Findings from the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial
Findings from the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial
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DOI：
10.1161/01.str.0000140891.70547.56
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发表时间：
2004-10-01
期刊：
影响因子：
8.3
通讯作者：
Christianson, TJH
中科院分区：
文献类型：
--
作者：
Ingall, TJ;O'Fallon, WM;Christianson, TJH
背景和目的--在对美国国家神经疾病和中风研究所(NINDS)静脉注射组织型纤溶酶原激活剂(t-PA)在急性中风治疗试验中的结果的担忧发表后，NINDS委托了一个独立委员会“解决是否存在这样的担忧，即符合条件的中风患者可能无法从根据试验中使用的方案给予的t-PA中受益，以及亚组失衡(在基线中风严重程度方面)是否使整个试验无效”。方法-重新分析原始的NINDS试验数据，以评估t-PA治疗效果，治疗组之间中风严重程度基线失衡对t-PA治疗效果的影响，结果：尽管t-PA治疗的患者在基础卒中严重程度和症状性脑出血发生率方面的亚组失衡，但还是确定了t-PA治疗的临床重要和统计学意义显著的益处。调整后的t-PA与安慰剂的优势比(OR)为2.1(95%可信区间，1.5至2.9)。虽然这些探索性分析没有发现t-PA治疗效果在不同患者亚组之间存在差异的统计证据，但这项研究没有能力检测亚组治疗的差异。结论--这些发现支持在NINDS t-PA试验方案下，在发病3小时内使用t-PA治疗急性缺血性中风患者。卫生专业人员应共同努力制定指南，以确保t-PA在急性缺血性中风患者中的适当使用。
Background and Purpose - Following publication of concerns about the results of the National Institute of Neurological Disorders and Stroke (NINDS) intravenous tissue plasminogen activator (t-PA) in acute stroke treatment trial, NINDS commissioned an independent committee "to address whether there is concern that eligible stroke patients may not benefit from t-PA given according to the protocol used in the trials and, whether the subgroup imbalance ( in baseline stroke severity) invalidates the entire trial."Methods - The original NINDS trial data were reanalyzed to assess the t-PA treatment effect, the effect of the baseline imbalance in stroke severity between the treatment groups on the t-PA treatment effect, and whether subgroups of patients did not benefit from receiving t-PA.Results - A clinically important and statistically significant benefit of t-PA therapy was identified despite subgroup imbalances in baseline stroke severity and an increased incidence of symptomatic intracerebral hemorrhage in t-PA treated patients. The adjusted t-PA to placebo odds ratio ( OR) of a favorable outcome was 2.1 (95% CI, 1.5 to 2.9). Although these exploratory analyses found no statistical evidence that the t-PA treatment effect differed among patient subgroups, the study was not powered to detect subgroup treatment differences.Conclusions - These findings support the use of t-PA to treat patients with acute ischemic stroke within 3 hours of onset under the NINDS t-PA trial protocol. Health professionals should work collaboratively to develop guidelines to ensure appropriate use of t-PA in acute ischemic stroke patients.