Dose-finding study on SY 5555 in bacterial pneumonia

Atsushi Saito; Hiroshi Fukuhara; Jun Inadome; Yuei Irabu; Hajime Ohshiro; Katsuyoshi Shimoji; Akira Saito; Ichiro Nakayama; Masumi Tomizawa; Yohmei Hiraga; Mitsuhide Ohmichi; Masashi Tamura; Kazuki Konishi; Akira Watanabe; Masakichi Motomiya; Tsukasa Yoshida; Kenichi Takeuchi; Yoshio Uzuka; Kaoru Shimada; Shinichi Oka; Yasuyuki Sano; Kohya Siba; Masaki Yoshida; Osamu Sakai; Hiroichi Tanimoto; Kazuo Ohara; Tetsuo Okamura; Atushi Saito; Koichiro Nakata; Koji Narui; Hiroyuki Kobayashi; Shin Kawai; Koichiro Kudo; Haruhito Sugiyama; Hitoshi Arioka; Junzaburo Kabe; Harumi Shishido; Hideaki Nagai; Koji Sato; Shoichiro Irimajiri; Yasuo Matsuoka; Kensuke Tsukada; Jingoro Shimada; Seiji Hori; Fumio Matsumoto; Takeo Imai; Shigeki Odagiri; Hiroshi Takahashi; Nobuki Aoki; Yasutoshi Suzuki; Osamu Sekine; Atsuhiko Sato; Kingo Chida; Atsushi Yoshitomi; Takeshi Yagi; Akihiko Okano; Hirokazu Okano; Toshihiko Takeuchi; Kazuhide Yamamoto; Yasuo Yamada; Ikuji Usami; Toshiyuki Yamamoto; Kanzo Suzuki; Satoru Adachi; Fumio Miki; Rinzo Soejima; Yoshihito Niki; Niro Okimoto; Toshiharu Matsushima; Makoto Kimura; Kotaro Oizumi; Takafumi Yano; Tsuneo Ishibashi; Masahiro Takamoto; Kohei Hara; Shigeru Kohno; Hironobu Koga; Mitsuo Kaku; Koichi Watanabe; Naofumi Suyama; Jun Araki; Yuichi Inoue; Takakazu Ohtsubo; Keizo Matsumoto; Akitaka Iwagaki; Kazunori Ohishi; Masakazu Takasugi; Masaru Nasu; Yoichiro Goto; Toru Yamasaki; Hiroyuki Nagai; Jun Goto; Hiroshi Nagaoka; Mitsuyoshi Nakashima; Keizo Yamaguchi; Yoichi Hirakata; Fusako Kashitani

doi:10.11250/chemotherapy1953.42.53

Dose-finding study on SY 5555 in bacterial pneumonia

Atsushi Saito, Hiroshi Fukuhara, Jun Inadome, Yuei Irabu, Hajime Ohshiro, Katsuyoshi Shimoji, Akira Saito, Ichiro Nakayama, Masumi Tomizawa, Yohmei Hiraga, Mitsuhide Ohmichi, Masashi Tamura, Kazuki Konishi, Akira Watanabe, Masakichi Motomiya, Tsukasa Yoshida, Kenichi Takeuchi, Yoshio Uzuka, Kaoru Shimada, Shinichi OkaYasuyuki Sano, Kohya Siba, Masaki Yoshida, Osamu Sakai, Hiroichi Tanimoto, Kazuo Ohara, Tetsuo Okamura, Atushi Saito, Koichiro Nakata, Koji Narui, Hiroyuki Kobayashi, Shin Kawai, Koichiro Kudo, Haruhito Sugiyama, Hitoshi Arioka, Junzaburo Kabe, Harumi Shishido, Hideaki Nagai, Koji Sato, Shoichiro Irimajiri, Yasuo Matsuoka, Kensuke Tsukada, Jingoro Shimada, Seiji Hori, Fumio Matsumoto, Takeo Imai, Shigeki Odagiri, Hiroshi Takahashi, Nobuki Aoki, Yasutoshi Suzuki, Osamu Sekine, Atsuhiko Sato, Kingo Chida, Atsushi Yoshitomi, Takeshi Yagi, Akihiko Okano, Hirokazu Okano, Toshihiko Takeuchi, Kazuhide Yamamoto, Yasuo Yamada, Ikuji Usami, Toshiyuki Yamamoto, Kanzo Suzuki, Satoru Adachi, Fumio Miki, Rinzo Soejima, Yoshihito Niki, Niro Okimoto, Toshiharu Matsushima, Makoto Kimura, Kotaro Oizumi, Takafumi Yano, Tsuneo Ishibashi, Masahiro Takamoto, Kohei Hara, Shigeru Kohno, Hironobu Koga, Mitsuo Kaku, Koichi Watanabe, Naofumi Suyama, Jun Araki, Yuichi Inoue, Takakazu Ohtsubo, Keizo Matsumoto, Akitaka Iwagaki, Kazunori Ohishi, Masakazu Takasugi, Masaru Nasu, Yoichiro Goto, Toru Yamasaki, Hiroyuki Nagai, Jun Goto, Hiroshi Nagaoka, Mitsuyoshi Nakashima, Keizo Yamaguchi, Yoichi Hirakata, Fusako Kashitani

