Clinical study on levofloxacin in the field of internal medicine

Atsushi Saito; Yoshiteru Shigeno; Yuei Irabu; Hiroshi Fukuhara; Akira Saito; Masumi Tomizawa; Ichiro Nakayama; Yohmei Hiraga; Mitsuhide Ohmichi; Kazuo Takebe; Masashi Tamura; Kazuki Konishi; Yoshiaki Mori; Akio Mizuno; Akiho Obara; Tamotsu Takishima; Yasuo Tanno; Masakichi Motomiya; Akira Watanabe; Yushi Nakai; Jun ichi Saito; Kiyoshi Konno; Satoshi Shindo; Kosaku Nagai; Kazunao Niizuma; Kotaro Oizumi; Masataka Katsu; Hiroshi Hirose; Masatoshi Ishii; Jingoro Shimada; Kohya Shiba; Masaki Yoshida; Osamu Sakai; Hiroichi Tanimoto; Kazuo Ohara; Kihachiro Shimizu; Kyoichi Totsuka; Junichi Katahira; Kaoru Shimada; Hazime Goto; Shinichi Oka; Yoshihisa Ogata; Takashi Inamatsu; Yoshishige Masuda; Hiroshi Sakamoto; Fumiko Kojima; Makoto Kodaira; Yasuyuki Sano; Yasufumi Miyamoto; Hiroyuki Kobayashi; Hideo Ikemoto; Takeshi Mori; Masayoshi Inagaki; Koichiro Nakata; Yoshitaka Nakamori; Tatsuo Nakatani; Takeshi Kawai; Mitsuo Honma; Junzaburo Kabe; Koichiro Kudo; Hitoshi Arioka; Masaru Koyama; Harumi Shishido; Norio Kikuchi; Hidetoshi Igari; Hiroshi Tabeta; Shigeki Odagiri; Kaneo Suzuki; Hiroshi Takahashi; Kenichi Takahashi; Yasuhiko Ashikari; Eri Hagiwara; Yasutsugu Amano; Akira Shohji; Fumio Matsumoto; Takero Imai; Shoichiro Irimajiri; Yasuo Matsuoka; Mitsuo Obana; Masaaki Arakawa; Kouichi Wada; Hiroki Tukada; Takashi Kawashima; Osamu Sekine; Yasutoshi Suzuki; Katsuji Uno; Nobuki Aoki; Atsuhiko Sato; Masatoshi Iwata; Kingo Chida; Izumi Shichi; Hirokazu Okano; Masahiko Okano; Masami Taniguchi; Tatsuo Satake; Kenzo Takagi; Kenichi Yamaki; Hiroyuki Miyatake; Toshiyuki Yamamoto; Kanzo Suzuki; Satoru Adachi; Toru Matsuura; Fumiyuki Kuze; Tatsuyoshi Ikeue; Katsuhiro Suzuki; Kenji Bando; Masaru Chiba; Yoshinori Hasegawa; Ryuhei Nawata; Nobuo Inaba; Akira Kagioka; Mitsuo Hase; Eiro Tsubura; Masaru Nakagawa; Susumu Kishimoto; Nakaaki Osawa; Iwao Igarashi; Kiyoshi Komuta; Keiji Maeda; Mitsunori Sakatani; Toshio Sone; Yasutake Takahashi; Tatsuya Okada; Mitsumasa Ogawara; Kazuya Higashino; Takashi Nakano; Fumio Miki; Shigenori Nakashima; Atsushi Yasukawa; Nobuhiro Narita; Masayoshi Sawaki; Keiichi Mikasa; Rinzo Soejima; Niro Okimoto; Masaru Sumi; Toshiharu Matsushima; Yoshihiko Tano; Takao Sasaki; Yukio Matsumoto; Yuji Sugimoto; Michio Yamakido; Kenji Hasegawa; Osamu Kurimura; Yoshiro Sawae; Koji Takagi; Nobuyuki Shimono; Atsushi Shinoda; Tsuneo Ishibashi; Masahiro Takamoto; Hozumi Yamada; Osamu Kato; Yosuke Aoki; Shigetaka Kuroki; Kohei Hara; Hironobu Koga; Kiyoyasu Fukushima; Hisasuke Nakamura; Tetsuro Kanda; Miyako Ishiguro; Takakazu Kiya; Shiro Kusano; Keizo Matsumoto; Hironori Masaki; Hirofumi Tanaka; Masaru Nasu; Yoichiro Goto; Hiroyuki Nagai; Toru Yamasaki; Takayoshi Tashiro; Shinobu Takenaka; Kiyoshi Shima; Mitsuo Kaku; Kazuyuki Sugawara; Keizo Yamaguchi

