A comparative study of pazufloxacin mesilate (T-3762) and ceftazidime (CAZ) in the treatment of complicated urinary tract infections

J. Kumazawa, T. Matsumoto, T. Tsukamoto, T. Hirose, Y. Ohishi, K. Kawabe, M. Oshi, N. Kawamura, K. Suzuki, M. Namiki, E. Tadika, A. Sakai, S. Kanda, Y. Kawada, Y. Ban, Y. Naide, S. Kamidono, S. Arakawa, H. Ohmori, H. KumonT. Usui, S. Kagawa, S. Noda, Y. Ohi, T. Goto, A. Nagayama, N. Ogawa

研究成果: Contribution to journalArticle査読

抄録

To assess the efficacy, safety, and usefulness of the new quinolone drug pazufloxacin mesilate (T-3762) for injection in the treatment of complicated urinary tract infections, a comparative study was conducted using ceftazidime (CAZ), an antibacterial cephem, as the control drug. These test drugs were intravenously administered by drip infusion for 5 days at 500 mg (b. i. d.), based on pazufloxacin (PZFX, developmental code: T-3761, active moiety of T-3762) for T-3762, and at 1,000 mg (b. i. d.) for CAZ. The following results were obtained. The test drugs were administered to a total of 300 patients: 146 in the T-3762 group and 154 in the CAZ group. Of these patients, 107 in the T-3762 group and 119 in the CAZ group were evaluated for efficacy, 135 in the T-3762 group and 144 in the CAZ group were evaluated for overall safety, while 108 in the T-3762 group and 116 in the CAZ group were evaluated for usefulness. The overall clinical efficacy rates according to the UTI Criteria were 92.5% (99/107) for the T-3762 group and 87.4% (104/119) for the CAZ group, showing no significant difference between the two groups. Regarding bacteriological response, the eradication rates on the first day were 86.2% (150/174) for the T-3762 group and 829% (165/199) for the CAZ group, while those on the fifth day were 87.9% (174/198) for the T-3762 group and 90.7% (196/216) for the CAZ group, showing no significant difference between the two groups. Although side effects were observed in 2.8% (4/145) of the patients in the T-3762 group and in 3.3% (5/152) of those in the CAZ group, these were all mild or moderate. Although abnormal clinical findings were observed in 11.2% (15/134) of the patients in the T-3762 group and in 18.8% (27/144) of those in the CAZ group, none were contributory. The overall safety rates (ratio of patients with 'safe' rating given by physician in charge) were 85.9% (116/135) for the T-3762 group and 77.6% (111/143) for the CAZ group, showing no significant difference between the two groups. The usefulness rates, determined in consideration of clinical efficacy and overall safety, were 85.2% (92/108) for the T-3762 group and 87.1% (101/116) for the CAZ group, showing no significant difference between the two groups. Judging from these findings, it is concluded that T-3762, a new quinolone drug, can be safely used with high clinical efficacy for injection in the treatment of complicated urinary tract infections.

本文言語英語
ページ(範囲)472-500
ページ数29
ジャーナルNishinihon Journal of Urology
62
8
出版ステータス出版済み - 2000

All Science Journal Classification (ASJC) codes

  • Urology

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