尿激酶静脉溶栓治疗急性脑梗死有效治疗时间窗分析

Clinical study on valid therapeutic time window of acute cerebral infarction by intravenous thrombolysis with urokinase

目的：探讨急性脑梗死尿激酶静脉溶栓疗效及安全性。方法采用开放性临床研究，将发病12 h内358例急性脑梗死随机分为溶栓治疗组178例，常规治疗组180例。溶栓治疗组采用常规治疗＋尿激酶150万U静脉注射，其中超早期（溶栓治疗距发病时间＜6 h ）溶栓组治疗123例，延迟（溶栓治疗距发病时间6～12 h ）溶栓治疗组55例。评价溶栓疗效和出血转化安全性。结果溶栓组总有效率89.89％（114／210），病死率3.8％（12／178），脑出血并发症5.7％（12／210），脑出血病死率2.9％（6／210）；常规治疗组总有效率48.0％（108／225），病死率9.3％（21／225），脑出血并发症0.9％（2／225），无1例死于脑出血。结论尿激酶在急性缺血性脑梗死患者超早期溶栓治疗方面效果显著，急性脑梗死发病12 h内尿激酶静脉溶栓疗效较好，但脑出血并发症明显增多，临床终点死亡结局不高。

Objective To evaluate the clinical efficacy and safety of intravenous thrombolysis with urokinase on patients with acute cerebral infarction （ACI） .Methods The open clinical trial was conducted on 358 patients with acute cerebral infrac‐tion attacked within 12 hours .Patients enrolled were randomly divided into group of thrombolytic therapy （178 cases ,treated by intravenous thrombolysis with urokinase） and control group （180 cases） .For the group of thrombolytic therapy ,150 mil‐lion U intravenous thrombolysis with urokinase was intravenous injected in addition to routine treatment .Among them ,123 ca‐ses used intravenous thrombolysis with urokinase in ultra‐early stage（thrombolysis therapy within 6 hours） and 55 cases used thrombolysis in the period of 6—12 hours after the onset .The efficacy of thrombolysis and safety of hemorrhagic transformation were evaluated .Results The overall improvement rate of treatment group with intravenous thrombolysis was 89 .89% （114/210） ,fatality rate was 3 .8% （12/178） ,cerebral hemorrhagic transformation rate was 5 .7% （12/210） ,cerebral hemorrhagic mortality rate was 2 .9% （6/210）;The Overall improvement rate of control group was 48% （108/225） ,fatality rate was 9 .3%（21/225） ,cerabral hemorrhagic transformation rate was 0 .9% （2/225） ,cerebral hemorrhagic mortality rate was 0 .There were no statistical differences on NIHSS score and prognostic outcome between ultra‐early thrombolysis therapy and delayed thrombolytic therapy .Conclusion For hyperacute ischemic stroke patients ,intravenous urokinase thrombolysis shows obvious effect on ultra early stage .AS for post therapeutic window （〈12 h）of cerebra1 infarction ,it is safe and effective to use intra‐venous thrombolysis with urokinase after attack .Although the risk of hemorrhagic transformation increased ,clinical end point w as no t .