尿激酶和巴曲酶治疗早期急性脑梗死的疗效和安全性研究

目的比较尿激酶和巴曲酶治疗超早期脑梗死的效果和安全性。方法比较150万单剂量尿激酶和不同剂量及给药时间的巴曲酶治疗发病6 h内脑梗死的效果。以治疗后3个月和6个月死亡率、改良Rankin评分(mRS)和巴塞尔指数(BI)作为主要终结指标,以美国国家卫生研究所卒中评分(NIHSS)变化作为次要终结指标,收录患者74例。分为A组(尿激酶组)26例,B组(巴曲酶常规剂量组)25例,C组(巴曲酶加大剂量及延长疗程组)23例。结果尿激酶和巴曲酶均可以改善部分患者神经功能评分,2h内尿激酶平均改善NIHSS较快,但是有波动,而巴曲酶效果较平缓而稳定。3个月时A、B、C各组的BI 95~100分患者占的比例分别是26.9%,33.3%,28.6%;mRS 0~2分患者分别为42.3%,41.7%,42.9%;6个月BI 95~100分患者占的比例分别是50.0%,58.3%,47.6%;mRS 0~2分患者分别为57.7%,66.7%,57.1%。差异均无显著性意义。结论缺血性脑卒中6 h内给予尿激酶或者巴曲酶对3个月和6个月后终结指标影响没有显著差异。

Comparison of the efficacy and safety between urokinase and batroxobin in treatment of acute ischemic stroke

Objectives To compare the efficacy and safety of thrombolysing and defibrating therapies in ischemic stroke patients within 6 hours of ictus.Methods Seventy-four patients suffering from ischemic stroke within 6 hours were divided into 3 groups:26 cases(Group A) received intravenous urokinase;25 cases(Group B) received batroxobin 10 U on day 1 and 5 U on days 3 and 5;23 cases(Group C) received batroxobin 10 U on days 1,3 and 5,then 5 U on days 7 and 9.Primary endpoints were the death rate and modified Rankin Scale(mRS)≤2 at the month 3 and the month 6.Barthel Index(BI) and NIHSS were used as secondary endpoints.Results Urokinase showed a faster effect in the first 6 hours,but the efficacy decreased from 12 hours to third day.Batroxobin showed slower but more stable effect.At 3 months of follow-up,the patients with BI of 95～100 points in Group A,Group B and Group C accounted for 26.9%,33.3%,and 28.6%,respectively,and patients with modified Rankin Scale ≤2 accounted for 42.3%,41.7% and 42.9% respectively.On day 180,the patients with BI 95～100 points in the 3 groups accounted for 50.0%,58.3% and 47.6%,respectively and the patients with mRS 0～2 accounted for 57.7%,66.7% and 57.1%,respectively.There was no statistically significant difference among the groups.Conclusion Urokinase or batroxobin used in acute stroke within 6 hour time window showed no significant difference in efficacy and safety on day 30 and day 180 of the follow-up.