论文部分内容阅读
2012年11月,美国FDA发布公告称,经对抗凝药达比加群酯(dabigatran etexilate/Pradaxa)和华法林(warfarin)的严重出血风险进行评估,结果表明达比加群酯的出血率并不高于华法林。这与在作为批准达比加群酯依据的一项大型临床试验中所观察到的结果一致。
In November 2012, the U.S. FDA issued a bulletin saying that the assessment of the risk of major bleeding with the anticoagulant dabigatran etexilate / warfarin showed that bleeding of dabigatran etexilate Rate is not higher than warfarin. This is consistent with what was observed in a large clinical trial based on the approval of dabigatran etexilate.