Double-blind study on grepafloxacin in chronic respiratory tract infection

Hiroyuki Kobayashi, Hiroaki Takeda, Susumu Sakayori, Yoshikazu Kawakami, Etsuro Yamaguchi, Akira Saito, Masumi Tomizawa, Yohmei Hiraga, Kunio Shirato, Yasuo Tanno, Akira Watanabe, Toshihiro Nukiwa, Kenji Baba, Yutaka Tokue, Masahiro Yaegashi, Hiroyuki Nakai, Yoshihiro Honda, Kazunao Niizuma, Shigeo Takizawa, Masahiro SakamotoTakayuki Kuriyama, Koichiro Tatsumi, Masataka Katsu, Akira Ohishi, Kaoru Shimada, Yasuyuki Sano, Yasufumi Miyamoto, Yasuo Arai, Hiroichi Tanimoto, Katsumi Komatsuzaki, Takeshi Mori, Koichiro Kudo, Tadashi Horiuchi, Harumi Shishido, Hisashi Watanabe, Hiroshi Nagano, Hiroshi Tada, Naohiko Chyonabayashi, Shoichiro Irimajiri, Mitsuo Obana, Hideyo Noguchi, Kazumasa Tanaka, Takanori Akisawa, Hidehiko Otsuka, Fumio Matsumoto, Takeo Imai, Shigeki Odagiri, Kaneo Suzuki, Hiroshi Takahashi, Kenichi Takahashi, Yasuhiro Yoshiike, Takashi Ogura

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    1 Citation (Scopus)

    Abstract

    The clinical efficacy, safety, and usefulness of a new quinolone antibacterial agent, greparfloxacin (GPFX), in the treatment of chronic respiratory tract infections were evaluated in a double-blind study using ofloxacin (OFLX) as the control drug. GPFX and OFLX were administered by the oral route in a daily dose of 300 mg q. d. and 200 mg t. i. d., respectively, for 14 successive days, in principle. 1. The clinical efficacy rates of GPFX and OFLX in the 190 efficacy-evaluable patients among the 203 patients enrolled in the study were 90.3% (84/93) and 90.7% (88/97), respectively. The difference was not statistically significant, between the two groups, and the 90% confidence interval was -7.3% to 6.5%, demonstrating the clinical equivalency of both drugs. 2. The bacterial eradication rate was 72.9% (35/48) in the GPFX group, and 84.2% (32/38) in the OFLX group. The difference in rates between the two groups was not significant. 3. Adverse reactions were observed in 8.3% (8/96) of the patients in the GPFX group and 4.1% (4/98) of the patients in the OFLX group. Abnormal clinical laboratory values were observed in 12.2% (11/90) of the patients in the GPFX group and 6.7% (6/89) of the patients in the OFLX group. There were no significant differences in the occurrence of adverse reactions in the two groups. The safety rate was 79.3% (73/92) in the GPFX group and 88.8% (79/89) in the OFLX group. The rates were not significantly different. 4. The usefulness rate was 86.8% (79/91) in the GPFX group and 87.5% (77/88) in the OFLX group. The difference between the two groups was not statistically significant and the 90% confidence interval of - 9.0% to 7.6% demonstrated the clinical equivalency of both drugs. The above results demonstrated that GPFX 300 mg q. d. is equivalent in clinical usefulness to OFLX 200 mg t. i. d. in the treatment of chronic respiratory tract infections.

    Original languageEnglish
    Pages (from-to)480-483
    Number of pages4
    JournalJapanese Journal of Chemotherapy
    Volume45
    Issue number6
    Publication statusPublished - 1997

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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