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欧盟支持阿哌沙班治疗深静脉血栓形成和肺栓塞

2014-07-03 cath 编译 医学论坛网

欧洲药品管理局(EMA)人用药产品委员会(CHMP)支持阿哌沙班(apixaban)适应证的扩大,即用于深静脉血栓形成(DVT)和肺栓塞(PE)的治疗和预防。 CHMP的意见是基于AMPLIFY 试验结果和其延伸试验AMPLIFY-EXT的。在试验中,阿哌沙班与标准依诺肝素联合华法林在治疗急性静脉血栓栓塞方面同样有效,但服用阿哌沙班的患者严重出血并发症风险减少了69%。在一年期的延伸试验中,与安

欧洲药品管理局(EMA)人用药产品委员会(CHMP)支持阿哌沙班(apixaban)适应证的扩大,即用于深静脉血栓形成(DVT)和肺栓塞(PE)的治疗和预防。

CHMP的意见是基于AMPLIFY 试验结果和其延伸试验AMPLIFY-EXT的。在试验中,阿哌沙班与标准依诺肝素联合华法林在治疗急性静脉血栓栓塞方面同样有效,但服用阿哌沙班的患者严重出血并发症风险减少了69%。在一年期的延伸试验中,与安慰剂相比,服用阿哌沙班的患者静脉血栓栓塞发生率显著减少。

阿哌沙班是一种口服选择性Xa因子抑制剂,已在欧盟、美国、日本等国家获准用于减少非瓣膜性房颤患者卒中和系统性栓塞的风险;在美国和欧盟也已获准用于行择期髋关节或膝关节置换术患者的DVT预防。

其他新型口服抗凝药(包括利伐沙班和达比加群)也已获准用于DVT/PE的治疗分预防复发。

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    2014-10-01 fusion
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    2014-08-24 rosa00tong

    进入新型抗凝药的厮杀时代

    0

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    2015-03-31 xue8602
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