Comparative study on the efficacy of ritipenem acoxil and cefotiam hexetil in chronic lower respiratory tract infections by the double-blind method

Atsushi Saito, Akira Saito, Yoshikazu Kawakami, Etsuro Yamaguchi, Hiroyuki Koba, Shosaku Abe, Mitsuhide Ohmichi, Yohmei Hiraga, Kenjiro Kikuchi, Yoshinobu Ohsaki, Hiroyuki Matsumoto, Hiroshi Inoue, Masami Yoshida, Takashi Mouri, Hitoshi Kobayashi, Takashi Ito, Takeshi Bando, Kenichi Takeuchi, Haruto Hirano, Yukio TanifujiYasuo Tanno, Kunio Shirato, Makoto Takahashi, Masahiro Sakamoto, Toshihiro Nukiwa, Akira Watanabe, Kazuo Sato, Toshio Nakamura, Kenji Yanase, Kunio Dote, Mitsunobu Homma, Nobuo Ito, Akira Ohishi, Kiyoshi Fukuda, Atsushi Nakazawa, Masataka Katsu, Hiroyuki Kobayashi, Susumu Sakayori, Hiroshi Miura, Hidehiro Watanabe, Kaoru Shimada, Shinichi Oka, Hirotaka Sugiyama, Takashi Inamatsu, Yasuyuki Sano, Yasuo Arai, Mamoru Otomo, Hideo Kobayashi, Takashige Kuraki, Hiroyuki Tanaka, Harumi Shishido, Shoko Tanoue, Keiko Tsuchihashi, Izumi Hayashi, Masaru Koyama, Koichiro Kudo, Takeshi Koshino, Jun Akiyama, Takao Okubo, Kenji Tani, Hirotada Ikeda, Akira Shoji, Jun Chiba, Shigeru Ono, Atsuro Honda, Kunihiko Ikehara, Shoichiro Irimajiri, Yasuo Matsuoka, Mitsuo Obana, Fumio Matsumoto, Iwao Sakurai, Shigeki Odagiri, Takashi Ogura, Hiroshi Takahashi, Masaaki Arakawa, Koichi Wada, Fumihide Iwata, Yoshinori Shimazu, Hiroyuki Sega, Hiroki Tsukada, Takashi Kawashima, Nobuki Aoki, Yasutoshi Suzuki, Osamu Sekine, Atsuhiko Sato, Kingo Chida, Masatoshi Iwata, Izumi Shichi, Kazumasa Yasuda, Katsutaka Torikai, Kenzo Takagi, Yoshiaki Watanabe, Hiroyuki Taniguchi, Naohiro Yamashita, Isao Usui, Saburo Izumi, Fumiyuki Kuze, Kenji Bando, Shinichiro Ohyama, Hideki Nishiyama, Takakazu Sugita, Sadao Horikawa, Tadamitsu Kishimoto, Yoshiro Tanio, Akinori Ikeda, Masami Ito, Takeshi Okumoto, Seibun Yonezu, Fumio Miki, Kentaro Okawa, Shigenori Nakajima, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Kazuya Higashino, Takashi Nakano, Akio Maebo, Takahiko Yoshimoto, Takashi Sonoda, Shigeo Nomura, Kazuyuki Yamaguchi, Hiroshi Tokumoto, Masakiyo Nakagawa, Masataka Hirabayashi, Naoki Togawa, Masao Yoshida, Yoshitaka Kawai, Rinzo Soejima, Niro Okimoto, Toshiharu Matsushima, Makoto Kimura, Takao Sasaki, Yukio Matsumoto, Michio Yamakido, Shinichi Ishioka, Masao Kuwahara, Nobuhiro Mochizuki, Teruomi Miyazawa, Jitsuro Yanagida, Kenichi Arita, Kazuhiro Daido, Tsuyoshi Ejima, Saburo Sone, Kenji Tani, Satoshi Miki, Yoshiro Sawae, Koji Takaki, Minoru Yoshida, Takamichi Aritomi, Kotaro Oizumi, Yoichiro Ichikawa, Tsuneaki Shiraishi, Masashi Kawahara, Shinzo Kawaguchi, Tomotaka Kawayama, Yoshihiro Sato, Yoshiaki Honda, Tsuneo Ishibashi, Masahiro Takamoto, Akira Kajiki, Yasuko Harada, Hozumi Yamada, Nobumitsu Fujisawa, Masayuki Ando, Moritaka Suga, Toshinori Doi, Katsumasa Tokunaga, Kiyoshi Shima, Shinobu Takenaka, Kohei Hara, Shigeru Kohno, Mitsuo Kaku, Nobuhiro Koga, Yuichi Inoue, Yuko Yamashita, Shingo Sakata, Takeshi Fujii, Kenji Irifune, Kazunori Shimoguchi, Yoshitsugu Miyazaki, Takashi Watanabe, Yoshifumi Soejima, Keizo Matsumoto, Tsuyoshi Nagatake, Tasuku Sakamoto, Misao Tao, Hiroshi Yamashita, Masakazu Takasugi, Moritoshi Akiyama, Mikio Fujishita, Masaru Nasu, Tohru Yamasaki, Yoichiro Goto, Kaoru Nakama, Soichi Inoue, Shigeru Matsukura, Hideo Mashimoto, Hiroshi Mukae, Atsushi Saito, Hiroshi Fukuhara, Masao Tateyama, Tominori Oyakawa, Koichi Deguchi, Mitsuyoshi Nakashima

