化膿性中耳炎に対する Roxithromycin (RU28965)と Midecamycin acetate (MOM) の薬効比較試験

抄録

The clinical effectiveness, safety and utility of Roxithromycin (RU 28965, RU) in the treat- ment of patients with suppurative otitis media were compared with patients treated with midecamycin acetate (Miocamycin, MOM) in a double blind study. Patients 15 years of age or older with acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media were administered either 300 mg of RU or 600 mg of MOM orally for 7 days, with the following results. 1. The clinical efficacy rates of the RU group and MOM group in acute suppurative otitis media were 63.3% and 62.5% judged by doctors, and 63.3% and 66.7% judged by the committee members, respectively. The rates of the RU group and MOM group in acute exacerbation of chronic otitis media were 53.2% and 43.8% judged by doctors, and 48.4% and 43.8% judged by the committee members, respectively. In all cases, no significant difference as observed. 2. As for bacteriological effects, the eradication rates in total cases were 66.2% in the RU group and 55.6% in the MOM group. No significant difference was observed between the two drug groups. 3. Adverse reactions were observed in 1 case of the RU group (incidence: 1%) and in 3 cases of the MOM group (incidence: 3%). However, no significant difference in the incidence (%) between the two drug groups was observed and all the adverse reactions were merely digestive symptoms of mild severity. 4. The rate of usefulness in the RU group was 59.1%, whereas the rate of usefulness in the MOM group was 52.6% ; no significant difference was observed between the two groups. On the basis of the above results, it was concluded that RU is a safe and useful antibacterial agent which is able to provide approximately the same clinical efficacy as MOM, at only half the dosage level.