Dose-finding study on fleroxacin in chronic respiratory tract infection

Kohei Hara, Masaki Hirota, Keizo Yamaguchi, Shigeru Kohno, Toshiaki Hayashi, Yasumasa Doutsu, Kouichi Watanabe, Hiroshi Mukai, Yuuichi Inoue, Koichiro Nakata, Tatsuo Nakatani, Yoshitaka Nakamori, Naohiko Chonabayashi, Masayuki Noguchi, Kohji Narui, Akira Saito, Masumi Tomizawa, Ichiro Nakayama, Shoichiro Irimajiri, Mitsuo ObanaKotaro Oizumi, Akira Watanabe, Seiichi Aonuma, Masakichi Motomiya, Kiyoshi Konno, Kohsaku Nagai, Shigeru Shimoda, Izumi Hayashi, Kikuo Ohnuma, Miki Hasuike, Masataka Katsu, Shinji Okui, Toshio Fukui, Hiroshi Hirose, Hiroyuki Kobayashi, Hiroshi Oshitani, Jingoro Shimada, Kohya Shiba, Masanobu Kaji, Atsushi Saito, Osamu Sakai, Kaoru Shimada, Takashi Inamatsu, Hideo Ikemoto, Kazuyoshi Watanabe, Tomoo Kohara, Takao Ohkubo, Hirotada Ikeda, Fumio Matsumoto, Takeo Imai, Shigeki Odagiri, Kaneo Suzuki, Kou Murohashi, Atuhiko Sato, Akihiko Okano, Hirokazu Okano, Masami Taniguchi, Fumio Miki, Rinzo Soejima, Niro Okimoto, Jiro Hino, Yoshihisa Nakagawa, Toshiharu Matsushima, Yoshihiko Tano, Michio Yamakido, Shinichi Ishioka, Masaru Nasu, Tohru Yamazaki, Hideaki Shigeno, Jun Goto, Takayoshi Tashiro, Keizo Matsumoto, Tsuyoshi Nagatake, Naoto Rikitomi, Kazunori Oishi, Atsushi Saito, Yoshihiro Shigeno, Yuei Irabu, Hiroshi Kohatsu, Junichi Ohshiro, Nobuya Ogawa, Koichi Deguchi

    Research output: Contribution to journalArticlepeer-review

    4 Citations (Scopus)

    Abstract

    To objectively evaluate the appropriate clinical dose of fleroxacin, a new quinolone antibacterial agent, in the treatment of chronic respiratory tract infections, we carried out a dose-finding comparative study using ofloxacin (OFLX) as the control drug. Patients were given fleroxacin at a single daily dose of 200 mg or 300mg or 600mg of OFLX (t. i. d.) for 14 days in principle. The following results were obtained. 1. The clinical efficacy rates (including excellent and good) as judged by the committee were 62.2%(28/45) in the fleroxacin 200 mg group, 90.0%(36/40) in the fleroxacin 300 mg group and 77.3%(34/44) in the OFLX group. There was a significant difference between the 200 mg and 300 mg fleroxacin groups. 2. Bacteriologically, the eradication rates were 65.4%(17/26) in the fleroxacin 200 mg group, 73.9%(17/23) in the fleroxacin 300 mg group and 75.9%(22/29) in the OFLX group. 3. The incidence of side effects was 8.5%(4/47) in the fleroxacin 200 mg group, 9.5%(4/42) in the fleroxacin 300 mg group and 4.3%(2/46) in the OFLX group. They were not serious in degree. 4. The incidence of abnormal changes in laboratory test values was 7.1%(3/42) in the fleroxacin 200 mg group, 8.3%(3/36) in the fleroxacin 300 mg group and 25.6%(11/43) in the OFLX group. All changes were mild in degree. 5. The utility rates (including markedly useful and useful) as judged by the committee were 62.2%(28/45) in the fleroxacin 200 mg group, 85.4%(35/41) in the fleroxacin 300 mg group and 75.6%(34/45) in the OFLX group. There was a significant difference between the 200mg and 300 mg fleroxacin groups. Our results suggest that a daily dose of 300mg of fleroxacin is a suitable clinical dosage in treating chronic respiratory tract infections.

    Original languageEnglish
    Pages (from-to)454-471
    Number of pages18
    JournalChemotherapy
    Volume38
    DOIs
    Publication statusPublished - 1990

    Keywords

    • Chronic respiratory tract infection
    • Dose-finding study
    • Fleroxacin

    ASJC Scopus subject areas

    • Pharmacology (medical)
    • Infectious Diseases
    • Pharmacology
    • Drug Discovery
    • Oncology

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