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アイゼンメンガー症候群の患者に対するボセンタン治療:多センター,ダブルブラインド,ランダム化,プラセボ対照試験

Nazzareno Galiè¹, Maurice Beghetti, Michael A Gatzoulis

¹Istituto di Cardiologia, Università di Bologna, Via Massarenti, 9 IT-40138, Bologna, Italy. nazzareno.galie@unibo.it

|June 28, 2006

まとめ

この研究は,エンドセリン受容体の抗体であるボセンタンが,酸素飽和度が悪化することなく,アイゼンメンガー症候群患者の運動能力と血液動力学を改善することを示しています. イット・イット・イット

科学分野:

心臓病学心臓病学
肺動脈高血圧肺動脈高血圧肺動脈高血圧肺動脈高血圧肺動脈高血圧
薬理学薬理学とは

背景:

アイゼンメンガー症候群は,肺動脈高血圧,右から左へのシャント,および先天性心疾患による低酸素症を含む.
アイゼンメンガー症候群におけるエンドセリン発現の増加は,エンドセリン受容体対抗性の潜在的な利益を示唆しています.
システム血管介入がシャントリングと低酸素症を悪化させる可能性があるという懸念がある.

研究の目的:

世界保健機関機能クラスIIIのアイゼンメンガー症候群の患者で,二重エンドセリン受容体対抗剤であるボセンタンの安全性と有効性を評価する.
ボゼンタンの全身パルス酸素測定 (主安全性エンドポイント) と肺血管抵抗 (主有効性エンドポイント) に対する効果を評価する.

主な方法:

16週間の,多センター,ランダム化,ダブルブラインド,プラセボ対照試験 (BREATHE-5) に54人の患者が参加した.
患者は,ボセンタン (n=37) またはプラセボ (n=17) のいずれかを受けるために,ランダムに 2:1に分けられました.
血液動力学は,右心と左心経導管で評価され,運動能力は6分の歩行距離で測定されました.

主要な成果:

ボセンタンは全身酸素飽和度を悪化させず,パルス酸素測定にプラセボ調整した1.0%の効果 (95%CI, -0.7〜2.8) を示した.
ボセンタンは肺血管抵抗指数 (-472.0 dyne.s.cm(-5); P=0.0383) と肺動脈平均圧 (-5.5 mm Hg; P=0.0363) を著しく低下させた.
ボセタン群の運動能力はプラセボ群と比較して53.1m (P=0.0079) 増加した. 不良事象の中止率は,グループによって類似していた (5%対12%).

結論:

ボセンタンは,アイゼンメンガー症候群の患者によく耐えます.
この研究では,ボセンタンが運動能力と血液動力学を改善することを示しました.
重要なことに,ボセタン治療は,この患者集団における周辺酸素飽和度を損ねませんでした.

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