降纤酶治疗急性脑梗死疗效双盲对照研究

Double Blind Comparesion of Therapeutic Effect of Defibrase on Acute Cerebral Infarction

目的 观察降纤酶治疗急性脑梗死的近期疗效及对纤维蛋白原的降解作用。方法 37例急性脑梗死患者 ,采用随机、双盲、安慰剂对照试验方法 ,随机分为两组 (治疗组 1 8例 ,其中除误诊 1例 ;安慰剂组 1 9例 )。比较治疗前与治疗第 1 4天神经功能缺损评分、出院及第 1 2周随访 Barthel指数、两组治疗前及治疗第 2、 4、 6天血纤维蛋白原变化情况。 结果 治疗组及安慰剂组治疗后第 1 4天神经功能改善、出院及第 1 2周随访 Barthel指数改善 ,经统计学处理无差异 (分别为 P =0 .2 4 2、P =0 .635、P =0 .870 )。用药第 2、 4、 6天血纤维蛋白原降低程度两组有显著性差异 (分别为 P =0 .0 4 3、P =0 .0 0 1、0 .0 0 1 )。死亡率治疗组为 1 7:2 ,安慰剂组 1 9:1 ,两组无差异性 (P =0 .2 )。 结论 降纤酶有降低纤维蛋白原作用 ,可作为溶栓药物 ,临床应用安全性好。两组疗效无显著性差异 ,是否与样本大小或药物剂量不足有关 。

Objective To observe the therapeutic effect of defibrase on acute cerebral infarction and its degradation of fribrinogen Methods 37 case of acute cerebral infarction were divided into test group of 18(one them was excluded later due to misdiagnosis),and control group of 19 with double blind methodThe control group was made between the two groups before treatment and the 14th day after the treatmentThe variations of blood fribrinogen of the two groups were observed before the admission to hospital and the 2nd,4th and 6th day after treatmentBarrthel indexes were recorded in the 12th week after they were discharged from hospital Results Both groups showed improvement in neuro function 14 days after receiving treatment and Barrthel indexes also improved in the 12th week of followups without statistical variation(P=0242,P=0635,P=0870)There were differences in fribrinogen reduction in the two groups in the observation on the 2nd,4th and 6th day after treatment(P=0043,P=0001,P=0870)The death rate in the test group was 17:2 while the control group 19:1(P=02) Conclusion Defribrinolysin proves safe clinically and has the effect of fribrinogen reduction and can be used as antithrombusHowever,whether little difference between the two groups in therapeutic effect is rel ated to the dosage needs further study