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

Abstract

To evaluate the appropriate dosage regimen for SY 5555, a new oral penem, in the treatment of bacterial pneumonia, a dose-finding comparative study, using cefotiam hexetil (CTM-HE) as the control drug, was conducted in various clinical institutes. Patients were given a daily dose of 600mg (L-group) of SY 5555, 900 mg of SY 5555 (H-group) or 600 mg of CTM-HE (C-group) for a period of 14 days. All dosages were divided into three administrations per day. 1. The clinical efficacy rates were 88.9%(24/27) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. 2. Bacteriologically, the eradication rates were 57.1%(4/7) in the L-group, 81.8%(9/11) in the H-group and 75.0%(6/8) in the C-group. 3. As side effects, gastro-intestinal symptoms were mainly observed in 6 of 32 patients in the L-group and 2 of 29 patients in the H-group. No adverse reaction was observed in the C-group. 4. The incidence of abnormal changes in laboratory findings were 13.8%(4/29) in the L-group, 21.4%(6/28) in the H-group and 14.8%(4/27) in the C-group. 5. The total usefulness rates were 75.9%(22/29) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. From the above findings, especially, the results of bacteriological effect and usefulness, we concluded that a daily dose of 300 mg t.i.d. was the suitable clinical dosage regimen for SY 5555 in the treatment of bacterial pneumonia.

Original language	English
Pages (from-to)	53-69
Number of pages	17
Journal	Chemotherapy
Volume	42
Issue number	1
DOIs	https://doi.org/10.11250/chemotherapy1953.42.53
Publication status	Published - 1994
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/chemotherapy1953.42.53

Cite this

Saito, A., Fukuhara, H., Inadome, J., Irabu, Y., Ohshiro, H., Shimoji, K., Saito, A., Nakayama, I., Tomizawa, M., Hiraga, Y., Ohmichi, M., Tamura, M., Konishi, K., Watanabe, A., Motomiya, M., Yoshida, T., Takeuchi, K., Uzuka, Y., Shimada, K., ... Kashitani, F. (1994). Dose-finding study on SY 5555 in bacterial pneumonia. Chemotherapy, 42(1), 53-69. https://doi.org/10.11250/chemotherapy1953.42.53

