A dose-finding comparative study on sparfloxacin (SPFX) in chronic respiratory tract infections

Rinzo Soejima, Hiroshi Kawane, Niro Okimoto, Osamu Tatara, Akira Saito, Ichiro Nakayama, Masumi Tomizawa, Kotaro Oizumi, Akira Watanabe, Izumi Hayashi, Nobuki Aoki, Jingoro Shimada, Atsushi Saito, Kohya Shiba, Masanobu Kaji, Masaki Yoshida, Osamu Sakai, Hiroyuki Kobayashi, Takashi Inoue, Koichiro NakataTatsuo Nakatani, Yoshitaka Nakamori, Naohiko Chonabayashi, Kohji Narui, Eiyasu Tuboi, Kihachiro Shimizu, Junichi Katahira, Kaoru Shimada, Yasuyuki Sano, Yasufumi Miyamoto, Fumio Matsumoto, Takero Imai, Shigeki Odagiri, Kaneo Suzuki, Toshihiko Takeuchi, Yoshimitsu Hayashi, Hidekazu Hanaki, Fumio Miki, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Takao Sasaki, Yukio Matsumoto, Yuji Sugimoto, Hidemi Teramoto, Toshiharu Matsushima, Makoto Kimura, Kenji Hasegawa, Michio Yamakido, Shunsuke Takami, Yukio Nishimoto, Yosiro Sawae, Masaru Nasu, Yoichiro Goto, Hiroyuki Nagai, Jun Goto, Kohei Hara, Shigeru Kono, Yasumasa Doutsu, Takashige Miyazaki, Akira Sakamoto, Koichi Watanabe, Sadahiro Asai, Hideo Mashimoto, Keizo Matsumoto, Kazunori Oishi, Yuei Irabu, Keizo Yamaguchi, Kazuyuki Sugawara, Mituyoshi Nakashima

    Research output: Contribution to journalArticlepeer-review

    Abstract

    A dose-finding study on sparfloxacin (SPFX : AT-4140), a new quinolone antimicrobial, was conducted by the double blind comparative design in patients with chronic respiratory tract infections. The patients were classified into three groups. Namely, SPFX 200 group was administered SPFX in a daily dose of 200 mg, SPFX 300 group received a daily dose of 300 mg SPFX, and ENX group received enoxacin (ENX), as a control, in a daily dose of 600 mg (200 mgX 3). The total number of patients enrolled in the trial was 148, of which 138 cases (48, 48, and 42 in SPFX 200, SPFX 300, and ENX groups, respectively), and 146 cases (52, 49 and 45 as grouped and ordered above), were evaluable by the committee for clinical efficacy and side effects, respectively. 1 ) The backgrounds of patients were well-balanced among the three groups. 2) The clinical efficacy rates were 72.9% for SPFX 200, 72.9% for SPFX 300, and 71.4% for ENX. In patients with only chronic bronchitis, the efficacy rate was 69.6%, 82.8% and 77.8%, respectively. The efficacy rate was highest in SPFX 300 group, but there was no significant difference among the three groups. 3) The bacterial eradication rates were 85.7%. 79.2% and 66.7%, without any significant difference in the three groups. 4 ) In the safety evaluation, the side effect rates were 7.7%. 12.2% and 11.1%, and the abnormal laboratory findings rates were 13.0%, 10.6% and 11.9%. There were no significant differences in the two safety evaluations. 5) The usefulness rates were 68.2%, 69.6% and 70.0%, without any significant difference among the three groups. These results indicate that SPFX in a daily dose of 200 mg and 300 mg, and 600 mg daily ENX in three 200 mg doses, are almost equivalent in both efficacy and safety for patients with chronic respiratory tract infections. However, among the three groups tested, a 300 mg dosage of SPFX was most excellent in patients with only chronic bronchitis. Therefore, the 300 mg daily dose was considered to be an appropriate medication for such intractable chronic respiratory tract infections.

    Original languageEnglish
    Pages (from-to)385-404
    Number of pages20
    JournalChemotherapy
    Volume39
    DOIs
    Publication statusPublished - 1991

    ASJC Scopus subject areas

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

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