Dose-finding study on lomefloxacin (NY-198, LFLX) in respiratory tract infections

Rinzos Soejima, Yoshihito Niki, Susumu Yagi, Izumi Hayashai, Kikuo Ohnum, Hiroyuki Kobayashi, Shin Kobayashi, Kaneo Suzuki, Kou Murohashi, Masaru Nakagawa, Toshiharu Matsushima, Michio Yamakido, Shioeru Matsuzaka, Hitoshi Nagano, Chiharu Kubo, Kohei Honda, Hozumi Yamada, Osamu Kato, Atsushi Shinoda, Tsuneo IshibashiMasahiro Takamoto, Kohei Hara, Masaki Hirota, Keizo Yamaguchi, Shigeru Kohno, Toshiaki Hayashi, Akira Yasuoka, Kazuo Sasayama, Masao Nakatomi, Kohta Kohno, Tsuneo Tsutsumi, Koichi Watanabe, Haruhiko Tokuomi, Yasutsugu Fukuda, Katsumasa Tokunaga, Mitsuyoshi Nakashima

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

We performed a dose-finding study for lomefloxacin (NY-198, LFLX), a new quinolone antibacterial agent used in the treatment of lower respiratory tract infections, using a double-blind method. Chronic respiratory tract diseases with infections and bacterial pneumonias were included in this study. LFLX was orally administered at a daily dose of either 400 mg b. i. d. or 600 mg t. i. d. for 14 days in principle. Of the total 102 cases, clinical efficacy and safety were evaluated in 94 cases (400 mg group: 48; 600 mg group: 46) and 97 cases (400 mg group: 49; 600 mg group: 48), respectively. There was no significant shift in the distribution of background factors, except that there were significantly more cases with severe initial symptoms (e. g. sputum property) and rales in all cases in the 600 mg group, and of polymicrobial infection in the chronic respiratory tract diseases with infection in the 600 mg group (p<0.05). 1) The clinical efficacy rate evaluated by the committee in all cases was 72.9%(35/48) in the 400 mg group and 69.6%(32/46) in the 600 mg group. In chronic respiratory tract diseases with infection the rate was 63.6%(21/33) in the 400 mg group and 65.7%(23/35) in the 600 mg group. There was no statistically significant difference between the two groups. 2) Bacteriologically, the eradication rate was 80.0%(24/30) in the 400 mg group and 67.9%(19/28) in the 600 mg group, with no significant difference between the two groups. 3) Side-effects were noted in 4.1%(2/49) of the 400 mg group and in 6.3%(3/48) of the 600 mg group. Abnormal changes in laboratory findings were observed in 12.2%(6/49) of the 400 mg group and in 15.9%(7/44) of the 600 mg group. There was no significant difference between the rates of the two groups. Neither serious side-effects nor evident abnormal changes in laboratory findings were noted. 4) The utility rate evaluated by the committee was 72.9%(35/48) in the 400 mg group and 66.0%(31/47) in the 600 mg group, with no significant difference between the two groups. From these results, we consider that a dose of 600 mg t. i. d. is the optimal dose of LFLX in the treatment of respiratory tract infections including chronic respiratory tract diseases with infection.

Original languageEnglish
Pages (from-to)776-795
Number of pages20
JournalChemotherapy
Volume37
Issue number6
DOIs
Publication statusPublished - Jan 1 1989
Externally publishedYes

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Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Bacterial Pneumonia
Quinolones
Respiratory Sounds
Sputum
Coinfection
Double-Blind Method
Anti-Bacterial Agents
Safety
lomefloxacin

All Science Journal Classification (ASJC) codes

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

Cite this

Soejima, R., Niki, Y., Yagi, S., Hayashai, I., Ohnum, K., Kobayashi, H., ... Nakashima, M. (1989). Dose-finding study on lomefloxacin (NY-198, LFLX) in respiratory tract infections. Chemotherapy, 37(6), 776-795. https://doi.org/10.11250/chemotherapy1953.37.776

Dose-finding study on lomefloxacin (NY-198, LFLX) in respiratory tract infections. / Soejima, Rinzos; Niki, Yoshihito; Yagi, Susumu; Hayashai, Izumi; Ohnum, Kikuo; Kobayashi, Hiroyuki; Kobayashi, Shin; Suzuki, Kaneo; Murohashi, Kou; Nakagawa, Masaru; Matsushima, Toshiharu; Yamakido, Michio; Matsuzaka, Shioeru; Nagano, Hitoshi; Kubo, Chiharu; Honda, Kohei; Yamada, Hozumi; Kato, Osamu; Shinoda, Atsushi; Ishibashi, Tsuneo; Takamoto, Masahiro; Hara, Kohei; Hirota, Masaki; Yamaguchi, Keizo; Kohno, Shigeru; Hayashi, Toshiaki; Yasuoka, Akira; Sasayama, Kazuo; Nakatomi, Masao; Kohno, Kohta; Tsutsumi, Tsuneo; Watanabe, Koichi; Tokuomi, Haruhiko; Fukuda, Yasutsugu; Tokunaga, Katsumasa; Nakashima, Mitsuyoshi.