Saito, A, Fukuhara, H, Inadome, J, Irabu, Y, Ohshiro, H, Shimoji, K, Saito, A, Nakayama, I, Tomizawa, M, Hiraga, Y, Ohmichi, M, Tamura, M, Konishi, K, Watanabe, A, Motomiya, M, Yoshida, T, Takeuchi, K, Uzuka, Y, Shimada, K, Oka, S, Sano, Y, Siba, K, Yoshida, M, Sakai, O, Tanimoto, H, Ohara, K, Okamura, T, Saito, A, Nakata, K, Narui, K, Kobayashi, H, Kawai, S, Kudo, K, Sugiyama, H, Arioka, H, Kabe, J, Shishido, H, Nagai, H, Sato, K, Irimajiri, S, Matsuoka, Y, Tsukada, K, Shimada, J, Hori, S, Matsumoto, F, Imai, T, Odagiri, S, Takahashi, H, Aoki, N, Suzuki, Y, Sekine, O, Sato, A, Chida, K, Yoshitomi, A, Yagi, T, Okano, A, Okano, H, Takeuchi, T, Yamamoto, K, Yamada, Y, Usami, I, Yamamoto, T, Suzuki, K, Adachi, S, Miki, F, Soejima, R, Niki, Y, Okimoto, N, Matsushima, T, Kimura, M, Oizumi, K, Yano, T, Ishibashi, T, Takamoto, M, Hara, K, Kohno, S, Koga, H, Kaku, M, Watanabe, K, Suyama, N, Araki, J, Inoue, Y, Ohtsubo, T, Matsumoto, K, Iwagaki, A, Ohishi, K, Takasugi, M, Nasu, M, Goto, Y, Yamasaki, T, Nagai, H, Goto, J, Nagaoka, H, Nakashima, M, Yamaguchi, K, Hirakata, Y & Kashitani, F 1994, 'Dose-finding study on SY 5555 in bacterial pneumonia', Chemotherapy, vol. 42, no. 1, pp. 53-69. https://doi.org/10.11250/chemotherapy1953.42.53

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title = "Dose-finding study on SY 5555 in bacterial pneumonia",

abstract = "To evaluate the appropriate dosage regimen for SY 5555, a new oral penem, in the treatment of bacterial pneumonia, a dose-finding comparative study, using cefotiam hexetil (CTM-HE) as the control drug, was conducted in various clinical institutes. Patients were given a daily dose of 600mg (L-group) of SY 5555, 900 mg of SY 5555 (H-group) or 600 mg of CTM-HE (C-group) for a period of 14 days. All dosages were divided into three administrations per day. 1. The clinical efficacy rates were 88.9%(24/27) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. 2. Bacteriologically, the eradication rates were 57.1%(4/7) in the L-group, 81.8%(9/11) in the H-group and 75.0%(6/8) in the C-group. 3. As side effects, gastro-intestinal symptoms were mainly observed in 6 of 32 patients in the L-group and 2 of 29 patients in the H-group. No adverse reaction was observed in the C-group. 4. The incidence of abnormal changes in laboratory findings were 13.8%(4/29) in the L-group, 21.4%(6/28) in the H-group and 14.8%(4/27) in the C-group. 5. The total usefulness rates were 75.9%(22/29) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. From the above findings, especially, the results of bacteriological effect and usefulness, we concluded that a daily dose of 300 mg t.i.d. was the suitable clinical dosage regimen for SY 5555 in the treatment of bacterial pneumonia.",

author = "Atsushi Saito and Hiroshi Fukuhara and Jun Inadome and Yuei Irabu and Hajime Ohshiro and Katsuyoshi Shimoji and Akira Saito and Ichiro Nakayama and Masumi Tomizawa and Yohmei Hiraga and Mitsuhide Ohmichi and Masashi Tamura and Kazuki Konishi and Akira Watanabe and Masakichi Motomiya and Tsukasa Yoshida and Kenichi Takeuchi and Yoshio Uzuka and Kaoru Shimada and Shinichi Oka and Yasuyuki Sano and Kohya Siba and Masaki Yoshida and Osamu Sakai and Hiroichi Tanimoto and Kazuo Ohara and Tetsuo Okamura and Atushi Saito and Koichiro Nakata and Koji Narui and Hiroyuki Kobayashi and Shin Kawai and Koichiro Kudo and Haruhito Sugiyama and Hitoshi Arioka and Junzaburo Kabe and Harumi Shishido and Hideaki Nagai and Koji Sato and Shoichiro Irimajiri and Yasuo Matsuoka and Kensuke Tsukada and Jingoro Shimada and Seiji Hori and Fumio Matsumoto and Takeo Imai and Shigeki Odagiri and Hiroshi Takahashi and Nobuki Aoki and Yasutoshi Suzuki and Osamu Sekine and Atsuhiko Sato and Kingo Chida and Atsushi Yoshitomi and Takeshi Yagi and Akihiko Okano and Hirokazu Okano and Toshihiko Takeuchi and Kazuhide Yamamoto and Yasuo Yamada and Ikuji Usami and Toshiyuki Yamamoto and Kanzo Suzuki and Satoru Adachi and Fumio Miki and Rinzo Soejima and Yoshihito Niki and Niro Okimoto and Toshiharu Matsushima and Makoto Kimura and Kotaro Oizumi and Takafumi Yano and Tsuneo Ishibashi and Masahiro Takamoto and Kohei Hara and Shigeru Kohno and Hironobu Koga and Mitsuo Kaku and Koichi Watanabe and Naofumi Suyama and Jun Araki and Yuichi Inoue and Takakazu Ohtsubo and Keizo Matsumoto and Akitaka Iwagaki and Kazunori Ohishi and Masakazu Takasugi and Masaru Nasu and Yoichiro Goto and Toru Yamasaki and Hiroyuki Nagai and Jun Goto and Hiroshi Nagaoka and Mitsuyoshi Nakashima and Keizo Yamaguchi and Yoichi Hirakata and Fusako Kashitani",

