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目的 :通过随机、双盲、安慰剂对照的临床研究 ,对降纤酶治疗急性脑梗死的有效性及安全性进行客观评价。方法 :选择 30例急性脑梗死病人随机分为降纤酶组和对照组。降纤酶的剂量为首次 1 5 U,以后隔日静脉滴注 5 U,共用 5次 ,在发病 1 2 h内开始治疗。对照组按同样方式给予安慰剂。评定的终点指标包括脑卒中的临床神经功能缺损程度评分、Barthel指数、药物副作用、血浆纤维蛋白原 ( FIB)水平、凝血酶原时间 ( PT)和凝血酶原活动度 ( PA)、肝肾功能。结果 :治疗后 1 4d神经功能缺损程度评分 ,3个月时 Barthel指数评分 ,降纤酶组与对照组相比差异有显著性。两组疗效相比降纤酶组优于对照组 ,总有效率分别为86.7%及 46.7%。与对照组比较 ,降纤酶组治疗后血浆 FIB水平明显下降 ,没有增加出血事件及其它副作用的发生。治疗后 PT延长和 PA降低也比对照组明显。两组 GPT和 BUN用药后与用药前比较差异无显著性。结论 :国产降纤酶能显著降低血浆 FIB,对急性脑梗死疗效显著 ,无明显副作用
OBJECTIVE: To objectively evaluate the efficacy and safety of defibrase in the treatment of acute cerebral infarction in a randomized, double-blind, placebo-controlled clinical study. Methods: Thirty patients with acute cerebral infarction were randomly divided into defibrase group and control group. Defibrase dosage for the first 15 U, after every other day intravenous infusion of 5 U, shared 5 times, in the onset of treatment within 1 2 h. The control group received placebo in the same manner. Outcome measures included clinical neurological deficit score, Barthel index, drug side effects, plasma fibrinogen (FIB), prothrombin time (PT), prothrombin activity (PA), liver and kidney function . Results: At 14 days after treatment, the score of neurological deficit, Barthel index at 3 months and defibrase group were significantly different from those in control group. Compared with the defibrase group, the total effective rate was 86.7% and 46.7% respectively. Compared with the control group, the level of plasma FIB decreased significantly after defibrase treatment, without increasing the incidence of bleeding and other side effects. After treatment, PT prolongation and PA decreased significantly than the control group. There was no significant difference between the two groups before and after treatment with GPT and BUN. Conclusion: Domestic defibrase can significantly reduce plasma FIB and has significant curative effect on acute cerebral infarction with no obvious side effects