Clinical evaluation of BMY-28100 for bacterial pneumonia in comparison with cefaclor in a double-blind study

Kotaro Oizumi, Akira Watanabe, Akira Saito, Masami Tomizawa, Ichiro Nakayama, Yohmei Hiraga, Mitsuhide Ohmichi, Masao Tamura, Kazuki Konishi, Kazutoshi Gomi, Hiroshi Kuramitsu, Kosaku Nagai, Izumi Hayashi, Masataka Katsu, Shinji Okui, Toshio Fukui, Keisuke Kuga, Kaoru Shimada, Yasuyuki Sano, Yasufumi MiyamotoHiroichi Tanimoto, Koichiro Nakata, Yoshitaka Nakamori, Naohiko Chonabayashi, Masayuki Noguchi, Tatsuo Nakatani, Yasushi Ueda, Tadashi Miyahara, Osamu Sakai, Jingoro Shimada, Kohya Shiba, Masanobu Kaji, Junzaburo Kabe, Koichiro Kudo, Hitoshi Arioka, Noriyasu Hirayama, Hiroyoshi Ishibashi, Futoshi Shibazaki, Masashi Mori, Kihachiro Shimizu, Hideo Ikemoto, Kazuyoshi Watanabe, Masaru Koyama, Hiroyuki Kobayashi, Hiroshi Oshitani, Takao Okubo, Hirotada Ikeda, Fumio Matsumoto, Iwao Sakurai, Shigeki Odagiri, Kaneo Suzuki, Kou Murohashi, Izumi Koyama, Shunichi Ishii, Takashi Ogura, Shoichiro Irimajiri, Yasuo Matsuoka, Satoshi Akizuki, Osamu Sekine, Nobuki Aoki, Tatsuo Satake, Kenzo Takagi, Kenichi Yamaki, Yasunobu Noda, Hideo Gonda, Toshihiko Takeuchi, Masahito Kato, Yoshimitsu Hayashi, Joichi Kato, Kazuo Yoshitomo, Toshiyuki Yamamoto, Kanzo Suzuki, Toru Matsuura, Kazuhide Yamamoto, Fumiyuki Kuze, Takuya Kurasawa, Nobuaki Ikeda, Fumio Miki, Keiji Kobayashi, Yoji Shimizu, Seibun Yonezu, Kojiro Yasunaga, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Mitsuru Furunishi, Rinzo Soejima, Jiro Okimoto, Yoshihisa Nakagawa, Susumu Yagi, Hiroshi Kawane, Toshiharu Matsushima, Masayoshi Kawanishi, Yoshiro Sawae, Minoru Yoshida, Satoko Miyahara, Susumu Harada, Yasuko Harada, Yoshinari Kitahara, Masahiro Takamoto, Tsuneo Ishibashi, Atsushi Shinoda, Kohei Hara, Toru Ishino, Masaki Hirota, Keizo Yamaguchi, Shigeru Kohno, Toshiaki Hayashi, Yasumasa Dotsu, Keizo Matsumoto, Naoto Rikitomi, Hirofumi Tanaka, Toshihiro Morito, Masaru Nasu, Hideaki Shigeno, Atsushi Saito, Yuei Irabu, Yoshiteru Shigeno, Hiroaki Nakamura, Nobuya Ogawa, Yasuyuki Hayashi, Toyoko Oguri

    Research output: Contribution to journalArticlepeer-review

    3 Citations (Scopus)

    Abstract

    The efficacy, safety and usefulness of BMY-28100 for the treatment of bacterial pneumonia were compared with those of cefaclor (hereinafter referred to as CCL) in a double-blind study. The daily dosages were 750 mg for BMY-28100 and 1,500 mg for CCL, divided into 3 administrations daily. These drugs were administered orally for at least 14 days. A total of 172 cases were enrolled in this study. Of these, cases which deviated from the protocols were excluded from evaluations. Thus, clinical efficacy was evaluated in 124 cases, adverse reactions were evaluated in 160 cases, and abnormal laboratory test values were evaluated in 146 cases. The following results were obtained. 1. Efficacy rates (“good” or better responses) in bacterial pneumonia cases as evaluated by the subcommittee were 81.7% (49/60) in the BMY-28100 group and 89.1% (41/46) in the CCL group, thus no significant difference was found between the 2 groups. 2. Efficacy rates (“good” or better responses), as evaluated by investigators, in the same bacterial pneumonia cases which were subjected to the evaluation by the subcommittee were 83.3% (50/60) in the BMY-28100 group and 88.9% (40/45) in the CCL group, thus no significant difference between the 2 groups was found also. 3. Bacteriological response rates in bacterial pneumonia cases were 86.2% (25/29) in the BMY-28100 group and 85.7% (18/21) in the CCL group with no significant difference between the 2 groups. 4. Incidences of subjective/objective clinical adverse symptoms were 3.5% (3/85) in the BMY-28100 group and 1.3% (1/75) in the CCL group, and no significant difference was observed between the 2 groups. No significant difference was also found between the 2 groups in incidences of abnormal laboratory test values, as abnormalities were found in 21.1% (16/76) of the cases in the BMY-28100 group and 25.7% (18/70) in the CCL group. 5. As for overall usefulness of the drug in bacterial pneumonia cases, utility rates (“useful” or better evaluations) as evaluated by the subcommittee were 83.6% (46/55) in the BMY-28100 group and 90.5% (38/42) in the CCL group, and the rates as evaluated by investigators in cases judged as evaluable by the subcommittee were 78.3% (47/60) and 82.2% (37/45), respectively. There were no significant differences between the 2 groups. The utility rates as evaluated by investigators in cases in which diseases were diagnosed as bacterial pneumonia or lung abscess by investigators were 78.3% (47/60) in the BMY-28100 group and 82.2% (37/45) in the CCL group. These results indicated that BMY-28100 750mg/day had comparable efficacy and safety to CCL but with only half of the CCL dosage, 1,500 mg/day. Therefore, BMY-28100 is very useful for the treatment of bacterial pneumonia.

    Original languageEnglish
    Pages (from-to)1914-1947
    Number of pages34
    JournalThe Japanese Journal of Antibiotics
    Volume43
    Issue number11
    DOIs
    Publication statusPublished - 1990

    ASJC Scopus subject areas

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

    Fingerprint Dive into the research topics of 'Clinical evaluation of BMY-28100 for bacterial pneumonia in comparison with cefaclor in a double-blind study'. Together they form a unique fingerprint.

    Cite this