Double-blind comparative study on TE-031 (clarithromycin) and mom (midecamycin acetate) in treatment of pneumonia

Koi iei Hara, Masaki Hirota, Shigeru Kohno, Toshiaki Hayashi, Naofumi Suyama, Akira Yasuoka, Kazuo Sasayama, Tsuneo Tsutsumi, Kohichi Watanabe, Yuicmi Inoue, Hiromado Iwasaki, Munetaka Komori, Mikio Oka, Akira Saito, Masumi Tomizawa, Yohmei Hiraga, Mitsuhide Ohmichi, Masao Tamura, Kazuki Konishi, Takashi ItoTetsuro Unoura, Kiyoshi Konno, Kotaro Oizumi, Seiichi Aonuma, Kosaku Nagai, Izumi Hayashi, Masataka Katsu, Shinji Okui, Toshio Fukui, Kazuo Mizukoshi, Keimei Mashimo, Tatsuo Kato, Masahiro Kawabata, Hiroyuki Kobayashi, Hiroaki Takeda, Hiroshi Oshitani, Hiroichi Tanimoto, Naohiko Chonabayashi, Tatsuo Nakatani, Koichiro Nakata, Masayuki Noguchi, Kaoru Shimada, Gen Goto, Yasuyuki Sano, Yasufumi Miyamoto, Otohiko Kunii, Yasuo Ono, Junzaburo Kabe, Koichiro Kudo, Futoshi Shibazaki, Kentaro Watanabe, Masaru Koyama, Ken Kawai, Takeo Toyoda, Shoichiro Irimajiri, Masakuni Tomii, Ippei Fujimori, 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, Yosmihito Niki, Toshiharu Matsushima, Yoshihiko Tano, Sadan Tomizawa, Jun Tanabe, 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, Mitsuo Kaku, Jun Araki, Masaru Nasu, Jun Goto, Hideaki Shigeno, Takayoshi Tashiro, Masayuki Ando, Moritaka Suga, Kiyoshi Shima, Atsushi Saito, Yoshiteru Shigeno, Yuei Irabu, Atsushi Saito, Nobuya Ogawa, Keizo Yamaguchi, Kazuhiro Tateda, Kazuyuki Sugawara

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

To evaluate the clinical efficacy, safety and usefulness of TE-031 in the treatment of pneumonia, We carried out a multi-center double-blind comparative clinical study using midecamycin acetate (MOM) as the control drug. TE-031 was administered orally in a daily dosage of 400 mg (in two doses of 200 mg each), while MOM was administered orally in a daily dosage of 600 mg (in three doses of 200 mg each). As a rule, the duration of administration was 14 days. The following results were obtained. 1) The clinical efficacy was judged by the attending committee, and the efficacy rates were 90.2% in the TE-031 group and 73.9% in the MOM group. The clinical efficacy in the TE-031 group was significantly higher. 2) When the clinical efficacy was evaluated by the doctors in charge, the efficacy rates were 91.5% in the TE-031 group and 77.9% in the MOM group. The efficacy rate in the TE-031 group was significantly higher. 3) The bacteriological efficacy rates were 90.5% in the TE-031 group and 76.2% in the MOM group. Although the eradication rate in the TE-031 group was higher, the difference was not statistically significant. 4) The improvement in the signs/symptoms, laboratory test values and chest X-rays was evaluated. The improvement in both body temperature and CRP was significantly superior in the TE-031 group, but none of the other parameters showed any significant differences between the two drug groups. 5) The incidence of side effects was 5.5% in the TE-031 group and 6.5% in the MOM group, while the incidence of laboratory test abnormalities was 12.1% and 9.1%, respectively. These differences were not statistically signifcant. 6) Usefulness, evaluated by the committee, showed satisfactory rates of 86.1% in the TE-031 group and 70.4% in the MOM group, the TE-031 group's rate being significantly higher. In the evaluation by the doctors in charge, the usefulness rates were 86.1% in the TE-031 group and 75.0% in the MOM group but the difference was not found to be statistically significant. 7) On the basis of the results summarized above, it was confirmed that, in comparison with MOM (at 600 mg/day), TE-031 (at 400 mg/day) showed a high degree of clinical usefulness as an antibiotic in the treatment of pneumonia.

Original languageEnglish
Pages (from-to)200-225
Number of pages26
JournalChemotherapy
Volume37
Issue number2
DOIs
Publication statusPublished - 1989

ASJC Scopus subject areas

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

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