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.