超声增强溶栓治疗急性缺血性卒中的有效性和安全性

目的 评价超声增强溶栓治疗急性缺血性卒中的有效性和安全性.方法 将50例急性大脑中动脉闭塞性卒中患者随机分为超声增强溶栓组[(重组组织型纤溶酶原激活剂(recombinant tissue plasminogen activator,rtPA) +2 MHz超声监测2h]和标准溶栓组(单用rtPA).收集患者人口学特征、血管危险因素、治疗前血压、溶栓前脑缺血溶栓治疗(thrombolysis in brain ischemia,TIBI)血流分级、闭塞血管部位.主要转归指标为3个月时的转归良好率(定义为改良Rankin量表评分0～1分),次要终点为溶栓后2h的完全再通、持久性完全再通、有症状脑出血和病死率.结果 超声增强溶栓组治疗后3个月时的转归良好率显著高于标准溶栓组(64％对36％;x2=6.522,P=0.011);超声增强溶栓组持久性完全再通率(40％对8％;P =0.018)和完全再通率(48％对12％;P=0.012)均显著高于标准溶栓组,但再闭塞率(8％对12％;P=0.637)、有症状脑出血发生率(4％对4％;P=1.000)和病死率(4％对4％;P=1.000)均与标准溶栓组无显著差异.结论 超声增强溶栓能提高rtPA推注后2h内持久性完全再通率和完全再通率以及3个月时的转归良好率,而且不增高有症状脑出血和死亡风险,是一种安全有效的辅助溶栓治疗方法.

Effectiveness and safety of ultrasound-enhanced thrombolysis for acute ischemic stroke

Objective To evaluate the effectiveness and safety of ultrasound-enhanced thrombolysis for acute ischemic stroke.Methods Fifty stroke patients with acute middle cerebral artery occlusion were randomly divided into either a ultrasound-enhanced thrombolysis group (recombinant tissue-plasminogen activator [rtPA] +2 MHz ultrasound monitoring for 2 h) or a standard thrombolysis group (rtPA alone).The demographic characteristics,vascular risk factors,blood pressure before treatment,thrombolysis in brain ischemia (TIBI) grade before thrombosis,and vascular occlusion site of the patients were collected.The primary outcome endpoint was the good outcome rate (defined as the modified Rankin Scale score 0-1) at 3 months.The secondary outcome endpoints were complete recanalization at 2 h after thrombolysis,sustained complete recanalization,symptomatic intracerebral hemorrhage,and mortalitY.Results The good outcome rate of the ultrasound-enhanced thrombolysis group at 3 months after treatment was significantly higher than that of the standard thrombolysis group (64％ vs.36％;P=0.011).The sustained complete recanalization rate (40％ vs.8％;P =0.018) and complete recanalization rate (48％ vs.12％;P =0.012) of the ultrasound-enhanced thrombolysis group were significantly higher than those of the standard thrombolysis group,but there were no significant differences in the reocclusion rate (8％ vs.12％;P =0.637),incidence of symptomatic intracerebral hemorrhage (4％ vs.4％;P=1.000),and mortality (4％ vs.4％;P=1.000) compared with the standard thrombolysis group.Conclusions Ultrasoundenhanced thrombolysis can improve the sustained complete recanalization rate,complete recanalization rate,and good outcome rate after using rtPA within 2 h,and it does not increase the risks of symptomatic cerebral hemorrhage and death.It is a safe and effective adjunctive thrombolytic therapy.