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 Oizumi; Kotaro 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

doi:10.11250/chemotherapy1953.40.Supplement3_97

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

MED - Medical Sciences

Research output: Contribution to journal › Article

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 language	English
Pages (from-to)	97-120
Number of pages	24
Journal	Chemotherapy
Volume	40
DOIs	https://doi.org/10.11250/chemotherapy1953.40.Supplement3_97
Publication status	Published - 1992 May

Keywords

DR-3355
Levofloxacin
Ofloxacin

ASJC Scopus subject areas

Pharmacology (medical)
Infectious Diseases
Pharmacology
Drug Discovery
Oncology

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Soejima, R., Kawane, H., Okimoto, N., Umeki, S., Sumi, M., Tamada, S., Kubota, Y., Saito, A., Nakayama, I., Tomizawa, M., Hiraga, Y., Ohmichi, M., Tamura, M., Konishi, K., Kobayashi, H., Maeda, S., Mohri, T., Takishima, T., Tanno, Y., ... Yamaguchi, K. (1992). Comparative study of levofloxacin and ofloxacin in chronic respiratory tract infections by the double-blind method. Chemotherapy, 40, 97-120. https://doi.org/10.11250/chemotherapy1953.40.Supplement3_97

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

In: Chemotherapy, Vol. 40, 05.1992, p. 97-120.

Research output: Contribution to journal › Article

Soejima, R, Kawane, H, Okimoto, N, Umeki, S, Sumi, M, Tamada, S, Kubota, Y, Saito, A, Nakayama, I, Tomizawa, M, Hiraga, Y, Ohmichi, M, Tamura, M, Konishi, K, Kobayashi, H, Maeda, S, Mohri, T, Takishima, T, Tanno, Y, Oizumi, K, Oizumi, K, Shimada, K, Kobayashi, H, Takeda, H, Sakai, O, Shiba, K, Yoshida, M, Shimada, J, Tanimoto, H, Ohara, K, Ikemoto, H, Mori, T, Nakata, K, Nakamori, Y, Nakatani, T, Hayashi, I, Shishido, H, Kawakami, K, Irimajiri, S, Obana, M, Matsumoto, F, Imai, T, Odagiri, S, Suzuki, K, Ashikari, Y, Amano, Y, Shohji, A, Sakuma, T, Sekine, O, Suzuki, Y, Aoki, N, Satake, T, Takagi, K, Yamaki, K, Miki, F, Nakajima, S, Fujita, E, Akiyama, H, Hazu, R, Teramoto, K, Sakurada, R, Nishimura, N, Seguchi, M, Mikasa, K, Sawaki, M, Narita, N, Matsushima, T, Tano, Y, Kurimura, O, Sawae, Y, Hara, K, Koga, H, Shinboku, H, Ohtsubo, T, Inoue, Y, Fukushima, K, Masuyama, Y, Matsumoto, K, Masaki, H, Tanaka, H, Yamamoto, S, Ishikawa, H, Shima, K, Takenaka, S, Nasu, M, Goto, Y, Nagai, H, Yamasaki, T, Saito, A, Ogawa, N, Kaku, M, Sugawara, K & Yamaguchi, K 1992, 'Comparative study of levofloxacin and ofloxacin in chronic respiratory tract infections by the double-blind method', Chemotherapy, vol. 40, pp. 97-120. https://doi.org/10.11250/chemotherapy1953.40.Supplement3_97

Soejima, Rinzo ; Kawane, Hiroshi ; Okimoto, Niro ; Umeki, Shigenobu ; Sumi, Masaru ; Tamada, Sadao ; Kubota, Yoshifumi ; Saito, Akira ; Nakayama, Ichiro ; Tomizawa, Masumi ; Hiraga, Yomei ; Ohmichi, Mitsuhide ; Tamura, Masashi ; Konishi, Kazuki ; Kobayashi, Hitoshi ; Maeda, Shizuko ; Mohri, Takashi ; Takishima, Tamotsu ; Tanno, Yasuo ; Oizumi, Kotaro ; Oizumi, Kotaro ; Shimada, Kaoru ; Kobayashi, Hiroyuki ; Takeda, Hiroaki ; Sakai, Osamu ; Shiba, Kohya ; Yoshida, Masaki ; Shimada, Jingoro ; Tanimoto, Hiroichi ; Ohara, Kazuo ; Ikemoto, Hideo ; Mori, Takeshi ; Nakata, Koichiro ; Nakamori, Yoshitaka ; Nakatani, Tatsuo ; Hayashi, Izumi ; Shishido, Harumi ; Kawakami, Kenji ; Irimajiri, Shoichiro ; Obana, Mitsuo ; Matsumoto, Fumio ; Imai, Takeo ; Odagiri, Shigeki ; Suzuki, Kaneo ; Ashikari, Yasuhiko ; Amano, Yasutsugu ; Shohji, Akira ; Sakuma, Takashi ; Sekine, Osamu ; Suzuki, Yasutoshi ; Aoki, Nobuki ; Satake, Tatsuo ; Takagi, Kenzo ; Yamaki, Kenichi ; Miki, Fumio ; Nakajima, Shigenori ; Fujita, Etsuo ; Akiyama, Hiroyuki ; Hazu, Ryuhei ; Teramoto, Kazuhiro ; Sakurada, Ryuichi ; Nishimura, Naomi ; Seguchi, Mitsuyo ; Mikasa, Keiichi ; Sawaki, Masayoshi ; Narita, Nobuhiro ; Matsushima, Toshiharu ; Tano, Yoshihiko ; Kurimura, Osamu ; Sawae, Yoshiro ; Hara, Kohei ; Koga, Hironobu ; Shinboku, Hiroki ; Ohtsubo, Takakazu ; Inoue, Yuichi ; Fukushima, Kiyoyasu ; Masuyama, Yasuharu ; Matsumoto, Keizo ; Masaki, Hironori ; Tanaka, Hirofumi ; Yamamoto, Shinji ; Ishikawa, Hidefumi ; Shima, Kiyoshi ; Takenaka, Shinobu ; Nasu, Masaru ; Goto, Yoichiro ; Nagai, Hiroyuki ; Yamasaki, Toru ; Saito, Atsushi ; Ogawa, Nobuya ; Kaku, Mitsuo ; Sugawara, Kazuyuki ; Yamaguchi, Keizo. / Comparative study of levofloxacin and ofloxacin in chronic respiratory tract infections by the double-blind method. In: Chemotherapy. 1992 ; Vol. 40. pp. 97-120.