doi:10.11250/chemotherapy1953.40.Supplement3_147

Clinical study on levofloxacin in the field of internal medicine

Atsushi Saito, Yoshiteru Shigeno, Yuei Irabu, Hiroshi Fukuhara, Akira Saito, Masumi Tomizawa, Ichiro Nakayama, Yohmei Hiraga, Mitsuhide Ohmichi, Kazuo Takebe, Masashi Tamura, Kazuki Konishi, Yoshiaki Mori, Akio Mizuno, Akiho Obara, Tamotsu Takishima, Yasuo Tanno, Masakichi Motomiya, Akira Watanabe, Yushi NakaiJun ichi Saito, Kiyoshi Konno, Satoshi Shindo, Kosaku Nagai, Kazunao Niizuma, Kotaro Oizumi, Masataka Katsu, Hiroshi Hirose, Masatoshi Ishii, Jingoro Shimada, Kohya Shiba, Masaki Yoshida, Osamu Sakai, Hiroichi Tanimoto, Kazuo Ohara, Kihachiro Shimizu, Kyoichi Totsuka, Junichi Katahira, Kaoru Shimada, Hazime Goto, Shinichi Oka, Yoshihisa Ogata, Takashi Inamatsu, Yoshishige Masuda, Hiroshi Sakamoto, Fumiko Kojima, Makoto Kodaira, Yasuyuki Sano, Yasufumi Miyamoto, Hiroyuki Kobayashi, Hideo Ikemoto, Takeshi Mori, Masayoshi Inagaki, Koichiro Nakata, Yoshitaka Nakamori, Tatsuo Nakatani, Takeshi Kawai, Mitsuo Honma, Junzaburo Kabe, Koichiro Kudo, Hitoshi Arioka, Masaru Koyama, Harumi Shishido, Norio Kikuchi, Hidetoshi Igari, Hiroshi Tabeta, Shigeki Odagiri, Kaneo Suzuki, Hiroshi Takahashi, Kenichi Takahashi, Yasuhiko Ashikari, Eri Hagiwara, Yasutsugu Amano, Akira Shohji, Fumio Matsumoto, Takero Imai, Shoichiro Irimajiri, Yasuo Matsuoka, Mitsuo Obana, Masaaki Arakawa, Kouichi Wada, Hiroki Tukada, Takashi Kawashima, Osamu Sekine, Yasutoshi Suzuki, Katsuji Uno, Nobuki Aoki, Atsuhiko Sato, Masatoshi Iwata, Kingo Chida, Izumi Shichi, Hirokazu Okano, Masahiko Okano, Masami Taniguchi, Tatsuo Satake, Kenzo Takagi, Kenichi Yamaki, Hiroyuki Miyatake, Toshiyuki Yamamoto, Kanzo Suzuki, Satoru Adachi, Toru Matsuura, Fumiyuki Kuze, Tatsuyoshi Ikeue, Katsuhiro Suzuki, Kenji Bando, Masaru Chiba, Yoshinori Hasegawa, Ryuhei Nawata, Nobuo Inaba, Akira Kagioka, Mitsuo Hase, Eiro Tsubura, Masaru Nakagawa, Susumu Kishimoto, Nakaaki Osawa, Iwao Igarashi, Kiyoshi Komuta, Keiji Maeda, Mitsunori Sakatani, Toshio Sone, Yasutake Takahashi, Tatsuya Okada, Mitsumasa Ogawara, Kazuya Higashino, Takashi Nakano, Fumio Miki, Shigenori Nakashima, Atsushi Yasukawa, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Rinzo Soejima, Niro Okimoto, Masaru Sumi, Toshiharu Matsushima, Yoshihiko Tano, Takao Sasaki, Yukio Matsumoto, Yuji Sugimoto, Michio Yamakido, Kenji Hasegawa, Osamu Kurimura, Yoshiro Sawae, Koji Takagi, Nobuyuki Shimono, Atsushi Shinoda, Tsuneo Ishibashi, Masahiro Takamoto, Hozumi Yamada, Osamu Kato, Yosuke Aoki, Shigetaka Kuroki, Kohei Hara, Hironobu Koga, Kiyoyasu Fukushima, Hisasuke Nakamura, Tetsuro Kanda, Miyako Ishiguro, Takakazu Kiya, Shiro Kusano, Keizo Matsumoto, Hironori Masaki, Hirofumi Tanaka, Masaru Nasu, Yoichiro Goto, Hiroyuki Nagai, Toru Yamasaki, Takayoshi Tashiro, Shinobu Takenaka, Kiyoshi Shima, Mitsuo Kaku, Kazuyuki Sugawara, Keizo Yamaguchi

