急性不補償性心不全患者のためのレボシメンダン対ドブタミン:SURVIVEランダム化試験
Alexandre Mebazaa1, Markku S Nieminen, Milton Packer
1Department of Anesthesiology, Université Paris Diderot and Hospital Lariboisière AP-HP, Paris, France. alexandre.mebazaa@lrb.aphp.fr
JAMA
|May 3, 2007
まとめ
レボシメンダンは,ドブタミンと比較して,急性不補償性心不全患者の180日間の死亡率を有意に低下させなかった. B型ナトリウレチンペプチドの濃度を低下させましたが,他の臨床結果を改善しませんでした.
科学分野:
- 心臓病学 心臓病学
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- 急性無補償性心不全 (ADHF) は,著しい罹病率と死亡率を示しています.
- 生存を危うくすることなく,血液動力学と症状を改善するために効果的な治療が必要である.
研究 の 目的:
- ADHF患者における短期間静脈注射レボシメンダンとドブタミンの長期的な生存効果を評価する.
主な方法:
- ランダム化され,ダブルブラインドで実施されたSURVIVE試験には,イノトロピックサポートを必要とする1327人のADHF患者が参加しました.
- 患者は静脈内レボシメンダン (n=664) またはドブタミン (n=663) を投与された.
- 主要エンドポイントは,180日後の全原因死亡率でした.
主要な成果:
- 180日後の全因死亡率は,レボシメンダンでは26%,ドブタミンでは28%でした (HR 0.91,P=.40).
- レボシメンダンは,B型ナトリウレチンペプチドの濃度においてより大きな減少を示した.
- 二次的な臨床結果において有意な差異は認められなかったが,ドブタミンで心不全の発生率が高く,レボシメンダンで心房細動,低血量,頭痛の発生率が高かった.
結論:
- レボシメンダンは,ドブタミンと比較して,ADHF患者の180日全因死亡率を有意に低下させたり,二次的な臨床結果を改善しなかった.
- B型ナトリウレチンペプチドの初期減少にもかかわらず,レボシメンダンの生存に対する臨床効果は実証されなかった.
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