Ofloxacin の下気道感染症に対する有用性, 用法・用量の検討

One hundred and thirteen patients who were treated at the Kyushu University Hospital and other related hospitals were randomly assigned to 2 groups to compare the effect of twice daily administration of 200 mg each and that of 300 mg each of ofloxacin (OFLX). The patients included 41 cases with pneumonia, 18 with acute bronchitis, 33 with chronic bronchitis, 15 with bronchiectasis with infection, 3 with diffused panbronchiolitis, and 3 with other secondary infectious diseases. Fifty-five cases were administered 400 mg OFLX a day and 58 cases received 600 mg. The number of severe cases in the 600 mg group was greater than that in the 400 mg group. The ratios of general amelioration of clinical symptoms were 92.6% in the 400 mg group and 82.1% in the 600 mg group. Thus, the ratio of the 400 mg group was better than that of the 600 mg group. However, the ratio of significant amelioration in the 600 mg group was 35.7% which was better than that in the 400 mg group, 27.8%. For bacteriological effects the rate of disappearance and decrease in number of bacteria was 92% in the 400 mg group and was significantly better than that of the 600 mg group, 70%. The incidence of side effects in the 600 mg group was 22.4% and this was high in contrast to that in the 400 mg group, 3.6%. Most of the side effects in the 600 mg group involved symptoms of the central nervous system such as sleeplessness. No significant differences were observed in incidences of abnormalities of laboratory tests at 1.8% and 1.7%, respectively. Safety in the 400 mg group were 96.4% which was significantly higher in number than those in the 600 mg group, 77.6%. Efficacy rates of twice daily administrations each with 200 mg and 300 mg OFLX for lower respiratory infections were 94.4 and 79.3%, respectively. In conclusion, the daily dose of 400 mg was the most effective.