Reassessment of Defibrase in the treatment of Acute Cerebral lnfarction
Objective: to assess the safety and efficacy of defibrase in the treatment of acute cerebral iinfarction by a large sample, multicerter, randomized, double-blind, and placebo-controlled clinical trial Methods: 2244 cases with acute infarction in 41centers were randomly allocated to receive either an imitial intrdvcnons infusion of defibrase 10Bu or placebo in 250ml of normal saline within 24 hours of stroke onset Subsequent in fusions of defibrase 5Bu or placebo on the third and fifth days respectively. This treatment protocol was determined on the bases of the pretrial of 114 patientsin 8 centers The end points fincluded Climcally Neurological De ficits Scale of Stroke, Barthel Index, Mortality, adverse reaction and the level of plasma fibrinogen (FIB)Results: (1) the level of plasma FIB in defibrase group was reurarkably declied after treatment whereas the bleeding evcnts and other adverse reaction was not incteased in comparison with control group There was difference in the imtcnsity of degrading plasna FIB between defibrase from Agkistrodon halys and that frorn Agkistrodon acutns. (2) Theare were no statistically significant differences at Clinically Neurological Deficits Scale of Stroke at 2 weeks, Barthel Index sc ore and mortality at 3 months between two groups. Conclutions: This study showed that defibrase atppears safe and effective in degading plastua FIB.The dose of defibrase should regnlate propcrly according to preparations from diffcrent snake venom .This study did not show that clinical efficacy of defibrase was supetior to those present used medicines for acute cerebral infarction It is necessary to further study about the relations between its clinical efficacy and the dose,protocol of drug administration and indication.
clinical efficacy、acute cerebral infarction、Neurological Deficits、drug administration、plasma fibrinogen、clinical trial、large sample、snake venom
8
R5 ;R28
2005-07-07（万方平台首次上网日期，不代表论文的发表时间）
共1页
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