Double-blind comparative study on TE-031 (clarithromycin) and cefaclor(CCL) in treatment of chronic respiratory tract infections

Kohei Hara, Masaki Hirota, Shigeru Kohno, Toshiaki Hayashi, Naofumi Suyama, Akira Yasuoka, Kazuo Sasayama, Tsuneo Tsutsumi, Kohichi Watanabe, Yuichi Inoue, Hiromado Iwasaki, Munetaka Komori, Mikio Oka, Akira Saito, Masumi Tomizawa, Yohmei Hiraga, Mitsuhide Ohmichi, Masao Tamura, Kazuki Konishi, Takashi ItoTetsuro Unoura, Izumi Hayashi, Masataka Katsu, Shinji Okui, Toshio Fukui, Kazuo Mizukoshi, Hiroyuki Kobayashi, Hiroaki Takeda, Hiroshi Oshitani, Hiroichi Tanimoto, Naohiko Chonabayashi, Yoshitaka Nakamori, Tatsuo Nakatani, Koichiro Nakata, Masayuki Noguchi, Kaoru Shimada, Gen Goto, Yasuyuki Sano, Yasufumi Miyamoto, Junzaburo Kabe, Koichiro Kudo, Futoshi Shibazaki, Kentaro Watanabe, Masaru Koyama, Hideo Ikemoto, Kazuyoshi Watanabe, Ken Kawai, Takeo Toyoda, Ippei Fujimori, Shoichiro Irimajiri, Masakuni Tomii, Fumio Matsumoto, Iwao Sakurai, Shigeki Odagiri, Keichiro Matsunaga, Kaneo Suzuki, Kou Murohashi, Kenichi Takahashi, Hiroyuki Numata, Izumi Koyama, Syunichi Ishii, Osamu Sekine, Nobuki Aoki, Kaoru Oyama, Toshihiko Takeuchi, Masahito Kato, Hidekazu Hanaki, Go Ito, Hideaki Kuroki, Toshiyuki Yamamoto, Kanzo Suzuki, Kazuhide Yamamoto, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Fumiyuki Kuze, Akira Kagioka, Kenji Bando, Fumio Miki, Kenzo Shiota, Keiji Kobayashi, Rinzo Soejima, Yoshihito Niki, Toshiharu Matsushima, Yoshihiko Tano, Sadao Tomizawa, Yukio Nishimoto, Michio Yamakido, Kenji Hasegawa, Osamu Kurimura, Hideo Sasaki, Hirofumi Fukuhara, Yoshiro Sawae, Toshiyuki Ishimaru, Koji Takagi, Masahide Takii, Hidenobu Shigeoka, Kenji Kohno, Ritsu Kamei, Hitoshi Nagano, Mamoru Inagaki, Atsushi Shinoda, Tsuneo Ishibashi, Keizo Matsumoto, Naoto Rikitomi, Harumi Shishido, Kinichi Izumikawa, Sadahiro Asai, Hideo Masumoto, Jun Araki, Mitsuo Kaku, Masayuki Ando, Moritaka Suga, Kiyoshi Shima, Atsushi Saito, Yoshiteru Shigeno, Yuei Irabu, Kotaro Oizumi, Atsushi Saito, Nobuya Ogawa, Keizo Yamaguchi, Kazuhiro Tateda, Kazuyuki Sugawara

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

To objectively evaluate the clinical efficacy, safety and usefulness of TE-031 (TE) in chronic respiratory tract infections, we carried out a double-blind comparative study using cefaclor (CCL) as the control drug. As a rule, treatment was by oral administration of 400 mg (in two divided doses) of TE daily and 1, 500 mg (in three divided doses) of CCL daily for 14 consecutive days. The following results were obtained. 1. The overall clinical efficacy as judged by the committee was 77.3%(58/75 cases) for TE and 67.2%(43/64 cases) for CCL. 2. The overall clinical efficacy as judged by the doctors in charge was 82.2%(60/73) for TE and 68.8%(44/64) for CCL. 3. In the bacteriological studies, the eradication rates were 54.8%(17/31) for TE and 63.2%(24/38) for CCL. 4. The incidence of side effects was 7.9%(7/89) for TE and 2.3%(2/88) for CCL. Almost all the instances of side effects were digestive tract symptoms, and none was serious in degree. 5. The incidence of abnormal changes in laboratory test values was 15.3%(13/85) for TE and 14.1%(12/85) for CCL. Eosinophilia was detected in 7 patients in the TE group and 4 in the CCL group, while the serum transaminase values were elevated in 4 patients in each group. All changes were mild in degree and soon returned to normal. 6. The usefulness of each drug regimen was evaluated by considering the clinical efficacy, the presence or absence of side effects and of abnormal changes in laboratory test values. The overall usefulness rates (including satisfactory and very satisfactory) were 72.7%(56/77) for TE and 67.2%(43/64) for CCL. On the basis of our results, we confirmed that the usefulness of TE, administered orally in two daily doses of 200 mg, in chronic respiratory tract infections is comparable to that of CCL administered orally in three daily doses of 500 mg.

Original languageEnglish
Pages (from-to)314-335
Number of pages22
JournalChemotherapy
Volume37
Issue number3
DOIs
Publication statusPublished - 1989

ASJC Scopus subject areas

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

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  • Cite this

    Hara, K., Hirota, M., Kohno, S., Hayashi, T., Suyama, N., Yasuoka, A., Sasayama, K., Tsutsumi, T., Watanabe, K., Inoue, Y., Iwasaki, H., Komori, M., Oka, M., Saito, A., Tomizawa, M., Hiraga, Y., Ohmichi, M., Tamura, M., Konishi, K., ... Sugawara, K. (1989). Double-blind comparative study on TE-031 (clarithromycin) and cefaclor(CCL) in treatment of chronic respiratory tract infections. Chemotherapy, 37(3), 314-335. https://doi.org/10.11250/chemotherapy1953.37.314