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阿哌沙班治疗癌症相关静脉血栓栓塞
Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer


Giancarlo Agnelli ... 肿瘤 • 2020.04.23
相关阅读
• 晚期肾脏病患者接受阿哌沙班与华法林抗凝治疗的比较 • 依度沙班治疗癌症相关静脉血栓栓塞 • 阿哌沙班预防癌症患者的静脉血栓栓塞

摘要


背景

最新指南建议考虑使用口服依杜沙班(edoxaban)或利伐沙班治疗癌症患者的静脉血栓栓塞。然而,与这些口服药物相关的出血风险增加限制了其益处。

 

方法

这是一项由研究者发起,对结局进行盲法集中裁定的多国、随机、开放标签、非劣效性试验。我们将有症状或偶发急性近端深静脉血栓形成或肺栓塞的连续癌症患者随机分组,分别接受阿哌沙班口服给药(前7日的剂量为每日2次,每次10 mg,之后为每日2次、每次5 mg)或者达肝素皮下给药(第一个月的剂量为每日1次,每次200 IU/kg,之后为每日1次,每次150 IU/kg)。治疗持续6个月。主要结局是试验期间客观证实的复发性静脉血栓栓塞。主要安全性结局是大出血。

 

结果

阿哌沙班组576例患者中的32例(5.6%)和达肝素组579例患者中的46例(7.9%)发生了复发性静脉血栓栓塞(风险比,0.63;95%置信区间[CI],0.37~1.07;非劣效性P<0.001)。阿哌沙班组22例患者(3.8%)和达肝素组23例患者(4.0%)发生了大出血(风险比,0.82;95% CI,0.40~1.69;P=0.60)。

 

结论

在癌症相关静脉血栓栓塞的治疗中,阿哌沙班口服给药不劣于达肝素皮下给药,并且大出血风险未增加(由百时美施贵宝-辉瑞联盟[Bristol-Myers Squibb-Pfizer Alliance]资助,Caravaggio在ClinicalTrials.gov注册号为NCT03045406)。





作者信息

Giancarlo Agnelli, M.D., Cecilia Becattini, M.D., Guy Meyer, M.D., Andres Muñoz, M.D., Menno V. Huisman, M.D., Jean M. Connors, M.D., Alexander Cohen, M.D., Rupert Bauersachs, M.D., Benjamin Brenner, M.D., Adam Torbicki, M.D., Maria R. Sueiro, M.D., Catherine Lambert, M.D., Gualberto Gussoni, M.D., Mauro Campanini, M.D., Andrea Fontanella, M.D., Giorgio Vescovo, M.D., and Melina Verso, M.D. for the Caravaggio Investigators*
From the Internal Vascular and Emergency Medicine–Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero–Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio–Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale–Università, Padua (G.V.) — all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique–Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) — both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women’s Hospital, and Harvard Medical School, Boston (J.M.C.); Guy’s and St. Thomas’ NHS Foundation Trust Hospital, King’s College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) — both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.). Address reprint requests to Dr. Agnelli at the Internal Vascular and Emergency Medicine–Stroke Unit, University of Perugia, Perugia 06124, Italy, or at giancarlo.agnelli@unipg.it. A complete list of the investigators in the Caravaggio trial is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

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