知識資本主義における貧困化の構図

  • 斎藤 厚
    日本赤十字社長崎原爆諌早病院
  • 谷川原 祐介
    慶應義塾大学医学部薬剤部
  • 渡辺 彰
    東北大学加齢医学研究所抗感染症薬開発研究部門
  • 青木 信樹
    新潟市社会事業協会信楽園病院内科
  • 二木 芳人
    昭和大学医学部臨床感染症学講座
  • 河野 茂
    長崎大学大学院医歯薬学総合研究科感染免疫学講座 (第二内科)
  • 賀来 満夫
    東北大学大学院医学系研究科内科病態学講座感染制御・検査診断学分野
  • 堀 誠治
    東京慈恵会医科大学薬理学講座
  • 戸塚 恭一
    東京女子医科大学感染対策部感染症科

書誌事項

タイトル別名
  • Open study of sitafloxacin in patients with respiratory tract infections
  • 呼吸器感染症に対するsitafloxacinの一般臨床試験
  • チシキ シホン シュギ ニ オケル ヒンコンカ ノ コウズ
  • PK/PD study

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抄録

Sitafloxacin (STFX), a fluoroquinolone antimicrobial agent, has a broad spectrum ofactivity and a potent antimicrobial activity against Streptococcus pneumoniae which is a major pathogen in respiratory tract infections (RTI). This clinical study was conducted to confirm the clinical recommended dose of STFX as 50mg b.i.d. for RTI from PK/PD.<BR>Clinical efficacy was 92.3%(96/104) in the 50mg b.i.d. group and 93.1%(27/29) in the 100 mg bid. group. Bacteriological efficacy was 89.1%(57/64) in the 50mg b.i.d. group and 82.4%(14/17) in the 100mg bid. group. Eradication of major causative organisms was 91.7%(22/24) in S.pneumoniae and 100%(24/24) in Haemophilus influenzae.<BR>Steady state Cmax and AUC0-24h after repeated oral administration of STFX to patients with RTI were 0.57±0.21μg/mL and 9.38±4.24μg·h/mL in the 50mg b.i.d. group, and 1.17±0.45μg/mL and 17.16±6.52μg·h/mL in the 100 mg b.i.d. group.<BR>If Cmax/MIC was 5 or below, or AUC0-24h/MIC was 100 or below, eradication were 33.3%(3/9) or 40.0%(4/10).In contrast, if Cmax/MIC was over 5, it was 96.3%(79/82). If AUC0-24h/MIC wasover 100, it was 96.3%(78/81).MIC90 of STFX against the causative organisms in this study was 0.1μg/mL. Results suggest that 50mg b.i.d. of STFX can achieve Cmax/MIC 5 and AUC0-24h/MIC 100 against 90% of the causative organisms in RTI.<BR>Adverse drug reactions (ADR) occurred in 43.5%(50/115 patients) in the 50mg b.i.d. group and 42.4%(14/33 patients) in the 100mg b.i.d. group. The major ADR was diarrhoea (20/148, 13.5%). Cmax and AUC0-24h of patientsin whom diarrhoea or soft stool occurred tended to be higher than in patients free of these symptoms. No severe ADRs were observed in either groups.<BR>Results suggest that a dose of 50mg b.i.d. of STFX is optimal in the treatment of RTI.

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