General Internal Medicine

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Levofloxacin (LVFX), an optical isomer of ofloxacin (OFLX), is twice as potent as OFLX against gram-positive and gram-negative bacteria such as Haemophilus influenzae, Streptococcus pneumoniae and Pseudomonas aeruginosa, while it has been shown to be as safe as OFLX in animal experiments. Phase 1 study showed that the pharmacokinetics of LVFX were similar to those of OFLX. We carried out a multicenter collaborative trial at 69 institutions to determine the clinical efficacy and safety of LVFX in the field of internal medicine, mainly in the treatment of respiratory tract infections. LVFX was orally administered to 463 patients in daily doses of 200 mg to 600 mg for 7 to 14 consecutive days. Out of the total patients enrolled, the clinical efficacy was evaluated in 423 patients and was 84.9% (321/378) against respiratory tract infections, 78.8% (26/33) against urinary tract infections, 100% (9/9) against infectious enteritis and 100% (3/3) against other infections. As for respiratory tract infections, the efficacy rate was 90.6% (77/85) for pharyngitis and tonsillitis, 80.2% (174/217) for infectious exacerbation of chronic respiratory disease and 91.8% (67/73) for pneumonia. The efficacy rate, as a function of the daily dose, was 79.2% (38/48) with 100mg b.i.d., 85.5% (253/296) with 100mg t.i.d., 87.7% (50/57) with 200mg t.i.d., and 81.8% (18/22) with other dose regimens. The bacteriological response was evaluated in 179 patients and showed an eradication rate of 77.4% (123/159) for monomicrobial infections and 40.0% (8/20) for polymicrobial infections. The MIC was determined for 78 strains, and the eradication rate was 78.9% (56/71) for strains with an MIC value of 1.56 µg/ml or lower and 0.0% (0/7) for strains with an MIC value of 3.13 µg/ml or higher. Out of 454 patients, clinical adverse reactions were recorded in 17 (3.7%), consisting of gastrointestinal disorder in 9, neurogenic symptoms in 7 and other symptoms in 1. Abnormal laboratory findings were recorded in 41 (10.0%) out of 409 patients, the main item being elevation of the eosinophil count and the transaminase level. None of them were serious. Based on the above results, we concluded that LVFX is a useful antibacterial agent for the treatment of infections in the field of internal medicine, mainly respiratory tract infections.

Original language	English
Pages (from-to)	147-169
Number of pages	23
Journal	Chemotherapy
Volume	40
DOIs	https://doi.org/10.11250/chemotherapy1953.40.Supplement3_147
Publication status	Published - May 1992

All Science Journal Classification (ASJC) codes

Pharmacology (medical)
Infectious Diseases
Pharmacology
Drug Discovery
Oncology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.11250/chemotherapy1953.40.Supplement3_147

Cite this

Saito, A., Shigeno, Y., Irabu, Y., Fukuhara, H., Saito, A., Tomizawa, M., Nakayama, I., Hiraga, Y., Ohmichi, M., Takebe, K., Tamura, M., Konishi, K., Mori, Y., Mizuno, A., Obara, A., Takishima, T., Tanno, Y., Motomiya, M., Watanabe, A., ... Yamaguchi, K. (1992). Clinical study on levofloxacin in the field of internal medicine. Chemotherapy, 40, 147-169. https://doi.org/10.11250/chemotherapy1953.40.Supplement3_147

