학술논문
Fundamental and clinical studies on the efficacy of Pazufloxacin for otitis media, otitis externa / 中耳炎および外耳炎に対するPazufloxacinの基礎的・臨床的検討
Document Type
Journal Article
Author
Akihiro UCHIZONO; Akira YOKOTA; Akitsugu KOZEKI; Atsushi SAKURAI; Atsushi SHINKAWA; Ayako SUGII; Eiichiro TOKUSHIGE; Fumiko DOKIYA; Fumio OHNO; Ginichiro ICHIKAWA; Hideaki TAKAHASHI; Hideshige KIMURA; Hiroko ISAJI; Hiromi ITO; Hirosato MIYAKE; Hiroshi FUKUSATO; Hiroshi WATANABE; Hisato MOTAI; Hitoshi OGINO; Ichiro MORIYAMA; Isato TSUGE; Johji HIROTA; Junko MURATA; Kaneaki HARAGUCHI; Kaoru KATO; Katsuhiro HIRAKAWA; Katsumi DOI; Kazuho MORIBE; Kazuyoshi FUJII; Keijiro FUKAZAWA; Ken KOJIMA; Kentaro ASHIDA; Kenzo MURANO; Koli YAJIN; Kouji DEGUCHI; Kumi SHIMADA; Makoto SAKAI; Mamoru SUZUKI; Masafumi SAKAGAMI; Masahiko EGAWA; Masaru OOYAMA; Masashi WADA; Masaya TAKUMIDA; Masumi MATSUMURA; Michiyo YAMAZAKI; Mutsumi SATO; Naoya MIYAMOTO; Nobuharu TAGASHIRA; Ototaka KAKI; Ryoji SASAKI; Shigeru FURUTA; Shinya MATSUNAGA; Shitau HIRATA; Shunkichi BABA; Soiku WATANABE; Sotaro KAMEI; Tadashi AKITAYA; Takatsugu ITABASHI; Takehiro KOBAYASHI; Takeshi KUBO; Takuya YAMAKAWA; Tatsumi KAGA; Tetsuya KASASHIMA; Tetsuya SHIMA; Tetsuya TSUDA; Toru MATSUNAGA; Tsutomu MATSUZAKI; Yasuhiro FUKUSHIMA; Yasuhiro MIYAZAKI; Yasujiro IMAKIIRE; Yasuo HARADA; Yasuo IWABUCHI; Yuko KOBAYASHI; Yuko MIYAMOTO; Yutaka OGAWA; 三宅 浩郷; 久保 武; 亀井 壮太郎; 今給黎 泰二郎; 伊佐治 弘子; 伊藤 弘美; 佐々木 良二; 佐藤 むつみ; 内薗 明裕; 出口 浩二; 加藤 薫; 加賀 達美; 原口 兼明; 原田 康夫; 古田 茂; 和田 昌士; 土井 勝美; 土器屋 富美子; 坂井 真; 夜陣 紘治; 大山 勝; 大野 文夫; 宮崎 康博; 宮本 ゆう子; 宮本 直哉; 小島 憲; 小川 裕; 小林 優子; 小林 武弘; 小関 晶嗣; 山崎 充代; 山川 卓也; 岩淵 康雄; 島 哲也; 島田 久美; 工田 昌也; 市川 銀一郎; 平川 勝洋; 平田 思; 廣田 常治; 徳重 栄一郎; 新川 敦; 木村 栄成; 杉井 亜也子; 村田 潤子; 村野 健三; 松崎 勉; 松村 益美; 松永 亨; 松永 信也; 板橋 隆嗣; 柘植 勇人; 柿 音高; 桜井 淳; 森山 一郎; 森部 一穂; 横田 明; 江川 雅彦; 津田 哲也; 深澤 啓二郎; 渡辺 洋; 渡辺 荘郁; 甕 久人; 田頭 宣治; 福島 康裕; 福里 博; 秋田谷 直; 笠島 哲也; 芦田 健太郎; 荻野 仁; 藤井 一省; 鈴木 衛; 阪上 雅史; 馬場 駿吉; 高橋 秀明
Source
耳鼻と臨床 / jibi to rinsho. 1996, 42(4):416
Subject
Language
Japanese
ISSN
0447-7227
2185-1034
2185-1034
Abstract
In order to evaluate the efficacy, safety of Pazufloxacin (PZFX) for otitis media and otitis externa, a general clinical trial, using a multicenter integrated protocol was performed in addition to the studies on the sensitivity distribution of isolated bacteria and the pharmacokinetics, including middle ear mucosa. The results were as follows:1. The sensitivity distribution of 100 strains, isolated from patients with otitis media and otitis externa, was 2-4 times superior to Ofloxacin (OFLX) and almost equal to Ciprofloxacin (CPFX).2. The concentration of PZFX in the tissue including middle ear mucosa, in two hours after administration at an oral dose, reached 1.20-3.60μg/g (2.39; ration to the serum level-average), which thus indicated good tissue penetration.3. The efficacy rate in 66 evaluable cases was 79% (52/66) for otitis media and 91% (20/22) for otitis externa.4. Adverse reactions were observed in 4 of 103 cases (incidence: 3.9%), which were mainly consisted of gastrointestinal disorders.As for abnormal laboratory changes, elevated GOT and GPT levels were observed in 1 case. These results therefore suggest that PZFX is a very useful drug for the treatment of otitis media and otitis externa.