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RESPECT研究是一项前瞻性多中心随机对照试验,对卵圆孔未闭(PFO)并发不明原因脑卒中患者应用Amplatzer PFO封堵器(St.Jude Medical,Inc.,St.Paul,MN)经导管PFO封堵+药物治疗与单独药物治疗进行对比,比较其二者在降低脑卒中复发风险方面是否有统计学差异。初步研究结果于2013年发表在新英格兰医学杂志上,其结果表明在预防不明原因脑卒中复发方面,经导管PFO封堵与药物治疗相比无统计学差异。但2015年10月15日在美国TCT会议上,公布了RESPECT研究的长期随访结果,得出了预防不明原因脑卒中复发,使用Amplatzer PFO封堵器行经导管PFO封堵优于药物治疗的最终结论。本文主要简介了RESPECT研究的主要内容和近期、远期结果,并对其作出笔者的评价。
The RESPECT study is a prospective, multicenter, randomized, controlled trial of Amplatzer PFO occluder (St. Jude Medical, Inc., St. Paul, MN) for patients with patent foramen ovale (PFO) complicated with unexplained stroke Catheter PFO occlusion + drug treatment compared with drug treatment alone, comparing the two in reducing the risk of stroke recurrence whether there is a statistically significant difference. The preliminary findings, published in the New England Journal of Medicine in 2013, showed no significant difference in catheterized PFO closure versus drug treatment in preventing unexplained stroke. However, at the TCT meeting in the United States on October 15, 2015, the long-term follow-up results of the RESPECT study were published, leading to the conclusion that propofol PFO closure with Amplatzer PFO occluder is superior to drug treatment in preventing unexplained stroke recurrence . This article mainly introduces the main content of RESPECT research and the recent and long-term results, and makes an evaluation of it.