Decourcelle A, Moulin S, Dequatre-Ponchelle N, Bodenant M, Rossi C, Girot M, Hénon H, Wiel E, Bordet R, Goldstein P, Pruvo J P, Cordonnier C, Leys D
Univ. Lille, Roger Salengro Hospital, 59037 Lille, France; CHU Lille, Roger Salengro Hospital, 59037 Lille, France.
Univ. Lille, Roger Salengro Hospital, 59037 Lille, France; CHU Lille, Roger Salengro Hospital, 59037 Lille, France; INSERM, U1171, Department of Neurology, Stroke Unit, Roger Salengro Hospital, 59037 Lille, France.
Rev Neurol (Paris). 2017 Jun;173(6):381-387. doi: 10.1016/j.neurol.2017.03.023. Epub 2017 Apr 25.
In patients with cerebral ischemia, intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) increases survival without handicap or dependency despite an increased risk of bleeding. This study evaluated whether the results of randomized controlled trials are reproduced in clinical practice.
Data from a registry of consecutive patients treated by rt-PA at Lille University Hospital were retrospectively analyzed for outcomes, using modified Rankin Scale (mRS) scores, at 3 months. The observed outcomes were then compared with the probability of good (mRS 0-1) and of catastrophic (mRS 5-6) outcomes, as predicted by the stroke-thrombolytic predictive instrument (STPI).
Of the 1000 consecutive patients (469 male, median age 74 years, median baseline National Institutes of Health Stroke Scale 11, median onset-to-needle time 143min), 438 (43.8%) had a good outcome, 565 (56.5%) had an mRS score 0-2 or similar to their pre-stroke mRS, 155 (15.5%) died within 3 months and 74 (7.4%) developed symptomatic intracerebral hemorrhage according to ECASS-II (Second European-Australasian Acute Stroke Study) criteria. Of the 613 patients (61.3%) eligible for evaluation by the s-TPI, the observed rate of good outcomes was 41.3% (95% CI: 37.5-45.3%), while expected rates with and without rt-PA were 48.8% (95% CI: 44.8-52.7%) and 32.5% (95% CI: 28.8-36.2%), respectively; the observed rate of catastrophic outcomes was 17.0% (95% CI: 14.0-19.9%), while the expected rate was 19.2% (95% CI: 16.1-22.4%) with or without rt-PA.
In clinical practice, the rate of good outcomes is slightly lower than expected, according to the s-TPI, except for the most severe cases, whereas the rate of catastrophic outcomes is roughly similar. However, the rate of good outcomes is higher than predicted without treatment. This finding suggests that rt-PA is effective for improving outcomes in clinical practice.
在脑缺血患者中，静脉注射重组组织型纤溶酶原激活剂（rt-PA）可提高生存率，且患者无残疾或无需依赖他人，尽管出血风险有所增加。本研究评估了随机对照试验的结果在临床实践中是否能够重现。
回顾性分析了里尔大学医院接受rt-PA治疗的连续患者登记数据，以改良Rankin量表（mRS）评分评估3个月时的结局。然后将观察到的结局与卒中溶栓预测工具（STPI）预测的良好结局（mRS 0-1）和灾难性结局（mRS 5-6）的概率进行比较。
在1000例连续患者中（469例男性，中位年龄74岁，基线美国国立卫生研究院卒中量表中位数为11，中位发病至穿刺时间143分钟），438例（43.8%）有良好结局，565例（56.5%）mRS评分为0-2或与卒中前mRS相似，155例（15.5%）在3个月内死亡，74例（7.4%）根据ECASS-II（第二次欧洲-澳大利亚急性卒中研究）标准发生症状性脑出血。在613例符合s-TPI评估条件的患者中（61.3%），观察到的良好结局发生率为41.3%（95%CI：37.5-45.3%），而使用rt-PA和不使用rt-PA时的预期发生率分别为48.8%（95%CI：44.8-52.7%）和32.5%（95%CI：28.8-36.2%）；观察到的灾难性结局发生率为17.0%（95%CI：14.0-19.9%），而无论是否使用rt-PA，预期发生率均为19.2%（95%CI：16.1-22.4%）。
在临床实践中，根据s-TPI，除最严重的病例外，良好结局的发生率略低于预期，而灾难性结局的发生率大致相似。然而，良好结局的发生率高于未治疗时的预测值。这一发现表明rt-PA在临床实践中对改善结局是有效的。
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