Reassessment of defibrase in treatment of cerebral infarction / 重庆医科大学学报

ABSTRACT

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