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急性内科疾病患者中应用利伐沙班预防血栓
Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients


Alexander T. Cohen ... 心脑血管疾病 • 2013.02.07
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• 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

在急性内科疾病住院患者中,血栓预防治疗的临床上合适持续时间尚不清楚。在这项多中心、随机、双盲试验中,我们评价了口服利伐沙班延长的疗程与皮下注射依诺肝素标准疗程序贯用安慰剂相比较的有效性和安全性。

 

方法

本研究纳入年龄≥40岁的急性内科疾病住院患者,随机分为两组:第一组接受依诺肝素皮下注射给药,40 mg每天1次,持续用药(10±4)天,并且口服安慰剂,持续(35±4)天;第二组接受皮下注射安慰剂,持续(10±4)天,并且口服利伐沙班治疗,10 mg每天1次,持续(35±4)天。主要疗效结局是到10天(非劣效性检验)和35天(优效性检验)发生的无症状近端静脉血栓栓塞或有症状的静脉血栓栓塞的复合结局。主要安全性结局是严重出血或临床相关的非严重出血的复合结局。

 

结果

共计8,101名患者接受了随机化。主要疗效结局事件发生的例数是:第10天,2,938名接受利伐沙班治疗的患者中有78名(2.7%),2,993名接受依诺肝素治疗的患者中有82名(2.7%)(与利伐沙班组比较,相对危险是0.97;95%可信区间[CI]为0.71~1.31;非劣效性P=0.003);第35天,2,967名接受利伐沙班的患者中有131名(4.4%);3,057名接受依诺肝素治疗后加安慰剂的患者中有175名(5.7%)(相对危险,0.77;95% CI,0.62~0.96;P=0.02)。主要安全结局事件发生的例数:第10天,3,997名利伐沙班组的患者中有111名(2.8%),4,001名依诺肝素组的患者中有49名(1.2%)(P<0.001);第35天,上述两组分别有164名(4.1%)和67名(1.7%)(P<0.001)。

 

结论

在急性内科疾病住院患者中,利伐沙班预防血栓的效果并不劣于依诺肝素标准疗程治疗。利伐沙班延长用药时间减少了血栓栓塞的风险。利伐沙班与出血风险的增加相关(由拜耳公司[Bayer HealthCare Pharmaceuticals]和杨森研发[Janssen Research and Development]资助;MAGELLAN在ClinicalTrials.gov注册号为NCT00571649)。





作者信息

Alexander T. Cohen, M.D., Theodore E. Spiro, M.D., Harry R. Büller, M.D., Lloyd Haskell, M.D., Dayi Hu, M.D., Russell Hull, M.B., B.S., Alexandre Mebazaa, M.D., Geno Merli, M.D., Sebastian Schellong, M.D., Alex C. Spyropoulos, M.D., and Victor Tapson, M.D., for the MAGELLAN Investigators
From King's College Hospital, London (A.T.C.); Bayer HealthCare Pharmaceuticals, Montville (T.E.S.), and Janssen Research and Development, Raritan (L.H.) — both in New Jersey; Academic Medical Center, Amsterdam (H.R.B.); People's Hospital of Peking University, Beijing (D.H.); Foothills Hospital, Calgary, AB, Canada (R.H.); University Paris Diderot, pôle de recherche et d'enseignement supérieur Sorbonne Paris Cite and Hôpital Lariboisière, Paris (A.M.); Thomas Jefferson Medical Center, Philadelphia (G.M.); Dresden-Friedrichstadt Hospital, Dresden, Germany (S.S.); Hofstra North Shore–Long Island Jewish School of Medicine, Manhasset, NY (A.C.S.); and Duke University Medical Center, Durham, NC (V.T.). Address reprint requests to Dr. Cohen at Vascular Medicine, Department of Vascular Surgery, King's College Hospital, London SE5 9RS, United Kingdom, or at alexander.cohen@kcl.ac.uk. *The investigators participating in the Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Acutely Ill Medical Patients Comparing Rivaroxaban with Enoxaparin (MAGELLAN) and the study committees are listed in theSupplementary Appendix, available at NEJM.org.

 

参考文献

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