CHEMOTHERAPY MAY 1992

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2 CHEMOTHERAPY MAY 1992

3 Fig. 1. Package of test drugs.

4 CHEMOTHERAPY MAY 1992

5 VOL.40 S-3 Table 1. Items and schedule of laboratory tests

6 CHEMOTHERAPY MAY 1992 Table 2. Evaluation criteria of symptoms, signs and laboratory findings

7 VOL.40 S-3 Table 3. Criteria for judgement of usefulness ++: markedly useful, +: useful, }: slightly useful, -: useless,?: undecided

8 CHEMOTHERAPY MAY 1992 Table 4. Case distribution

9 Table 5. Reasons for exclusion from clinical efficacy

10 CHEMOTHERAPY MAY 1992 Table 6. Patients characteristics

11 VOL.40 S-3 Table 7. Initial symptoms, signs and laboratory findings

12 CHEMOTHERAPY MAY 1992 Table 8. Initial chest X-ray findings a) includes one patient with lung abscess in levofloxacin group b) MP: mycoplasmal pneumonia, CP: chlamydial pneumonia Table 9. Distribution of causative organism Table 10. Sensitivity distribution of causative organism

13 VOL.40 S-3 Table 11. Clinical efficacy judged by the committee a) includes one patient with lung abscess in levofloxacin group b) MP: mycoplasmal pneumonia, CP: chlamydial pneumonia Table 12. Clinical efficacy classified by severity of illness (by the committee) a) includes one patient with lung abscess in levofloxacin group

14 CHEMOTHERAPY MAY 1992 a) includes one patient with lung abscess in levofloxacin group

15 Table 14. Clinical efficacy classified by causative organism (by the committee) Table 15. Clinical efficacy judged by doctors in charge a) includes one patient with lung abscess in levofloxacin group b) MP: mycoplasmal pneumonia, CP: chlamydial pneumonia

16 CHEMOTHERAPY Table 16. Bacteriological efficacy classified by causative organism (by the committee)

17 Table Improvement of symptoms, signs and laboratory findings

18 CHEMOTHERAPY Table Improvement of symptoms, signs and laboratory findings

19 Table 18. Improvement of chest X-ray findings *) improved rate: >slightly improved Table 19. Side effects judged by the committee

20 CHEMOTHERAPY Table 20. Abnormal laboratory findings judged by the committee Table 21. Usefulness judged by the committee a) includes one patient with lung abscess in levofloxacin group Table 22. Usefulness judged by doctors in charge a) includes one patient with lung abscess in levofloxacin group

21

22 CHEMOTHERAPY MAY , ) Hayakawa I, Atarashi S, Yokohama S, Imamura M, Sakano K, and Furukawa M: Synthesis and antibacterial activities of optically active ofloxacin. Antimicrob Agents Chemother 29: 163 ` 164, ) Une T, Fujimoto T, Sato K, and Osada Y: In vitro activity of DR-3355, an optically active ofloxacin. Antimicrob Agents Chemother 32: 3) Fujimoto T and Mitsuhashi S: In vitro antibacterial activity of DR-3355, the S-(-)-isomer of ofloxacin. Chemotherapy (Basel) 36: , ) Tanaka M, Otsuki M, Une T, and Nishino T: In vitro and in vivo activity of DR-3355, an optically active isomer of ofloxacin. J Antimicrob Chemother 26: , ) Nakashima M, Uematsu T, Kanamaru M, Okazaki 0, Hashimoto S, and Tachizawa H: Pharmacokinetics of DR-3355, a new quinolone in healthy volunteers. 28th Intersci Conf Antimicrob Agents Chemother, Los Angeles, abstr no.951, ) Tachizawa H, Okazaki 0, Kurata T, Mitsugi K, and Ezumi Y: Metabolic disposition of DR- 3355, a new quinolone antibacterial. Intersci Conf Antimicrob Agents Chemother, New Orleans, abstr no.260, 1987 `2

23 COMPARATIVE STUDY OF LEVOFLOXACIN AND OFLOXACIN IN BACTERIAL PNEUMONIA BY THE DOUBLE BLIND-METHOD Rinzo Soejima, Hiroshi Kawane, Niro Okimoto, Shigenori Umeki, Masaru Sumi, Sadao Tamada and Yoshifumi Kubota Division of Respiratory Diseases, Department of Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki , Japan Akira Saito College of Medical Technology, Hokkaido University Kazuo Takebe and Tsuneharu Baba The Third Department of Internal Medicine, Hirosaki University, School of Medicine Masakichi Motomiya, Kotaro Oizumi#, Akira Watanabe, Shigeo Takizawa, Tsukasa Yoshida Ken-ichi Takeuchi, Toshiharu Ito and Hiromi Kanayama Department of Internal Medicine, The Research Institute for Chest Diseases and Cancer, Tohoku University and Affiliated Hospitals (*The First Department of Internal Medicine, Kurume University, School of Medicine). Masataka Katsu, Masatoshi Ishii and Hiroshi Hirose Department of Internal Medicine, Kasumigaura National Hospital Norio Kikuchi Department of Internal Medicine, Chiba Kaihin Municipal Hospital Hiroshi Tabeta Department of Internal Medicine, Funabashi Municipal Medical Center The Fourth Department Hiroichi Tanimoto of Internal Medicine, School of Medicine, The Jikei University