Saito, A, Shigeno, Y, Irabu, Y, Fukuhara, H, Saito, A, Tomizawa, M, Nakayama, I, Hiraga, Y, Ohmichi, M, Takebe, K, Tamura, M, Konishi, K, Mori, Y, Mizuno, A, Obara, A, Takishima, T, Tanno, Y, Motomiya, M, Watanabe, A, Nakai, Y, Saito, JI, Konno, K, Shindo, S, Nagai, K, Niizuma, K, Oizumi, K, Katsu, M, Hirose, H, Ishii, M, Shimada, J, Shiba, K, Yoshida, M, Sakai, O, Tanimoto, H, Ohara, K, Shimizu, K, Totsuka, K, Katahira, J, Shimada, K, Goto, H, Oka, S, Ogata, Y, Inamatsu, T, Masuda, Y, Sakamoto, H, Kojima, F, Kodaira, M, Sano, Y, Miyamoto, Y, Kobayashi, H, Ikemoto, H, Mori, T, Inagaki, M, Nakata, K, Nakamori, Y, Nakatani, T, Kawai, T, Honma, M, Kabe, J, Kudo, K, Arioka, H, Koyama, M, Shishido, H, Kikuchi, N, Igari, H, Tabeta, H, Odagiri, S, Suzuki, K, Takahashi, H, Takahashi, K, Ashikari, Y, Hagiwara, E, Amano, Y, Shohji, A, Matsumoto, F, Imai, T, Irimajiri, S, Matsuoka, Y, Obana, M, Arakawa, M, Wada, K, Tukada, H, Kawashima, T, Sekine, O, Suzuki, Y, Uno, K, Aoki, N, Sato, A, Iwata, M, Chida, K, Shichi, I, Okano, H, Okano, M, Taniguchi, M, Satake, T, Takagi, K, Yamaki, K, Miyatake, H, Yamamoto, T, Suzuki, K, Adachi, S, Matsuura, T, Kuze, F, Ikeue, T, Suzuki, K, Bando, K, Chiba, M, Hasegawa, Y, Nawata, R, Inaba, N, Kagioka, A, Hase, M, Tsubura, E, Nakagawa, M, Kishimoto, S, Osawa, N, Igarashi, I, Komuta, K, Maeda, K, Sakatani, M, Sone, T, Takahashi, Y, Okada, T, Ogawara, M, Higashino, K, Nakano, T, Miki, F, Nakashima, S, Yasukawa, A, Narita, N, Sawaki, M, Mikasa, K, Soejima, R, Okimoto, N, Sumi, M, Matsushima, T, Tano, Y, Sasaki, T, Matsumoto, Y, Sugimoto, Y, Yamakido, M, Hasegawa, K, Kurimura, O, Sawae, Y, Takagi, K, Shimono, N, Shinoda, A, Ishibashi, T, Takamoto, M, Yamada, H, Kato, O, Aoki, Y, Kuroki, S, Hara, K, Koga, H, Fukushima, K, Nakamura, H, Kanda, T, Ishiguro, M, Kiya, T, Kusano, S, Matsumoto, K, Masaki, H, Tanaka, H, Nasu, M, Goto, Y, Nagai, H, Yamasaki, T, Tashiro, T, Takenaka, S, Shima, K, Kaku, M, Sugawara, K & Yamaguchi, K 1992, 'Clinical study on levofloxacin in the field of internal medicine', Chemotherapy, vol. 40, pp. 147-169. https://doi.org/10.11250/chemotherapy1953.40.Supplement3_147

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title = "Clinical study on levofloxacin in the field of internal medicine",

abstract = "Levofloxacin (LVFX), an optical isomer of ofloxacin (OFLX), is twice as potent as OFLX against gram-positive and gram-negative bacteria such as Haemophilus influenzae, Streptococcus pneumoniae and Pseudomonas aeruginosa, while it has been shown to be as safe as OFLX in animal experiments. Phase 1 study showed that the pharmacokinetics of LVFX were similar to those of OFLX. We carried out a multicenter collaborative trial at 69 institutions to determine the clinical efficacy and safety of LVFX in the field of internal medicine, mainly in the treatment of respiratory tract infections. LVFX was orally administered to 463 patients in daily doses of 200 mg to 600 mg for 7 to 14 consecutive days. Out of the total patients enrolled, the clinical efficacy was evaluated in 423 patients and was 84.9% (321/378) against respiratory tract infections, 78.8% (26/33) against urinary tract infections, 100% (9/9) against infectious enteritis and 100% (3/3) against other infections. As for respiratory tract infections, the efficacy rate was 90.6% (77/85) for pharyngitis and tonsillitis, 80.2% (174/217) for infectious exacerbation of chronic respiratory disease and 91.8% (67/73) for pneumonia. The efficacy rate, as a function of the daily dose, was 79.2% (38/48) with 100mg b.i.d., 85.5% (253/296) with 100mg t.i.d., 87.7% (50/57) with 200mg t.i.d., and 81.8% (18/22) with other dose regimens. The bacteriological response was evaluated in 179 patients and showed an eradication rate of 77.4% (123/159) for monomicrobial infections and 40.0% (8/20) for polymicrobial infections. The MIC was determined for 78 strains, and the eradication rate was 78.9% (56/71) for strains with an MIC value of 1.56 µg/ml or lower and 0.0% (0/7) for strains with an MIC value of 3.13 µg/ml or higher. Out of 454 patients, clinical adverse reactions were recorded in 17 (3.7%), consisting of gastrointestinal disorder in 9, neurogenic symptoms in 7 and other symptoms in 1. Abnormal laboratory findings were recorded in 41 (10.0%) out of 409 patients, the main item being elevation of the eosinophil count and the transaminase level. None of them were serious. Based on the above results, we concluded that LVFX is a useful antibacterial agent for the treatment of infections in the field of internal medicine, mainly respiratory tract infections.",

