降纤酶治疗急性脑梗死的临床再评价--前瞻性随机双盲对照研究

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:将在我院神经内科就诊的65例急性脑梗死病人随机分为降纤酶组和对照组.降纤酶的首剂量为10U,第2、3次剂量为5U,在发病24h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、副作用、血浆纤维蛋白原(FIB)水平及发病3个月和1年时的病死率及脑卒中复发率.结果:(1)与对照组比较,降纤酶组治疗后血浆FIB水平明显下降(P＜0.001),没有增加出血事件及其他副作用的发生.(2)治疗后14天神经功能缺损程度评分、3个月时Barthel指数评分及病死率,降纤酶组与对照组比较差异无显著性.(3)随访1年时,两组病死率比较,差异无显著性,但卒中复发率对照组高于降纤酶组(P＜0.05).结论:降纤酶是降解血浆FIB安全有效的药物.在本研究方案下,降纤酶未显示出优于目前治疗急性脑梗死,常用药物的临床疗效.其在适应证、治疗剂量、给药方法及用药时限等方面与临床疗效的关系有待进一步研究.

Reassessment of defibrase in treatment of cerebral infarction

Objective:To assess the safety and efficacy of defibrase in the treatment of acute cerebral infarction by a randomized,double-blind,and placebo-controlled clinical trial.Methods:65 cases with acute infarction were randomly allocated to receive either an initial intravenous infusion of defibrase 10U or placebo 250ml of normal saline within 24 hours of stroke onset.Subsequent infusions of defibrase 5U or placebo were given on the third and the fifth day respectively.The end points included Clinically Neurological Deficits Scale of Stroke,Barthel Index,fatality rate of stroke in 3 months and 12 months,adverse reaction and the level of plasma fibrinogen(FIB).Results:(1)The level of plasma FIB in defibrase group was remarkably declined after treatment whereas the bleeding event and other adverse reaction were not increased as compared with the control group.(2)There were no statistically significant differences at Clinically Neurological Deficits Scale of Stroke at 2 weeks,Barthel Index score and fatality rate at 3 months between two groups.(3)The recurring rate of stroke in control group was higher than that in defibrase group at 12 months(P<0.05).Conclusion:This study shows that defibrase appears safe and effective in degrading plasma FIB.This study does not show that clinical efficacy of defibrase is superior to those medicines used at present for acute cerebral infarction. It is necessary to carry out further study on the relations between clinical efficacy and the dose of defibrase,protocol of drug administration and indication.