A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections

Rinzo Soejima; Hiroshi Kawane; Niro Okimoto; Osamu Tatara; Akira Saito; Ichiro Nakayama; Masumi Tomizawa; Kotaro Oizumi; Akira Watanabe; Izumi Hayashi; Nobuki Aoki; Jingoro Shimada; Atsushi Saito; Kohya Shiba; Masanobu Kaji; Masaki Yoshida; Osamu Sakai; Hiroyuki Kobayashi; Takashi Inoue; Koichiro Nakata; Tatsuo Nakatani; Yoshitaka Nakamori; Naohiko Chonabayashi; Kohji Narui; Eiyasu Tuboi; Kihachiro Shimizu; Junichi Katahira; Kaoru Shimada; Yasuyuki Sano; Yasufumi Miyamoto; Fumio Matsumoto; Takero Imai; Shigeki Odagiri; Kaneo Suzuki; Toshihiko Takeuchi; Yoshimitsu Hayashi; Hidekazu Hanaki; Fumio Miki; Nobuhiro Narita; Masayoshi Sawaki; Keiichi Mikasa; Takao Sasaki; Yukio Matsumoto; Yuji Sugimoto; Hidemi Teramoto; Toshiharu Matsushima; Makoto Kimura; Kenji Hasegawa; Michio Yamakido; Shunsuke Takami; Yukio Nishimoto; Yosiro Sawae; Masaru Nasu; Yoichiro Goto; Hiroyuki Nagai; Jun Goto; Kohei Hara; Shigeru Kono; Yasumasa Doutsu; Takashige Miyazaki; Akira Sakamoto; Koichi Watanabe; Sadahiro Asai; Hideo Mashimoto; Keizo Matsumoto; Kazunori Oishi; Yuei Irabu; Keizo Yamaguchi; Kazuyuki Sugawara; Mituyoshi Nakashima

doi:10.11250/chemotherapy1953.39.Supplement4_385

A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections

Rinzo Soejima, Hiroshi Kawane, Niro Okimoto, Osamu Tatara, Akira Saito, Ichiro Nakayama, Masumi Tomizawa, Kotaro Oizumi, Akira Watanabe, Izumi Hayashi, Nobuki Aoki, Jingoro Shimada, Atsushi Saito, Kohya Shiba, Masanobu Kaji, Masaki Yoshida, Osamu Sakai, Hiroyuki Kobayashi, Takashi Inoue, Koichiro NakataTatsuo Nakatani, Yoshitaka Nakamori, Naohiko Chonabayashi, Kohji Narui, Eiyasu Tuboi, Kihachiro Shimizu, Junichi Katahira, Kaoru Shimada, Yasuyuki Sano, Yasufumi Miyamoto, Fumio Matsumoto, Takero Imai, Shigeki Odagiri, Kaneo Suzuki, Toshihiko Takeuchi, Yoshimitsu Hayashi, Hidekazu Hanaki, Fumio Miki, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Takao Sasaki, Yukio Matsumoto, Yuji Sugimoto, Hidemi Teramoto, Toshiharu Matsushima, Makoto Kimura, Kenji Hasegawa, Michio Yamakido, Shunsuke Takami, Yukio Nishimoto, Yosiro Sawae, Masaru Nasu, Yoichiro Goto, Hiroyuki Nagai, Jun Goto, Kohei Hara, Shigeru Kono, Yasumasa Doutsu, Takashige Miyazaki, Akira Sakamoto, Koichi Watanabe, Sadahiro Asai, Hideo Mashimoto, Keizo Matsumoto, Kazunori Oishi, Yuei Irabu, Keizo Yamaguchi, Kazuyuki Sugawara, Mituyoshi Nakashima