author = "Atsushi Saito and Yoshiteru Shigeno and Yuei Irabu and Hiroshi Fukuhara and Akira Saito and Masumi Tomizawa and Ichiro Nakayama and Yohmei Hiraga and Mitsuhide Ohmichi and Kazuo Takebe and Masashi Tamura and Kazuki Konishi and Yoshiaki Mori and Akio Mizuno and Akiho Obara and Tamotsu Takishima and Yasuo Tanno and Masakichi Motomiya and Akira Watanabe and Yushi Nakai and Saito, {Jun ichi} and Kiyoshi Konno and Satoshi Shindo and Kosaku Nagai and Kazunao Niizuma and Kotaro Oizumi and Masataka Katsu and Hiroshi Hirose and Masatoshi Ishii and Jingoro Shimada and Kohya Shiba and Masaki Yoshida and Osamu Sakai and Hiroichi Tanimoto and Kazuo Ohara and Kihachiro Shimizu and Kyoichi Totsuka and Junichi Katahira and Kaoru Shimada and Hazime Goto and Shinichi Oka and Yoshihisa Ogata and Takashi Inamatsu and Yoshishige Masuda and Hiroshi Sakamoto and Fumiko Kojima and Makoto Kodaira and Yasuyuki Sano and Yasufumi Miyamoto and Hiroyuki Kobayashi and Hideo Ikemoto and Takeshi Mori and Masayoshi Inagaki and Koichiro Nakata and Yoshitaka Nakamori and Tatsuo Nakatani and Takeshi Kawai and Mitsuo Honma and Junzaburo Kabe and Koichiro Kudo and Hitoshi Arioka and Masaru Koyama and Harumi Shishido and Norio Kikuchi and Hidetoshi Igari and Hiroshi Tabeta and Shigeki Odagiri and Kaneo Suzuki and Hiroshi Takahashi and Kenichi Takahashi and Yasuhiko Ashikari and Eri Hagiwara and Yasutsugu Amano and Akira Shohji and Fumio Matsumoto and Takero Imai and Shoichiro Irimajiri and Yasuo Matsuoka and Mitsuo Obana and Masaaki Arakawa and Kouichi Wada and Hiroki Tukada and Takashi Kawashima and Osamu Sekine and Yasutoshi Suzuki and Katsuji Uno and Nobuki Aoki and Atsuhiko Sato and Masatoshi Iwata and Kingo Chida and Izumi Shichi and Hirokazu Okano and Masahiko Okano and Masami Taniguchi and Tatsuo Satake and Kenzo Takagi and Kenichi Yamaki and Hiroyuki Miyatake and Toshiyuki Yamamoto and Kanzo Suzuki and Satoru Adachi and Toru Matsuura and Fumiyuki Kuze and Tatsuyoshi Ikeue and Katsuhiro Suzuki and Kenji Bando and Masaru Chiba and Yoshinori Hasegawa and Ryuhei Nawata and Nobuo Inaba and Akira Kagioka and Mitsuo Hase and Eiro Tsubura and Masaru Nakagawa and Susumu Kishimoto and Nakaaki Osawa and Iwao Igarashi and Kiyoshi Komuta and Keiji Maeda and Mitsunori Sakatani and Toshio Sone and Yasutake Takahashi and Tatsuya Okada and Mitsumasa Ogawara and Kazuya Higashino and Takashi Nakano and Fumio Miki and Shigenori Nakashima and Atsushi Yasukawa and Nobuhiro Narita and Masayoshi Sawaki and Keiichi Mikasa and Rinzo Soejima and Niro Okimoto and Masaru Sumi and Toshiharu Matsushima and Yoshihiko Tano and Takao Sasaki and Yukio Matsumoto and Yuji Sugimoto and Michio Yamakido and Kenji Hasegawa and Osamu Kurimura and Yoshiro Sawae and Koji Takagi and Nobuyuki Shimono and Atsushi Shinoda and Tsuneo Ishibashi and Masahiro Takamoto and Hozumi Yamada and Osamu Kato and Yosuke Aoki and Shigetaka Kuroki and Kohei Hara and Hironobu Koga and Kiyoyasu Fukushima and Hisasuke Nakamura and Tetsuro Kanda and Miyako Ishiguro and Takakazu Kiya and Shiro Kusano and Keizo Matsumoto and Hironori Masaki and Hirofumi Tanaka and Masaru Nasu and Yoichiro Goto and Hiroyuki Nagai and Toru Yamasaki and Takayoshi Tashiro and Shinobu Takenaka and Kiyoshi Shima and Mitsuo Kaku and Kazuyuki Sugawara and Keizo Yamaguchi",

