药物洗脱支架与关键路径计划：安全性评估的不断演变范式

Drug eluting stents and the critical path initiative: Evolving paradigms for safety evaluation.

作者信息

Sanhai Wendy R, Stockbridge Norman, Fiorentino Robert P, Uchida Takahiro, Uhl Kathleen, Krucoff Mitch W

机构信息

Office of the Commissioner, Food and Drug Administration (FDA), Rockville, MD, USA.

Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, FDA, Rockville, MD, USA.

出版信息

Drug Discov Today Technol. 2007 Winter;4(2):43-6. doi: 10.1016/j.ddtec.2007.10.004.

DOI:10.1016/j.ddtec.2007.10.004

PMID:24980839

Abstract

Recent discussions between FDA and other stakeholders have focused on the benefits and risks associated with drug eluting stents (DES). A particular topic of focus is DES thrombosis, a rare, but serious, clinical event that may occur months to years after the initial implantation. FDA continues vigilant postmarket surveillance of DES currently on the market and is working with stent manufactures to ensure that new DES platforms in the development pipeline are safe and effective. FDA is also taking steps, under its Critical Path Initiative (CPI) [FDA. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, March 2004.http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html], to help address current and future DES safety issues. This article describes some of these activities.:

摘要

美国食品药品监督管理局（FDA）与其他利益相关者最近的讨论集中在药物洗脱支架（DES）的益处和风险上。一个特别关注的话题是DES血栓形成，这是一种罕见但严重的临床事件，可能在初次植入后的数月至数年发生。FDA继续对市场上现有的DES进行严格的上市后监测，并与支架制造商合作，以确保正在研发中的新DES平台的安全性和有效性。FDA还根据其关键路径计划（CPI）[FDA.《创新还是停滞：新医疗产品关键路径上的挑战与机遇》，2004年3月。http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html]采取措施，以帮助解决当前和未来的DES安全问题。本文介绍了其中的一些活动。