year = "1994",

doi = "10.11250/chemotherapy1953.42.53",

language = "English",

volume = "42",

pages = "53--69",

journal = "CHEMOTHERAPY",

issn = "0009-3165",

number = "1",

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TY - JOUR

T1 - Dose-finding study on SY 5555 in bacterial pneumonia

AU - Saito, Atsushi

AU - Fukuhara, Hiroshi

AU - Inadome, Jun

AU - Irabu, Yuei

AU - Ohshiro, Hajime

AU - Shimoji, Katsuyoshi

AU - Saito, Akira

AU - Nakayama, Ichiro

AU - Tomizawa, Masumi

AU - Hiraga, Yohmei

AU - Ohmichi, Mitsuhide

AU - Tamura, Masashi

AU - Konishi, Kazuki

AU - Watanabe, Akira

AU - Motomiya, Masakichi

AU - Yoshida, Tsukasa

AU - Takeuchi, Kenichi

AU - Uzuka, Yoshio

AU - Shimada, Kaoru

AU - Oka, Shinichi

AU - Sano, Yasuyuki

AU - Siba, Kohya

AU - Yoshida, Masaki

AU - Sakai, Osamu

AU - Tanimoto, Hiroichi

AU - Ohara, Kazuo

AU - Okamura, Tetsuo

AU - Saito, Atushi

AU - Nakata, Koichiro

AU - Narui, Koji

AU - Kobayashi, Hiroyuki

AU - Kawai, Shin

AU - Kudo, Koichiro

AU - Sugiyama, Haruhito

AU - Arioka, Hitoshi

AU - Kabe, Junzaburo

AU - Shishido, Harumi

AU - Nagai, Hideaki

AU - Sato, Koji

AU - Irimajiri, Shoichiro

AU - Matsuoka, Yasuo

AU - Tsukada, Kensuke

AU - Shimada, Jingoro

AU - Hori, Seiji

AU - Matsumoto, Fumio

AU - Imai, Takeo

AU - Odagiri, Shigeki

AU - Takahashi, Hiroshi

AU - Aoki, Nobuki

AU - Suzuki, Yasutoshi

AU - Sekine, Osamu

AU - Sato, Atsuhiko

AU - Chida, Kingo

AU - Yoshitomi, Atsushi

AU - Yagi, Takeshi

AU - Okano, Akihiko

AU - Okano, Hirokazu

AU - Takeuchi, Toshihiko

AU - Yamamoto, Kazuhide

AU - Yamada, Yasuo

AU - Usami, Ikuji

AU - Yamamoto, Toshiyuki

AU - Suzuki, Kanzo

AU - Adachi, Satoru

AU - Miki, Fumio

AU - Soejima, Rinzo

AU - Niki, Yoshihito

AU - Okimoto, Niro

AU - Matsushima, Toshiharu

AU - Kimura, Makoto

AU - Oizumi, Kotaro

AU - Yano, Takafumi

AU - Ishibashi, Tsuneo

AU - Takamoto, Masahiro

AU - Hara, Kohei

AU - Kohno, Shigeru

AU - Koga, Hironobu

AU - Kaku, Mitsuo

AU - Watanabe, Koichi

AU - Suyama, Naofumi

AU - Araki, Jun

AU - Inoue, Yuichi

AU - Ohtsubo, Takakazu

AU - Matsumoto, Keizo

AU - Iwagaki, Akitaka

AU - Ohishi, Kazunori

AU - Takasugi, Masakazu

AU - Nasu, Masaru

AU - Goto, Yoichiro

AU - Yamasaki, Toru

AU - Nagai, Hiroyuki

AU - Goto, Jun

AU - Nagaoka, Hiroshi

AU - Nakashima, Mitsuyoshi

AU - Yamaguchi, Keizo

AU - Hirakata, Yoichi

AU - Kashitani, Fusako

PY - 1994

Y1 - 1994

