呼吸器感染症に対するgatifloxacinの後期第II相臨床試験

DOI 被引用文献6件 参考文献23件

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  • LATE-PHASE-II CLINICAL STUDY OF GATIFLOXACIN, AN ORAL NEW QUINOLONE, IN RESPIRATORY TRACT INFECTIONS

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We investigated the clinical and bacteriological efficacy, safety, usefulness, and fluid concentrations of gatifloxacin (GFLX) in respiratory tract infections. GFLX was administered in once-daily or twice-daily doses of 100, 150, or 200 mg for up to 7 days in cases of acute bronchitis and for up to 14 days in cases of chronic respiratory infection and pneumonia.<BR>The results were as follows:<BR>1. Clinical efficacy was evaluated in 87 cases, of whom 83 received twice-daily and 4 once-daily doses. The overall clinical efficacy rate (excellent or good) was 92.0%(80/87).<BR>2. Bacteriological efficacy was evaluated in 34 cases of identified bacteria. The eradication rate was 91.2%(31/34).<BR>3. Side effects were evaluated in 97 cases, and their incidence was 6.2%(6/97). Laboratory test findings were evaluated in 84 cases, and the incidence of abnormal findings was 11.9%(10/84).<BR>4. Clinical usefulness was evaluated in 89 cases. The usefulness rate (very useful or useful) was 84.3%(75/89).<BR>5. Serum and sputum concentrations of GFLX were measured in one case of chronic respiratory-tract infection after the 5th and 9th doses of 200mg twice daily. The sputum to serum concentration ratios were 1.60 and 2.38, respectively.<BR>These results indicate good clinical and bacteriological efficacy for GFLX and suggest a satisfactory penetration into sputum. Therefore, it was concluded that GFLX, 100 to 200mg twice daily, is a useful and satisfactory antimicrobial drug for the treatment of respiratory tract infections.

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