In: Chemotherapy, Vol. 37, No. 6, 01.01.1989, p. 776-795.

Research output: Contribution to journalArticle

Soejima, R, Niki, Y, Yagi, S, Hayashai, I, Ohnum, K, Kobayashi, H, Kobayashi, S, Suzuki, K, Murohashi, K, Nakagawa, M, Matsushima, T, Yamakido, M, Matsuzaka, S, Nagano, H, Kubo, C, Honda, K, Yamada, H, Kato, O, Shinoda, A, Ishibashi, T, Takamoto, M, Hara, K, Hirota, M, Yamaguchi, K, Kohno, S, Hayashi, T, Yasuoka, A, Sasayama, K, Nakatomi, M, Kohno, K, Tsutsumi, T, Watanabe, K, Tokuomi, H, Fukuda, Y, Tokunaga, K & Nakashima, M 1989, 'Dose-finding study on lomefloxacin (NY-198, LFLX) in respiratory tract infections', Chemotherapy, vol. 37, no. 6, pp. 776-795. https://doi.org/10.11250/chemotherapy1953.37.776
Soejima R, Niki Y, Yagi S, Hayashai I, Ohnum K, Kobayashi H et al. Dose-finding study on lomefloxacin (NY-198, LFLX) in respiratory tract infections. Chemotherapy. 1989 Jan 1;37(6):776-795. https://doi.org/10.11250/chemotherapy1953.37.776
Soejima, Rinzos ; Niki, Yoshihito ; Yagi, Susumu ; Hayashai, Izumi ; Ohnum, Kikuo ; Kobayashi, Hiroyuki ; Kobayashi, Shin ; Suzuki, Kaneo ; Murohashi, Kou ; Nakagawa, Masaru ; Matsushima, Toshiharu ; Yamakido, Michio ; Matsuzaka, Shioeru ; Nagano, Hitoshi ; Kubo, Chiharu ; Honda, Kohei ; Yamada, Hozumi ; Kato, Osamu ; Shinoda, Atsushi ; Ishibashi, Tsuneo ; Takamoto, Masahiro ; Hara, Kohei ; Hirota, Masaki ; Yamaguchi, Keizo ; Kohno, Shigeru ; Hayashi, Toshiaki ; Yasuoka, Akira ; Sasayama, Kazuo ; Nakatomi, Masao ; Kohno, Kohta ; Tsutsumi, Tsuneo ; Watanabe, Koichi ; Tokuomi, Haruhiko ; Fukuda, Yasutsugu ; Tokunaga, Katsumasa ; Nakashima, Mitsuyoshi. / Dose-finding study on lomefloxacin (NY-198, LFLX) in respiratory tract infections. In: Chemotherapy. 1989 ; Vol. 37, No. 6. pp. 776-795.
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abstract = "We performed a dose-finding study for lomefloxacin (NY-198, LFLX), a new quinolone antibacterial agent used in the treatment of lower respiratory tract infections, using a double-blind method. Chronic respiratory tract diseases with infections and bacterial pneumonias were included in this study. LFLX was orally administered at a daily dose of either 400 mg b. i. d. or 600 mg t. i. d. for 14 days in principle. Of the total 102 cases, clinical efficacy and safety were evaluated in 94 cases (400 mg group: 48; 600 mg group: 46) and 97 cases (400 mg group: 49; 600 mg group: 48), respectively. There was no significant shift in the distribution of background factors, except that there were significantly more cases with severe initial symptoms (e. g. sputum property) and rales in all cases in the 600 mg group, and of polymicrobial infection in the chronic respiratory tract diseases with infection in the 600 mg group (p<0.05). 1) The clinical efficacy rate evaluated by the committee in all cases was 72.9{\%}(35/48) in the 400 mg group and 69.6{\%}(32/46) in the 600 mg group. In chronic respiratory tract diseases with infection the rate was 63.6{\%}(21/33) in the 400 mg group and 65.7{\%}(23/35) in the 600 mg group. There was no statistically significant difference between the two groups. 2) Bacteriologically, the eradication rate was 80.0{\%}(24/30) in the 400 mg group and 67.9{\%}(19/28) in the 600 mg group, with no significant difference between the two groups. 3) Side-effects were noted in 4.1{\%}(2/49) of the 400 mg group and in 6.3{\%}(3/48) of the 600 mg group. Abnormal changes in laboratory findings were observed in 12.2{\%}(6/49) of the 400 mg group and in 15.9{\%}(7/44) of the 600 mg group. There was no significant difference between the rates of the two groups. Neither serious side-effects nor evident abnormal changes in laboratory findings were noted. 4) The utility rate evaluated by the committee was 72.9{\%}(35/48) in the 400 mg group and 66.0{\%}(31/47) in the 600 mg group, with no significant difference between the two groups. From these results, we consider that a dose of 600 mg t. i. d. is the optimal dose of LFLX in the treatment of respiratory tract infections including chronic respiratory tract diseases with infection.",
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AU - Soejima, Rinzos

