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 journalArticle

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 languageEnglish
Pages (from-to)53-69
Number of pages17
JournalChemotherapy
Volume42
Issue number1
DOIs
Publication statusPublished - 1994

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases
  • Pharmacology
  • Drug Discovery
  • Oncology

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  • 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