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安定した冠動脈疾患の患者におけるXA因子の直接阻害に関する最初の経験: 薬理動力学および薬理動力学評価
Christopher K Dyke1, Richard C Becker, Neal S Kleiman
1Duke Clinical Research Institute, Durham, NC 27715, USA.
Circulation
|May 22, 2002
まとめ
この研究では,安定した冠動脈疾患の患者で,新しい因子Xa阻害剤であるDX-9065aを評価しました. 抗凝固剤は,最小限の出血で好ましい安全性プロファイルを示し,アテロトロンボシスのさらなる研究を支援しました.
科学分野:
- 心血管医学は,心臓血管医学である.
- 薬理学 薬理学とは
- 血液学 ヘマトロジ
背景:
- トロンビン生成は,動脈硬化性プラークの破裂後の動脈血栓形成の鍵です.
- 標準治療を受けている安定した冠動脈疾患の患者を研究した.
- DX-9065aは,新しい,直接的,選択的,および可逆的な小分子因子Xa阻害剤です.
研究 の 目的:
- DX-9065a.a.の薬理動力学,薬理動力学,および安全性を評価する.
- 冠動脈動脈栓塞症の治療におけるDX-9065aの可能性を評価する.
主な方法:
- 安定した冠動脈疾患を有する73人の患者を対象とした二重盲検試験.
- 患者は,プラセボまたは4つの体重調整されたDX-9065aレジメントの1つを,静脈注射ボラスおよび輸液で受けました.
- プラズマサンプルは,輸液と24時間の排出期間中に採取されました.
主要な成果:
- 軽度の出血,主にエキモスは,プラセボを含むすべてのグループで同様に発生しました.
- ヘモグロビン,血小板数,クレアチニン,または肝機能検査における有意な変化は観察されなかった.
- 血薬の濃度は,抗因子XA活性,プロトロンビン時間,国際正常化比率と強く相関していた.
結論:
- これは,この患者集団における選択的,可逆的,直接的な小分子因子Xa阻害剤の最初の研究である.
- この発見は,冠動脈動脈栓塞症の治療におけるXA因子阻害剤の調査のための基礎を提供します.
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