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心肺バイパスによる冠動脈バイパス移植を受けた低エジェクション分数患者の低心力出力症候群に対するレボシメンダンの効果: LICORN ランダム化臨床試験
Bernard Cholley1, Thibaut Caruba2, Sandrine Grosjean3
1Department of Anesthesiology and Critical Care Medicine, Hôpital Européen Georges Pompidou, AP-HP, and University Paris Descartes-Sorbonne Paris Cité, Paris, France.
JAMA
|August 9, 2017
まとめ
術前のレボシメンダンは,左心房機能障害の冠動脈バイパス移植を受けた患者の低心室出力症候群を有意に軽減しませんでした. 重大な有害事象を予防する効果は示されなかった.
科学分野:
- 心臓病科
- 心臓外科
- 薬理学について
背景:
- 低心力出力症候群 (LCOS) は,心臓手術後の重大な合併症であり,特に左心室機能が低下した患者で,高い罹病率と死亡率につながる.
- LCOSを予防する効果的な戦略を特定することは,心臓外科手術における患者のアウトカムを改善するために不可欠です.
研究 の 目的:
- 冠動脈バイパス移植 (CABG) を受け,左心室放出分数 (LVEF) が低下した患者の術後低心量症候群 (LCOS) の予防におけるレボシメンダン投与の有効性を評価する.
主な方法:
- ランダム化,ダブルブラインド,プラセボ対照試験は13のフランスの心臓外科センターで行われました.
- 心肺バイパスによるCABGを予定していたLVEFの40%の患者は,麻酔誘導後に開始された24時間レボシメンダン (0. 1μg/ kg/ min) またはプラセボを投与された.
- 主なエンドポイントは,長期のカテキオラミン注入,機械的補助装置の必要性,または特定の術後期間の腎置換療法でした.
主要な成果:
- レボシメンダンを受けた患者の52%で,プラセボを受けた患者の61%で,複合プライマリエンドポイント (絶対リスク差: - 7%;95%CI, - 17%から3%;P=. 15) が発生し,統計的に有意な差は示されなかった.
- 副群の分析では,LVEF,手術の種類,または術前薬剤の使用に基づいて有意な相互作用は示されなかった.
- 低血圧および心房細動を含む有害事象の発生率は,レボシメンダン群とプラセボ群の間で有意に異なるものではありません.
結論:
- 手術前のレボシメンダン投与は,低心出力症候群の複合エンドポイントの発生率を有意に低下させなかった.
- これらの結果は,この特定の患者集団におけるLCOSの予防のためにレボシメンダンを日常的に使用することを支持しません.
- 高リスクの心臓外科手術患者のLCOSの管理のための代替戦略を探求するには,さらなる研究が必要です.
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