year = "1992",

month = may,

doi = "10.11250/chemotherapy1953.40.Supplement3_147",

language = "English",

volume = "40",

pages = "147--169",

journal = "CHEMOTHERAPY",

issn = "0009-3165",

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TY - JOUR

T1 - Clinical study on levofloxacin in the field of internal medicine

AU - Saito, Atsushi

AU - Shigeno, Yoshiteru

AU - Irabu, Yuei

AU - Fukuhara, Hiroshi

AU - Saito, Akira

AU - Tomizawa, Masumi

AU - Nakayama, Ichiro

AU - Hiraga, Yohmei

AU - Ohmichi, Mitsuhide

AU - Takebe, Kazuo

AU - Tamura, Masashi

AU - Konishi, Kazuki

AU - Mori, Yoshiaki

AU - Mizuno, Akio

AU - Obara, Akiho

AU - Takishima, Tamotsu

AU - Tanno, Yasuo

AU - Motomiya, Masakichi

AU - Watanabe, Akira

AU - Nakai, Yushi

AU - Saito, Jun ichi

AU - Konno, Kiyoshi

AU - Shindo, Satoshi

AU - Nagai, Kosaku

AU - Niizuma, Kazunao

AU - Oizumi, Kotaro

AU - Katsu, Masataka

AU - Hirose, Hiroshi

AU - Ishii, Masatoshi

AU - Shimada, Jingoro

AU - Shiba, Kohya

AU - Yoshida, Masaki

AU - Sakai, Osamu

AU - Tanimoto, Hiroichi

AU - Ohara, Kazuo

AU - Shimizu, Kihachiro

AU - Totsuka, Kyoichi

AU - Katahira, Junichi

AU - Shimada, Kaoru

AU - Goto, Hazime

AU - Oka, Shinichi

AU - Ogata, Yoshihisa

AU - Inamatsu, Takashi

AU - Masuda, Yoshishige

AU - Sakamoto, Hiroshi

AU - Kojima, Fumiko

AU - Kodaira, Makoto

AU - Sano, Yasuyuki

AU - Miyamoto, Yasufumi

AU - Kobayashi, Hiroyuki

AU - Ikemoto, Hideo

AU - Mori, Takeshi

AU - Inagaki, Masayoshi

AU - Nakata, Koichiro

AU - Nakamori, Yoshitaka

AU - Nakatani, Tatsuo

AU - Kawai, Takeshi

AU - Honma, Mitsuo

AU - Kabe, Junzaburo

AU - Kudo, Koichiro

AU - Arioka, Hitoshi

AU - Koyama, Masaru

AU - Shishido, Harumi

AU - Kikuchi, Norio

AU - Igari, Hidetoshi

AU - Tabeta, Hiroshi

AU - Odagiri, Shigeki

AU - Suzuki, Kaneo

AU - Takahashi, Hiroshi

AU - Takahashi, Kenichi

AU - Ashikari, Yasuhiko

AU - Hagiwara, Eri

AU - Amano, Yasutsugu

AU - Shohji, Akira

AU - Matsumoto, Fumio

AU - Imai, Takero

AU - Irimajiri, Shoichiro

AU - Matsuoka, Yasuo

AU - Obana, Mitsuo

AU - Arakawa, Masaaki

AU - Wada, Kouichi

AU - Tukada, Hiroki

AU - Kawashima, Takashi

AU - Sekine, Osamu

AU - Suzuki, Yasutoshi

AU - Uno, Katsuji

AU - Aoki, Nobuki

AU - Sato, Atsuhiko

AU - Iwata, Masatoshi

AU - Chida, Kingo

AU - Shichi, Izumi

AU - Okano, Hirokazu

AU - Okano, Masahiko

AU - Taniguchi, Masami

AU - Satake, Tatsuo

AU - Takagi, Kenzo

AU - Yamaki, Kenichi

AU - Miyatake, Hiroyuki

AU - Yamamoto, Toshiyuki

AU - Suzuki, Kanzo

AU - Adachi, Satoru

AU - Matsuura, Toru

AU - Kuze, Fumiyuki

AU - Ikeue, Tatsuyoshi

AU - Suzuki, Katsuhiro

AU - Bando, Kenji

AU - Chiba, Masaru

AU - Hasegawa, Yoshinori

AU - Nawata, Ryuhei

AU - Inaba, Nobuo

AU - Kagioka, Akira

AU - Hase, Mitsuo

AU - Tsubura, Eiro

AU - Nakagawa, Masaru

AU - Kishimoto, Susumu

AU - Osawa, Nakaaki

AU - Igarashi, Iwao

AU - Komuta, Kiyoshi

AU - Maeda, Keiji

AU - Sakatani, Mitsunori

AU - Sone, Toshio

AU - Takahashi, Yasutake

AU - Okada, Tatsuya

AU - Ogawara, Mitsumasa

AU - Higashino, Kazuya

