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 Kowata; Yukio 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

doi:10.11250/chemotherapy1995.45.442

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 journal › Article › peer-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 language	English
Pages (from-to)	442-462
Number of pages	21
Journal	Japanese Journal of Chemotherapy
Volume	45
Issue number	6
DOIs	https://doi.org/10.11250/chemotherapy1995.45.442
Publication status	Published - 1997
Externally published	Yes

Keywords

OPC-17116
grepafloxacin
ofloxacin

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

Access to Document

10.11250/chemotherapy1995.45.442

Cite this

Hiroyuki, K., Hiroaki, T., Susumu, S., Saito, A., Tomizawa, M., Hiraga, Y., Ohmichi, M., Takebe, K., Matsukawa, M., Nakahata, H., Osonoi, T., Saito, M., Tamura, M., Konishi, K., Obara, K., Yoshida, M., Mohri, T., Takeuehi, K., Yoahida, T., ... Deguchi, K. (1997). Double-blind study on grepafloxacin in pneumonia. Japanese Journal of Chemotherapy, 45(6), 442-462. https://doi.org/10.11250/chemotherapy1995.45.442

Hiroyuki, K, Hiroaki, T, Susumu, S, Saito, A, Tomizawa, M, Hiraga, Y, Ohmichi, M, Takebe, K, Matsukawa, M, Nakahata, H, Osonoi, T, Saito, M, Tamura, M, Konishi, K, Obara, K, Yoshida, M, Mohri, T, Takeuehi, K, Yoahida, T, Kowata, T, Tanifuji, Y, Shirato, K, Tanno, Y, Hayashi, M, Sato, K, Takahashi, M, Kudo, K, Ishii, M, Sugiyama, M, Ono, Y, Shindo, Y, Hashiguchi, R, Yoshinaga, K, Wada, T, Matoba, N, Tominaga, T, Watanabe, A, Nukiwa, T, Baba, K, Tokue, Y, Nakai, H, Honda, Y, Sato, K, Niizuma, K, Takizawa, S, Nakamura, M, Sakamoto, M, Katsu, M, Oishi, A, Shimada, K, Kikuchi, N, Sakai, O, Shiba, K, Tanimoto, S, Saito, A, Nakata, K, Nakatani, T, Kudol, K, Horiuchi, T, Shishido, H, Nagano, H, Tada, H, Chyonabayashi, N, Noguehi, H, Tanaka, K, Otsuka, H, Matsumotol, F, Imai, T, Tani, K, Okubo, T, Ikeda, H, Matsumoto, H, Kaneko, T, Arakawa, M, Wada, K, Iwata, F, Hoshino, S, Tsukada, H, Kawashima, T, Aoki, N, Sekine, O, Suzuki, Y, Takeda, H, Izumi, S, Yoshimi, T, Sato, A, Iwata, M, Takeuchi, T, Hanaki, H, Takeyama, S, Kawakami, M, Shimokata, K, Ogasawara, T, Mogi, H, Sakai, S, Minami, H, Senda, K, Yamamoto, M, Nagatake, M, Suzuki, S, Taguchi, O, Ibata, H, Sumida, Y, Miki, F, Yano, S, Nakagawa, M, Soejima, R, Okimoto, N, Niki, Y, Matsushima, T, Kimura, M, Yamakido, M, Hasegawa, K, Egawa, H, Yanagida, J, Watanabe, K, Ishibashi, N, Kurimura, O, Nakano, K, Takeda, K, Yoshida, M, Aritomi, T, Oizumi, K, Ichikawa, Y, Tokunaga, N, Tanaka, F, Kawahara, M, Saisho, M, Shigematsu, H, Kawaguchi, S, Fukuda, K, Kataoka, H, Mitsutake, Y, Ishibashi, T, Masashiro, T, Kitahara, Y, Hara, K, Kohno, S, Kaku, M, Koga, H, Ito, N, Watanabe, K, Kusano, S, Sakito, O, Matsumoto, K, Takasugi, M, Nasu, M, Goto, Y, Yamasaki, T, Goto, J, Kitagawa, K, Saito, A, Fukuhara, H, Inadome, J, Nakashima, M & Deguchi, K 1997, 'Double-blind study on grepafloxacin in pneumonia', Japanese Journal of Chemotherapy, vol. 45, no. 6, pp. 442-462. https://doi.org/10.11250/chemotherapy1995.45.442

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title = "Double-blind study on grepafloxacin in pneumonia",

