with GNB. 3. As for bacteriological effects, the eradication rates in the total cases were 60.9 % (70/115) in the CPFX group and 54.6% (59/108) in the group. The difference was not significant. In patients with polymicrobial infection with GPB, a higher eradication rate was observed in the CPFX group (p<0.1). In the patients with monomicrobial infections with GPB or GNB or polymicrobial infections with GNB or GPB plus GNB, there was no significant difference. 4. Side effects were noted in 5 of 138 cases (3.6%) treated with CPFX and in 10 of 140 cases (7.1 %) treated with PPA. The difference was not statistically significant. 5. The utility rates by doctors in charge of the cases were 67.9 % (89/131) in the CPFX group and 55.7% (68/122) in the PPA group, respectively. The difference was statistically significant (p<0.05). In patients with acute exacerbation of chronic otitis media, moderately severe infection, both monomicrobial infection, and polymicrobial infection with GPB or GNB, the utility rates of CPFX group were higher than those of the PPA group (p<0.05). In monomicrobial infections with GPB or GNB, the CPFX group showed a trend of a higher rate of utility (p<0.1). From these results, it was concluded that CPFX was very useful drug in the treatment of suppurative otitis media caused by gram positive or negative bacteria at a dose approximately 1/3 that of PPA.