Cefmenoxime (CMX) 耳用液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

• 馬場 駿吉

  Department of Otorhinolaryngology, Nagoya City University, School of Medicine

• 木下 治二

  Department of Otorhinolaryngology, Nagoya City University, School of Medicine

• 森 慶人

  Department of Otorhinolaryngology, Nagoya City University, School of Medicine

• 戸村 卓爾

  Department of Otorhinolaryngology, Sapporo Railway Hospital

• 谷内 美栄子

  Department of Otorhinolaryngology, Sapporo Railway Hospital

• 山田 彰

  Department of Otorhinolaryngology, Sapporo Railway Hospital

• 杉森 久一

  Department of Otorhinolaryngology, Sapporo National Hospital

• 佐々木 亨

  Department of Otorhinolaryngology, Asahikawa Municipal Hospital

• 高橋 健一

  Department of Otorhinolaryngology, Sendai National Hospital

• 中谷 俊彦

  Department of Otorhinolaryngology, Sendai National Hospital

• 河村 正三

  Department of Otorhinolaryngology, Juntendo University, School of Medicine

• 杉田 麟也

  Department of Otorhinolaryngology, Juntendo University, School of Medicine

• 藤巻 豊

  Department of Otorhinolaryngology, Juntendo University, School of Medicine

• 石井 哲夫

  Department of Otorhinolaryngology, Tokyo Women's Medical College

• 古内 一郎

  Department of Otorhinolaryngology, Dokkyo University, School of Medicine

• 長江 大介

  Department of Otorhinolaryngology, Dokkyo University, School of Medicine

• 島田 均

  Department of Otorhinolaryngology, Dokkyo University, School of Medicine

• 三宅 浩郷

  Department of Otorhinolaryngology, Tokai University, School of Medicine

• 新川 敦

  Department of Otorhinolaryngology, Tokai University, School of Medicine

• 坂井 真

  Department of Otorhinolaryngology, Tokai University, School of Medicine

• 大西 信治郎

  Clinic of Otorhinolaryngology, Kanto Teishin Hospital

• 伊藤 依子

  Clinic of Otorhinolaryngology, Kanto Teishin Hospital

• 上田 良穂

  Clinic of Otorhinolaryngology, Kanto Teishin Hospital

• 小林 恵子

  Clinic of Otorhinolaryngology, Kanto Teishin Hospital

• 坂本 裕

  Department of Otorhinolaryngology, Kawasaki Hospital

• 浦尾 弥須子

  Department of Otorhinolaryngology, Kawasaki Hospital

• 蓼原 東紅

  Department of Otorhinolaryngology, Kawasaki Hospital

• 瀧本 勲

  Department of Otorhinolaryngology, Aichi Medical University

• 稲福 繁

  Department of Otorhinolaryngology, Aichi Medical University

• 岩田 重信

  Department of Otorhinolaryngology, Fujita Gakuen University, School of Medicine

• 八木沢 幹夫

  Department of Otorhinolaryngology, Fujita Gakuen University, School of Medicine

• 内藤 雅夫

  Department of Otorhinolaryngology, Fujita Gakuen University, School of Medicine

• 関谷 忠雄

  Department of Otorhinolaryngology, National Nagoya Hospital

• 田中 八郎

  Department of Otorhinolaryngology, National Nagoya Hospital

• 佐藤 喜一

  Department of Otorhinolaryngology, Kanazawa Medical University

• 宮崎 巨

  Department of Otorhinolaryngology, Kanazawa Medical University

• 山下 公一

  Department of Otorhinolaryngology, Kanazawa Medical University

• 水越 治

  Department of Otorhinolaryngology, Kyoto Prefectural University of medicine

• 橘 正芳

  Department of Otorhinolaryngology, Kyoto Prefectural University of medicine

• 大島 渉

  Department of Otorhinolaryngology, Kyoto Prefectural University of medicine

• 松永 亨

  Department of Otorhinolaryngology, Osaka University, Medical School

• 久保 武

  Department of Otorhinolaryngology, Osaka University, Medical School

• 浅井 英世

  Department of Otorhinolaryngology, Osaka University, Medical School

• 中井 義明

  Department of Otorhinolaryngology, Osaka City University, School of Medicine

• 杉山 正夫

  Department of Otorhinolaryngology, Osaka City University, School of Medicine

• 小西 一夫

  Department of Otorhinolaryngology, Osaka City University, School of Medicine

• 張 寛正

  Department of Otorhinolaryngology, Osaka City University, School of Medicine

• 小松崎 篤

  Department of Otorhinolaryngology, Thoho University, School of Medicine

• 山本 昌彦

  Department of Otorhinolaryngology, Thoho University, School of Medicine

• 熊沢 忠躬

  Department of Otorhinolaryngology, Kansai Medical University

• 中山 尭之

  Department of Otorhinolaryngology, Kansai Medical University

• 太田 文彦

  Department of Otorhinolaryngology, Kinki University, School of Medicine

• 米井 潔

  Department of Otorhinolaryngology, Kinki University, School of Medicine

• 酒井 國男

  Department of Otorhinolaryngology, Kansai Rosai Hospital

• 松永 喬

