Department of Neurology, University of Washington, Seattle, 98195, USA.
Am J Emerg Med. 2010 Mar;28(3):359-63. doi: 10.1016/j.ajem.2009.01.025.
Since publication in 1995 of the National Institute of Neurological Disorders and Stroke (NINDS) trial of intravenous tissue plasminogen activator (IV tPA) for acute ischemic stroke, the benefit and frequency of use of IV tPA in the elderly have remained uncertain.
We obtained data from the NINDS trial to summarize outcomes for randomized subjects older than 80 years. We used data from the Cardiovascular Health Study, a cohort study of 5888 elderly participants from 4 US communities followed longitudinally for stroke since 1989 to estimate the use of and hospital outcome after IV tPA in older adults following publication of the trial in 1995.
In the NINDS trial, 44 subjects older than 80 years were randomized, and their 3-month functional outcomes were not significantly improved with IV tPA. Of 25 randomized to IV tPA, 4 experienced symptomatic intracranial hemorrhages within 36 hours of treatment. Compared with younger patients, older patients were 2.87 times more likely to experience a symptomatic intracranial hemorrhage within 36 hours of IV tPA (95% confidence interval, 1.04-7.93). Of 227 Cardiovascular Health Study participants hospitalized for ischemic stroke between 1995 and 2002, seven, whose mean age was 84 years, were treated with IV tPA (3.1%; 95% confidence interval 1.2-6.2). Two had symptomatic intracranial hemorrhages, 3 failed to improve, and 2 of the 7 had good outcomes.
These data highlight the need to clarify the risk-benefit profile of IV tPA in ischemic stroke victims who are older than 80 years.
自 1995 年美国国立神经病学与卒中研究院（NINDS）开展静脉注射组织型纤溶酶原激活剂（IV tPA）治疗急性缺血性脑卒中的试验以来，高龄患者使用 IV tPA 的获益和频率仍存在不确定性。
我们从 NINDS 试验中获取数据，总结 80 岁以上随机受试者的结局。我们利用心血管健康研究（一项对来自美国 4 个社区的 5888 名老年参与者进行的队列研究）的数据，这些参与者自 1989 年以来一直进行纵向随访，以评估该试验发表后（1995 年）老年患者接受 IV tPA 治疗的使用情况和住院结局。
在 NINDS 试验中，44 名 80 岁以上的受试者被随机分组，他们接受 IV tPA 治疗后 3 个月的功能结局并未得到显著改善。在接受 IV tPA 治疗的 25 名受试者中，有 4 名在治疗后 36 小时内出现症状性颅内出血。与年轻患者相比，高龄患者在接受 IV tPA 治疗后 36 小时内发生症状性颅内出血的风险增加了 2.87 倍（95%置信区间，1.04-7.93）。在 1995 年至 2002 年期间因缺血性脑卒中住院的 227 名心血管健康研究参与者中，有 7 名（平均年龄 84 岁）接受了 IV tPA 治疗（3.1%；95%置信区间 1.2-6.2）。其中 2 名出现症状性颅内出血，3 名未改善，7 名中有 2 名结局良好。
这些数据突出表明，需要明确 80 岁以上缺血性脑卒中患者使用 IV tPA 的风险-获益情况。
