摘要
目的 评价国产降纤酶治疗急性脑梗死的疗效及安全性。方法 采用前瞻性随机双盲对照方法 ,2 8例患者随机分两组。治疗中监测纤维蛋白原水平、凝血酶原时间及凝血酶原活动度。评估指标包括临床神经功能缺损程度评分、Barthel指数、安全性及治疗一年后患者卒中复发率。结果 ( 1)治疗 14d临床神经功能缺损程度评分和Barthel指数 ,降纤酶组与对照组相比有显著性差异 (P <0 0 5 ) ,1年后两组卒中复发率有显著性差异。降纤酶组没有增加出血事件及肝肾功能损害等不良反应。 ( 2 )用药后降纤酶组与同期对照组纤维蛋白原、凝血酶原时间及凝血酶原活动度有显著性差异 (P <0 0 5 )。结论 降纤酶是降解纤维蛋白原安全有效的药物 。
Objective To assess the safety and efficacy of defibrase in treatment of acute cerebral infarction.Methods 28 cases with acute cerebral infarction were randomly allocated to defibrase group or placebo controlled group,end points include Clinically Neurological Deficits Scale of stroke,Barthel Index,recurring rate of stroke in 12 months,the level of plasma fibrinogen,prothrombin time and prothrombin activity.Results (1)There was statistically significant difference at neuroglical dificits scale of stroke and Barthel index between defibrase group and placebo group after treatment 14 days later,the bleeding event and other adverse reaction was not increased as compared with placebo group,and recurring rat at 12 months between two groups had significant difference.(2)There was statistically significant difference at plasma fibrinogen between defibrase group and placebo group.Conclusion This study showed that defibrase appearsed safe and effective in degrading plasma fibrinogen,the defibrase should improved the clinically neurogical deficits scale of stroke and barthel index after treatment 14 days.
出处
《河南实用神经疾病杂志》
2004年第2期3-5,共3页
Henan Journal of Practical Nervous Diseases
