EARLY PHASE II CLINICAL STUDY OF GATIFLOXACIN, AN ORAL NEW QUINOLONE, FOR INFECTIONS IN THE FIELD OF INTERNAL MEDICINE

DOI 10 Citations 27 References
  • Saito Atsushi
    Department of General Internal Medicine, The Jikei University School of Medicine, Kashiwa Hospital

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  • 内科領域感染症に対するgatifloxacinの前期第II相臨床試験

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Abstract

We investigated the clinical and bacteriological efficacy, safety, usefulness and fluid concentrations of gatifloxacin (GFLX) for the treatment of infections in the field of internal medicine.<BR>The subjects were 170 patients with respiratory tract infection and 2 with urinary tract infection. GFLX was administered in once-daily or twice-daily doses of 100, 150 or 200mg for 3 to 14 days.<BR>The results were as follows:<BR>1. Clinical efficacy was evaluated in 172 cases, and the majority had received twice-daily doses. The overall clinical efficacy rate (excellent or good) was 94.2%(162/172).<BR>2. Bacteriological efficacy was evaluated in 72 cases of identified bacteria. The eradication rate was 90.3%(65/72).<BR>3. Side effects were evaluated in 192 cases, and their incidence was 4.2%(8/192). Laboratory test findings were evaluated in 156 cases, and the incidence of abnormal findings was 10.3%(16/156).<BR>4. Clinical usefulness was evaluated in 175 cases. The usefulness rate (very useful or useful) was 90.9%(159/175).<BR>5. Serum and sputum concentrations of GFLX were measured after the first dose of 200mg twice daily, and the maximum sputum concentration was 2.13μg/mL. The sputum to serum concentration ratio was 1.09μg/mL. These results suggest the favorable penetration of GFLX.<BR>The results indicate good clinical and bacteriological efficacy of GFLX, as well as, its satisfactory penetration into sputum. Therefore, it was concluded that GFLX would be a useful antimicrobial drug and that the dosage of 100 to 200 mg twice daily is well tolerated and satisfactory for the treatment of infections in the field of internal medicine.

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