AU - Niki, Yoshihito

AU - Yagi, Susumu

AU - Hayashai, Izumi

AU - Ohnum, Kikuo

AU - Kobayashi, Hiroyuki

AU - Kobayashi, Shin

AU - Suzuki, Kaneo

AU - Murohashi, Kou

AU - Nakagawa, Masaru

AU - Matsushima, Toshiharu

AU - Yamakido, Michio

AU - Matsuzaka, Shioeru

AU - Nagano, Hitoshi

AU - Kubo, Chiharu

AU - Honda, Kohei

AU - Yamada, Hozumi

AU - Kato, Osamu

AU - Shinoda, Atsushi

AU - Ishibashi, Tsuneo

AU - Takamoto, Masahiro

AU - Hara, Kohei

AU - Hirota, Masaki

AU - Yamaguchi, Keizo

AU - Kohno, Shigeru

AU - Hayashi, Toshiaki

AU - Yasuoka, Akira

AU - Sasayama, Kazuo

AU - Nakatomi, Masao

AU - Kohno, Kohta

AU - Tsutsumi, Tsuneo

AU - Watanabe, Koichi

AU - Tokuomi, Haruhiko

AU - Fukuda, Yasutsugu

AU - Tokunaga, Katsumasa

AU - Nakashima, Mitsuyoshi

PY - 1989/1/1

Y1 - 1989/1/1

N2 - We performed a dose-finding study for lomefloxacin (NY-198, LFLX), a new quinolone antibacterial agent used in the treatment of lower respiratory tract infections, using a double-blind method. Chronic respiratory tract diseases with infections and bacterial pneumonias were included in this study. LFLX was orally administered at a daily dose of either 400 mg b. i. d. or 600 mg t. i. d. for 14 days in principle. Of the total 102 cases, clinical efficacy and safety were evaluated in 94 cases (400 mg group: 48; 600 mg group: 46) and 97 cases (400 mg group: 49; 600 mg group: 48), respectively. There was no significant shift in the distribution of background factors, except that there were significantly more cases with severe initial symptoms (e. g. sputum property) and rales in all cases in the 600 mg group, and of polymicrobial infection in the chronic respiratory tract diseases with infection in the 600 mg group (p<0.05). 1) The clinical efficacy rate evaluated by the committee in all cases was 72.9%(35/48) in the 400 mg group and 69.6%(32/46) in the 600 mg group. In chronic respiratory tract diseases with infection the rate was 63.6%(21/33) in the 400 mg group and 65.7%(23/35) in the 600 mg group. There was no statistically significant difference between the two groups. 2) Bacteriologically, the eradication rate was 80.0%(24/30) in the 400 mg group and 67.9%(19/28) in the 600 mg group, with no significant difference between the two groups. 3) Side-effects were noted in 4.1%(2/49) of the 400 mg group and in 6.3%(3/48) of the 600 mg group. Abnormal changes in laboratory findings were observed in 12.2%(6/49) of the 400 mg group and in 15.9%(7/44) of the 600 mg group. There was no significant difference between the rates of the two groups. Neither serious side-effects nor evident abnormal changes in laboratory findings were noted. 4) The utility rate evaluated by the committee was 72.9%(35/48) in the 400 mg group and 66.0%(31/47) in the 600 mg group, with no significant difference between the two groups. From these results, we consider that a dose of 600 mg t. i. d. is the optimal dose of LFLX in the treatment of respiratory tract infections including chronic respiratory tract diseases with infection.

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