Clinical Evaluation of Cefotiam Hexetil in Chronic Respiratory Tract Infections —Double-blind controlled trial using cefaclor as a positive control—

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, Toru Takijima, Yasuo Tanno, Kiyoshi Konno, Kotaro Oizumi, Akira Watanabe, Seiichi Aonuma, Hiroyuki Nakai, Junichi Saito, Teruo Hasuike, Izumi Hayashi, Masataka Katsu, Shinji Okui, Toshio Fukui, Satoki Honma, Satoshi Kitamura, Ryokuro Matsuoka, Kaoru Shimada, Yasuyuki Sano, Yasufumi Miyamoto, Koh Nakata, Jingoro Shimada, Kohya Shiba, Hiroyuki Kobayashi, Hiroshi Oshitani, Keimei Mashimo, Yoshiji Yamane, Masakazu 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, 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, Fumiyuki Kuse, Takako Murayama, Naoshi Nishimura, Shunsaku Oshima, Takateru Izumi, Kohichi Nishimura, Shinichiro Heki, Naoki Fujimura, Hitoshi Asamoto, Sadao Ikeda, Michio Nakajima, Fumio Miki, Hisao Takahashi, Tadao Ochi, Norio Itakura, Takashi Osugi, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, 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, Masaru Nasu, Hideaki Shigeno, Jun Goto, Takayoshi Tashiro, Kohei Hara, Shigeru Kohno, Toshiaki Hayashi, Mitsuo Kaku, 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 Ggawa

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Using the double-blind method, we evaluated the efficacy, safety and usefulness of cefotiam hexetil (CTM-HE) for the treatment of chronic respiratory tract infections using cefaclor (CCL) as control drug. The results obtained were as follows: Patients were given orally, in 3 divided doses, CTM-HE in a daily dose of 1200mg (as cefotiam) or CCL in a daily dose of 1500 mg for 14 consecutive days as a rule. 1) Clinical response was judged by the committee as good and excellent in 67. 3%(76/113) of thepatients on CTM-HE treatment and 65.2%(73/112) of those on CCL treatment, and by the attending physicians in 67.0%(75/112) of those on CTM-HE and 59. 8%(67/112) of those on CCL. 2) Bacteriological response by causative organisms was judged as eradicated in 64.0%(48/75) in the CTM-HE treatment group and 55.8%(43/77) in the CCL treatment group. 3) As for the safety evaluation, adverse reactions were reported in 7.6%(9/119) of the patients on CTM-HE and 8.8%(11/125) of those on CCL. Abnormal alterations of laboratory findings occured in 21.4%(24/112) of the patients on CTM-HE and 13.3%(15/113) of those on CCL. Major adverse reactions to both treatments included gastrointestinal disorders such as diarrhea. Most of the abnormal laboratory findings were increase in eosinophils and in serum transaminases, which did not particularly differ from those observed with conventionally available cephem antibiotics. 4) As to utility, the drug was judged as fairly useful and better by the committee in 66.4%(75/113) of the patients on CTM-HE and 62.6%(72/115) of those on CCL, and by the attending physicians in 65.2%(73/112) of those on CTM-HE and 59.1%(68/115) of those on CCL. The above results indicate that the daily dose of 1200 mg of CTM-HE is comparable to 1500 mg of CCL in efficacy and safety, and we conclude that CTM-HE is useful for the treatment of chronic respiratory tract infections.

Original languageEnglish
Pages (from-to)455-481
Number of pages27
JournalChemotherapy
Volume37
Issue number4
DOIs
Publication statusPublished - 1989

ASJC Scopus subject areas

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

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