Department of Cardiothoracic Surgery, NYU-Langone Medical Center, New York, NY, USA.
J Thorac Cardiovasc Surg. 2012 Nov;144(5):998-1002. doi: 10.1016/j.jtcvs.2012.06.035. Epub 2012 Jul 15.
In 2008, we saw the withdrawal of aprotinin from the US markets after preliminary results from a large, randomized clinical trial in Canada. This drug, a potent antifibrinolytic, was used primarily in complex and/or redo cardiac surgery as an adjunct to decrease postoperative bleeding and complications. The Canadian study raised questions previously brought up in similar studies-does aprotinin increase the risk of mortality and renal failure after cardiac surgery? Recently, a re-review of the Canadian data noted flaws in the study, as well as in the interpretation of the results. The present review revisits the aprotinin controversy.
2008 年,我们在美国市场看到抑肽酶的撤出,此前加拿大进行了一项大型、随机临床试验的初步结果。这种药物是一种强效的抗纤维蛋白溶解剂,主要用于复杂和/或再次心脏手术中,作为辅助手段来减少术后出血和并发症。加拿大的这项研究提出了之前在类似研究中提出的问题——抑肽酶是否会增加心脏手术后的死亡率和肾衰竭风险?最近,对加拿大数据的重新审查注意到该研究以及结果解释存在缺陷。本综述重新审视了抑肽酶的争议。