  Department of Otorhinolaryngology, Nara Medical University

• 森 望

  Department of Otorhinolaryngology, Nara Medical University

• 田中 治

  Department of Otorhinolaryngology, Nara Medical University

• 和久田 幸之助

  Department of Otorhinolaryngology, Nara Medical University

• 岡坂 利章

  Department of Otorhinolaryngology, Nara Medical University

• 原田 康夫

  Department of Otorhinolaryngology, Hiroshima University, School of Medicine

• 夜陣 紘治

  Department of Otorhinolaryngology, Hiroshima University, School of Medicine

• 田頭 宣治

  Department of Otorhinolaryngology, Hiroshima University, School of Medicine

• 鈴木 衛

  Department of Otorhinolaryngology, Hiroshima University, School of Medicine

• 関谷 透

  Department of Otorhinolaryngology, Yamaguchi University, School of Medicine

• 門 啓子

  Department of Otorhinolaryngology, Yamaguchi University, School of Medicine

• 日吉 正明

  Department of Otorhinolaryngology, Yamaguchi University, School of Medicine

• 今手 祐二

  Department of Otorhinolaryngology, Yamaguchi University, School of Medicine

• 高須賀 信夫

  Ehime Prefectural Central Hospital

• 田中 幸穂

  Ehime Prefectural Central Hospital

• 町田 敏之

  Ehime Prefectural Central Hospital

• 大山 勝

  Department of Otorhinolaryngology, School of Medicine, Kagoshima University

• 昇 卓夫

  Department of Otorhinolaryngology, School of Medicine, Kagoshima University

• 山本 誠

  Department of Otorhinolaryngology, School of Medicine, Kagoshima University

• 橋本 真実

  Department of Otorhinolaryngology, School of Medicine, Kagoshima University

• 島 哲也

  Department of Otorhinolaryngology, School of Medicine, Kagoshima University

• 花田 武浩

  Department of Otorhinolaryngology, School of Medicine, Kagoshima University

• 田中 恒男

  Department of Health Administration, School of Health Sciences, Faculty of Medicine, University of Tokyo

• 橋本 連生

  Department of Health Administration, School of Health Sciences, Faculty of Medicine, University of Tokyo

• 出口 浩一

  Tokyo Clinical Research Center

書誌事項

タイトル別名

• Double Blind Clinical Test Result of Cefmenoxime (CMX) Otic Solution for the Treatment of Chronic Purulent Otitis Media and its Acute Exacerbations

抄録

In order to evaluate the clinical of and safety of Cefmenoxime (CMX) otic solution on purulent otitis media, a double blind clinical test was carried out by means of topical administration of CMX otic solution and placebo respectively to the patients with chronic purulent otitis media and its acute exacerbatins. Cefalexin was orally administered as basic treatment. Both 90 patients treated with CMX otic solution and 90 patients with placebo were subjected to the clinical evaluation. The effectiveness rate including “remarkably effective” and “effective” observed in CMX group by the judgement of chief physicians was 75.6%, while placebo group showed 41.1% of effectiveness rate (p≤0.001). By the judgement of the committee member, however, 75.6% effectiveness rate was obtained in CMX group and 37.8% in placebo group respectively (p≤0.01), and thus, the clinical efficacy of CMX otic solution was confirmed statistically. With respect to the bacteriological efficacy judged by the committee member, CMX otic solution exerted an antibacterial effect on S. aureus and P. aeruginosa and the total bacteria eradication rate was 71.4% with CMX and 38.0% with placebo, the significant difference being observed between the two groups (p≤0.001). As to the safety of CMX otic solution, side effects were observed in 3 cases among 100 patients treated with CMX otic solution (3.0%) and also in 3 cases among 97 placebo treated patients (3.1%). All the side effects observed were transient and not severe at all. CMX otic solution was confirmed, therefore, to be a highly tolerable and safe preparation. It is concluded that, based on the above clinical test results, 1% CMX otic solution which possessed an excellent antibacterial activity, is quite an efficacious and safe topical preparation for the treatment of purulent otitis media.

収録刊行物

• 耳鼻と臨床

  耳鼻と臨床 31 (3), 525-568, 1985

  JIBI TO RINSHO KAI

キーワード

• 化膿性中耳炎
• 二重盲検比較試験

詳細情報

• CRID: 1390282680476588544
• NII論文ID: 130004403039
• NII論文ID: 80002505591
• NII書誌ID: AN00107114
• DOI: 10.11334/jibi1954.31.3_525
• ISSN: 04477227
• Web Site: https://search.jamas.or.jp/link/ui/1986112961
• 本文言語コード: ja
• データソース種別:
  • JaLC
  • CiNii Articles
• 抄録ライセンスフラグ: 使用不可