发病3～6h应用rt-PA静脉溶栓治疗急性脑梗死的有效性与安全性分析

Safety and Efficacy of Recombinant Tissue Plasminogen Activator in Ischemic Stroke

目的探讨重组组织型纤溶酶原激活物(rt-PA)静脉溶栓治疗扩大时间窗至6 h的疗效与安全性。方法试验组选择发病3 h内的患者(A组)16例,3～6 h的患者(B组)10例做为观察对象,分别给予rt-PA(0.7 mg/kg)静脉溶栓治疗;另选择发病在0～6 h内未选择溶栓治疗的患者为对照组(16例)。试验组与对照组均给予奥扎格雷钠80 mg,1次/d,静点;舒雪宁20 mL,1次/d,静点;阿司匹林0.1 g,1次/d,口服治疗。评定患者治疗前、治疗后2 h、24 h、7 d、30 d的NIHSS评分及治疗后90 d的Barthel指数评分。治疗前、治疗后1 d查头部CT,判定是否出血(根据影像学判定是梗死后还是实质出血)并记录各组出血和死亡例数。结果试验组与对照组各自NIHSS评分治疗前无差别(P>0.05),治疗后各时间点比较有统计学意义(P<0.05),试验A组与B组治疗前后各时间点差别无统计学意义(P>0.05);试验组与对照组B I指数治疗前与治疗后90d比较差异有统计学意义。A组出血2例,1例为梗死后出血,1例为脑实质出血,死亡1例;B组出血1例,为梗死后出血,死亡0例;对照组出血1例,1例为梗死后出血,死亡1例。结论用rt-PA溶栓治疗,扩大时间窗至6 h,疗效确切,未增加出血几率。因此,将溶栓时间窗扩大至6 h可行。

Objective To investigate the safety and efficacy of recombinant tissue plasminogen activator（rtPA） in acute ischemic stroke in the time windows between 3 hours and 6 hours of onset.Methods 42 patients with acute cerebral infarction were divided into rtPA group（26 case） and control group（16 case）.rtPA was administered in a dose of 0.7 mg/kg（maximum dose 50 mg）,with 10% intravenous injection and others as a constant infusion about a period of 60 minutes in rtPA group.Whereas the control group received only routine treatment.Hemorrhagic transformation were classified by using radiological criteria as follows： hemorrhagic infarction（HI）,parenchymal hemorrhage（PH）.The neurologic function deficits of patients with both groups were evaluated before and after the treatment.Results The efficacy in rtPAgroup was significantly higher than that in control group（P0.01）.Also,PH but not HI were more severe in rtPA-treated patients than in those receiving only routine treatment.Conclusion Thrombolytic therapy of intravenous rtPA can be performed efficaciously in patients with acute ischemic stroke in the time windows from 3 to 6 hours.The findings also suggest that rate of PH and death does not rise even we extend the time windows to 6 hours.