癌と急性低リスク肺栓塞の患者で18ヶ月間のリバロキサバンと6ヶ月間のリバロキサバン:オープンラベル,マルチセンター,ランダム化臨床試験 (ONCO PE試験)
PubMedで要約を見る
まとめ
この要約は機械生成です。低リスクの肺栓塞 (PE) のがん患者では,リバロキサバの18カ月投与は,重発性静脈血栓塞 (VTE) を6ヶ月の治療と比較して,大きな出血リスクを増加させずに有意に減少させた.
科学分野
- 心臓病科
- 腫瘍学
- 薬理学について
背景
- 急性低リスク肺栓塞 (PE) のがん患者に対する最適の抗凝固投与期間は不明である.
- 長期にわたる治療は血栓形成を予防するが,出血のリスクを増加させる.
研究 の 目的
- 癌と急性低リスクPE患者の18ヶ月対6ヶ月間のリバロキサバン治療の有効性と安全性を比較する.
主な方法
- 低リスクPE患者178人を対象とした多センターランダム化臨床試験 (簡略化されたPE重症指数スコア1).
- 患者はリバロキサバンを18ヶ月または6ヶ月投与した.
- 主要エンドポイント: 再発性静脈血栓塞栓症 (VTE) 18ヶ月.
- 主要な二次エンドポイントは,18ヶ月で大出血です.
主要な成果
- 再発性VTEは18ヶ月の治療を受けた患者の5. 6%で,6ヶ月の治療を受けた患者の19. 1%で発生した (確率比,0. 25; P=0. 01).
- 重度の出血は18ヶ月のグループでは7. 8% ,6ヶ月のグループでは5. 6% (P=0. 55) であった.
結論
- 低リスクPEのがん患者のVTEの再発を予防するために,リバロキサバン治療は6ヶ月よりも優れています.
- 延長された治療期間は重度の出血のリスクを有意に増加させなかった.
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