Analysis of the National Institute of Neurological Disorders and Stroke tissue plasminogen activator studies following European Cooperative Acute Stroke Study III patient selection criteria.

Analysis of the National Institute of Neurological Disorders and Stroke tissue plasminogen activator studies following European Cooperative Acute Stroke Study III patient selection criteria.
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DOI:
10.1016/j.jstrokecerebrovasdis.2009.06.001
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发表时间:
2010-07
影响因子:
2.5
通讯作者:
Lyden, Patrick D.
Lyden, Patrick D.
中科院分区:
医学4区
文献类型:
--
作者:
Hemmen, Thomas M.;Rapp, Karen S.;Emond, Jennifer A.;Raman, Rema;Lyden, Patrick D.

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1995年,NINDS的两项研究表明,在卒中发作后3小时内给予静脉注射t-PA的卒中患者上级安慰剂。最近发表的ECASS III研究引入了新的患者选择标准和3至4.5小时的治疗。使用这些标准,t-PA显示在较晚的时间窗有效。两项分析均使用3个月mRS作为主要主要结局。我们试图研究将ECASS III选择标准应用于原始NINDS队列的效果。我们分析了NINDS样本中符合ECASSS III研究标准的患者亚组,并检查了调整和未调整混杂因素的3个月结局。NINDS t-PA研究纳入了624例患者。在应用ECASS III标准后,选择了200名t-PA治疗组和199名安慰剂组。在这些选定的患者中,t-PA组中52%的患者在3个月时的mRS为0或1,而t-PA组中31%的患者在3个月时的mRS为0或1(p<0.001)。第90天mRS 0-1 vs 2-6时,t-PA治疗与安慰剂相比的未校正OR为2.45(95% CI:1.63-3.69)。校正基线NIHSS、吸烟状态、至治疗时间和高血压病史后,OR为2.14(95% CI:1.34-3.41)(p<0.001)。使用ECASS III患者选择在3小时内接受治疗的患者,52%的t-PA治疗患者在3个月时结局良好。
In 1995 two studies by the NINDS showed that intravenous t-PA was superior to placebo in stroke patients when given less than 3 hours from stroke onset. The recently published ECASS III study introduced new patient selection criteria and treatment between 3 and 4.5 hours. Using these criteria, t-PA was shown effective at the later time window. Both analyses used the 3 month mRS as main primary outcome. We sought to study the effect of applying the ECASS III selection criteria to the original NINDS cohort. We analyzed the subgroup of patients from NINDS sample who matched the ECASSS III study criteria and examined 3-month outcomes adjusted and unadjusted for confounding factors. The NINDS t-PA study included 624 patients. Two hundred in the t-PA treated and 199 in the placebo group were selected after applying ECASS III criteria. Of these selected patients, 52% in the t-PA group versus 31% had an mRS of 0 or 1 at 3 months (p<0.001). The unadjusted OR for t-PA treatment versus placebo on day 90 mRS 0–1 versus 2–6 was 2.45 (95% CI: 1.63–3.69) When adjusted for baseline NIHSS, smoking status, time to treatment and history of hypertension the OR was 2.14 (95% CI: 1.34–3.41) (p<0.001). Using the ECASS III patient selection in patient treated in less than 3 hours, 52% of t-PA treated patient had a favorable outcome at 3 months.
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