Research output: Contribution to journal › Article › peer-review

Abstract

A dose-finding study on sparfloxacin (SPFX : AT-4140), a new quinolone antimicrobial, was conducted by the double blind comparative design in patients with chronic respiratory tract infections. The patients were classified into three groups. Namely, SPFX 200 group was administered SPFX in a daily dose of 200 mg, SPFX 300 group received a daily dose of 300 mg SPFX, and ENX group received enoxacin (ENX), as a control, in a daily dose of 600 mg (200 mgX 3). The total number of patients enrolled in the trial was 148, of which 138 cases (48, 48, and 42 in SPFX 200, SPFX 300, and ENX groups, respectively), and 146 cases (52, 49 and 45 as grouped and ordered above), were evaluable by the committee for clinical efficacy and side effects, respectively. 1 ) The backgrounds of patients were well-balanced among the three groups. 2) The clinical efficacy rates were 72.9% for SPFX 200, 72.9% for SPFX 300, and 71.4% for ENX. In patients with only chronic bronchitis, the efficacy rate was 69.6%, 82.8% and 77.8%, respectively. The efficacy rate was highest in SPFX 300 group, but there was no significant difference among the three groups. 3) The bacterial eradication rates were 85.7%. 79.2% and 66.7%, without any significant difference in the three groups. 4 ) In the safety evaluation, the side effect rates were 7.7%. 12.2% and 11.1%, and the abnormal laboratory findings rates were 13.0%, 10.6% and 11.9%. There were no significant differences in the two safety evaluations. 5) The usefulness rates were 68.2%, 69.6% and 70.0%, without any significant difference among the three groups. These results indicate that SPFX in a daily dose of 200 mg and 300 mg, and 600 mg daily ENX in three 200 mg doses, are almost equivalent in both efficacy and safety for patients with chronic respiratory tract infections. However, among the three groups tested, a 300 mg dosage of SPFX was most excellent in patients with only chronic bronchitis. Therefore, the 300 mg daily dose was considered to be an appropriate medication for such intractable chronic respiratory tract infections.

Original language	English
Pages (from-to)	385-404
Number of pages	20
Journal	Chemotherapy
Volume	39
DOIs	https://doi.org/10.11250/chemotherapy1953.39.Supplement4_385
Publication status	Published - 1991
Externally published	Yes

ASJC Scopus subject areas

Pharmacology (medical)
Infectious Diseases
Pharmacology
Drug Discovery
Oncology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.11250/chemotherapy1953.39.Supplement4_385

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Soejima, R., Kawane, H., Okimoto, N., Tatara, O., Saito, A., Nakayama, I., Tomizawa, M., Oizumi, K., Watanabe, A., Hayashi, I., Aoki, N., Shimada, J., Saito, A., Shiba, K., Kaji, M., Yoshida, M., Sakai, O., Kobayashi, H., Inoue, T., ... Nakashima, M. (1991). A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections. Chemotherapy, 39, 385-404. https://doi.org/10.11250/chemotherapy1953.39.Supplement4_385

Soejima, R, Kawane, H, Okimoto, N, Tatara, O, Saito, A, Nakayama, I, Tomizawa, M, Oizumi, K, Watanabe, A, Hayashi, I, Aoki, N, Shimada, J, Saito, A, Shiba, K, Kaji, M, Yoshida, M, Sakai, O, Kobayashi, H, Inoue, T, Nakata, K, Nakatani, T, Nakamori, Y, Chonabayashi, N, Narui, K, Tuboi, E, Shimizu, K, Katahira, J, Shimada, K, Sano, Y, Miyamoto, Y, Matsumoto, F, Imai, T, Odagiri, S, Suzuki, K, Takeuchi, T, Hayashi, Y, Hanaki, H, Miki, F, Narita, N, Sawaki, M, Mikasa, K, Sasaki, T, Matsumoto, Y, Sugimoto, Y, Teramoto, H, Matsushima, T, Kimura, M, Hasegawa, K, Yamakido, M, Takami, S, Nishimoto, Y, Sawae, Y, Nasu, M, Goto, Y, Nagai, H, Goto, J, Hara, K, Kono, S, Doutsu, Y, Miyazaki, T, Sakamoto, A, Watanabe, K, Asai, S, Mashimoto, H, Matsumoto, K, Oishi, K, Irabu, Y, Yamaguchi, K, Sugawara, K & Nakashima, M 1991, 'A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections', Chemotherapy, vol. 39, pp. 385-404. https://doi.org/10.11250/chemotherapy1953.39.Supplement4_385

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title = "A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections",

abstract = "A dose-finding study on sparfloxacin (SPFX : AT-4140), a new quinolone antimicrobial, was conducted by the double blind comparative design in patients with chronic respiratory tract infections. The patients were classified into three groups. Namely, SPFX 200 group was administered SPFX in a daily dose of 200 mg, SPFX 300 group received a daily dose of 300 mg SPFX, and ENX group received enoxacin (ENX), as a control, in a daily dose of 600 mg (200 mgX 3). The total number of patients enrolled in the trial was 148, of which 138 cases (48, 48, and 42 in SPFX 200, SPFX 300, and ENX groups, respectively), and 146 cases (52, 49 and 45 as grouped and ordered above), were evaluable by the committee for clinical efficacy and side effects, respectively. 1 ) The backgrounds of patients were well-balanced among the three groups. 2) The clinical efficacy rates were 72.9% for SPFX 200, 72.9% for SPFX 300, and 71.4% for ENX. In patients with only chronic bronchitis, the efficacy rate was 69.6%, 82.8% and 77.8%, respectively. The efficacy rate was highest in SPFX 300 group, but there was no significant difference among the three groups. 3) The bacterial eradication rates were 85.7%. 79.2% and 66.7%, without any significant difference in the three groups. 4 ) In the safety evaluation, the side effect rates were 7.7%. 12.2% and 11.1%, and the abnormal laboratory findings rates were 13.0%, 10.6% and 11.9%. There were no significant differences in the two safety evaluations. 5) The usefulness rates were 68.2%, 69.6% and 70.0%, without any significant difference among the three groups. These results indicate that SPFX in a daily dose of 200 mg and 300 mg, and 600 mg daily ENX in three 200 mg doses, are almost equivalent in both efficacy and safety for patients with chronic respiratory tract infections. However, among the three groups tested, a 300 mg dosage of SPFX was most excellent in patients with only chronic bronchitis. Therefore, the 300 mg daily dose was considered to be an appropriate medication for such intractable chronic respiratory tract infections.",

