心臓手術を受ける高リスク患者の急性腎臓損傷の予防のための小さな干渉RNAであるテプラシラン:ランダム化臨床試験
Matthias Thielmann1, David Corteville2, Gabor Szabo3
1Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Duisburg-Essen, Germany (M.T.).
Circulation
|September 3, 2021
まとめ
高リスクの心臓手術患者の急性腎臓損傷 (AKI) の発生率,重症度,および持続時間を有意に減少させた. この新しいRNA治療は 手術後の腎臓の損傷を 防ぐことが期待されています
科学分野:
- 腎臓科
- 心臓病科
- 薬理学について
背景:
- 急性腎損傷 (AKI) は心臓手術後の重大な合併症であり,患者の罹病率と死亡率に影響します.
- 心臓外科手術後のAKIの現在の治療法は限られており,新しい治療方法が必要である.
研究 の 目的:
- 心臓外科手術を受ける高リスクの患者におけるAKIの予防と軽減におけるテプラシアンの有効性と安全性を評価する.
- AKIの発生,重症度,持続時間に対するテプラシランの影響を評価する.
主な方法:
- 360人の高リスクの心臓外科手術の患者を対象とした前向きな多センター,ダブルブラインド,ランダム化制御フェーズ2試験です.
- 患者は,テプラシラン10 mg/ kgの単回投与またはプラセボを投与され,血清クレアチニンとシスタチンCで術後5日目までAKIが評価されました.
- 二次的エンドポイントには,AKIの重症度,持続時間,90日における主要な腎臓不良事件の複合が含まれていた.
主要な成果:
- テプラシランはAKIの発生率を12. 8% 減少させた (プラセボ群では37%,プラセボ群では50%,P=0. 02).
- 3度目のAKIまたは長期のAKIを患った患者数が少なく,AKIの重度と持続期間において有意な改善が観察されました.
- 90日目の主要な腎臓の有害事象の有意な違いは認められず,テプラシランは好ましい安全性プロファイルを示した.
結論:
- テプラシランは,心臓手術後の高リスク患者における早期のAKIの発生率,重症度,および持続時間を効果的に減少させます.
- これらの発見は,この脆弱な集団における腎臓損傷を予防する治療薬としてのテプラシランの可能性を裏付けています.
- これらの有望な結果に基づいて,90日目の主要な腎臓不良事件に焦点を当てた第3相試験が完了しました.
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