N2 - To evaluate the appropriate dosage regimen for SY 5555, a new oral penem, in the treatment of bacterial pneumonia, a dose-finding comparative study, using cefotiam hexetil (CTM-HE) as the control drug, was conducted in various clinical institutes. Patients were given a daily dose of 600mg (L-group) of SY 5555, 900 mg of SY 5555 (H-group) or 600 mg of CTM-HE (C-group) for a period of 14 days. All dosages were divided into three administrations per day. 1. The clinical efficacy rates were 88.9%(24/27) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. 2. Bacteriologically, the eradication rates were 57.1%(4/7) in the L-group, 81.8%(9/11) in the H-group and 75.0%(6/8) in the C-group. 3. As side effects, gastro-intestinal symptoms were mainly observed in 6 of 32 patients in the L-group and 2 of 29 patients in the H-group. No adverse reaction was observed in the C-group. 4. The incidence of abnormal changes in laboratory findings were 13.8%(4/29) in the L-group, 21.4%(6/28) in the H-group and 14.8%(4/27) in the C-group. 5. The total usefulness rates were 75.9%(22/29) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. From the above findings, especially, the results of bacteriological effect and usefulness, we concluded that a daily dose of 300 mg t.i.d. was the suitable clinical dosage regimen for SY 5555 in the treatment of bacterial pneumonia.

AB - To evaluate the appropriate dosage regimen for SY 5555, a new oral penem, in the treatment of bacterial pneumonia, a dose-finding comparative study, using cefotiam hexetil (CTM-HE) as the control drug, was conducted in various clinical institutes. Patients were given a daily dose of 600mg (L-group) of SY 5555, 900 mg of SY 5555 (H-group) or 600 mg of CTM-HE (C-group) for a period of 14 days. All dosages were divided into three administrations per day. 1. The clinical efficacy rates were 88.9%(24/27) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. 2. Bacteriologically, the eradication rates were 57.1%(4/7) in the L-group, 81.8%(9/11) in the H-group and 75.0%(6/8) in the C-group. 3. As side effects, gastro-intestinal symptoms were mainly observed in 6 of 32 patients in the L-group and 2 of 29 patients in the H-group. No adverse reaction was observed in the C-group. 4. The incidence of abnormal changes in laboratory findings were 13.8%(4/29) in the L-group, 21.4%(6/28) in the H-group and 14.8%(4/27) in the C-group. 5. The total usefulness rates were 75.9%(22/29) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. From the above findings, especially, the results of bacteriological effect and usefulness, we concluded that a daily dose of 300 mg t.i.d. was the suitable clinical dosage regimen for SY 5555 in the treatment of bacterial pneumonia.

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U2 - 10.11250/chemotherapy1953.42.53

DO - 10.11250/chemotherapy1953.42.53

M3 - Article

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JO - CHEMOTHERAPY

JF - CHEMOTHERAPY

SN - 0009-3165

IS - 1

ER -

Dose-finding study on SY 5555 in bacterial pneumonia

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UN SDGs

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