A double-blind comparative study of prulifloxacin and ofloxacin in lower chronic respiratory tract infections

Hiroyuki Kobayashi, Shin Kawai, Susumu Sakayori, Hiroshi Miura, Yoshikaza Kawakami, Etsuro Yamaguchi, Hiroshi Isobe, Takao Koike, Masaya Mukai, Yohmei Hiraga, Mitsuhide Ohmichi, Toshihiro Nukiwa, Akira Watanabe, Kazuo Sato, Yushi Nakai, Yoshihiro Honda, Satoru Shoji, Masataka Katsu, Akira Ohishi, Kotaro KanekoOsamu Sakai, Kohya Shiba, Kohji Yoshikawa, Kaoru Shimada, Yasuyuki Sano, Yasuo Arai, Hirokazu Yamada, Yasufumi Miyamoto, Izumi Hayashi, Masaru Koyama, Koichiro Kudo, Nobuyuki Kobayashi, Fumio Matsumoto, Takeo Imai, Masao Inoue, Iwao Sakurai, Shigeki Odagiri, Kaneo Suzuki, Takashi Ogura, Yasuhiro Yoshiike, Satoshi Inoue, Tadashi Akahori, Yoshihiro Hirai, Hiroshi Takahashi, Takao Ohkubo, Hirotada Ikeda, Hiroshi Matsumoto, Jingoro Shimada, Masaaki Arakawa, Kohichi Wada, Kenichi Igarashi, Hiroki Tsukada, Fumihide Iwata, Yukiyoshi Kon, Fumitoshi Yoshimine, Akio Kasai, Nobuki Aoki, Osamu Sekine, Yasutoshi Suzuki, Atsuhiko Sato, Kingo Chida, Shiro Imokawa, Akihito Todate, Mikio Toyoshima, Katsunori Tsukamoto, Kaoru Shimokata, Masashi Yamamoto, Atsushi Kawabata, Tetsuya Yagi, Maki Ando, Mitsuo Sato, Sadaaki Yamori, Norio Takagi, Jinya Ohhama, Yoshitugu Linuma, Tomohisa Shibagaki, Shinji Maruyama, Atsushi Watanabe, Toshihiko Takeuchi, Yasuo Yamada, Hidekazu Hanaki, Makoto Kawakami, Takayuki Asano, Fumiyuki Kuze, Nobuaki Ikeda, Takuya Kurasawa, Michiyasu Nakanishi, Nobuhiro Narita, Keiichi Mikasa, Rinzo Soejima, Yoshihito Niki, Niro Okimoto, Toshio Kishimoto, Masamitsu Nakazima, Toshiharu Matsushima, Makoto Kimura, Sadao Miyazawa, Yoshihiro Kobashi, Hirohide Yoneyama

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    1 Citation (Scopus)

    Abstract

    The clinical efficacy, safety and usefulness of prulifloxacin (PUFX, NM 441), a new quinolone, were evaluated in lower chronic respiratory tract infections under a doubleblind comparative study with ofloxacin (OFLX). PUFX was administered orally at a dose of 300 mg twice daily and OF X at a dose of 200 mg three times daily. The following results were obtained. 1. Of the total 211 patients evaluated, 176 were evaluated for clinical efficacy. There was no significant bias among patients' back ground factors between the two groups except 'property of sputum' and 'chest pain . However, no influence on the drug evaluation from these biases was verified from the viewpoint of the statistical analysis test. 2. The clinical efficacy rates were 94.3% (83/88) in the PUFX group and 96.6% (85/88) in the OFLX group. Both groups showed high efficacy. The clinical equivalency of PUFX to OFLX was confirmed at A= 10%. 3. The bacteriological elimination rates were 77.5% (31/40) in the PUFX group and 82.5% (33/40) in the OFLX group. 4. Side effects were noted in 1 of 94 patients (1.1%) in the PUFX group and in 5 of 97 patients (5.2%) in the OFLX group. 5. Abnormalities on laboratory findings were observed in 7.9% (7/89) of patients in the PUFX group and in 7.5% (7/93) of patients in the OFLX group. 6. The safety rates ('safe' in the overall safety) were 91.5% (86/94) in the PUFX group and 88.7% (86/97) in the OFLX group. 7. The usefulness rates (markedly useful+useful) were 94.3% (83/88) in the PUFX group and 94.4% (84/89) in the OFLX group. No significant difference was observed between the two groups in any of the above ratings. There results indicate that PUFX is one of the most highly effective drugs for the treatment of lower chronic respiratory tract infections.

    Original languageEnglish
    Pages (from-to)294-317
    Number of pages24
    JournalJapanese Journal of Chemotherapy
    Volume45
    Issue number5
    Publication statusPublished - 1997

    Keywords

    • Prulifloxacin
    • ofloxacin

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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  • Cite this

    Kobayashi, H., Kawai, S., Sakayori, S., Miura, H., Kawakami, Y., Yamaguchi, E., Isobe, H., Koike, T., Mukai, M., Hiraga, Y., Ohmichi, M., Nukiwa, T., Watanabe, A., Sato, K., Nakai, Y., Honda, Y., Shoji, S., Katsu, M., Ohishi, A., ... Yoneyama, H. (1997). A double-blind comparative study of prulifloxacin and ofloxacin in lower chronic respiratory tract infections. Japanese Journal of Chemotherapy, 45(5), 294-317.