Clinical evaluation of cefotiam hexetil in bacterial pneumonia: Double-blind controlled trial using cefaclor as a standard drug

Atsushi Saito, Yoshiteru Shigeno, Yuei Irabu, Yoshikazu Kawakami, Shosaku Abe, Tsuguo Terai, Takashi Yoshikawa, Tatsuo Nagai, Hidekazu Inaba, Akira Saito, Masumi Tomizawa, Ichiro Nakayama, Osamu Yajima, Yohmei Hiraga, Mitsuhide Ohmichi, Susumu Ito, Akiji Kasagi, Kazuo Takebe, Takeshi Osonoi, Masato HayashiJun Hori, Kenjiro Akai, Masahiro Yaekashiwa, Kiyoshi Konno, Kotaro Oizumi, Seiichi Aonuma, Kohsaku Nagai, Hiroyuki Nakai, Junichi Saito, Teruo Hasuike, Izumi Hayashi, Masataka Katsu, Shinji Okui, Toshio Fukui, Satoki Honma, Fuyuhiko Higashi, Satoshi Kitamura, Ryokuro Matsuoka, Kaoru Shimada, Hajime Orimo, Kenzo Terashita, Yasuyuki Sano, Yasufumi Miyamoto, Kazufuto Fukaya, Hikaru Nakata, Yasushi Ueda, Atsushi Saito, Jingoro Shimada, Kohya Shiba, Tadashi Miyahara, Otohiko Kunii, Norio Nozue, Hiroyuki Kobayashi, Hiroshi Oshitani, Keimei Mashimo, Yoshiji Yamane, Syoichi Kato, Takao Tashiro, Hiroichi Tanimoto, Koichiro Nakata, Yoshitaka Nakamori, Naohiko Chonabayashi, Kentaro Watanabe, Masaru Koyama, Shoichiro Irimajiri, Yasuo Matsuoka, Yasuhisa Kitagawa, Ippei Fujimori, Yoshio Kobayashi, Takao Okubo, Akira Ito, Hirotada Ikeda, Shigeki Odagiri, Kaneo Suzuki, Kou Murohashi, Fumio Matsumoto, Masaaki Arakawa, Kouichi Wada, Osamu Sekine, Nobuki Aoki, Kaoru Oyama, Toshiyuki Yamamoto, Kanzo Suzuki, Kazuhide Yamamoto, Toshihiko Takeuchi, Masahito Kato, Joichi Kato, Yasuo Yamada, Hidekazu Hanaki, Go Ito, Shunsaku Oshima, Takateru Izumi, Shinichiro Heki, Naoki Fujimura, Hitoshi Asamoto, Sadao Ikeda, Michio Nakajima, Fumio Miki, Toshio Terashita, Rinzo Soejima, Yoshihito Niki, Takao Sasaki, Yukio Matsumoto, Yuji Sugimoto, Yoshiro Sawae, Toshiyuki Ishimaru, Koji Takagi, Takayoshi Yamane, Kazuhiro Hayashida, Yukio Kumagaya, Michio Fukuma, Hiroshi Murata, Hideyuki Gondo, Masahide Takii, Mikio Sato, Takafumi Ohdo, Masaru Nasu, Hideaki Shigeno, Kohei Hara, Shigeru Kohno, Toshiaki Hayashi, Mitsuo Kaku, Yuichi Inoue, Kazuo Sasayama, Akira Yasuoka, Kinichi Izumikawa, Kohichi Watanabe, Kazuhiro Okuno, Kohta Kohno, Naomi Ito, Hiromaru Iwasaki, Hiroshige Oda, Keizo Matsumoto, Tsuyoshi Nagatake, Toshiaki Yoshida, Masayuki Ando, Moritaka Suga, Keizo Yamaguchi, Kazuyuki Sugawara, Nobuya Ogawa

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Using a double-blind controlled trial, we compared the clinical efficacy, safety and usefulness of cefotiam hexetil (CTM-HE) with those of cefaclor (CCL) in patients with bacterial pneumonia. Patients with obvious clinical signs and symptoms were given orally CTM-HE (at a daily dose of 600 mg) or CCL (at a daily dose of 1, 500 mg) for 14 days as a rule. We then assessed clinical and bacteriological efficacy, improvement in signs and symptoms, side effects, changes in laboratory findings and clinical usefulness. The results were as follows: 1) The clinical efficacy rate (excellent and good) was: in the committee's evaluation, 79.0%(64/81) for CTM-HE versus 83.3%(65/78) for CCL, and in the attending physician's evaluation, 77.0%(77/100) for CTM-HE versus 78.9%(75/95) for CCL. Thus, both evaluations generated similar results. 2) As to bacteriological effect, the eradication rate was 76.5%(26/34) for CTM-HE versus 83.9%(26/31) for CCL. 3) The safety evaluation showed that the two drugs were almost equivalent with regard to the incidence of side effects: 2.0%(2/102) for CTM-HE versus 3.0%(3/99) for CCL, and abnormal laboratory findings: 24.2%(23/95) for CTM-HE versus 18.7%(17/91) for CCL. With both drugs, gastrointestinal disorders and fever were found as accompanying symptoms, and most of the abnormal laboratory findings were eosinophilia and changes in liver function. No side effects were found particularly different from those reported with cephems.

Original languageEnglish
Pages (from-to)59-83
Number of pages25
JournalChemotherapy
Volume37
Issue number1
DOIs
Publication statusPublished - 1989

ASJC Scopus subject areas

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

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  • Cite this

    Saito, A., Shigeno, Y., Irabu, Y., Kawakami, Y., Abe, S., Terai, T., Yoshikawa, T., Nagai, T., Inaba, H., Saito, A., Tomizawa, M., Nakayama, I., Yajima, O., Hiraga, Y., Ohmichi, M., Ito, S., Kasagi, A., Takebe, K., Osonoi, T., ... Ogawa, N. (1989). Clinical evaluation of cefotiam hexetil in bacterial pneumonia: Double-blind controlled trial using cefaclor as a standard drug. Chemotherapy, 37(1), 59-83. https://doi.org/10.11250/chemotherapy1953.37.59