急性脑梗死静脉溶栓治疗的临床对照研究

Intravenous thrombolysis with urokinase in treating acute cerebral infarctions.

目的 评价尿激酶 (UK)对急性脑梗死进行静脉溶栓的疗效及安全性。方法 本研究为开放性随机对照临床研究 ,入选患者随机分为两组 :UK组 (48例 )接受UK 5 0万～ 12 5万IU静脉滴注 ,随后静滴低分子右旋糖酐及口服阿司匹林。对照组 (96例 )则只接受低分子右旋糖酐及阿司匹林治疗。神经功能缺损评价采用欧洲卒中量表 (ESS)。结果 UK平均用量为 6 7 19万IU。溶栓后ESS分值增加迅速 ,两组间有显著性差异 ,治疗后 2 1d时 ,总有效率 ,UK组为89 5 7%,对照组为 72 92 %(P <0 0 5 ) ;脑出血发生率分别为 10 4 2 %与 8 33%(P >0 0 5 ) :病死率分别为 6 94%与 6 2 5 %(P >0 0 5 )。结论 提示尿激酶静脉溶栓治疗急性脑梗死是有效的 ,如严格掌握时间窗及适应症 ,该疗法相对比较安全。

Objective To evaluate the efficacy and safety of intravenous thrombolysis with urokinase(UK) in the treatment of acute cerebral infarctions. Methods This was an open-label,randomized and placebo controlled clinical trial. The eligible patients were randomized into 2 groups. UK group received UK 0.5～1.25MU in 5% glucose 100～200ml intravenously over 30min. Then 500ml of low molecular dextral was infused intravenously and aspirin was administered per day for 21 days. The control group received low molecular dextral intravenously and aspirin orally. The European Stroke Scale(ESS) was used to evaluate the neurological functions. Results The dosage of UK was 0.67MU on average. ESS scores increased rapidly after thrombolysis. There was significant difference between the two groups. At 21d after therapy,the total effective rates were 89.57% in UK group and 72.92% in control group;The cerebral hemorrhagic rates were 10.42% and 8.33% respectively;and the mortality rates were 6.94% and 6.25% respectively. Conclusion This study reveals that intravenous thrombolysis with UK is effective in the treatment of acute cerebral infarctions and relatively safe if the indications are strictly controlled.