Research output: Contribution to journalReview articlepeer-review

4 Citations (Scopus)

Abstract

To objectively evaluate the efficacy, safety and usefulness of the newly developed penem oral antibiotic, ritipenem acoxil (RIPM-AC), against chronic lower respiratory tract infections, we conducted a multi-center double-blind comparative study using cefotiam hexetil (CTM-HE) as a control drug. RIPM-AC was orally administered at 200 mg, and CTM-HE at 400 mg, t.i.d. for 14 days, in principle. The results were as follows: The total number of patients enrolled in this trial was 202, of which 151 cases (RIPM-AC group: 75, CTM-HE group: 76) were evaluable for clinical efficacy. 1. The clinical efficacy rates (excellent+good) were 85.3% (64/75) in the RIPM-AC group and 80.3% (61/76) in the CTM-HE group. There was no significant difference between the two groups, hence the clinical equivalency of RIPM-AC to CTM-HE was demonstrated. 2. In the patients enrolled in the evaluation of clinical efficacy, the eradication rates of the causative organisms were 50.0% (13/26) in the RIPM-AC group and 75.0% (18/24) in the CTM-HE group, with no significant difference between the two groups. 3. Side effects were noted in 10 cases (11.0%) of the RIPM-AC group and 10 cases (10.9%) of the CTM-HE group. Abnormal laboratory test findings were observed in 8 cases(9.5%) of the RIPM-AC group and in 14 cases (16.7%) of the CTM-HE group. There were no significant differences between the two groups in the incidence of side effects and abnormal laboratory test findings. In the safety evaluation, RIPM-AC was judged to be safe in 73 cases (80.2%) and CTM-HE in 71 cases (77.2%), with no significant difference. 4. The usefulness rates (markedly useful+useful) were 79.5% (62/78) in the RIPM-AC group and 76.9% (60/78) in the CTM-HE group. There was no significant difference between the two groups. Since RIPM-AC showed clinical efficacy similar to those of CTM-HE and posed no particular safety problems, it is expected to be a useful antibiotic for the treatment of chronic lower respiratory tract infections.

Original languageEnglish
Pages (from-to)244-249
Number of pages6
JournalThe Japanese Journal of Antibiotics
Volume49
Issue number3
Publication statusPublished - 1996 Mar
Externally publishedYes

ASJC Scopus subject areas

  • Microbiology (medical)
  • Pharmacology (medical)
  • Infectious Diseases

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