Dose-finding comparative study of ritipenem acoxil in bacterial pneumonia by the double-blind method

Atsushi Saito, Akira Saito, Masumi Tomizawa, Yohmei Hiraga, Mitsuhide Ohmichi, Kazuki Konishi, Kazuo Obara, Masashi Tamura, Yasuo Tanno, Kunio Shirato, Akira Watanabe, Masakichi Motomiya, Kazuo Sato, Mitsunobu Homma, Toshio Nakamura, Shigeo Takizawa, Kohya Shiba, Osamu Sakai, Hiroichi Tanimoto, Hiroyuki KobayashiSusumu Sakayori, Noritaka Ohgaki, Kaoru Shimada, Shinichi Oka, Hirotaka Sugiyama, Takashi Inamatsu, Yasuyuki Sano, Yasuo Arai, Yasufumi Miyamoto, Koichiro Nakata, Yoshitaka Nakamori, Eiyasu Tsuboi, Izumi Hayashi, Masaru Koyama, Masataka Katsu, Akira Ohishi, Reiko Watanabe, Shoichiro Irimajiri, Yasuo Matsuoka, Atsushi Suzuki, Fumio Matsumoto, Iwao Sakurai, Shigeki Odagiri, Yoshihiro Hirai, Masaaki Arakawa, Koichi Wada, Fumihide Iwata, Shigeyuki Hoshino, Hiroki Tsukada, Takashi Kawashima, Nobuki Aoki, Yasutoshi Suzuki, Osamu Sekine, Atsuhiko Sato, Sumihito Morita, Izumi Shichi, Yutaka Nakano, Toshihiko Takeuchi, Yasuo Yamada, Yoshimitsu Hayashi, Katsutaka Torikai, Tatsuo Hamamoto, Kojiro Yasunaga, Seibun Yonezu, Yoshitaka Yamanaka, Fumio Miki, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Rinzo Soejima, Niro Okimoto, Toshiharu Matsushima, Makoto Kimura, Takao Sasaki, Yukio Matsumoto, Yoshiro Sawae, Kotaro Oizumi, Naoto Tokunaga, Masaru Nasu, Yoichiro Goto, Tohru Yamasaki, Kohei Hara, Yuichi Inoue, Takakazu Ohtsubo, Keizo Matsumoto, Yoshiaki Utsunomiya, Masakazu Takasugi, Tetsuji Sato, Atsushi Saito, Hiroshi Fukuhara, Jun Inadome, Tominori Oyakawa, Koichi Deguchi, Mitsuyoshi Nakashima

    Research output: Contribution to journalArticle

    Abstract

    To evaluate the clinically optimal dose of ritipenem acoxil (RIPM-AC), a new oral penem antibiotic, in respiratory tract infections, a dose-finding comparative study was conducted by the double-lind method in patients with bacterial pneumonia using cefotiam hexetil (CTM-HE) as a control drug. Patients were given 200 mg t. i. d. of RIPM-AC (L-group), 300 mg t. i. d. of RIPM-AC (H-group) or 200 mg t. i. d. of CTM-E (C-group). In principle, these drugs were administered for 14 days. The total number of patients enrolled in this trial was 118, of which 99 cases (L-group: 33, H-group: 31, C-group: 35) were evaluable for clinical efficacy. There were no significant differences in the distribution of background factors. 1) The clinical efficacy rates were 87.9%(29/33) in the L-group and 80.6%(25/31) in the H-group. There was no significant difference between the two groups. The clinical efficacy rate in the C-group was 91.4%(32/35). 2) The bacterial eradication rates (Eradicated+Replaced) were 70.0%(7/10) in the L-group and 72.7%(8/11) in the H-group. There was no significant difference between the two groups. The eradication rate in the C-group was 75.0%(9/12). 3) There were no cases of side effects in the L-group, but there were 2 cases (5.6%) in the H-group. Abnormal laboratory test findings were observed in 8 cases (21.6%) in the L-group and 11 cases (32.4%) in the H-group. There were no significant differences between the two groups in the incidence of side effects and abnormal laboratory test findings. The safety rates were 78.4%(29/37) in the L-group and 63.9%(23/36) in the H-group, with no significant difference. In the C-group, there were no patients with side effects. Abnormal laboratory test findings were observed in 10 cases (26.3%), and the safety rate was 74.4%(29/39). 4) The usefulness rates were 87.9%(29/33) in the L-group and 78.1%(25/32) in the H-group. There was no significant difference between the two groups. The usefulness rate in the C-group was 91.4%(32/35). From the above findings, we concluded that a daily dose of 200 mg t. i. d. was the clinically optimal dose for RIPM-AC in the treatment of bacterial pneumonia.

    Original languageEnglish
    Pages (from-to)200-217
    Number of pages18
    JournalJapanese Journal of Chemotherapy
    Volume43
    DOIs
    Publication statusPublished - 1995

    Keywords

    • bacterial pneumonia
    • cefotiam hexetil
    • dose-finding comparative study
    • penem antibiotics
    • ritipenem acoxil

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

    Fingerprint Dive into the research topics of 'Dose-finding comparative study of ritipenem acoxil in bacterial pneumonia by the double-blind method'. Together they form a unique fingerprint.

  • Cite this

    Saito, A., Saito, A., Tomizawa, M., Hiraga, Y., Ohmichi, M., Konishi, K., Obara, K., Tamura, M., Tanno, Y., Shirato, K., Watanabe, A., Motomiya, M., Sato, K., Homma, M., Nakamura, T., Takizawa, S., Shiba, K., Sakai, O., Tanimoto, H., ... Nakashima, M. (1995). Dose-finding comparative study of ritipenem acoxil in bacterial pneumonia by the double-blind method. Japanese Journal of Chemotherapy, 43, 200-217. https://doi.org/10.11250/chemotherapy1995.43.Supplement3_200