Tissue plasminogen activator for acute ischemic stroke in clinical practice - A meta-analysis of safety data
Tissue plasminogen activator for acute ischemic stroke in clinical practice - A meta-analysis of safety data
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DOI：
10.1161/01.str.0000101752.23813.c3
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发表时间：
2003-12-01
期刊：
影响因子：
8.3
通讯作者：
Graham, GD
中科院分区：
文献类型：
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作者：
Graham, GD
背景和目的-组织纤溶酶原激活剂(TPA)治疗急性缺血性卒中的安全性一直受到关注。已经发表了大量tPA临床经验的病例系列，为溶栓治疗的安全性提供了更多的数据。方法-这是对15项已发表的开放标签研究的荟萃分析，这些研究广泛遵循tPA在非选择性患者群体中的批准适应症和指南。结果-在2639名接受治疗的患者中，症状性脑出血发生率为5.2%(95%可信区间，4.3到6.0)，略低于国家神经疾病和中风研究所(NINDS)随机、安慰剂对照试验的6.4%。平均总死亡率(13.4%)和获得非常有利结果的受试者比例(37.1%)与NINDS试验结果相当。有19.8%的患者报告了协议偏差。跨研究比较显示，死亡率与违反方案的百分比相关(r=0.67，P=0.018)。结论批准后的数据支持tPA静脉溶栓治疗急性缺血性卒中的安全性，特别是在遵循既定的治疗指南的情况下。
Background and Purpose - Concerns persist regarding the safety of tissue plasminogen activator ( tPA) therapy for acute ischemic stroke. Numerous case series of clinical experience with tPA have been published that provide additional data on the safety of thrombolytic therapy.Methods - This is a meta- analysis of 15 published, open- label studies that broadly followed approved indications and guidelines for tPA use in nonselective patient populations.Results - In 2639 treated patients, the symptomatic intracerebral hemorrhage rate was 5.2% ( 95% confidence interval, 4.3 to 6.0), slightly lower than the 6.4% rate in the treated group of the randomized, placebo- controlled National Institute of Neurological Disorders and Stroke ( NINDS) trial. The mean total death rate ( 13.4%) and proportion of subjects achieving a very favorable outcome ( 37.1%) were comparable to the NINDS trial results. Protocol deviations were reported in 19.8%. Comparing across studies showed that the mortality rate was correlated with the percentage of protocol violations ( r = 0.67, P = 0.018).Conclusions - Postapproval data support the safety of intravenous thrombolytic therapy with tPA for acute ischemic stroke, especially when established treatment guidelines are followed.