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目的评价降纤酶治疗急性缺血性脑卒中的疗效和安全性。方法急性缺血性脑卒中 80例随机分为两组 :治疗组(42例 )和对照组 (38例 )。治疗组于发病后连续 3天分别给予降纤酶 1 0U、5U、5U静脉滴注 ,对照组给予安慰剂 ,两组其它治疗均相同。观察治疗前后临床神经功能缺损程度评分、Barthel指数、凝血功能 (PT、APTT、Fib)及病死率和副作用。结果治疗后临床神经功能缺损程度评分及Barthel指数 ,治疗组较对照组明显下降 ,两组比较有显著性差异 (P <0 .0 1 )。两组凝血功能比较 :治疗组血浆Fib含量明显降低 ,差异有显著性 (P <0 .0 0 1 ) ,而对照组则无明显下降 (P >0 .0 5) ;部分患者出现PT、APTT延长 (48% )及不凝现象 (9% ) ,而对照组未发现延长和不凝现象。两组均没有明显的出血事件和其它副作用。头颅CT显示治疗组较对照组患者脑梗死面积缩小 ,脑水肿程度明显减轻。治疗组病死率为 7.2 % ,对照组病死率为 1 3 .4% ,两组比较有显著性差异 (P <0 .0 1 )。结论降纤酶连续给药方案治疗缺血性脑卒中未致明显的凝血功能异常 ,无明显的出血事件发生 ,可以降低脑卒中的病死率和致残率 ,缩小脑梗死面积 ,减轻脑梗死后脑水肿程度 ,连续给药方案安全有效 ,可作为有效治疗急性缺血性脑卒中的药物之一
Objective To evaluate the efficacy and safety of defibrase in the treatment of acute ischemic stroke. Methods 80 cases of acute ischemic stroke were randomly divided into two groups: treatment group (42 cases) and control group (38 cases). The treatment group were given 10U, 5U, 5U intravenous infusion of defibrase for 3 consecutive days after the onset of disease, while the control group was given placebo. The other two groups were the same. The score of clinical neurological deficit, Barthel index, coagulation function (PT, APTT, Fib) and mortality and side effects were observed before and after treatment. Results After treatment, the scores of clinical neurological deficits and Barthel index decreased significantly in the treatment group compared with the control group. There was significant difference between the two groups (P <0.01). The coagulation function of the two groups was significantly lower than that of the control group (P <0.01), but not in the control group (P> 0.05). Some patients had PT, APTT Prolonged (48%) and no coagulation (9%), while the control group did not find prolonged and non-coagulation phenomenon. There were no significant bleeding episodes and other side effects in both groups. Head CT showed that the infarct size of the treated group was smaller than that of the control group, and the degree of cerebral edema was significantly reduced. The case fatality rate was 7.2% in the treatment group and 13.3% in the control group, with significant difference between the two groups (P <0.01). Conclusion Continuous defibrase administration for ischemic stroke has no obvious coagulation dysfunction, no obvious bleeding events, can reduce the mortality and morbidity of stroke, reduce the infarct size, reduce the cerebral infarction after the brain Degree of edema, continuous administration of safe and effective program can be used as an effective treatment of acute ischemic stroke drugs