Dose-finding comparative study of temafloxacin in chronic lower respiratory tract infections

Atsushi Saito, Akira Saito, Masumi Tomizawa, Ichiro Nakayama, Ichiro Nakayama, Masakichi Motomiya, Akira Watanabe, Masakichi Motomiya, Akira Watanabe, Mitsunobu Honma, Kiyoshi Konno, Hideo Arai, Shigeru Shimoda, Osamu Sakai, Kohya Shiba, Hiroichi Tanimoto, Hiroyuki Kobayashi, Susumu Sakayori, Hiroaki Takeda, Koichiro NakataTatsuo Nakatani, Yoshitaka Nakamori, Izumi Hayashi, Masaru Koyama, Hammi Shishido, Hideaki Nagai, Kenji Kawakami, Masaaki Arai, Koichi Wada, Takashi Kawashima, Masanaga Takatou, Nobuki Aoki, Fumio Matsumoto, Takeo Imai, Shigeki Odagiri, Masanori Matsumura, Kaneo Suzuki, Hiroshi Takahashi, Kenichi Takahashi, Yasuhiko Ashikari, Taiji Amano, Takashi Sakuma, Akira Shoji, Toshihiko Takeuchi, Kazuhide Yamamoto, Yoshimitsu Hayashi, Kojiro Yasunaga, Seibun Yonezu, Yoshitaka Yamanaka, Fumio Miki, Rinzo Soejima, Niro Okimoto, Michio Yamakido, Kenji Hasegawa, Yoshiro Sawae, Kotaro Oizumi, Yoichiro Ichikawa, Naoto Tokunaga, Masaru Nasu, Yoichiro Goto, Hiroyuki Nagai, Tom Yamasaki, Kohei Hara, Shigeru Kono, Hironobu Koga, Nobuo Morikawa, Kohta Kono, Tatsuya Katsumata, Keizo Matsumoto, Yoshiaki Utsunomiya, Hirofumi Tanaka, Atsushi Saito, Yuei Irabu, Koichi Deguchi, Nobuya Ogawa, Nobuya Ogawa

    Research output: Contribution to journalArticlepeer-review

    Abstract

    To determine the optimal dose of temafloxacin (TMFX), a new quinolone antibacterial agent, in respiratory tract infections, a dose-finding study was conducted in patients with chronic lower respiratory tract infections using ofloxacin (OFLX) as the control drug. A TMFX 300 group (150 mg b.i.d.) and TMFX 600 group (300 mg b.i.d.) were compared by the double blind method. In principle, these drugs were administered for 14 days. The total number of patients enrolled in the trial was 147, 132 of which (TMFX 300 group: 44, TMFX 600 group: 47, OFLX group: 41) were eligible for evaluation of clinical efficacy. There were no significant differences in the distribution of background factors, but the number of patients previously treated with other antibiotics in the TMFX 600 group was significantly larger than in the other groups (p<0.05). 1) The clincal efficacy rate was 86.4%ln the TMFX 300 group and 85.1% in the TMFX 600 group. The percentages of cases in which clinical efficacy was “excellent” (the “excellent” rate) were 4.5% and 8.5% in the TMFX 300 group and the TMFX 600 group, respectively. In the patients with chronic bronchitis, the efficacy rates were 88.5% and 89.3%, and the “excellent” rates were 7.7% and 10.7%, in the TMFX 300 group and the TMFX 600 group, respectively. In patients whose infection severity was moderate, the efficacy rates were 88.9% and 90.0%, and the “excellent” rates were 11.1% and 20.0% in the TMFX 300 group and the TMFX 600 group, respectively. The differences between these two groups, however, were not significant. In the OFLX group, the clinical efficacy rate was 92.7% in the patients as a whole, 94.1% in the patients with chronic bronchitis and 92.9% in the patients whose infection severity was moderate. The “excellent” rates were 2.4%, 5.9% and 7.1%, respectively. 2) The bacterial eradication rate (eradicated + replaced) was 85.7% in the TMFX 300 group and 87.0% in the TMFX 600 group, with no significant difference between the two groups. The eradication rate in the OFLX group was 81.8%. 3) There were no cases of adverse drug reactions (ADRs) in the TMFX 300 group, but there was one case (2.1%) in the TMFX 600 group. Abnormal laboratory test findings were observed in 6 cases (13.6%) in the TMFX 300 group and in 9 cases (20.5%) in the TMFX 600 group. There were no significant differences between these two groups in incidence of ADRs or abnormal laboratory test findings. In the OFLX group, ADRs were observed in 2 cases (4.5%), and abnormal laboratory test findings were observed in 3 (7.3%). 4) The usefulness rates were 84.1% in the TMFX 300 group and 83.0% in the TMFX 600 group. The percentages of cases in which degree of usefulness was “markedly useful” were 4.5% and 6.4% in the TMFX 300 group and the TMFX 600 group, respectively. There were no significant differences between these two groups. In the OFLX group, the utility rate was 90.5%, and the “markedly useful” rate was 2.4%. These results indicate that the TMFX 300 group and 600 group were almost equal in terms of both efficacy and safety for chronic lower respiratory tract infections. However, the TMFX 600 group was slightly better than the TMFX 300 group in the “excellent” rate and the bacterial eradication rate. In addition, among the patients with chronic bronchitis, the TMFX 600 group was superior in terms of both the clinical efficacy rate and the “excellent” rate, as well as among patients whose severity of infection was moderate. Therefore, a daily dose of 600 mg of TMFX was considered necessary to treat respiratory tract infections, including intractable cases.

    Original languageEnglish
    Pages (from-to)489-509
    Number of pages21
    JournalChemotherapy
    Volume41
    DOIs
    Publication statusPublished - 1993

    Keywords

    • chronic lower respiratory tract infections
    • dose-finding study
    • double blind comparative study
    • ofloxacin
    • temafloxacin

    ASJC Scopus subject areas

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

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