author = "Rinzo Soejima and Hiroshi Kawane and Niro Okimoto and Osamu Tatara and Akira Saito and Ichiro Nakayama and Masumi Tomizawa and Kotaro Oizumi and Akira Watanabe and Izumi Hayashi and Nobuki Aoki and Jingoro Shimada and Atsushi Saito and Kohya Shiba and Masanobu Kaji and Masaki Yoshida and Osamu Sakai and Hiroyuki Kobayashi and Takashi Inoue and Koichiro Nakata and Tatsuo Nakatani and Yoshitaka Nakamori and Naohiko Chonabayashi and Kohji Narui and Eiyasu Tuboi and Kihachiro Shimizu and Junichi Katahira and Kaoru Shimada and Yasuyuki Sano and Yasufumi Miyamoto and Fumio Matsumoto and Takero Imai and Shigeki Odagiri and Kaneo Suzuki and Toshihiko Takeuchi and Yoshimitsu Hayashi and Hidekazu Hanaki and Fumio Miki and Nobuhiro Narita and Masayoshi Sawaki and Keiichi Mikasa and Takao Sasaki and Yukio Matsumoto and Yuji Sugimoto and Hidemi Teramoto and Toshiharu Matsushima and Makoto Kimura and Kenji Hasegawa and Michio Yamakido and Shunsuke Takami and Yukio Nishimoto and Yosiro Sawae and Masaru Nasu and Yoichiro Goto and Hiroyuki Nagai and Jun Goto and Kohei Hara and Shigeru Kono and Yasumasa Doutsu and Takashige Miyazaki and Akira Sakamoto and Koichi Watanabe and Sadahiro Asai and Hideo Mashimoto and Keizo Matsumoto and Kazunori Oishi and Yuei Irabu and Keizo Yamaguchi and Kazuyuki Sugawara and Mituyoshi Nakashima",

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doi = "10.11250/chemotherapy1953.39.Supplement4_385",

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pages = "385--404",

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T1 - A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections

