부산대학교 도서관

To evaluate the clinical efficacy, safety, and tissue penetration of gatifloxacin (GFLX) in genitourinary tract infections, we performed a multi-center clinical open study.Patients with uncomplicated urinary tract infections (acute pyelonephritis and acute cystitis), complicated urinary tract infections, urethritis, prostatitis, and epididymitis were admitted to the study and received 150 mg to 400 mg of GFLX daily for 3 to 14 days.Common dose regimens were 150 mg b. i. d., 200 mg once a day, and 200 mg b. i. d.Clinical efficacy, assessed by the doctors in charge, was obtained in 96.6% of 29 patients with uncomplicated urinary tract infections (UTI), 68.8% of 32 patients with complicated UTI, 97.1% of 35 patients with urethritis, 86.7% of 15 patients with prostatitis, and 87.5% of 8 patients with epididymitis. Overall clinical efficacy and bacteriological eradication, evaluated according to the criteria of the Japanese UTI Committee, were 100% of 21 patients and 100% of 33 strains in uncomplicated UTI; 70.0% of 30 patients, 87.7% of 57 strains in complicated UTI; 88.9% of 9 patients, 88.9% of 9 strains in gonococcal urethritis; 100% of 10 patients, 100% of 10 strains in chlamydial urethritis;and 100% of 9 patients and 100% of 14 strains in chronic prostatitis.The incidence of clinical adverse reactions was 3.3%(4 in 122 patients) and of laboratory adverse reactions, 3.9%(3 in 76 patients). None of the findings in adverse reactions were serious.In prostate and epididymis, the concentration ratios of tissue to serum were 1.0 or higher, suggesting good penetration of GFLX into these tissues.From the results of this study, we conclude that GFLX is well tolerated and effective in the treatment of genitourinary tract infections.