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NEJM:XI因子抑制剂预防静脉血栓形成安全有效

2014-12-16 清热解毒2号 丁香园

近日,一项II期试验发现,一个新型的抗凝药物—XI因子抑制剂可有效降低全膝关节置换术后静脉血栓栓塞症的风险,并且不会增加出血风险。[pdf free] 全膝关节置换术后患者的静脉血栓栓塞症的风险升高,而传统的预防治疗方法包括使用Xa因子抑制剂或凝血酶抑制剂,尽管这类药物很有效,但患者的出血风险也相应升高。 外科手术后出现静脉血栓栓塞症的发病机制仍不明确,但组织因子暴露于手术部位激活

近日,一项II期试验发现,一个新型的抗凝药物—XI因子抑制剂可有效降低全膝关节置换术后静脉血栓栓塞症的风险,并且不会增加出血风险。[pdf free]

全膝关节置换术后患者的静脉血栓栓塞症的风险升高,而传统的预防治疗方法包括使用Xa因子抑制剂或凝血酶抑制剂,尽管这类药物很有效,但患者的出血风险也相应升高。

外科手术后出现静脉血栓栓塞症的发病机制仍不明确,但组织因子暴露于手术部位激活外源性凝血途径被认为是主要的驱动因素,而内源性凝血途径在这一过程中的作用仍不确定。

实验显示,以凝血因子XI为靶标可以减弱血栓形成而不影响止血。尽管凝血因子XI在人类血栓形成中的作用仍然未知,但有证据表明先天性凝血因子XI缺乏的患者的静脉血栓栓塞风险降低,因而这类患者在严重创伤后容易出现出血。

第二代反义核苷酸FXI-ASO(ISIS 416858)可特异性地降低人类凝血因子XI信使RNA在肝脏的表达,从而降低凝血因子XI的水平。

因此,为评估降低凝血因子XI的水平是否可以预防静脉血栓栓塞症而不增加出血风险,来自阿姆斯特丹大学的Harry R. Büller等比较了不同剂量的FXI-ASO与依度沙班对全膝关节置换术后患者静脉血栓栓塞和出血的影响,研究全文发表于近日的 NEJM。

该研究为开放标签的平行组研究,参与者为300例接受择期单侧全膝关节置换术的患者,患者随机接受每日一次FXI-ASO(200mg或300mg)或依度沙班(40mg),研究的主要有效性终点为静脉血栓栓塞症的发生率,主要的安全性终点为大出血或临床相关的非大出血。

研究发现,在手术期间,200-mg FXI-ASO组、 300-mg FXI-ASO组和依度沙班组患者的凝血因子XI水平分别为0.38±0.01单位/mL、0.20±0.01单位/mL 、0.93±0.02单位/mL;三组出现有效性终点的比例分别为6/134人(27%)、3/71人(4%)和21/69人(30%);出血比例分别为3%、3%、8%。

比较分析后发现,200mg的FXI-ASO不劣于依度沙班,300mg的FXI-ASO优于依度沙班。

研究者认为,降低凝血因子XI水平不仅可有效降低预防全膝关节置换术后静脉血栓栓塞症的风险,并且不会增加出血的风险。

原始出处:

Harry R. Büller, M.D., Claudette Bethune, Ph.D., Sanjay Bhanot, M.D., Ph.D., David Gailani, M.D., Brett P. Monia, Ph.D., Gary E. Raskob, Ph.D., Annelise Segers, M.D., Peter Verhamme, M.D., and Jeffrey I. Weitz, M.D. for the FXI-ASO TKA Investigators.Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis.NEJM December 7, 2014.DOI: 10.1056/NEJMoa1405760[pdf free]



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    2015-07-12 jklm09
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    2015-09-02 xue8602
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    2015-11-08 fusion
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