重症患者の再結合ヒトエリトポエチンの有効性:ランダム化制御試験
Howard L Corwin1, Andrew Gettinger, Ronald G Pearl
1Critical Care Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA. howard.l.corwin@hitchcock.org
JAMA
|December 11, 2002
まとめ
週1回の再結合ヒトエリトポエチン (rHuEPO) は,重症患者の赤血球 (RBC) 輸血を著しく減少させた. この治療はまた,死亡率や有害事象に影響を与えることなく,ヘモグロビンレベルを上昇させた.
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:
- 貧血は重症の患者に多く見られ,赤血球 (RBC) 輸血が頻繁に行われる.
- この集団における赤血球輸血に関連した潜在的否定的な臨床結果に関する懸念がある.
研究 の 目的:
- 重症患者の間で赤血球輸血を減らすために,再結合ヒトエリトロポエチン (rHuEPO) の週1回の投与療法の有効性を評価する.
- 集中治療室 (ICU) のヘモグロビンレベルと臨床結果に対するrHuEPOの影響を評価する.
主な方法:
- 1302人の重症患者が参加した前向き,ランダム化,ダブルブラインド,プラセボ対照,マルチセンター試験です.
- 患者はICUの第3日に40万単位のrHuEPOまたはプラセボを皮下投与し,その後4回まで毎週投与された.
- 主要エンドポイントは,研究28日までに輸血独立であった;二次エンドポイントには,輸血されたRBC単位,死亡率,およびヘモグロビン変化が含まれていた.
主要な成果:
- rHuEPOで治療された患者は,赤血球輸血の発生率が有意に低かった (50.5%対プラセボの60.4%,P<.001).
- rHuEPOグループでは,輸血された赤血球総数の19%の減少が観察され,ヘモグロビン濃度の有意な上昇 (1.32 g/dL vs 0.94 g/dL,P<.001) が観察されました.
- rHuEPO群とプラセボ群の間で死亡率や不良臨床イベントの有意な違いは見つかりませんでした.
結論:
- rHuEPOの4万単位を毎週投与することは,アロゲン性赤血球輸血を減少させ,重症患者のヘモグロビンレベルを上昇させるのに効果的です.
- 赤血球輸血における観察された減少が,改善された臨床結果に翻訳されるかどうかを確認するために,さらなる研究が必要である.
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