COVID-19 の重症患者の21日間の死亡率または呼吸器支援に対するヒドロコルチゾンの効果:ランダム化臨床試験
Pierre-François Dequin1,2,3, Nicholas Heming4,5, Ferhat Meziani6,7
1Médecine Intensive-Réanimation, CHU de Tours, Tours, France.
JAMA
|September 3, 2020
まとめ
低用量ヒドロコルチゾンは,重症のCOVID-19患者の治療失敗を大幅に軽減しませんでした. この研究は,重症急性呼吸器症候群新型コロナウイルス2型 (SARS-CoV-2型) 感染症の結果における有意義な差異を検出する能力が不足したため,早期に中止された.
科学分野:
- 集中治療薬
- 感染症
- 薬理学について
背景:
- コロナウイルス病 2019 (COVID-19) は重度の肺損傷を引き起こす可能性があります.
- コルチコステロイドは,COVID-19に関連する急性呼吸器不全の潜在的な治療法として調査されています.
研究 の 目的:
- COVID-19 と急性呼吸器不全の重症患者の21日までに治療失敗を軽減する低用量のヒドロコルチゾンの有効性を評価する.
主な方法:
- 多中心,ランダム化,ダブルブラインド,プラセボ対照試験が行われました.
- COVID-19に関連した急性呼吸器不全の重症患者は,低用量ヒドロコルチゾン (n=76) またはプラセボ (n=73) を投与された.
- 主なアウトカムは21日目の治療失敗であり,死亡または機械呼吸器または高フロー酸素療法への持続的必要性として定義された.
主要な成果:
- 149人の患者が登録された後,研究は早期に中止された.
- プラセボ群の50. 7%に対して,ヒドロコルチゾン群の42. 1%で21日目に治療が失敗した (P=0. 29).
- グループ間の主要結果や事前に指定された二次結果において,有意な差異は認められなかった. 深刻な有害事象は報告されていません.
結論:
- 低用量ヒドロコルチゾンは,重症のCOVID-19患者の治療失敗を21日目に有意に軽減しませんでした.
- 臨床試験は統計的に有意な差を検出するために早期に終了したため,おそらく不足していた.
- 深刻なCOVID-19の管理におけるコルチコステロイドの役割を完全に解明するには,さらなる研究が必要である可能性があります.
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