降纤酶对脑梗死急性期患者神经功能缺损的影响:随机、双盲、对照的II期临床研究

Effects of defibrase on neurologic impairment in patients with acute cerebral infarction:a randomized,double-blind and controlled study at stage Ⅱ

目的:通过临床研究,探讨降纤酶治疗急性脑梗死的有效性和安全性,并进行客观评价。方法:按照全国脑防办《降纤酶治疗急性脑梗死第二阶段临床再评价研究》实施方案,对49例符合标准的急性脑梗死患者,采用前瞻性、随机、双盲,安慰剂对照的临床研究方法,随机分为降纤酶组和对照组。评定指标包括脑卒中的临床神经功能缺损程度评分、Barthel指数、血浆纤维蛋白原水平、副作用。结果:治疗组23例,终止治疗5例,其中1例自动退出试验,2例消化道出血,1例出现皮肤大片瘀斑,1例突然死亡;对照组26例,终止1例,为自动退出试验。与对照组比较,治疗组应用降纤酶后血浆纤维蛋白原水平降低非常显著(P<0.001),尤其用药第6天最显著犤治疗组为(68.10±54.46)g/L,对照组为(327.44±142.17)g/L犦;治疗后14d临床神经功能缺损评分减少优于对照组,但差异无显著性意义(P>0.05),但14d,3个月时Barthel指数评分并无显著差异;治疗组应用降纤酶后有1例病情加重,而对照组中有4例病情加重。结论:降纤酶降低血浆纤维蛋白原作用确切显著,在此样本中对减少神经功能缺损评分疗效显著,具有抑制急性脑梗死病情进展的作用,但可能有增加出血的危险性。

AIM:To investigate and objectively assess the safety and efficacy of defibrase in the treatment of acute cerebral infarction through a clinical study. METHODS:A total of 49 patients with acute infarction were divided into defibrase group and control group via the clinical study of prospective,randomized,double-blind and plasebo controlled method.All patients were in accordance with the diagnosis criteria of the Defibrase for the Treatment of Acute Cerebral Infarction in the Second Stage of Clinical Re-evaluation in National Brain Prevention Office.The evaluated indexes included clinical neurological defect scale of stroke,Barthel Index,the level of plasma fibrinogen(FIB) and side effects. RESULTS:Among 23 patients in treatment group,five patients stopped treatment,including one case of text voluntarily,two of alimentary tract hemorrhage,one of massive congestion of skin and one of death suddenly.Among 26 patients in control group,one patient stopped and had test voluntarily.The level of plasma FIB in defibrase group was remarkably decreased after defibrase treatment as compared with the control group(P< 0.001),especially on the sixth day of medicine[(68.10±54.46) g/L in treatment group,(327.44 ±142.17) g/L in control group].Clinical neurological defect scale of stroke after 14-day treatment was not decreased significantly as compared with the control group(P >0.05).But there was no significant difference at the Barthel index after 14 days and three months.One and four patients'condition got worse in the treatment group and in the control group respectively after defibrase treatment. CONCLUSION:The study shows that defibrase is effective in decreasing plasma FIB and clinical neurological defect scale of stroke,and restrains acute cerebral infarction. However, there may be also an elevated risk of hemorrhage.