AU - Nakano, Takashi

AU - Miki, Fumio

AU - Nakashima, Shigenori

AU - Yasukawa, Atsushi

AU - Narita, Nobuhiro

AU - Sawaki, Masayoshi

AU - Mikasa, Keiichi

AU - Soejima, Rinzo

AU - Okimoto, Niro

AU - Sumi, Masaru

AU - Matsushima, Toshiharu

AU - Tano, Yoshihiko

AU - Sasaki, Takao

AU - Matsumoto, Yukio

AU - Sugimoto, Yuji

AU - Yamakido, Michio

AU - Hasegawa, Kenji

AU - Kurimura, Osamu

AU - Sawae, Yoshiro

AU - Takagi, Koji

AU - Shimono, Nobuyuki

AU - Shinoda, Atsushi

AU - Ishibashi, Tsuneo

AU - Takamoto, Masahiro

AU - Yamada, Hozumi

AU - Kato, Osamu

AU - Aoki, Yosuke

AU - Kuroki, Shigetaka

AU - Hara, Kohei

AU - Koga, Hironobu

AU - Fukushima, Kiyoyasu

AU - Nakamura, Hisasuke

AU - Kanda, Tetsuro

AU - Ishiguro, Miyako

AU - Kiya, Takakazu

AU - Kusano, Shiro

AU - Matsumoto, Keizo

AU - Masaki, Hironori

AU - Tanaka, Hirofumi

AU - Nasu, Masaru

AU - Goto, Yoichiro

AU - Nagai, Hiroyuki

AU - Yamasaki, Toru

AU - Tashiro, Takayoshi

AU - Takenaka, Shinobu

AU - Shima, Kiyoshi

AU - Kaku, Mitsuo

AU - Sugawara, Kazuyuki

AU - Yamaguchi, Keizo

PY - 1992/5

Y1 - 1992/5

N2 - Levofloxacin (LVFX), an optical isomer of ofloxacin (OFLX), is twice as potent as OFLX against gram-positive and gram-negative bacteria such as Haemophilus influenzae, Streptococcus pneumoniae and Pseudomonas aeruginosa, while it has been shown to be as safe as OFLX in animal experiments. Phase 1 study showed that the pharmacokinetics of LVFX were similar to those of OFLX. We carried out a multicenter collaborative trial at 69 institutions to determine the clinical efficacy and safety of LVFX in the field of internal medicine, mainly in the treatment of respiratory tract infections. LVFX was orally administered to 463 patients in daily doses of 200 mg to 600 mg for 7 to 14 consecutive days. Out of the total patients enrolled, the clinical efficacy was evaluated in 423 patients and was 84.9% (321/378) against respiratory tract infections, 78.8% (26/33) against urinary tract infections, 100% (9/9) against infectious enteritis and 100% (3/3) against other infections. As for respiratory tract infections, the efficacy rate was 90.6% (77/85) for pharyngitis and tonsillitis, 80.2% (174/217) for infectious exacerbation of chronic respiratory disease and 91.8% (67/73) for pneumonia. The efficacy rate, as a function of the daily dose, was 79.2% (38/48) with 100mg b.i.d., 85.5% (253/296) with 100mg t.i.d., 87.7% (50/57) with 200mg t.i.d., and 81.8% (18/22) with other dose regimens. The bacteriological response was evaluated in 179 patients and showed an eradication rate of 77.4% (123/159) for monomicrobial infections and 40.0% (8/20) for polymicrobial infections. The MIC was determined for 78 strains, and the eradication rate was 78.9% (56/71) for strains with an MIC value of 1.56 µg/ml or lower and 0.0% (0/7) for strains with an MIC value of 3.13 µg/ml or higher. Out of 454 patients, clinical adverse reactions were recorded in 17 (3.7%), consisting of gastrointestinal disorder in 9, neurogenic symptoms in 7 and other symptoms in 1. Abnormal laboratory findings were recorded in 41 (10.0%) out of 409 patients, the main item being elevation of the eosinophil count and the transaminase level. None of them were serious. Based on the above results, we concluded that LVFX is a useful antibacterial agent for the treatment of infections in the field of internal medicine, mainly respiratory tract infections.

