학술논문

Clinical Early Phase II Study of Gatifloxacin in Urinary Tract Infections / 泌尿器科領域感染症に対するgatifloxacinの前期第II相臨床試験
Document Type
Journal Article
Source
日本化学療法学会雑誌 / Japanese Journal of Chemotherapy. 1999, 47(Supplement2):292
Subject
AM-1155
gatifloxacin
体内動態
前期第II相臨床試験
尿路感染症
Language
Japanese
ISSN
1340-7007
1884-5886
Abstract
To evaluate the clinical efficacy, safety, and tissue penetration of gatifloxacin (GFLX) in urinary tract infections (UTI), we performed a multi-center clinical open study.Patients with either uncomplicated UTI (acute pyelonephritis and acute cystitis) or complicated UTI were admitted to the study and received mainly 100 mg to 300 mg of GFLX once or twice a day for 3 to 14 days. The most common dose regimen was 100 mg b. i. d.Clinical efficacy, as assessed by the doctors in charge, was obtained in 96.4% of 55 patients with uncomplicated UTI and 80.2% of 197 patients with complicated UTI. The overall clinical efficacy and bacteriological eradication rates, evaluated according to the criteria of the Japanese UTI Committee, were 100% of 34 patients and 100% of 47 strains in acute uncomplicated cystitis, and 84.1% of 164 patients and 86.2% of 239 strains in complicated UTI.The incidence of clinical adverse reactions was 1.8%(5 in 271 patients) and of laboratory adverse reactions, 3.1%(7 in 223 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 urinary tract infections at a dose of 100 mg to 200 mg at once or twice a day.