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口服利伐沙班治疗有症状的肺栓塞
Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism


The EINSTEIN–PE Investigators* 心脑血管疾病 呼吸系统疾病 • 2012.04.05
相关阅读
• 对有孤立性亚段肺栓子的患者是否进行抗凝治疗 • 骑跨型与非骑跨型肺栓塞患者的院内死亡率相似 • 利伐沙班和阿司匹林在预防复发性静脉血栓栓塞方面的比较

摘要


背景

利伐沙班是一种口服的Xa因子抑制剂,既往研究已显示,固定剂量的利伐沙班在治疗深静脉血栓方面与标准抗凝剂疗法同样有效,并且无需实验室监测。这一方法还有可能简化肺栓塞的治疗。

 

方法

在一项纳入了4,832名急性有症状的肺栓塞(伴或不伴深静脉血栓形成)患者的随机、开放标签、事件驱动、非劣效性试验中,我们比较了利伐沙班(15 mg,每天2次,治疗3周,随后20 mg,每天1次)与依诺肝素继以调整剂量的维生素K拮抗剂标准疗法治疗3、6或12个月的疗效。主要疗效结局为有症状的复发性静脉血栓栓塞。主要安全性结局为大出血或临床相关的非大出血。

 

结果

对于主要疗效结局,利伐沙班不劣于标准疗法(非劣效性界值为2.0;P=0.003)。利伐沙班组50起(2.1%)(主要疗效终点)事件对标准疗法组44起(1.8%)事件(风险比,1.12;95%可信区间[CI],0.75~1.68)。利伐沙班组10.3%的患者及标准疗法组11.4%的患者发生主要安全性结局(相对风险为0.90;95% CI,0.76~1.07;P=0.23)。利伐沙班组26例(1.1%)患者及标准疗法组52例(2.2%)患者出现了大出血(相对风险为0.49;95% CI,0.31~0.79;P=0.003)。其他不良事件的发生率两组相近。

 

结论

对于初始和长期肺栓塞治疗,单独使用固定剂量的利伐沙班不劣于标准疗法,而且(患者的)获益-风险特征有潜在的改善(拜耳公司[Bayer HealthCare]和杨森制药有限公司[Janssen Pharmaceuticals]资助; EINSTEIN-PE在ClinicalTrials.gov注册号为NCT00439777)。





作者信息

The EINSTEIN–PE Investigators*
The members of the writing committee (Harry R. Büller, M.D., Martin H. Prins, M.D., Anthonie W.A. Lensing, M.D., Hervé Decousus, M.D., Barry F. Jacobson, M.D., Erich Minar, M.D., Jaromir Chlumsky, M.D., Peter Verhamme, M.D., Phil Wells, M.D., Giancarlo Agnelli, M.D., Alexander Cohen, M.D., Scott D. Berkowitz, M.D., Henri Bounameaux, M.D., Bruce L. Davidson, M.D., Frank Misselwitz, M.D., Alex S. Gallus, M.D., Gary E. Raskob, Ph.D., Sebastian Schellong, M.D., and Annelise Segers, M.D.) take responsibility for the content and integrity of this article. Address reprint requests to Dr. Büller at the Department of Vascular Medicine, Academic Medical Center, F4-275, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands, or at h.r.buller@amc.uva.nl. The affiliations of the writing committee members are listed in the Appendix. *The investigators participating in the EINSTEIN–Pulmonary Embolism (PE) Study and the study committees are listed in the Supplementary Appendix, available at NEJM.org.

 

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