AB - Levofloxacin (LVFX), an optical isomer of ofloxacin (OFLX), is twice as potent as OFLX against gram-positive and gram-negative bacteria such as Haemophilus influenzae, Streptococcus pneumoniae and Pseudomonas aeruginosa, while it has been shown to be as safe as OFLX in animal experiments. Phase 1 study showed that the pharmacokinetics of LVFX were similar to those of OFLX. We carried out a multicenter collaborative trial at 69 institutions to determine the clinical efficacy and safety of LVFX in the field of internal medicine, mainly in the treatment of respiratory tract infections. LVFX was orally administered to 463 patients in daily doses of 200 mg to 600 mg for 7 to 14 consecutive days. Out of the total patients enrolled, the clinical efficacy was evaluated in 423 patients and was 84.9% (321/378) against respiratory tract infections, 78.8% (26/33) against urinary tract infections, 100% (9/9) against infectious enteritis and 100% (3/3) against other infections. As for respiratory tract infections, the efficacy rate was 90.6% (77/85) for pharyngitis and tonsillitis, 80.2% (174/217) for infectious exacerbation of chronic respiratory disease and 91.8% (67/73) for pneumonia. The efficacy rate, as a function of the daily dose, was 79.2% (38/48) with 100mg b.i.d., 85.5% (253/296) with 100mg t.i.d., 87.7% (50/57) with 200mg t.i.d., and 81.8% (18/22) with other dose regimens. The bacteriological response was evaluated in 179 patients and showed an eradication rate of 77.4% (123/159) for monomicrobial infections and 40.0% (8/20) for polymicrobial infections. The MIC was determined for 78 strains, and the eradication rate was 78.9% (56/71) for strains with an MIC value of 1.56 µg/ml or lower and 0.0% (0/7) for strains with an MIC value of 3.13 µg/ml or higher. Out of 454 patients, clinical adverse reactions were recorded in 17 (3.7%), consisting of gastrointestinal disorder in 9, neurogenic symptoms in 7 and other symptoms in 1. Abnormal laboratory findings were recorded in 41 (10.0%) out of 409 patients, the main item being elevation of the eosinophil count and the transaminase level. None of them were serious. Based on the above results, we concluded that LVFX is a useful antibacterial agent for the treatment of infections in the field of internal medicine, mainly respiratory tract infections.

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U2 - 10.11250/chemotherapy1953.40.Supplement3_147

DO - 10.11250/chemotherapy1953.40.Supplement3_147

M3 - Article

AN - SCOPUS:0026648382

SN - 0009-3165

VL - 40

SP - 147

EP - 169

JO - CHEMOTHERAPY

JF - CHEMOTHERAPY

ER -

Clinical study on levofloxacin in the field of internal medicine

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