COVID-19で入院した患者におけるトシリズマブ (RECOVERY):ランダム化,制御,オープンラベル,プラットフォーム試験
Lancet (London, England)
|May 2, 2021
まとめ
トシリズマブは,低酸素および全身性炎症を患った入院COVID-19患者の生存率を大幅に改善しました. この治療は,退院を含む臨床的結果を改善し,死亡リスクを下げました.
科学分野:
- クリティカル ケア 医療
- 感染症
- 薬理学について
背景:
- COVID-19は低酸素と全身の炎症が重症の場合で特徴的です.
- インターロイキン-6受容体阻害剤であるトシリズマブは,重度のCOVID-19における免疫調節効果について調査されています.
- 低酸素および炎症の入院COVID-19患者におけるトシリズマブの有効性を評価することは極めて重要です.
研究 の 目的:
- 低酸素症および全身炎症の入院COVID-19患者の死亡率および臨床結果に対するトシリズマブの影響を評価する.
- トシリズマブは,この患者群で標準治療以上の効果があるかどうかを判断する.
主な方法:
- ランダム化され,制御され,オープンラベルのプラットフォーム試験 (RECOVERY) で,英国で入院しているCOVID-19患者は対象となった.
- 適切な患者は低酸素 (酸素飽和度<92%または酸素を必要とする) と全身性炎症 (C反応性タンパク質≥75 mg/ L) を有していた.
- 参加者は1対1で通常の治療または通常の治療とトシリズマブ (400〜800 mgIV,第二投与の可能性) にランダムに割り当てられました.
主要な成果:
- トシリズマブは4116人の患者で28日間の死亡率を減少させた (31%対35%;率比0. 85,p=0. 0028).
- トシリズマブを投与した患者の退院率は高かった (57%対50%),機械呼吸器を必要とし,死亡する確率は低かった (35%対42%).
- 全身用コルチコステロイドを投与したグループを含むサブグループ全体で利益は一貫していました.
結論:
- トシリズマブは,低酸素症と全身炎症の入院COVID-19患者の生存率と臨床結果を大幅に改善します.
- トシリズマブの効果は呼吸支援レベルとは無関係です.
- トシリズマブの陽性効果は,全身用コルチコステロイドの効果を補足しています.
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