24 CHEMOTHERAPY Kaoru Shimada, Yasuyuki Sano, Yasufumi Miyamoto, Takashi Inamatsu, Hiroshi Sakamoto, Makoto Kodaira and Makiko Fukayama Department of Infectious Disease, Institute of Medical Science, University of Tokyo and Affiliated Hospital Hiroyuki Kobayashi The First Department of Internal Medicine, School of Medicine, Kyorin University Junzaburo Kabe, Koichiro Kudo and Hitoshi Arioka Department of Respiratory Disease, National Medical Center Hospital Masaru Koyama Department of Internal Medicine, Tokyo Kyosai Hospital Harumi Shishido Department of Respiratory Diseases, Tokyo National Chest Hospital Masaaki Arakawa and Kouichi Wada The Second Department of Internal Medicine, Niigata University, School of Medicine Osamu Sekine and Yasutoshi Suzuki Department of Internal Medicine, Suibarago Hospital Nobuki Aoki Department of Internal Medicine, Shinrakuen Hospital Fumio Miki Department of Internal Medicine, Tane General Hospital Atsuhiko Sato, Masatoshi Iwata, Kingo Chida, Takafumi Suda, Takashi Hayakawa, Hirokazu Okano, Masahiko Okano, Masami Taniguchi and Masao Shibata The Second Department of Internal Medicine, Hamamatsu University, School of Medicine and Affiliated Hospitals Katsutaka Torikai and Tatsuo Hamamoto Department of Internal Medicine, Fujita Health University, School of Medicine Fumiyuki Kuze, Kyosuke Ishihara, Takekuni Iwata, Kazukiyo Oida Yoshio Taguchi, Yoshiaki Kori and Keisuke Tomii The First Clinic of Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals Eiro Tsubura, Masaru Nakagawa, Min Kyong-yob, Mitsunori Sakatani Department of Internal Medicine, Toneyama National Hospital and Related Hospital

25 VOL.40 S-3 Takao Sasaki, Yukio Matsumoto and Yuji Sugimoto The Third Department of Internal Medicine, Tottori University, School of Medicine Michio Yamakido, Kenji Hasegawa and Naoki Yamaoka The Second Department of Internal Medicine, Hiroshima University, School of Medicine Kohei Hara The Second Department of Internal Medicine, School of Medicine, Nagasaki University Keizo Matsumoto Department of Internal Medicine, Institute of Tropical Medicine, Nagasaki University Atsushi Shinoda, Tsuneo Ishibashi and Masahiro Takamoto Department of Internal Medicine, Ohmuta National Hospital Hozumi Yamada, Osamu Katoh, Kenya Hiura, Yosuke Aoki, Shigetaka Kuroki and Masaya Yamaguchi Department of Internal Medicine, Saga Medical School Atsushi Saito, Yoshiteru Sigeno, Yuei Irabu, Hiroshi Fukuhara, Kenji Shiroma and Hisayuki Uehara The First Department of Internal Medicine, School of Medicine, University of the Ryukyus and Affiliated Hospitals Nobuya Ogawa Department of Pharmacology, Ehime University, School of Medicine Mitsuo Kaku, Kazuyuki Sugawara and Keizo Yamaguchi" Clinical Laboratory, Nagasaki University Hospital (##Department of Microbiology, School of Medicine, Toho University) Levofloxacin (LVFX), a new oral quinolone antibacterial, was evaluated for its efficacy, safety and usefulness in patients with bacterial pneumonia by a randomized double-blind comparative study using ofloxacin (OFLX) as the control drug. The patients were given either LVFX (100mg t. i. d) or OFLX (200mg t. i. d) for 14 days, in principle. The results were as follows: 1) A total of 159 patients (LVFX 77, OFLX 82) were enrolled in the trial. The number of evaluable cases, assessed by the committee, was 140 for clinical efficacy (LVFX 68, OFLX 72), 158 for side effects (LVFX 76, OFLX 82), 150 for laboratory findings (LVFX 71, OFLX 79), and 141 for usefulness (LVFX 65, OFLX 76). There were no significant differences in the background factors of the patients between the two groups. 2) The overall clinical efficacy rates judged by the committee were 85.3% (58/68) for the LVFX group and 93.1% (67/72) for the OFLX group, and judged by the doctors in charge they were 85.3% (58/68) and OFLX 91.7% (66/72), respectively. There were no significant differences between the two groups. 3) The bacteriological eradication rates were 100% (21/21) in the LVFX group and 100% (33/33) in the OFLX group, without any significant difference between the two groups.

26 CHEMOTHERAPY 4) The incidences of side effects were 3.9% (3/76) in the LVFX group and 14.6% (12/82) in the OFLX group, and the difference between the two groups was statistically significant (P=0.03). The incidences of abnormal laboratory findings were 15.5% (11/71) in the LVFX group and 13.9% (11/79) in the OFLX group, and the difference between the two groups was not statistically significant. 5) The usefulness rates judged by the committee were 86.2% (56/65) for the LVFX group and 87.8% (65/76) for the OFLX group, and judged by the doctors in charge they were 87.7% (57/65) and 88.2% (67/76), respectively. There was no significant difference. The above results indicate that LVFX (100mg t. i. d) is as useful as OFLX (200mg t. i. d) in the treatment of patients with bacterial pneumonia.

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