A double-blind comparative study of prulifloxacin and ofloxacin in bacterial pneumonia

Hiroyuki Kobayashi, Shin Kawai, Susumu Sakayori, Hiroshi Miura, Takao Koike, Katsunori Ohnishi, Hiroshi Inoue, Masami Yoshida, Kohei Yamauchi, Kazuki Konishi, Kenichi Takeuchi, Haruto Hirano, Toshihiro Nukiwa, Akira Watanabe, Kazuo Sato, Yushi Nakai, Satoru Shoji, Kiyoshi Konno, Tsuneo Sayama, Masataka KatsuKotaro Kaneko, Shigeo Irimajiri, Tetsuro Amamiya, Kaoru Shimada, Yasuyuki Sano, Yasuo Arai, Hirokazu Yamada, Hideo Kobayashi, Izumi Hayashi, Masaru Koyama, Koichiro Kudo, Nobuyuki Kobayashi, Shoichiro Irimajiri, Mitsuo Obana, Fumio Matsumoto, Takeo Imai, Masao Inoue, Iwao Sakurai, Shigeki Odagiri, Kaneo Suzuki, Yuriko Ishimaru, Yuji Watanuki, Takao Ohkubo, Hirotada Ikeda, Hiroshi Matsumoto, Masaaki Arakawa, Kohichi Wada, Kenichi Igarashi, Hiroki Tsukada, Fumihide Iwata, Hiroyuki Sega, Kiyotomo Togashi, Masanaga Takatoh, Toshiaki Nakajima, Yoshinori Shimazu, Hachiro Obata, Fumitoshi Yoshimine, Hidefumi Kishimoto, Nobuki Aoki, Osamu Sekine, Yasutoshi Suzuki, Atsuhiko Sato, Kingo Chida, Shiro Imokawa, Kaoru Shimokata, Masashi Yamamoto, Maki Ando, Chiyoe Kitagawa, Mitsuo Sato, Akifumi Kumazawa, Sadaaki Yamori, Norio Takagi, Jinya Ohhama, Yoshitsugu Linuma, Tomohisa Shibagaki, Toshihiko Takeuchi, Yasuo Yamada, Kazuo Yoshitomo, Tohru Matsuura, Yoshimitsu Hayashi, Fumiyuki Kuze, Hideki Nishiyama, Hideki Kobayashi, Takakazu Sugita, Sadao Horikawa, Michiyasu Nakanishi, Fumio Miki, Rinzo Soejima, Yoshihito Niki, Niro Okimoto, Toshio Kishimoto, Masamitsu Nakashima, Toshiharu Matsushima, Makoto Kimura, Sadao Miyazawa, Yoshihiro Kobashi, Hirohide Yoneyama, Takehiko Hiramoto, Michio Yamakido

    Research output: Contribution to journalArticlepeer-review

    Abstract

    The clinical efficacy, safety and usefulness of prulifloxacin (PUFX, NM 441), a new quinolone, were evaluated in bacterial pneumonia under a double- blind comparative study with ofloxacin (OFLX). PUFX was administered orally at a dose of 300 mg twice daily and OFLX at a dose of 200 mg three times daily. The following results were obtained. 1. Of the total 201 patients evaluated, 156 were evaluated for clinical efficacy. There was no significant bias among patients' back ground factors between the two groups. 2. The clinical efficacy rates were 96.5% (82/85) in the PUFX group and 93.0% (66/71) in the OFLX group. Both groups showed high efficacy. The clinical equivalency of PUFX to OFLX was confirmed at Δ = 10%. 3. The bacteriological elimination rates were 90.3% (28/31) in the PUFX group and 95.2% (20/21) in the OFLX group. 4. Side effects were noted in 2 of 97 patients (2.1%) in the PUFX group and in 3 of 90 patients (3.3%) in the OFLX group. 5. Abnormalities on laboratory findings were observed in 16.0% (15/94) of patients in the PUFX group and in 16.1% (14/87) of patients in the OFLX group. 6. The safety rates ('safe' in the overall safety) were 82.5% (80/97) in the PUFX group and 82.2% (74/90) in the OFLX group. 7. The usefulness rates (markedly useful + useful) were 94.2% (81/86) in the PUFX group and 89.0% (65/73) in the OFLX group. No significant difference was observed between the two groups in any of the above ratings. These results indicate that PUFX is one of the most highly effective drugs for the treatment of bacterial pneumonia.

    Original languageEnglish
    Pages (from-to)271-293
    Number of pages23
    JournalJapanese Journal of Chemotherapy
    Volume45
    Issue number5
    Publication statusPublished - 1997

    Keywords

    • Ofloxacin
    • Prulifloxacin

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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