학술논문
A Double Blind Clinical Study of Fosfomycin (FOM) Otic Solution for the Treatment of Chronic Suppurative Otitis Media and its Acute Exacerbations / 耳用Fosfomycin(FOM)の慢性化膿性中耳炎および慢性化膿性中耳炎急性増悪症に対する二重盲検比較試験成績
Document Type
Journal Article
Author
Akimasa NAKAMURA; Akira KANO; Akiteru YUMISAKI; Atsushi SHINKAWA; Daisuke CHIKUIE; Eriko TABUCHI; Fujihiko KASANO; Fumihiro KAMIDE; Goro MOGI; Haruo ITO; Hideki TAKADA; Hideki WADA; Hideyuki KAWAUCHI; Hideyuki ONUMA; Hirofumi MATSUYAMA; Hirosato MIYAKE; Hiroshi TANAKA; Hitoshi SAITO; Hitoshi SYOJI; Ichiro MATSUMOTO; Itaru YAMAMICHI; Jun HONDO; Jun KAWAKUBO; Jun MORIMOTO; Junichiro SHIMADA; Kanemasa MIZUKOSHI; Kaoru SOYANO; Kataya HIRAYAMA; Katsuhisa KAMITANI; Kazuharu OKAWA; Kazuhiro TOMONAGA; Keiichi DATE; Ken MUKAI; Ken TAKADA; Kenji KATSUTA; Kenji TOYOTA; Kenji WADA; Kiichi SATO; Koichi DEGUCHI; Koichi SHIBUI; Koichi YAMASHITA; Koji MAKINO; Koji SERA; Koji YAJIN; Kozo FUKAMI; Kunihiko SAKAMOTO; Makoto HASHIMOTO; Makoto SAKAI; Mamoru SUZUKI; Masami TAKANO; Masaru OYAMA; Masayoshi TACHIBANA; Mashiko ANDO; Masuhiro NODA; Michinori KUROKAWA; Midori NABESHIMA; Mikiko TAKAYAMA; Mitsuaki INAGAKI; Mitsuru FURUKAWA; Mitsuyoshi Nakajima; Miwa HYUGA; Nobuharu TAGASHIRA; Nobukazu TADAKI; Norio UEHARA; Osamu MIZUKOSHI; Ryozo UMEDA; Ryuji KIYOTA; SYOZO KAWAMURA; Saburo MIMAKI; Satoshi ONO; Satoshi TAKENOUCHI; Seiji INOUE; Shigekazu TSUBAKI; Shigeru FURUTA; Shigeru WATANABE; Shinji KATO; Shunkichi BABA; Sumio ARAKI; Syunbun TAKEBAYASHI; Takahisa SAITO; Takashi KAWAI; Takashi MATSUI; Takeo IIDA; Takeo KOBAYASHI; Takeshi MARUO; Takeshige NISHIMURA; Takumi MIYAZAKI; Takuo NOBORI; Tamotsu MORIMITSU; Tetsuo ISHII; Tetsuya SHIMA; Tomohiro YASUNO; Tsuneharu HIROTA; Tsutomu Hatano; Tsutomu MATSUZAKI; Tsuyoshi TAKANO; Wataru Oshima; Yasuo HARADA; Yasuo MIZUTA; Yo Watanabe; Yoshiaki HIRASUGI; Yotaka FUJIMAKI; Yukio WATANABE; Yuzuru MURAKAMI; 三宅 浩郷; 三牧 三郎; 上出 文博; 上原 紀夫; 世良 公志; 中島 光好; 中村 明正; 丸尾 猛; 井上 靖二; 伊藤 晴夫; 伊達 敬一; 佐藤 喜一; 出口 浩一; 加納 晃; 加藤 眞二; 勝田 兼司; 原田 康夫; 友永 和宏; 古川 仭; 古田 茂; 只木 信和; 向井 研; 和田 健二; 和田 秀毅; 坂井 真; 坂本 邦彦; 夜陣 紘治; 大山 勝; 大島 渉; 大川 和春; 大沼 秀行; 安藤 真姿子; 安野 友博; 宮崎 巨; 小林 武夫; 小野 聡; 山下 公一; 山道 至; 島 哲也; 島田 純一郎; 川久保 淳; 川内 秀之; 平山 方哉; 平杉 嘉昭; 廣田 常治; 弓崎 明輝; 征矢野 薫; 斉藤 武久; 斉藤 等; 新川 敦; 日向 美和; 昇 卓夫; 昌子 均; 本堂 潤; 村上 譲; 松井 隆史; 松元 一郎; 松山 博文; 松崎 勉; 梅田 良三; 森本 純; 森満 保; 椿 茂和; 橋本 真実; 橘 正芳; 水田 康雄; 水越 治; 水越 鉄理; 河合 窄; 河村 正三; 波多野 努; 深水 浩三; 清田 隆二; 渋井 弘一; 渡辺 洋; 渡辺 繁; 渡辺 行雄; 牧野 浩二; 田中 博; 田渕 えり子; 田頭 宣治; 石井 哲夫; 神谷 勝久; 稲垣 光昭; 竹之内 智; 竹林 脩文; 笠野 藤彦; 築家 大介; 茂木 五郎; 荒木 澄夫; 藤巻 豊; 西村 武重; 豊田 健司; 貴田 秀樹; 野田 益弘; 鈴木 衛; 鍋島 みどり; 飯田 武雄; 馬場 駿吉; 高山 幹子; 高田 憲; 高野 剛; 高野 正美; 黒川 道徳
Source
耳鼻と臨床 / jibi to rinsho. 1986, 32(5Supplement2):868
Subject
Language
Japanese
ISSN
0447-7227
2185-1034
2185-1034
Abstract
In order to evaluate the clinical efficacy and safety of 3 % Fosfomycin (FOM) otic solution on suppurative otitis media, a double blind study was carried out comparing topical administration of FOM otic solution or placebo solution to patients with chronic suppurative otitis media and its acute exacerbations. Cephalexin was orally administered as a basic treatment. Clinical efficacy was analyzed in 247 patients (126 administered FOM, 121 administered placebo). Side effects were analyzed in 259 patients (129 administered FOM, 130 administered placebo) and clinical usefulness was analyzed in 248 patients (126 administered FOM, 122 administered placebo). The following results were obtained: 1) The overall clinical effectiveness rate judged by chief physicians was 66.7 % for the FOM group and 43.8 % for the placebo group. These results are significantly different. 2) The overall clinical offectiveness rate judged by a committee was significantly different for the two treatments (64.3 % for the FOM group and 40.5 % for the placebo group). 3) As to improvement rate of subjective and objective symptoms, a significant higher rate was obtained with the FOM group than with the placebo group. 4) The bacteriological elimination rate of causative organisms in all cases was 69.2 % treated with FOM and 46.7 % treated with placebo; the difference was significant. 5) Some side effects and adverse reactions were observed in 2 patients (1.6 %) in FOM group and in 2 patients (1.5 %) in the placebo group. Therefore, no singificant difference was observed in the incidence of adverse reactions. All adverse reactions observed were transient and not severe. 6) The overall clinical usefulness rate judged by the chief physicians was significantly greater for the FOM group (67.5 %) than for the placebo group (44.3 %). From the above results it was concluded that 3 % FOM otic solution possessed an excellent antibacterial activity, and is a efficient and safe topical preparation for the treatment of suppurative otitis media.