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危篤な病気の患者の世話をする. 重度のセプシスにおける高用量抗トロビンIII:ランダム化対照試験
1Brown University School of Medicine, Infectious Disease Division, Memorial Hospital of Rhode Island, 111 Brewster St, Pawtucket, RI 02860, USA.
JAMA
|October 26, 2001
まとめ
高用量のアンチトロンビンIIIは,重度のセプシス患者の生存率を改善しませんでした. しかし,ヘパリンを投与しないサブグループでは潜在的生存効果を示したが,ヘパリンと併用すると出血リスクが増加した.
科学分野:
- クリティカルケア・メディシン
- 血液学 ヘマトロジ
- 薬理学 薬理学とは
背景:
- 重度のセプシスとセプティックショックが凝固を活性化し,マイクロトロンブ,臓器機能障害,死亡率につながる.
- アンチトロンビンIII (ATIII) は,内生性抗凝固剤であり,重篤な疾患において保護を提供することができる.
研究 の 目的:
- 重度のセプシスまたはセプティックショックを有する患者の生存率を改善するために,高用量のアンチトロンビンIIIの有効性を評価する.
主な方法:
- 多センター,ダブルブラインド,プラセボ対照の第3相試験 (KyberSept) で,2314人の成人患者をランダムに選択しました.
- 患者は,静脈内アンチトロンビンIII (4日間にわたって3万IU) またはプラセボを投与された.
- 主なアウトカムは,全原因による28日間の死亡率でした.
主要な成果:
- 28日間の全死亡率は,ATIII群とプラセボ群の間で (38.9%対38.7%,P=.94) 類似していた.
- ICU生存率などの二次エンドポイントでは有意な差異はありません.
- ヘパリン投与を受けていない患者では,AT IIIは28日間の死亡率の低下 (P=0.08) と90日間の生存率の有意な改善 (P=0.03) を示した.
- 併用ヘパリンとAT IIIの併用は出血のリスクを大幅に増加させた (23.8%対13.5%,P<.001).
結論:
- セプシスの発症から6時間以内に投与された高用量の抗トロビンIIIは,28日間の生存率を改善しません.
- ATIIIをヘパリンと併用すると,出血のリスクが増加します.
- 同時期にヘパリンを投与しないセプシス患者において,AT IIIの潜在的生存効果は存在することがあります.
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