Generalized efficacy of t-PA for acute stroke - Subgroup analysis of the NINDS t-PA stroke trial
Generalized efficacy of t-PA for acute stroke - Subgroup analysis of the NINDS t-PA stroke trial
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DOI：
10.1161/01.str.28.11.2119
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发表时间：
1997-11-01
期刊：
影响因子：
8.3
通讯作者：
Fong, WC
中科院分区：
文献类型：
--
作者：
Brott, T;Broderick, J;Fong, WC
背景和目的我们试图确定中风患者的亚组，方法我们进行了一项随机、双盲、安慰剂对照的临床试验，静脉注射组织纤溶酶原激活剂（t-PA）治疗症状发作后3小时内出现的中风患者。治疗前，总结了病史、体格检查和实验室检查结果。我们确定了可能预测t-PA治疗结果和/或差异反应的变量。治疗3个月后，采用4种卒中评定量表测量结局。统计学显著性采用同时考虑所有四个量表结果的全局结果程序进行评估。使用回归分析，我们将治疗前收集的信息与总体结果进行比较。多因素分析法用于寻找可指导患者选择t-PA治疗的信息。结果治疗前信息对患者t-PA疗效无显著影响。该模型检测治疗相互作用的把握度大于90%，因此II类错误的概率非常低。除t-PA治疗外，结局还与年龄-缺陷严重程度相互作用、糖尿病、年龄-血压相互作用和早期CT结果相关。这些变量和相互作用改变长期患者的结果，无论t-PA治疗，但并没有改变的可能性，积极响应t-PA therapy.Conclusions患者应选择t-PA溶栓根据NINDS t-PA卒中试验的报告中公布的指南。我们的事后分析不支持对患者进行进一步的亚组选择，例如根据年龄或卒中严重程度进行亚组选择。
Background and Purpose We sought to identify subgroups of stroke patients in wMethods We conducted a post hoc subgroup analysis of a randomized, double-blind, placebo-controlled clinical trial of intravenous tissue plasminogen activator (t-PA) for stroke patients presenting within 3 hours after symptom onset. Before treatment, historical, physical, and laboratory findings were summarized. We identified variables that might predict outcome and/or differential response to t-PA therapy. Outcome was measured with four stroke rating scales administered 3 months after treatment. Statistical significance was assessed with a global outcome procedure that considers the results of all four scales simultaneously. Using regression analysis, we compared the information collected before treatment with the global outcome. Multivariable procedures were used to find information that could guide selection of patients for t-PA.Results No pretreatment information significantly affected patients' response to t-PA. The power of the model to detect a treatment interaction was greater than 90%, and therefore the probability of a type II error is very low. Apart from t-PA therapy, outcome was related to age-by-deficit severity interaction, diabetes, age-by-blood pressure interaction, and early CT findings. These variables and interactions altered long-term patient outcome irrespective of t-PA treatment but did not alter the likelihood of responding favorably to t-PA therapy.Conclusions Patients should be selected for t-PA thrombolysis according to the guidelines published in the report of the NINDS t-PA Stroke Trial. Further subselection of patients, such as by age or stroke severity, is not supported by our post hoc analysis.