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阿哌沙班延续治疗静脉血栓栓塞的临床研究
Apixaban for Extended Treatment of Venous Thromboembolism


Giancarlo Agnelli ... 心脑血管疾病 • 2013.02.21
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摘要


背景

阿哌沙班是一种给药剂量固定、服用方便的凝血因子Ⅹa抑制剂,在临床上有可能用于静脉血栓栓塞的延续治疗。

 

方法

在本项随机、双盲、对照的研究中,我们在静脉血栓栓塞患者中比较了两个剂量组(每次2.5 mg及每次5 mg,均为2次/天给药)阿哌沙班与安慰剂的临床疗效与安全性,这些患者已完成6~12个月初始抗凝治疗,且关于继续治疗或停药存在临床均势。给药时间为12个月。

 

结果

试验共对2,486例患者随机化分组,其中2,482例患者入组意向治疗分析。结果显示在复发静脉血栓栓塞或静脉血栓栓塞相关死亡事件的发生率方面,安慰剂组为8.8%(73/829),2.5 mg阿哌沙班组为1.7%(14/840,较安慰剂组降低7.2%,95%可信区间[CI]5.0~9.3),5 mg剂量组为1.7%(14/813,较安慰剂组降低7.0%,95% CI,4.9~9.1)(与安慰剂组比较均P<0.001)。安慰剂组、2.5 mg及5 mg阿哌沙班组的严重出血事件分别为0.5%、0.2%与0.1%,临床相关的非严重出血事件率分别为2.3%、3.0%与4.2%,任何原因死亡率分别为1.7%、0.8%与0.5%。

 

结论

用阿哌沙班的治疗剂量(5 mg)或预防血栓剂量(2.5 mg)延续抗凝治疗均降低了静脉血栓栓塞患者的复发风险,并且不增加严重出血的发生率(研究由施贵宝[Bristol-Myers Squibb]和辉瑞[Pfizer]公司资助,AMPLIFY-EXT在ClinicalTrails.gov注册号为NCT00633893)。





作者信息

Giancarlo Agnelli, M.D., Harry R. Buller, M.D., Ph.D., Alexander Cohen, M.D., Madelyn Curto, D.V.M., Alexander S. Gallus, M.D., Margot Johnson, M.D., Anthony Porcari, Ph.D., Pharm.D., Gary E. Raskob, Ph.D., and Jeffrey I. Weitz, M.D., for the AMPLIFY-EXT Investigators*
From the Department of Internal and Cardiovascular Medicine–Stroke Unit, University of Perugia, Perugia, Italy (G.A.); the Academic Medical Center, Department of Vascular Medicine, Amsterdam (H.R.B.); King's College Hospital, London (A.C.); Pfizer, Groton, CT (M.C., M.J., A.P.); Flinders Medical Centre and Flinders University, Department of Haematology, Adelaide, SA, Australia (A.S.G.); the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); and the Departments of Medicine and Biochemistry and Biomedical Sciences, McMaster University, and the Thrombosis and Atherosclerosis Research Institute — both in Hamilton, ON, Canada (J.I.W.). Address reprint requests to Dr. Agnelli at the University of Perugia, Piazzale Menghini 1, 06100 Perugia, Italy, or at agnellig@unipg.it. *Additional investigators and committees for the Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy–Extended Treatment (AMPLIFY-EXT) study are listed in the Supplementary Appendix, available at NEJM.org.

 

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