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

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.",

keywords = "DR-3355, Levofloxacin, Ofloxacin",

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

year = "1992",

month = may,

doi = "10.11250/chemotherapy1953.40.Supplement3_97",

language = "English",

volume = "40",

pages = "97--120",

journal = "CHEMOTHERAPY",

issn = "0009-3165",

}

TY - JOUR

T1 - Comparative study of levofloxacin and ofloxacin in chronic respiratory tract infections by the double-blind method

AU - Soejima, Rinzo

AU - Kawane, Hiroshi

AU - Okimoto, Niro

AU - Umeki, Shigenobu

AU - Sumi, Masaru

AU - Tamada, Sadao

AU - Kubota, Yoshifumi

AU - Saito, Akira

AU - Nakayama, Ichiro

AU - Tomizawa, Masumi

AU - Hiraga, Yomei

AU - Ohmichi, Mitsuhide

AU - Tamura, Masashi

AU - Konishi, Kazuki

AU - Kobayashi, Hitoshi

AU - Maeda, Shizuko

AU - Mohri, Takashi

AU - Takishima, Tamotsu

AU - Tanno, Yasuo

AU - Oizumi, Kotaro

AU - Shimada, Kaoru

AU - Kobayashi, Hiroyuki

AU - Takeda, Hiroaki

AU - Sakai, Osamu

AU - Shiba, Kohya

AU - Yoshida, Masaki

AU - Shimada, Jingoro

AU - Tanimoto, Hiroichi

AU - Ohara, Kazuo

AU - Ikemoto, Hideo

AU - Mori, Takeshi

AU - Nakata, Koichiro

AU - Nakamori, Yoshitaka

AU - Nakatani, Tatsuo

AU - Hayashi, Izumi

AU - Shishido, Harumi

AU - Kawakami, Kenji

AU - Irimajiri, Shoichiro

AU - Obana, Mitsuo

AU - Matsumoto, Fumio

AU - Imai, Takeo

AU - Odagiri, Shigeki

AU - Suzuki, Kaneo

AU - Ashikari, Yasuhiko

AU - Amano, Yasutsugu

AU - Shohji, Akira

AU - Sakuma, Takashi

AU - Sekine, Osamu

AU - Suzuki, Yasutoshi

AU - Aoki, Nobuki

AU - Satake, Tatsuo

AU - Takagi, Kenzo

AU - Yamaki, Kenichi

AU - Miki, Fumio

AU - Nakajima, Shigenori

AU - Fujita, Etsuo

AU - Akiyama, Hiroyuki

AU - Hazu, Ryuhei

AU - Teramoto, Kazuhiro

AU - Sakurada, Ryuichi

AU - Nishimura, Naomi

AU - Seguchi, Mitsuyo

AU - Mikasa, Keiichi

AU - Sawaki, Masayoshi

AU - Narita, Nobuhiro

AU - Matsushima, Toshiharu

AU - Tano, Yoshihiko

AU - Kurimura, Osamu

AU - Sawae, Yoshiro

AU - Hara, Kohei

AU - Koga, Hironobu

AU - Shinboku, Hiroki

AU - Ohtsubo, Takakazu

AU - Inoue, Yuichi

AU - Fukushima, Kiyoyasu

AU - Masuyama, Yasuharu

AU - Matsumoto, Keizo

AU - Masaki, Hironori

AU - Tanaka, Hirofumi

AU - Yamamoto, Shinji

AU - Ishikawa, Hidefumi

AU - Shima, Kiyoshi

AU - Takenaka, Shinobu

AU - Nasu, Masaru

AU - Goto, Yoichiro

AU - Nagai, Hiroyuki

AU - Yamasaki, Toru

AU - Saito, Atsushi

AU - Ogawa, Nobuya

AU - Kaku, Mitsuo

AU - Sugawara, Kazuyuki

AU - Yamaguchi, Keizo

PY - 1992/5

Y1 - 1992/5

N2 - 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.

AB - 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.

KW - DR-3355

KW - Levofloxacin

KW - Ofloxacin

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