術後のN-アセチルシステインが,CABG手術を受ける高リスク患者の腎機能障害を予防する:ランダム化制御試験
Karen E A Burns1, Michael W A Chu, Richard J Novick
1Division of Critical Care Medicine, University of Western Ontario, London, Ontario, Canada. burnske2@yahoo.ca
JAMA
|July 21, 2005
まとめ
術後のN-アセチルシステインは,心臓肺バイパス (CPB) による冠動脈バイパス移植 (CABG) 手術を受けた高リスク患者の腎臓機能障害を予防しませんでした. リスクの高い患者を特定し,効果的な介入を行うためにさらなる研究が必要である.
科学分野:
- 心臓病学 心臓病学
- ネフロロジーは腎臓科
- 手術による合併症
背景:
- 腎機能不全は,心臓肺バイパス (CPB) による冠動脈バイパス移植 (CABG) 手術後の重大な合併症であり,罹病率と死亡率を増加させます.
- N-アセチルシステインは,抗酸化剤と血管拡張剤であり,腎不全と低酸素症に対抗する可能性を示しています.
研究 の 目的:
- 術後の静脈内投与のN-アセチルシステインの腎機能の保全に対する有効性を評価するために,CPB.CPBでCABG手術を受ける高リスクの患者で.
- N-アセチルシステインとプラセボグループ間の術後の腎機能障害の発生率を比較するために.
主な方法:
- CABG手術を受ける高リスクの患者295人を対象としたランダム化,四重盲検,プラセボ対照試験です.
- 患者は24時間間にわたり,N-アセチルシステイン (600 mg) またはプラセボを4回投与された.
- プライマリアウトカム:手術後の腎機能不全の患者の割合 (5日以内にクレアチニンの上昇>0.5 mg/dLまたはベースラインから25%).
主要な成果:
- N-アセチルシステイン (29.7%) とプラセボ (29.0%) グループ (P = .89) の間での術後の腎機能不全の有意な違いは認められなかった.
- 腎置換療法,有害事象,および死亡率を含む二次的アウトカムも,有意な違いを示さなかった.
- ベースラインでクレアチニンが上昇した患者のサブグループ分析では,N-アセチルシステイン (25.0%対37.1%,P = .29) による利益への非有意な傾向が示されました.
結論:
- 術後のN-アセチルシステインは,高リスクのCABG患者における術後の腎機能障害,合併症,または死亡を予防しませんでした.
- リスクのある患者,腎機能不全の信頼できるマーカー,および臨床的に関連する腎臓の値を特定するために,さらなる研究が必要です.
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