摘要
目的 评价尿激酶对急性脑梗死静脉溶栓的疗效及安全性。方法 凡符合入组标准的患者接受尿激酶 5 0万 U～ 15 0万 U溶于生理盐水 10 0～ 2 0 0 ml内 ,3 0 m in内滴完。随后静脉滴注低分子右旋醣酐 5 0 0 m l每日 1次共 10 d。溶栓后 2 4 h加用口服水溶性阿司匹林 3 0 0 mg每日 1次共 10 d,然后改为 10 0 mg每日 1次共 80 d。神经功能缺损评价采用欧洲卒中量表 ( ESS) ,并记录在下列时间点 :溶栓前 ,溶栓后 2 h、2 4 h、3 d、7d、14 d、3 0 d和 90 d。结果 符合入选标准者共 4 0 9例。尿激酶平均用量为 13 1万 U。溶栓后 ESS分值增加迅速 ,溶栓后 2 4 h有 87.5 3 %的患者 ESS分值增加≥ 10分。溶栓后 90 d有 4 6.6%的患者 ESS分值达到≥ 95分。本组发生非症状性脑出血共 19例( 4 .64%) ,发生症状性脑出血 16例 ( 3 .91%)。死亡率为 12 .2 2 %( 5 0 /40 9) ,其中 6.3 5 %( 2 6/40 9)死于大面积脑梗死 ,1.90 %( 8/40 9)死于脑实质内出血。结论 提示尿激酶静脉溶栓治疗急性脑梗死 ( 6h以内 )是有效的 ,如严格掌握时间窗及适应证 ,该疗法相对比较安全 ,并为第二阶段多中心、随机、双盲、安慰剂对照试验打下基础。
Objective This is a pilot study of a 5-year National Project,also an open-label clinical trial. The purpose is to evaluate the efficacy and safety of urokinase (UK) in the treatment of acute cerebral infactions within 6h from symptom onset. Methods Patients consistent with the inclusion criteria received UK 0.5~1.5 MU in normal saline (NS) 100~200ml intravenously over 30 min. Then 500ml of low molecular dextran was infused intravenously per day for 10 days. 24h after thrombolysis,300mg of aspirin was administered per day for 10 days and then 100mg per day for 80 days. The European Stroke Scale (ESS) was used to evaluate the neurological deficits and the ESS scores were recorded on the following time points: pretherapy,2h,24h,3d,7d,14d,30d and 90d after thrombolysis. Results 409 patients were consistent with the inclusion criteria. The dosage of UK was 1.31 MU on average. ESS scores increased rapidly after thrombolysis. ESS scores increased ≥ 10 points in 87.53% pateints at 24h after therapy. At 90d after therapy,46.6% patients had the ESS scores ≥ 95.In our study,the non-symptomatic hemorrhagic rate was 4.65% (19/409),symptomatic hemorrhagic rate was 3.91% (16/409). The mortality rate was 12.22% (50/409),in which,6.35% (26/409) died of large infarctions,1.90%,(8/409) died of intraparenchymal hemorrhage. Conclusion This study reveale that UK is effective in treatment of acute cerebral infarctions within 6h from symptom onset and ralatively safe if the indications are strictly controlled. The results will be further confirmed by the second phase of the National Projecte,a multicenter,randomized,double-blind,placebo controlled clinical study which will be finished by the end of 2000.
出处
《中风与神经疾病杂志》
CAS
CSCD
北大核心
2001年第5期259-261,共3页
Journal of Apoplexy and Nervous Diseases
基金
国家"九五"攻关课题 ( 96-90 6-0 2 -2 2 )
关键词
急性脑梗死
溶栓治疗
尿激酶
Acute cerebral infarcion
Thrombolysis
Urokinase
