Gladstone D J, Black S E
Division of Neurology, Department of Medicine, Sunnybrook and Women's College Health Sciences Centre.
CMAJ. 2001 Aug 7;165(3):311-7.
Tissue plasminogen activator (tPA) injected intravenously within 3 hours of symptom onset has emerged as a treatment option for acute ischemic stroke. Although controversial and not universally accepted, its use in carefully selected patients is supported by evidence from randomized controlled trials and by mounting community experience. In this paper we review the literature published in the past 5 years regarding the safety, clinical trial efficacy and real-world effectiveness of intravenous tPA for stroke. First we review data from the phase III clinical trials on which approval for tPA is based. Then we summarize a growing literature of postmarketing phase IV studies and discuss the limitations and challenges that lie ahead. Our aim is to provide clinicians with an overview of this evolving therapy.
在症状出现3小时内静脉注射组织型纤溶酶原激活剂（tPA）已成为急性缺血性卒中的一种治疗选择。尽管存在争议且未被普遍接受，但随机对照试验的证据以及越来越多的临床经验支持在精心挑选的患者中使用tPA。在本文中，我们回顾了过去5年发表的关于静脉注射tPA治疗卒中的安全性、临床试验疗效及实际效果的文献。首先，我们回顾作为tPA获批依据的III期临床试验数据。然后，我们总结上市后IV期研究不断增加的文献，并讨论未来的局限性和挑战。我们的目的是为临床医生提供这种不断发展的治疗方法的概述。
