不同剂量rt-PA治疗急性轻型缺血性脑卒中的临床疗效与安全性分析

Comparison of Clinical Efficacy and Safety of Different Doses Recombinant Tissue Plasminogen Activator in the Treatment of Acute Minor Ischemic Stroke

目的探讨不同剂量重组组织型纤溶酶原激活剂(rt-PA)治疗急性轻型缺血性脑卒中(MIS)的临床疗效与安全性。方法选取2017年12月至2019年11月收治的150例发病时间≤4.5 h的MIS患者,接受rt-PA静脉溶栓患者根据剂量分为低剂量(rt-PA 0.6 mg·kg^(-1))组(47例)和标准剂量(rt-PA0.9mg·kg^(-1))组(50例),另53例未溶栓患者纳入双抗治疗组。以治疗后90 d改良Rankin量表(mRS)评分0~1分比例为主要终点指标、治疗后24 h、7 d的NIHSS和MESSS评分变化为次要终点指标;安全性终点指标包括治疗后36 h内的全身出血发生率、治疗后延续随访观察90 d期间脑脑卒中复发率和总病死率。结果治疗90 d后低剂量组mRS评分0~1分比例与标准剂量组比较,差异无统计学意义(P>0.05),且均高于双抗组,差异有统计学意义(P<0.05)。治疗24 h、7 d后低剂量组与标准剂量组NIHSS和MESSS评分比较,差异无统计学意义(P>0.05),且均低于同时间点的双抗组,差异有统计学意义(P<0.05)。3组患者治疗后延续随访观察90 d期间,低剂量组脑卒中复发率低于双抗组,高于标准剂量组,但组间差异无统计学意义(P>0.05);低剂量组病死率低于标准剂量组,高于双抗组,组间比较差异无统计学意义(P>0.05);低剂量组治疗后36 h内全身出血并发症发生率低于标准剂量组,高于双抗组,组间比较差异无统计学意义(P>0.05)。结论 rt-PA溶栓治疗发病≤4.5 h MIS患者临床疗效及安全性较好,90 d良好预后优于双抗治疗,同时复发率、病死率及全身出血并发症发生率较双抗治疗低;rt-PA低剂量的临床疗效与标准剂量相当,且相关出血并发症发生率可能更低,值得临床推广。

Aim To investigate the clinical efficacy and safety of different doses of recombinant tissue plasminogen activator(rt-PA) in the treatment of acute minor ischemic stroke(MIS). Method 150 patients with acute mild stroke who were admitted to our hospital from December 2017 to November 2019 were selected and divided into a low-dose rt-PA group, a standard-dose rt-PA group and a DAPT group by random number table method. There were 47 patients in the low-dose rt-PA group, 50 patients in the standard-dose rt-PA group, and 53 patients in the DAPT group. For the low-dose group, intravenous drip of rt-PA(0.6 mg·kg^(-1)) was given;for the standard-dose group, intravenous drip of rt-PA(0.9 mg·kg^(-1)) was given;for the DAPT group, after oral administration of aspirin enteric-coated tablets(100 mg·d^(-1)) and clopidogrel tablets(75 mg·d^(-1)) for 21 days, a single antiplatelet drug treatment was given until the 90 th day(aspirin enteric-coated tablets(100 mg·d^(-1)) or clopidogrel(75 mg·d^(-1)). The 0-1 scale of the modified Rankin scale(mRS) score 90 d after the treatment was used as the primary end point, and the changes in NIHSS and MESSS scores 24 h and 7 d after the treatment were used as the secondary end points. The safety end points included the incidence of systemic bleeding within 36 h after the treatment, the recurrence rate of stroke and the total mortality during the 90 d follow-up after the treatment. Results ① After 90 d of the treatment, there was no statistically significant difference in the proportion of patients with mRS score 0-1 between the low-dose group and the standard dose group(P>0.05), both of which were higher than the dual-dose group(P<0.05). ② After 24 h and 7 d of the treatment, there were no statistically significant differences in NIHSS and MESSS scores between the low-dose thrombolytic group and the standard dose thrombolytic group(P>0.05), and both of them were lower than the doubleantibody group at the same time point(P<0.05). ③ The recurrence rate of stroke in the low-dose group was lower than that in the dual-dose group and higher than that in the standard dose group during the 90 d follow-up period after the treatment, but the difference was not statistically significant(P>0.05). The mortality rate of the low-dose group was lower than that of the standard dose group and higher than that of the dual-dose group, but there was no statistically significant difference among the three groups(P<0.05). The incidence of systemic bleeding complications in the low-dose group was lower than the standard dose group and higher than the dual-dose group within 36 h after the treatment, but there was no statistically significant difference among the three groups(P<0.05). Conclusion For patients with acute MIS within 4.5 h of onset, rt-PA thrombolytic therapy has good clinical efficacy and safety. In addition, the total effective rate of the low-dose rt-PA thrombolytic group(0.6 mg·kg^(-1)) is similar to that of the standard dose rt-PA thrombolytic group(0.9 mg·kg^(-1)), and the incidence of related complications may be lower.