Laboratory and clinical studies of pazufloxacin in the treatment of genitourinary tract infection

Pazufloxacin (PZFX), a new family of oral newer quinolones, was tested for the in vitro activity on several strains of Pseudomonas aeruginosa isolated from UTI. For clinical evaluation, the drug was administered in the treatment of UTI, prostatitis. The results obtained were shown in the following 1) In vitro activity on several clinical isolates of P. aeruginosa: The MIC values on the strains tested, varied according to the pH values of medium. When comparing with other conventional drugs, the in vitroactivity of PZFX was less influenced by the culture medium than the other control drugs. The MIC values of PZFX had a tendency to more active in acid media than in alkaline media. 2) Penetration into human prostatic fluid after intake of 200 mg of PZFX: Average concentration (μg/ml) of prostatic fluid (PF) was 0.18 ± 0.11 (n=4) at 1 hour, and it was 0.20 (n=2) at 2 hours. The ratio between PF/serum was 0.12± 0.11 (1h), 0.26 (2 h) respectively. 3) Patients with genitourinary tract infection were treated with oral administration of PZFX 50~200 mg b.i.d. or t.i.d. after meal for 3~14 days. According to the criteria proposed by the Japanese UTI Committee, the overall clinical efficacy of PZFX was 100%(14/14) in uncomplicated UTI, 90%(18/20) in complicated urinary tract infection and 3/3 in prostatitis. 4) For safety, mild loose stool was observed in one patient, during the course of therapy. Laboratory abnormal values were detected for slight elevation of GPT in one case, also that of GOT, GPT and AlP in the other case.