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The clinical efficacy and safety of Roxithromycin (RU) were compared with those of Midecamycin acetate (MOM) in patients with pneumonia in a double blind study. RU and MOM were administered orally for 14 days with daily doses of 300 mg (150 mg b.i.d.) and 600 mg (200 mg t.i.d.), respectively. The following results were obtained. 1. RU and MOM were administered to a total of 204 patients (RU: 101, MOM: 103). The clinical efficacy was judged in 150 patients (RU: 70, MOM: 80), with 54 of the patients excluded from the total by the committee. 2. The clinical efficacy rates were 81.4% for RU and 70.0% for MOM on the basis of the committee's judgement. There was no significant difference between the two groups. In the evaluation of the clinical efficacy by the doctors in charge, the efficacy rates were 81.4% for RU and 67.5% for MOM, which constitutes a significant difference between the two groups (p less than 0.05). 3. No significant difference was found between the two drugs in bacteriological efficacy. 4. No significant differences were observed in either the incidence of side effects between RU (4.3%) and MOM (4.0%) or in abnormal changes in the laboratory findings. 5. Regarding the clinical usefulness judged by the committee, RU showed a significantly higher rate than MOM (79.2% vs. 67.9%). There was no significant difference in the judgement by the doctors in charge. From the above results, it was concluded that a daily dosage of 300 mg of RU was equal in usefulness to 600 mg daily of MOM in the treatment of mild to moderate pneumonia.

Double-Blind Comparative Study of Roxithromycin (RU 28965) and Midecamycin acetate (MOM) in the Treatment of Pneumonia