AU - Soejima, Rinzo

AU - Kawane, Hiroshi

AU - Okimoto, Niro

AU - Tatara, Osamu

AU - Saito, Akira

AU - Nakayama, Ichiro

AU - Tomizawa, Masumi

AU - Oizumi, Kotaro

AU - Watanabe, Akira

AU - Hayashi, Izumi

AU - Aoki, Nobuki

AU - Shimada, Jingoro

AU - Saito, Atsushi

AU - Shiba, Kohya

AU - Kaji, Masanobu

AU - Yoshida, Masaki

AU - Sakai, Osamu

AU - Kobayashi, Hiroyuki

AU - Inoue, Takashi

AU - Nakata, Koichiro

AU - Nakatani, Tatsuo

AU - Nakamori, Yoshitaka

AU - Chonabayashi, Naohiko

AU - Narui, Kohji

AU - Tuboi, Eiyasu

AU - Shimizu, Kihachiro

AU - Katahira, Junichi

AU - Shimada, Kaoru

AU - Sano, Yasuyuki

AU - Miyamoto, Yasufumi

AU - Matsumoto, Fumio

AU - Imai, Takero

AU - Odagiri, Shigeki

AU - Suzuki, Kaneo

AU - Takeuchi, Toshihiko

AU - Hayashi, Yoshimitsu

AU - Hanaki, Hidekazu

AU - Miki, Fumio

AU - Narita, Nobuhiro

AU - Sawaki, Masayoshi

AU - Mikasa, Keiichi

AU - Sasaki, Takao

AU - Matsumoto, Yukio

AU - Sugimoto, Yuji

AU - Teramoto, Hidemi

AU - Matsushima, Toshiharu

AU - Kimura, Makoto

AU - Hasegawa, Kenji

AU - Yamakido, Michio

AU - Takami, Shunsuke

AU - Nishimoto, Yukio

AU - Sawae, Yosiro

AU - Nasu, Masaru

AU - Goto, Yoichiro

AU - Nagai, Hiroyuki

AU - Goto, Jun

AU - Hara, Kohei

AU - Kono, Shigeru

AU - Doutsu, Yasumasa

AU - Miyazaki, Takashige

AU - Sakamoto, Akira

AU - Watanabe, Koichi

AU - Asai, Sadahiro

AU - Mashimoto, Hideo

AU - Matsumoto, Keizo

AU - Oishi, Kazunori

AU - Irabu, Yuei

AU - Yamaguchi, Keizo

AU - Sugawara, Kazuyuki

AU - Nakashima, Mituyoshi

PY - 1991

Y1 - 1991

N2 - A dose-finding study on sparfloxacin (SPFX : AT-4140), a new quinolone antimicrobial, was conducted by the double blind comparative design in patients with chronic respiratory tract infections. The patients were classified into three groups. Namely, SPFX 200 group was administered SPFX in a daily dose of 200 mg, SPFX 300 group received a daily dose of 300 mg SPFX, and ENX group received enoxacin (ENX), as a control, in a daily dose of 600 mg (200 mgX 3). The total number of patients enrolled in the trial was 148, of which 138 cases (48, 48, and 42 in SPFX 200, SPFX 300, and ENX groups, respectively), and 146 cases (52, 49 and 45 as grouped and ordered above), were evaluable by the committee for clinical efficacy and side effects, respectively. 1 ) The backgrounds of patients were well-balanced among the three groups. 2) The clinical efficacy rates were 72.9% for SPFX 200, 72.9% for SPFX 300, and 71.4% for ENX. In patients with only chronic bronchitis, the efficacy rate was 69.6%, 82.8% and 77.8%, respectively. The efficacy rate was highest in SPFX 300 group, but there was no significant difference among the three groups. 3) The bacterial eradication rates were 85.7%. 79.2% and 66.7%, without any significant difference in the three groups. 4 ) In the safety evaluation, the side effect rates were 7.7%. 12.2% and 11.1%, and the abnormal laboratory findings rates were 13.0%, 10.6% and 11.9%. There were no significant differences in the two safety evaluations. 5) The usefulness rates were 68.2%, 69.6% and 70.0%, without any significant difference among the three groups. These results indicate that SPFX in a daily dose of 200 mg and 300 mg, and 600 mg daily ENX in three 200 mg doses, are almost equivalent in both efficacy and safety for patients with chronic respiratory tract infections. However, among the three groups tested, a 300 mg dosage of SPFX was most excellent in patients with only chronic bronchitis. Therefore, the 300 mg daily dose was considered to be an appropriate medication for such intractable chronic respiratory tract infections.

AB - A dose-finding study on sparfloxacin (SPFX : AT-4140), a new quinolone antimicrobial, was conducted by the double blind comparative design in patients with chronic respiratory tract infections. The patients were classified into three groups. Namely, SPFX 200 group was administered SPFX in a daily dose of 200 mg, SPFX 300 group received a daily dose of 300 mg SPFX, and ENX group received enoxacin (ENX), as a control, in a daily dose of 600 mg (200 mgX 3). The total number of patients enrolled in the trial was 148, of which 138 cases (48, 48, and 42 in SPFX 200, SPFX 300, and ENX groups, respectively), and 146 cases (52, 49 and 45 as grouped and ordered above), were evaluable by the committee for clinical efficacy and side effects, respectively. 1 ) The backgrounds of patients were well-balanced among the three groups. 2) The clinical efficacy rates were 72.9% for SPFX 200, 72.9% for SPFX 300, and 71.4% for ENX. In patients with only chronic bronchitis, the efficacy rate was 69.6%, 82.8% and 77.8%, respectively. The efficacy rate was highest in SPFX 300 group, but there was no significant difference among the three groups. 3) The bacterial eradication rates were 85.7%. 79.2% and 66.7%, without any significant difference in the three groups. 4 ) In the safety evaluation, the side effect rates were 7.7%. 12.2% and 11.1%, and the abnormal laboratory findings rates were 13.0%, 10.6% and 11.9%. There were no significant differences in the two safety evaluations. 5) The usefulness rates were 68.2%, 69.6% and 70.0%, without any significant difference among the three groups. These results indicate that SPFX in a daily dose of 200 mg and 300 mg, and 600 mg daily ENX in three 200 mg doses, are almost equivalent in both efficacy and safety for patients with chronic respiratory tract infections. However, among the three groups tested, a 300 mg dosage of SPFX was most excellent in patients with only chronic bronchitis. Therefore, the 300 mg daily dose was considered to be an appropriate medication for such intractable chronic respiratory tract infections.

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A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections

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