Comparative study of levofloxacin and ofloxacin in chronic respiratory tract infections by the double-blind method

Rinzo Soejima, Hiroshi Kawane, Niro Okimoto, Shigenobu Umeki, Masaru Sumi, Sadao Tamada, Yoshifumi Kubota, Akira Saito, Ichiro Nakayama, Masumi Tomizawa, Yomei Hiraga, Mitsuhide Ohmichi, Masashi Tamura, Kazuki Konishi, Hitoshi Kobayashi, Shizuko Maeda, Takashi Mohri, Tamotsu Takishima, Yasuo Tanno, Kotaro OizumiKotaro Oizumi, Kaoru Shimada, Hiroyuki Kobayashi, Hiroaki Takeda, Osamu Sakai, Kohya Shiba, Masaki Yoshida, Jingoro Shimada, Hiroichi Tanimoto, Kazuo Ohara, Hideo Ikemoto, Takeshi Mori, Koichiro Nakata, Yoshitaka Nakamori, Tatsuo Nakatani, Izumi Hayashi, Harumi Shishido, Kenji Kawakami, Shoichiro Irimajiri, Mitsuo Obana, Fumio Matsumoto, Takeo Imai, Shigeki Odagiri, Kaneo Suzuki, Yasuhiko Ashikari, Yasutsugu Amano, Akira Shohji, Takashi Sakuma, Osamu Sekine, Yasutoshi Suzuki, Nobuki Aoki, Tatsuo Satake, Kenzo Takagi, Kenichi Yamaki, Fumio Miki, Shigenori Nakajima, Etsuo Fujita, Hiroyuki Akiyama, Ryuhei Hazu, Kazuhiro Teramoto, Ryuichi Sakurada, Naomi Nishimura, Mitsuyo Seguchi, Keiichi Mikasa, Masayoshi Sawaki, Nobuhiro Narita, Toshiharu Matsushima, Yoshihiko Tano, Osamu Kurimura, Yoshiro Sawae, Kohei Hara, Hironobu Koga, Hiroki Shinboku, Takakazu Ohtsubo, Yuichi Inoue, Kiyoyasu Fukushima, Yasuharu Masuyama, Keizo Matsumoto, Hironori Masaki, Hirofumi Tanaka, Shinji Yamamoto, Hidefumi Ishikawa, Kiyoshi Shima, Shinobu Takenaka, Masaru Nasu, Yoichiro Goto, Hiroyuki Nagai, Toru Yamasaki, Atsushi Saito, Nobuya Ogawa, Mitsuo Kaku, Kazuyuki Sugawara, Keizo Yamaguchi

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

To evaluate the efficacy, safety and usefulness of levofloxacin (LVFX, DR-3355) in chronic respiratory tract infections, we carried out a double-blind comparative study with ofloxacin (OFLX) as the control drug. LVFX at a dose of 300mg (100mg × 3/day) and OFLX at a dose of 600mg (200mg × 3/day) were orally administered for 14 days. The results were as follows: 1) A total of 165 patients (LVFX 83, OFLX 82) were enrolled in the trial. The number of evaluable cases, based on the criteria of the investigators' committee, was 148 for clinical efficacy (LVFX 72, OFLX 76), 159 for side effects (LVFX 78, OFLX 81), 150 for laboratory findings (LVFX 73, OFLX 77), and 149 for usefulness (LVFX 73, OFLX 76). There were no significant differences in the background factors of the patients, except in the distribution of underlying diseases and/or complications between the two groups. 2) The clinical efficacy rates, judged by the committee, were 87.5% (63/72) for the LVFX group and 78.7% (59/75) for the OFLX group, and judged by the doctors in charge they were 86.1% (62/72) and 82.2% (60/73), respectively. There was no significant difference between the two groups. 3) The bacteriological eradication rates were 86.4% (38/44) in the LVFX group and 79.2% (38/48) in the OFLX group. There was no significant difference between the two groups. 4) The incidences of side effects were 6.4% (5/78) in the LVFX group and 11.1% (9/81) in the OFLX group. There was no significant difference between the two groups. The incidences of abnormal laboratory findings were 6.9% (5/73) in the LVFX group and 18.2% (14/77) in the OFLX group. The incidence of abnormal laboratory findings in the LVFX group was significantly lower than that in the OFLX. 5) The usefulness rates, judged by the committee, were 86.1% (62/72) for the LVFX group and 73.3% (55/75) for the OFLX group, and judged by the doctors in charge they were 84.7% (61/72) and 79.5% (58/73), respectively. There was no significant difference between the two groups. The above results indicate that LVFX (100mg × 3/day) is as useful as OFLX (200mg × 3/day) in the treatment of chronic respiratory tract infections.

Original languageEnglish
Pages (from-to)97-120
Number of pages24
JournalChemotherapy
Volume40
DOIs
Publication statusPublished - 1992 May

Keywords

  • DR-3355
  • Levofloxacin
  • Ofloxacin

ASJC Scopus subject areas

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

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