Abstract:

Objective To evaluate the role of early neurologic improvement (ENI) in predicting the outcome of acute ischemic stroke (AIS) patients with intravenous (IV) recombinant tissue plasminogen activator (rt-PA) at 90 days, by using the National Institutes of Health Stroke Scale (NIHSS) score. Methods Data were collected from the Thrombolysis Implementation and Monitoring of Acute Ischemic Stroke in China (TIMS-China) registry study. NIHSS scores were recorded before IV rt- PA, at 2 and 24 hours after IV rt-PA. ENI at 2 hours was defined as a reduction in NIHSS score by 5 or more points from baseline or a total NIHSS score of 0 at 2 hours. ENI at 24 hours was defined as a reduction in NIHSS score by 8 or more points from baseline or a total NIHSS score of 0 at 24 hours. The outcome indexes included symptomatic intracranial hemorrhage (SICH), mortality, and 90-day functional outcomes. Logistic regression analysis was used to evaluate the role of ENI in predicting the 3-month outcome of patients. Results A total of 1100 patients were included. Among which, 310 (28.18%) had ENI at 2 hours

and 272 (24.73%) had ENI at 24 hours after intravenous thrombolysis. In the multivariable Logistic regression model, after adjusted for potential confounding factors including age, history of atrial fibrillation, baseline level of blood glucose, baseline NIHSS score level and other correlated variates, no matter 2 hours or 24 hours after intravenous thrombolysis, patients in ENI group had a significant improvement of favorable outcome (2 h: OR 3.772; 95%CI 2.676~5.316, P <0.001; 24 h: OR 16.392; 95%CI 10.370~25.912, P <0.001; respectively), lower mortality (2 h: OR 0.504; 95%CI 0.268~0.950, P =0.034; 24 h: OR 0.149; 95%CI 0.061~0.366, P <0.001; respectively) and the risk of SICH (2 h: OR 1.979; 95%CI 0.621~6.301, P =0.248; 24 h: OR -; 95%CI -, P =0.928; respectively) was not increased at the 3-month follow-up. Conclusion IV rt-PA appears to have a favorable outcome at month 3 in ENI of patients with AIS.

Key words: Acute ischemic stroke; Thrombolysis; Outcome; Early neurologic improvement

摘要：

目的 探究缺血性卒中患者静脉溶栓后基于美国国立卫生研究院卒中量表（National I nstitutes o f Health Stroke Scale，NIHSS）评分的早期神经功能改善（early neurologic improvement，ENI）对患者3个月 结局的预测作用。 方法 本研究的入选患者来自中国急性缺血性卒中溶栓监测登记研究（Thrombolysis Implementation and Monitoring of Acute Ischemic Stroke in China，TIMS-China），从中选取所有进行溶栓前NIHSS评分、 溶栓后2 h和24 h NIHSS评分的患者，将ENI定义为溶栓后2 h NIHSS评分减少≥5分或NIHSS评分等于0分， 以及溶栓后24 h NIHSS评分减少≥8分或NIHSS评分等于0分，结局指标包括溶栓后90 d的改良Rankin量 表（modified Rankin Scale，mRS）评分、症状性颅内出血（symptomatic intracranial hemorrhage，SICH）情 况及患者的死亡率，采用Logistics回归模型分析早期神经功能改善对患者3个月结局的预测作用。 结果 共纳入1100例患者，在溶栓后2 h，310（28.18%）例患者具有ENI，在溶栓后24 h，272（24.73%） 例患者具有ENI 。在多因素Logi sti c回归分析模型中，调整了年龄、心房颤动病史、基线血糖水平、基 线NIHSS评分水平及其他相关变量后发现，无论是溶栓后2 h还是溶栓后24 h，ENI组患者与非-ENI 组患者相比，均具有更好的3个月良好功能结局（2 h：OR 3.772；95%CI 2.676～5.316，P <0.001；24 h： OR 16.392；95%CI 10.370～25.912，P <0.001）以及更低的死亡率（2 h：OR 0.504；95%CI 0.268～0.950， P =0.034；24 h：OR 0.149；95%CI 0.061～0.366，P <0.001），同时，其出血风险（2 h：OR 1.979； 95%CI 0.621～6.301，P =0.248；24 h：OR -；95%CI -，P =0.928）均未增加。 结论 静脉注射重组组织纤溶酶原激活剂（recombinant tissue-type plasminogen activator，rt-PA）溶栓 后早期神经功能改善的缺血性卒中患者具有更加良好的3个月功能预后。

关键词: 急性缺血性卒中; 静脉溶栓; 预后; 早期神经功能改善