依达拉奉右莰醇联合阿替普酶治疗急性缺血性脑卒中疗效的随机对照试验

Efficacy of edaravone dexborneol combined with alteplase in the treatmentof acute ischemic stroke:a randomized controlled trial

目的探讨依达拉奉右莰醇联合阿替普酶静脉溶栓治疗急性缺血性脑卒中(AIS)的临床疗效。方法选取2021年1月7日—2022年12月31日接受阿替普酶静脉溶栓的AIS患者,随机分为观察组和对照组,对照组按AIS指南进行标准治疗,观察组在对照组治疗基础上,于溶栓后至发病48 h内给予依达拉奉右莰醇注射液。比较2组患者溶栓后7 d和出院时美国国立卫生研究院卒中量表(NIHSS)评分、溶栓后7 d与溶栓前NIHSS评分差值,以及治疗3个月后的全因死亡率和不良预后比例。结果232例AIS患者被随机分配到观察组(116例)和对照组(116例)。2组患者溶栓后7 d的NIHSS评分、溶栓后7 d与溶栓前NIHSS评分差值比较,差异均无统计学意义(P>0.05)。观察组患者3个月后不良预后比例明显低于对照组[12.1%vs.28.4%;OR=0.252,95%CI(0.105,0.602),P=0.002]。结论依达拉奉右莰醇可提高阿替普酶静脉溶栓治疗AIS的疗效,改善患者3个月后的临床预后。

Objective To explore the clinical efficacy of edaravone dexborneol combined with intravenous thrombolysis with alteplase,in the treatment of patients with acute ischemic stroke(AIS).Methods The patients with AIS undergoing intravenous thrombolysis with alteplase between January 7,2021 and December 31,2022 were enrolled and randomly divided into observation group and control group.The control group was treated with standard treatment according to the AIS guidelines,and the observation group was treated with edaravone dexborneol injection within 48 hours from thrombolysis to the onset of the disease on the basis of the treatment in the control group.7-day post-thrombolysis National Institutes of Health stroke scale(NIHSS),discharged NIHSS,difference between 7-day post-thrombolysis NIHSS and pre-thrombolysis NIHSS,and 3-month all-cause mortality and 3-month poor prognosis ratio were compared between the two groups.Results A total of 232 patients with AIS were randomly allocated to the observation group(n=116)and the control group(n=116).The differences between the two groups were not statistically significant for 7-day post-thrombolysis NIHSS and difference between 7-day post-thrombolysis NIHSS and pre-thrombolysis NIHSS(P>0.05),and there were statistical differences in distribution of the discharged NIHSS score between the observation group and control group[2.0(0,3.0)vs.2.0(1.0,5.0),P<0.05].The 3-month poor prognosis ratio was significantly lower in the observation group than in the control group(12.1%vs.28.4%;OR=0.252,95%CI 0.105 to 0.602,P=0.002).Conclusion Edaravone dexborneol enhances the efficacy of AIS undergoing intravenous thrombolysis with alteplase and improves the 3-month outcome of patients.