rt-PA静脉溶栓联合丁苯酞治疗急性缺血性脑卒中的临床疗效及安全性研究

Clinical efficacy and safety of rt-PA intravenous thrombolysis combined with butylphthalide in the treatment of acute ischemic stroke

目的研究丁苯酞联合重组组织型纤溶酶原激活剂(rt-PA)静脉溶栓治疗急性缺血性脑卒中(AIS)的安全性及临床疗效。方法 130例AIS患者,按1∶1的比例随机分为观察组和对照组,每组65例。两组均给予基础治疗,观察组给予丁苯酞联合rt-PA静脉溶栓治疗,对照组给予rt-PA静脉溶栓治疗。比较两组基本资料[年龄、男性占比、美国国立卫生研究院卒中量表(NIHSS)评分及高血压病史、糖尿病史、高脂血症史、冠心病史],治疗前后NIHSS评分与改良Rankin量表(mRs)评分,不良事件(颅内出血、死亡、肝功能损害、肾功能损害)发生情况, 3个月后良好结局比例。结果 130例患者中有11例(观察组5例,对照组6例)因中途退出或脱落等各种原因未能完成,最终纳入统计的为119例患者,其中观察组60例,对照组59例。两组年龄、男性占比、NIHSS评分及高血压病史、糖尿病史、高脂血症史、冠心病史占比比较差异无统计学意义(P>0.05)。治疗前、治疗后7 d和治疗后3个月,两组患者的NIHSS评分与mRs评分比较差异无统计学意义(P>0.05)。两组患者颅内出血、死亡、肝功能损害、肾功能损害发生率比较差异均无统计学意义(P>0.05)。观察组患者3个月后良好结局比例为61.67%(37/60),高于对照组的40.68%(24/59),差异具有统计学意义(P<0.05)。结论丁苯酞联合rt-PA静脉溶栓治疗AIS安全性好,能进一步改善AIS患者的预后。

Objective To study the safety and clinical efficacy of recombinant tissue plasminogen activator(rt-PA)intravenous thrombolysis combined with butylphthalide in the treatment of acute ischemic stroke(AIS).Methods A total of 130 AIS patients were randomly divided into observation group and control group,with 65 cases in each group.Both groups received basic therapy.The observation group was treated with butylphthalide and rt-PA intravenous thrombolysis,and the control group was treated with rt-PA intravenous thrombolysis.The basic data[age,males ratio,National Institutes of Health stroke scale(NIHSS)score,history of hypertension,history of diabetes,history of hyperlipidemia,history of coronary heart disease],NIHSS score and modified Rankin scale(mRs)score before and after treatment,occurrence of adverse events(intracranial hemorrhage,death,liver damage,kidney damage),and proportion of good outcomes after 3 months of treatment were compared between the two groups.Results Among the 130 patients,11 patients(5 cases in the observation group and 6 cases in the control group)failed to complete due to various reasons such as withdrawal.Finally,119 patients were included in the statistics,including 60 cases in the observation group and 59 cases in the control group.There was no statistically significant difference in age,male ratio,NIHSS score,history of hypertension,history of diabetes,history of hyperlipidemia,history of coronary heart disease between the two groups(P>0.05).Before treatment,7 d after treatment,and 3 months after treatment,there was no statistically significant difference in NIHSS score and mRs score between the two groups(P>0.05).There was no statistically significant difference in incidence of intracranial hemorrhage,death,liver damage,kidney damage between the two groups(P>0.05).The proportion of good outcomes of the observation group after 3 months of treatment was 61.67%(37/60),which was higher than 40.68%(24/59)of the control group,and the difference was statistically significant(P<0.05).Conclusion Combination of butylphthalide and rt-PA intravenous thrombolysis is safe in the treatment of AIS,and can further improve the prognosis of AIS patients.