依达拉奉治疗急性脑梗死的随机双盲对照试验

RANDOMIZED CONTROLLED TRIAL OF EDARAVONE INJECTION IN THE TREATMENT OF ACUTE CEREBRAL INFARCTION

[目的]评价依达拉奉治疗急性颈内动脉系统脑梗死的效果及其安全性。[方法]随机、双盲、安慰剂平行对照临床研究。凡符合入选标准的病人随机分为两组:治疗组22例静脉滴注依达拉奉30mg bid以及维脑路通注射液200mg qd,口服肠溶阿司匹林100mg qd,共14d;对照组22例静脉滴注安慰剂30mg bid以及维脑路通注射液200mg qd,口服肠溶阿司匹林100mg qd,共14d;采用欧洲脑卒中量表(ESS)和Barthel指数(BI)评价神经功能恢复状况。[结果]治疗组受试者治疗后的ESS量表评分改善和Barthel指数改善情况优于对照组,两者比较差异有统计学意义(P﹤0.01),两组均未发生严重不良反应。[结论]依达拉奉治疗急性颈内动脉系统脑梗死所致的神经功能缺损效果及安全性良好。

[Objective] To evaluate the efficacy and safety of Edaravone injection in the treatment of acute cerebral infarction in the vascular distribution of the internal carotid artery within 48 hours from the onset. [Methods] Patients consistent with the inclusion criteria were asked to participate in the trial. They were randomized in a double-blind manner to receive intravenously either Edaravone injection 30 mg twice per day （study group; 22 cases） or placebo 30 mg twice per day （control group; 22 cases） .Patients in each group were given Venoruton injection 200 mg once per day intravenously and Aspirin 100 mg once per day orally. The duration of treatment was 14 days for both groups. The European Stroke Scale （ESS） and Barthel Index （BI） were used to evaluate the recovery of neurological functions. [Results] ESS and BI scores increased significantly in study group compared with that of control group after treatment. No serious adverse drug reaction were found in these two groups. [Conclusion] Edaravone injection is effective and relatively safe in the treatment of acute cerebral infarction in the vascular distribution of the internal carotid artery.