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.",

keywords = "OPC-17116, grepafloxacin, ofloxacin",

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

year = "1997",

doi = "10.11250/chemotherapy1995.45.442",

language = "English",

volume = "45",

pages = "442--462",

journal = "Japanese Journal of Chemotherapy",

issn = "1340-7007",

publisher = "Japan Society of Chemotherapy",

number = "6",

}

TY - JOUR

T1 - Double-blind study on grepafloxacin in pneumonia

AU - Hiroyuki, Kobayashi

AU - Hiroaki, Takeda

AU - Susumu, Sakayori

AU - Saito, Akira

AU - Tomizawa, Masumi

AU - Hiraga, Yohmei

AU - Ohmichi, Mitsuhide

AU - Takebe, Kazuo

AU - Matsukawa, Masakatsu

AU - Nakahata, Hisashi

AU - Osonoi, Takeshi

AU - Saito, Miyoko

AU - Tamura, Masashi

AU - Konishi, Kazuki

AU - Obara, Kazuo

AU - Yoshida, Masami

AU - Mohri, Takashi

AU - Takeuehi, Kenichi

AU - Yoahida, Taiji

AU - Kowata, Teruo

AU - Tanifuji, Yukio

AU - Shirato, Kunio

AU - Tanno, Yasuo

AU - Hayashi, Masato

AU - Sato, Koichi

AU - Takahashi, Makoto

AU - Kudo, Kunio

AU - Ishii, Munehiko

AU - Sugiyama, Masaharu

AU - Ono, Yasuo

AU - Shindo, Yuriko

AU - Hashiguchi, Ryoichi

AU - Yoshinaga, Kaoru

AU - Wada, Tokuo

AU - Matoba, Naoya

AU - Tominaga, Tadahiro

AU - Watanabe, Akira

AU - Nukiwa, Toshihiro

AU - Baba, Kenji

AU - Tokue, Yutaka

AU - Nakai, Hiroyuki

AU - Honda, Yoshihiro

AU - Sato, Kazuo

AU - Niizuma, Kazunao

AU - Takizawa, Shigeo

AU - Nakamura, Mikae

AU - Sakamoto, Masahiro

AU - Katsu, Masataka

AU - Oishi, Akira

AU - Shimada, Kaoru

AU - Kikuchi, Norio

AU - Sakai, Osamu

AU - Shiba, Koya

AU - Tanimoto, Shinichi

AU - Saito, Atsushi

AU - Nakata, Koichiro

AU - Nakatani, Tatsuo

AU - Kudol, Koichiro

AU - Horiuchi, Tadashi

AU - Shishido, Harumi

AU - Nagano, Hiroshi

AU - Tada, Hiroshi

AU - Chyonabayashi, Naohiko

AU - Noguehi, Hideyo

AU - Tanaka, Kazumasa

AU - Otsuka, Hidehiko

AU - Matsumotol, Fumio

AU - Imai, Takeo

AU - Tani, Kenji

AU - Okubo, Takao

AU - Ikeda, Hirotada

AU - Matsumoto, Hiroshi

AU - Kaneko, Tamotsu

AU - Arakawa, Masaaki

AU - Wada, Koichi

AU - Iwata, Fumihide

AU - Hoshino, Shigeyuki

AU - Tsukada, Hiroki

AU - Kawashima, Takashi

AU - Aoki, Nobuki

AU - Sekine, Osamu

AU - Suzuki, Yasutoshi

AU - Takeda, Hajimu

AU - Izumi, Saburo

AU - Yoshimi, Teruya

AU - Sato, Atsuhiko

AU - Iwata, Masatoshi

AU - Takeuchi, Toshihiko

AU - Hanaki, Hidekazu

AU - Takeyama, Shinji

AU - Kawakami, Makoto

AU - Shimokata, Kaoru

AU - Ogasawara, Tomohiko

AU - Mogi, Hitoshi

AU - Sakai, Shuzo

AU - Minami, Hironobu

AU - Senda, Kazuyoshi

AU - Yamamoto, Masashi

AU - Nagatake, Masaaki

AU - Suzuki, Shiro

AU - Taguchi, Osamu

AU - Ibata, Hidenori

AU - Sumida, Yasuhiro

AU - Miki, Fumio

AU - Yano, Saburo

AU - Nakagawa, Masaru

AU - Soejima, Rinzo

AU - Okimoto, Niro

AU - Niki, Yoshihito

AU - Matsushima, Toshiharu

AU - Kimura, Makoto

AU - Yamakido, Michio

AU - Hasegawa, Kenji

AU - Egawa, Hiroya

AU - Yanagida, Jitsuro

AU - Watanabe, Kenichiro

AU - Ishibashi, Nobuzo

AU - Kurimura, Osamu

AU - Nakano, Kikuo

AU - Takeda, Koji

AU - Yoshida, Minoru

AU - Aritomi, Takamichi

AU - Oizumi, Kotaro

AU - Ichikawa, Yoichiro

AU - Tokunaga, Naoto

AU - Tanaka, Fumio

AU - Kawahara, Masao

AU - Saisho, Masazumi

AU - Shigematsu, Hiromichi

AU - Kawaguchi, Shinzo

AU - Fukuda, Kenji

AU - Kataoka, Hirofumi

AU - Mitsutake, Yoshiyuki

AU - Ishibashi, Tsuneo

AU - Masashiro, Takamoto

AU - Kitahara, Yoshinari

AU - Hara, Kohei

AU - Kohno, Shigeru

AU - Kaku, Mitsuo

AU - Koga, Hironobu

AU - Ito, Naomi

AU - Watanabe, Koichi

AU - Kusano, Shiro

AU - Sakito, Osamu

AU - Matsumoto, Keizo

AU - Takasugi, Masakazu

AU - Nasu, Masaru

AU - Goto, Yoichiro

AU - Yamasaki, Tohru

AU - Goto, Jun

AU - Kitagawa, Kazuo

AU - Saito, Atsushi

AU - Fukuhara, Hiroshi

AU - Inadome, Jun

AU - Nakashima, Mitsuyoshi

AU - Deguchi, Koichi

PY - 1997

Y1 - 1997

N2 - 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.

AB - 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.

KW - OPC-17116

KW - grepafloxacin

KW - ofloxacin

UR - http://www.scopus.com/inward/record.url?scp=0030746186&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030746186&partnerID=8YFLogxK

U2 - 10.11250/chemotherapy1995.45.442

DO - 10.11250/chemotherapy1995.45.442

M3 - Article

AN - SCOPUS:0030746186

SN - 1340-7007

VL - 45

SP - 442

EP - 462

JO - Japanese Journal of Chemotherapy

JF - Japanese Journal of Chemotherapy

IS - 6

ER -

Double-blind study on grepafloxacin in pneumonia

Abstract

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