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临床试验:过去、现在与未来。

Clinical trials: past, present, and future.

作者信息

Gray William A

机构信息

Cardiovascular Research Foundation, Columbia University Medical Center, New York, NY 10032, USA.

出版信息

Semin Vasc Surg. 2008 Jun;21(2):80-7. doi: 10.1053/j.semvascsurg.2008.03.007.

DOI:10.1053/j.semvascsurg.2008.03.007
PMID:18565414
Abstract

Carotid stenting has been in evolution for the past 15 years. Initially limited by a lack of dedicated equipment, pivotal trials using both dedicated stent technology and embolic protection filters in patients at high risk for surgical endarterectomy have been largely completed, and results have compared favorably to both direct and historical surgical controls. While this has led to Food and Drug Administration approval of at least six carotid stent systems in the US, European randomized trials in standard surgical risk patients have had mixed results and confused the perception of the place of this technology in the care of patients with carotid stenosis. Current US trials are in progress, one nearing completion, and they will further contribute an understanding as to the place of stent therapy in the standard surgical risk patient, regardless of symptomatic status.

摘要

在过去15年里,颈动脉支架置入术一直在不断发展。最初,该技术因缺乏专用设备而受到限制,目前,针对外科内膜切除术高风险患者使用专用支架技术和栓塞保护滤网的关键试验已基本完成,结果与直接手术对照和历史手术对照相比都更具优势。虽然这已促使美国食品药品监督管理局批准了至少六种颈动脉支架系统,但欧洲针对标准手术风险患者的随机试验结果不一,这使得人们对该技术在颈动脉狭窄患者治疗中的地位认识不清。目前美国的试验正在进行中,其中一项即将完成,这些试验将进一步帮助我们了解支架治疗在标准手术风险患者中的地位,无论患者有无症状。

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Clinical trials: past, present, and future.临床试验:过去、现在与未来。
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