尤瑞克林联合巴曲酶治疗急性脑梗死的临床研究

Clinical Trial of Urinary Kallikrein Combined with Batroxobin Therapy in Acute Ischemic Stroke

目的观察尤瑞克林联合巴曲酶治疗急性脑梗死的疗效及安全性。方法采用随机分组1:1对照研究方法,共入选74例患者,试验组(n=37)为尤瑞克林与巴曲酶联合治疗,对照组(n=37)为巴曲酶单独治疗,于治疗前、治疗后第21、90天分别采用美国国立卫生院神经功能缺损评分(National lrstitutes of Heaith stroke scale,NIHSS)和Barthel指数(Barthel index,BI)评定神经功能缺损程度及日常生活活动能力,并评价疗效及不良反应。结果治疗后第21天试验组及对照组NIHSS评分为2.54±2.48及4.17±4.21(P=0.038);治疗后第90天试验组及对照组NIHSS评分为1.40±1.54及2.65±3.96(P=0.013)。治疗后第21天试验组及对照组BI评分为86.49±12.74和78.37±19.35(P=0.027);治疗后第90天试验组及对照组B1评分为94.73±7.06和87.02±17.38(P=0.002)。试验组临床有效率(基本痊愈和显著改善)显著高于对照组(89.2%vs62.1%,P=0.011)。试验组有1例患者出现面色潮红,恶心及呕吐症状,给予对症处理后好转。结论尤瑞克林联合巴曲酶治疗急性期脑梗死比单独使用巴曲酶临床效果良好而且无明显不良反应。

Objective To observe the effect and safety of urinary kallikrein combined with batroxobin in acute ischemic stroke patients. Methods A randomized 1：1 control clinical study was performed in 74 patients. The study group （n=37） was administrated kallikrein combined with batroxobin and the placebo group was administrated batroxobin. National Institutes of Health Stroke Scale （NIHSS） and Barthel Index （BI）, which were used to evaluate defect of neurological function and daily living activity, were compared between study group and placebo group before treatment, and after treatment on 21th day and 90th day, in addition curative effect and adverse reaction were evaluated. Results NIHSS on the 21th day of study group and placebo group was 2.54±2.48 and 4.17±4.21 （P=0.038） respectively. NIHSS on the 90th day of study group and placebo group was 1.40±1.54 and 2.65±3.96 （P=-0.013） respectively. NIHSS of study group was significant lower than placebo group. BI on 21th day of study group and placebo group was 86.49±12.74 and 78.37±19.35 （P=0.027） respectively. BI on 90th day of study group and placebo group was 94.73±7.06 and 87.02±17.38 （P=0.002）. BI of study group was significant higher than placebo group. Clinical effective rate （almost recovery and significant improvement） of study group （89.2%） was significant higher than placebo group （62.1%） （P=0.011）. One patient in study group had symptoms of flushed face, nausea and vomiting, but got improvement after symptomatic treatment. Conclusion Urinary kallikrein combined with batroxobin was more effective than batroxobin alone in acute ischemic stroke and had no obvious side effect.