Double-blind study on grepafloxacin in pneumonia

Kobayashi Hiroyuki, Takeda Hiroaki, Sakayori Susumu, Akira Saito, Masumi Tomizawa, Yohmei Hiraga, Mitsuhide Ohmichi, Kazuo Takebe, Masakatsu Matsukawa, Hisashi Nakahata, Takeshi Osonoi, Miyoko Saito, Masashi Tamura, Kazuki Konishi, Kazuo Obara, Masami Yoshida, Takashi Mohri, Kenichi Takeuehi, Taiji Yoahida, Teruo KowataYukio Tanifuji, Kunio Shirato, Yasuo Tanno, Masato Hayashi, Koichi Sato, Makoto Takahashi, Kunio Kudo, Munehiko Ishii, Masaharu Sugiyama, Yasuo Ono, Yuriko Shindo, Ryoichi Hashiguchi, Kaoru Yoshinaga, Tokuo Wada, Naoya Matoba, Tadahiro Tominaga, Akira Watanabe, Toshihiro Nukiwa, Kenji Baba, Yutaka Tokue, Hiroyuki Nakai, Yoshihiro Honda, Kazuo Sato, Kazunao Niizuma, Shigeo Takizawa, Mikae Nakamura, Masahiro Sakamoto, Masataka Katsu, Akira Oishi, Kaoru Shimada, Norio Kikuchi, Osamu Sakai, Koya Shiba, Shinichi Tanimoto, Atsushi Saito, Koichiro Nakata, Tatsuo Nakatani, Koichiro Kudol, Tadashi Horiuchi, Harumi Shishido, Hiroshi Nagano, Hiroshi Tada, Naohiko Chyonabayashi, Hideyo Noguehi, Kazumasa Tanaka, Hidehiko Otsuka, Fumio Matsumotol, Takeo Imai, Kenji Tani, Takao Okubo, Hirotada Ikeda, Hiroshi Matsumoto, Tamotsu Kaneko, Masaaki Arakawa, Koichi Wada, Fumihide Iwata, Shigeyuki Hoshino, Hiroki Tsukada, Takashi Kawashima, Nobuki Aoki, Osamu Sekine, Yasutoshi Suzuki, Hajimu Takeda, Saburo Izumi, Teruya Yoshimi, Atsuhiko Sato, Masatoshi Iwata, Toshihiko Takeuchi, Hidekazu Hanaki, Shinji Takeyama, Makoto Kawakami, Kaoru Shimokata, Tomohiko Ogasawara, Hitoshi Mogi, Shuzo Sakai, Hironobu Minami, Kazuyoshi Senda, Masashi Yamamoto, Masaaki Nagatake, Shiro Suzuki, Osamu Taguchi, Hidenori Ibata, Yasuhiro Sumida, Fumio Miki, Saburo Yano, Masaru Nakagawa, Rinzo Soejima, Niro Okimoto, Yoshihito Niki, Toshiharu Matsushima, Makoto Kimura, Michio Yamakido, Kenji Hasegawa, Hiroya Egawa, Jitsuro Yanagida, Kenichiro Watanabe, Nobuzo Ishibashi, Osamu Kurimura, Kikuo Nakano, Koji Takeda, Minoru Yoshida, Takamichi Aritomi, Kotaro Oizumi, Yoichiro Ichikawa, Naoto Tokunaga, Fumio Tanaka, Masao Kawahara, Masazumi Saisho, Hiromichi Shigematsu, Shinzo Kawaguchi, Kenji Fukuda, Hirofumi Kataoka, Yoshiyuki Mitsutake, Tsuneo Ishibashi, Takamoto Masashiro, Yoshinari Kitahara, Kohei Hara, Shigeru Kohno, Mitsuo Kaku, Hironobu Koga, Naomi Ito, Koichi Watanabe, Shiro Kusano, Osamu Sakito, Keizo Matsumoto, Masakazu Takasugi, Masaru Nasu, Yoichiro Goto, Tohru Yamasaki, Jun Goto, Kazuo Kitagawa, Atsushi Saito, Hiroshi Fukuhara, Jun Inadome, Mitsuyoshi Nakashima, Koichi Deguchi

Research output: Contribution to journalArticlepeer-review

Abstract

The clinical efficacy, safety, and usefulness of a new quinolone synthetic antibacterial agent, grepafloxacin (GPFX), in the treatment of pneumonia were evaluated in a double-blind study using ofloxacin (OFLX) as the control drug. GPFX and OFLX were administered by the oral route at 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 rate of GPFX and OFLX in the 225 efficacy-evaluable patients among the 256 patients enrolled in the study was 96.4% (108/112) and 92.9% (105/113), respectively. The difference between the two groups was not statistically significant, and the 90% confidence interval of -1.4% to 8.4% demonstrated the clinical equivalency of the two drugs. 2. The bacterial eradication rate was 96.4% (27/28) in the GPFX group and 97.0% (32/33) in the OFLX group. The rates were not significantly different. 3. Adverse reactions were observed in 2.4% (3/125) of the patients in the GPFX group and 5.0% (6/120) of the patients in the OFLX group. Abnormal clinical laboratory values were observed in 15.8% (19/120) of the patients in the GPFX group and 11.4% (13/114) of the patients in the OFLX group. The differences between the two groups were not statistically significant. The safety rates were 81.8% (98/121) in the GPFX group and 83.5% (96/115) in the OFLX group. The rates were not significantly different. 4. The usefulness rates were 94.5% (104/110) in the GPFX group and 91.0% (101/111) in the OFLX group. The difference between the two groups was not statistically significant, and the 90% confidence interval of -2.2% to 9.3% demonstrated clinical equivalency of the two drugs. The above findings demonstrate that GPFX at 300 mg q.d. is equivalent to OFLX at 200 mg t.i.d. in clinical usefulness in the treatment of pneumonia.

Original languageEnglish
Pages (from-to)442-462
Number of pages21
JournalJapanese Journal of Chemotherapy
Volume45
Issue number6
DOIs
Publication statusPublished - 1997

Keywords

  • OPC-17116
  • grepafloxacin
  • ofloxacin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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