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 10IU or placebo 250ml of normal saline within 24 hours of stroke onset. Subsequent infusions of defibrase 5IU or placebo were given on the third and the fifth day respectively. The end points included Clinically Neurological Deficits Scale of Stroke

Barthel Index in 3 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 events and other adverse reactions 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 between two groups. 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 being used at present for acute cerebral infarction.