安德克萨尼特用于与XA因子抑制剂相关的急性脑内出血
Stuart J Connolly1, Mukul Sharma1, Alexander T Cohen1
1From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both in Canada; Guy's and St. Thomas' Hospital, King's College London (A.T.C.), and Imperial College (R.V.), London, NIHR Biomedical Research Centre and College of Life Sciences, University of Leicester, Leicester (T.G.R.), and Alexion Pharmaceuticals UK, Uxbridge (A.L.) - all in the United Kingdom; the Second Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland (A.C.); the Department of Clinical Sciences Lund, Neurology, Lund University, and the Department of Neurology, Skåne University Hospital, Lund (A.G.L.), and AstraZeneca Biopharmaceuticals Research and Development, Late-stage Development, Cardiovascular, Renal, and Metabolism, Gothenburg (A.H., P.L., M.K., E.E.) - all in Sweden; Vall d'Hebron University Hospital, Barcelona (C.A.M.); Semmelweis University, Budapest, Hungary (D.B.); Sapienza University of Rome, Rome (D. Toni); the Department of Neurology, Inselspital University Hospital and University of Bern, Bern, Switzerland (D.J.S.); Rambam Health Care Campus, Technion, Israel Institute of Technology, Haifa (D. Tanne); the Department of Neurology, Oslo University Hospital, and the Norwegian Air Ambulance Foundation - both in Oslo (E.C.S.); the Second Department of Neurology, National and Kapodistrian University of Athens, "Attikon" University Hospital, Athens (G.T.); Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen (H.C.); the Department of Medicine 1, Division "Thrombosis and Hemostasis," University Hospital Dresden, Dresden (J.B.-W.), Alfried Krupp Krankenhaus, Essen (R.V.), the Department of Neurology and Stroke (S.P.) and the Hertie Institute for Clinical Brain Research (S.P.), Eberhard-Karls University, Tübingen, the Department of Neurology, Universitätsklinikum Erlangen, Erlangen (B.K.), and the Department of Neurology, Heidelberg University Hospital, Heidelberg (C.G.) - all in Germany; the Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (J.M.C.), and Radboud University Medical Center, Nijmegen (S.M.) - both in the Netherlands; University Hospitals Leuven, University of Leuven (P.V.), the Department of Neurosciences and Experimental Neurology, KU Leuven (R.L.), and the Department of Neurology, University Hospitals Leuven (R.L.) - all in Leuven, Belgium; Bichat Claude-Bernard Hospital, Paris (P.A.); Turku University Hospital, Turku, Finland (R.O.R.); Tomas Bata Regional Hospital, Zlín, Czech Republic (R.M.); Dell Medical School, University of Texas, Austin, and the University of Houston, Houston (T.J.M.); University of Porto, Porto, Portugal (V.T.-C.); and Hospital of St. John of God, Sigmund Freud University, Medical Faculty, Vienna (W.L.).
在服用XA因子抑制剂的脑内出血患者中,安德克萨尼特阿尔法改善了血瘤扩张的控制. 然而,这种逆转剂与血栓事件的风险增加有关,包括缺血性中风.
科学领域:
- 神经学 神经学
- 血液学 血液学 血液学
- 药理学 药理学是指药理学的学科.
背景情况:
- 服用XA因子抑制剂的急性脑内出血 (ICH) 患者面临血液瘤扩张的风险.
- 作为XA因子抑制剂的逆转剂,安德克萨内特阿尔法在缓解ICH中血液瘤扩张的有效性尚未得到充分证实.
研究的目的:
- 评估与常规护理相比,安德克萨内特阿尔法对急性ICH患者血瘤扩张的影响,这些患者曾服用XA因子抑制剂.
主要方法:
- 一项随机试验分配了患者 (在ICH发作15小时内) 接受安德克萨尼特阿尔法或常规治疗.
- 主要终点:静血疗效 (血瘤扩张≤35%,NIHSS得分增加<7,没有救援疗法).
- 安全终点包括血栓事件和死亡.
主要成果:
- 在安德克萨尼特阿尔法治疗时,血静效率达到67.0%,在通常治疗时为53.1% (P=0.003).
- 安德克萨尼特阿尔法显著降低了抗Xa因子的活性 (94.5%与26.9%,P<0.001).
- 血栓事件发生在安德克萨尼特阿尔法治疗的10.3%,与通常护理的5.6%相比 (P=0.048),包括缺血性中风 (6.5%与1.5%).
结论:
- 与常规护理相比,安德克萨内特阿尔法在接受XA因子抑制剂的ICH患者中表现出更好的血瘤扩张控制.
- 安德克萨内特阿尔法的使用与血栓事件,特别是缺血性中风的发病率增加有关.
- 虽然在血液静止中有效,但血栓前风险需要在临床实践中仔细考虑.
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