依达拉奉治疗缺血性卒中后认知功能障碍的随机对照研究

Randomized controlled study of edaravone injection in the treatment of patients with cognitive dysfunction after ischemic stroke

目的:评估依达拉奉注射液治疗缺血性卒中后认知功能障碍的临床疗效及安全性。方法:选取在72 h内发病的缺血性卒中后认知功能障碍患者180例,随机分为治疗组和对照组,各90例。入院后对照组给予常规治疗,治疗组在此基础上给予依达拉奉注射液静脉滴注。入院1 d、3 d、7 d、14 d、30 d、90 d时对两组患者进行简易智能状态量表(mini-mental state examination,MMSE)和蒙特利尔认知评估量表(montreal cognitive assessment,Mo CA)评分,评价临床疗效及安全性。结果:入院1 d、3 d、7 d时,两组患者MMSE、Mo CA评分无统计学差异(P>0.05)。入院14 d、30 d、90 d时,治疗组MMSE、Mo CA量表评分显著增加,与对照组比较,差异具有统计学意义(P<0.01)。治疗期间两组不良反应发生率无显著差异(P>0.05)。结论:依达拉奉注射液对缺血性卒中后认知功能障碍患者认知功能有一定改善作用,且安全。

Objective： To evaluate the clinical efficacy and safety of Edaravone Injection in the treatment of patients with cognitive dysfunction after ischemic stroke. Methods： A total of 180 patients with cognitive dysfunction after ischemic stroke who had attack within 72 h were selected and randomly divided into treatment group and control group,90 cases for each. Control group was treated with routine therapies,on which basis treatment group was added with intravenous injection of Edaravone Injection 30 mg. Mini-mental state examination（ MMSE） and montreal cognitive assessment（ Mo CA） 1 d,3 d,7 d,14 d,30 d and 90 d after hospitalization were compared between two groups,and clinical efficacy and safety were evaluated. Results： 1 d,3 d and 7 d after hospitalization,there was no significant difference between two groups in MMSE and Mo CA scores（ P〉0. 05）. 14 d,30 d and 90 d after hospitalization,MMSE and Mo CA scores increased evidently in treatment group,and the differences were significant when compared with control group（ P〈0. 01）. During treatment,there was no significant difference in the rate of adverse responses between two groups（ P〉0. 05）. Conclusion： Edaravone Injection is safe and effective and can significantly improve the cognitive function of patients with cognitive dysfunction after ischemic stroke.