国产降纤酶治疗急性脑梗死60例分析

The Analysis of 60 Cases of Acute Cerebral Infarction Treated with the Native Products of Defibrase

目的 观察国产降纤酶对急性脑梗死临床疗效和纤维蛋白原下降情况 ,进一步验证注射用降纤酶治疗急性脑梗死的有效性和安全性。 方法 选择 1 998年 2月至 1 2月发病 1天内急性脑梗死住院病人6 0例。用随机双盲对照的临床研究 ,揭盲 4 0例 ,分为治疗组 ( 2 4例 )和对照组 ( 1 6例 ) ,均在起病后 2 4 h内给药 ,首剂 1 0 u降纤酶冻干剂加入 2 5 0 ml生理盐水中静脉点滴 ,在 2～ 3h内滴完 ,其后 5 u隔日 1次静滴 ,共连用 3次 ,总剂量 2 0 u。观察期间合并给予低分子右旋糖酐 5 0 0 ml,或灯盏花注射液 4 0 ml静脉点滴 ,连续用药 1 4天。按全国第四界脑血管病学术会议通过的评分标准 ,分别对治疗前 ,治疗后 1 4天的疗效和生活状态进行评定和评估。 结果 治疗前后神经功能评分 :治疗组 :治疗前 1 2 .3± 9.75 ,治疗后 1 4天为 5 .93± 7.6 0 ,治疗前后统计学有极显著性差异 ( P <0 .0 1 ) ,治疗 1 4天总有效率 92 % ;对照组 :治疗前为 1 4.6± 1 0 .6 ,治疗后 1 4天为 6 .4 6± 8.6 5 ,治疗前后统计学有显著性差异 ( P <0 .0 5 ) ,治疗后 1 4天总有效率 6 2 %。血液学指标 :治疗组 FIB含量治疗后较治疗前明显下降 ( P <0 .0 0 1 ) ;对照组治疗前后无明显变化 ( P >0 .1 0 )。治疗组 PT用药后第 2。

Objective To observe the clinical therapeutical effects with the native product of defibrase for acute cerebral infarctions,and the depletion of serum fibrinogen concentrations and secondly,to prove the effectiveness and saftiness of the defibrase Method 60 hospitalized patients of acute cerbral infarction in the first day after disease onset from February to December in 1998 were selected Using the random diblinded controlled clinical test for 40 patients had been chosen and diveded into 2 groups:24 cases in medication group and 16 cases in control group All the treatments were started during 24h, after disease onset,with a first dose of 10u dry frozen defibrase disolved in 250ml N S dripped intravenously within 2~3h, followed by 5u Q O D for 2 times The total dosage were 20u Low molecular weight dextran 500ml or Ergeron breviscapus solution 40ml was given continuously for 14 days during the observing stage According to the evaluation standard from the 4th national cerebrovascular conference the effects and living states were evaluated before treatment and 14 days afterwards Results The neuro functions scored before and after treatments:medication group:It was 12 3±9 75 before treatment 14 days after treatment scored 5 93±7 60 Following statistical analysis their results had differed significantly The total effective rate of the 24 cases after 14 days treatment reached 92% Control group:Before treatment it was 14 6±10 6,while after 14 days treatment it was 6 46±8 65 Following statistical analysis the result compared with that before treatment had differed significantly The total effective rate of the 16 cases after 14 days treatment was 62% Index in hematology:In the medication group the serum fibrinogen contents had decreased significantly after treatment,P<0 001, and that of the control group had changed insignificantly,P>0 10 The prothrombin time(PT) in the medication group had prolonged significantly than that before treatment on the 2nd and 6th day Following statistical analyses there were significant differences,P<0 001 In the control group the PT had no significant change and had been within normal ranges The renal and hepatic functions of the two groups had no change In the 40 cases there were not any side effects except 1 case in the control group had some rashes One case in the control group died There was no relationship with the defibrase Conclusion The total effect of the native products of defibrase in the tereatment of acute cerebral infarction had reached 92%,while the total effect in the control group was 62% It had signified the good effects of the defibrase in treating the cerebral infarction in the acute stage The serum fibrinogen content had been lowered significantly and the prothrombin time had been prolonged significantly It had demonstrated that this drug has the effect of fibrinogen lowering and anticoagulation,and thus of protection of thrombus and thrombosis evolution