老年卒中患者阿替普酶和尿激酶静脉溶栓疗效和安全性:INTRECIS研究二次分析  

The efficacy and safety of intravenous alteplase and urokinase in elderly stroke patients:a secondary analysis of INTRECIS study

作　　者：宁乐馨 李宪东 陈会生 NING Yuexin;LI Xiandong;CHEN Huisheng(Department of Neurology,General Hospital of Northern Theater Command,Shenyang 110016,China)

机构地区：[1]北部战区总医院神经内科,沈阳110016 [2]沈阳药科大学研究生院

出　　处：《中国神经精神疾病杂志》2023年第2期76-84,共9页Chinese Journal of Nervous and Mental Diseases

基　　金：国家重点研发计划(编号:2017YFC1308200)。

摘　　要：目的 分析老年急性缺血性卒中患者发病4.5 h内接受阿替普酶(recombinant tissue plasminogen activator,r-tPA)和尿激酶(urokinase,UK)静脉溶栓的临床预后。方法 基于中国发病4.5 h内缺血性卒中的静脉溶栓登记研究(the intravenous trombolysis registry for Chinese ischaemic stroke within 4.5 h of onset,INTRECIS)队列,回顾性连续收集年龄≥75岁且接受基于指南推荐剂量的r-tPA和UK溶栓患者,分为r-tPA组和UK组,进一步使用倾向评分匹配(propensity score matching, PSM)1∶1匹配两组患者。根据患者是否合并房颤(atrial fibrillation,AF)分组,进一步分析房颤亚组和非房颤亚组。主要结局为90 d极好预后(mRS 0~1分),次要结局为良好预后(mRS 0~2分)、NIHSS评分变化(基线与1 d、14 d的差值),主要安全性结局为症状性颅内出血(symptomatic intracranial hemorrhage, sICH)发生率。结果共有692例患者符合标准纳入分析,包括r-tPA组509例[年龄79(77, 82)岁,男性占49.7%,NIHSS评分7 (4, 13)]和UK组183例[年龄78 (76, 81)岁,男性占54.1%,NIHSS评分7 (4, 12)]。多因素logistic回归结果表明,r-tPA和UK两组的主要结局、良好预后和sICH均没有统计学差异(P>0.05)。按照1∶1匹配147对患者,结果提示两组临床预后也相似,但r-tPA组死亡率低于UK组(2.0%vs. 9.5%,OR=0.20,95%CI:0.06~0.70,P=0.012)。合并房颤患者中r-tPA组106例,UK组39例,非房颤患者中r-tPA组376例,UK组132例。亚组分析两组疗效均相当(P>0.05),但房颤患者中r-tPA组死亡率更低(8.5%vs. 23.1%,OR=0.28,95%CI:0.08~0.92,P=0.036)。结论 在≥75岁老年急性缺血性卒中患者,4.5 h内给予r-tPA和UK显示了相似的疗效和安全性。Objective To analyse the efficacy and safety of elderly patients with acute ischemic stroke who underwent intravenous thrombolysis with alteplase(recombinant tissue plasminogen activator,r-tPA)and urokinase(UK)within 4.5 h of onset.Methods Based on the intravenous thrombolysis registry for Chinese ischemic stroke within 4.5 h of onset(INTRECIS)cohort,we retrospectively screened consecutive patients aged≥75 years who received intravenous thrombolysis with r-tPA or UK according to current guideline.The patients were divided into two groups:the r-tPA group and the UK group.The two groups were matched in a 1:1 ratio using propensity score matching(PSM).In addition,according to the presence or absence of atrial fibrillation(AF),each group was subdivided into two groups:AF group and non-AF group.The primary end point was excellent functional outcome(mRS 0-1)at 90 days.The secondary end points included good functional outcome(mRS 0-2)at 90 days and changes in NIHSS from baseline to 1 or 14 days.The primary safety outcome was symptomatic intracranial hemorrhage(sICH).Logistic regression analysis was used.Results Six hundred and ninety-two eligible patients were included in the analysis:509 in r-tPA group[median(Q_(L),Q_(U))age,79(77,82)years;men(49.7%);median(Q_(L),Q_(U))NIHSS score,7(4,13)]and 183 in UK group[median(Q_(L),Q_(U))age,78(76,81)years;men(54.1%);median(QL,QU)NIHSS score,7(4,11)].Multifactorial logistic regression results showed that there was no significant difference between the r-tPA and UK groups in terms of primary end point,secondary end points,and sICH(P>0.05).After PSM,294 patients(147/group)were further analyzed and similar results were achieved except lower mortality in the r-tPA group than in the UK group(2.0%vs.9.5%,OR=0.20,95%CI:0.06~0.70,P=0.012).Furthermore,subgroup analysis showed that there was no significant difference in primary and secondary end points between r-tPA and UK in AF group or non-AF group,except lower mortality in the r-tPA vs UK group in patients with atrial fibrillation(8.5

关 键 词：老年人 阿替普酶 尿激酶 急性缺血性卒中 静脉溶栓 心房颤动 预后 

分 类 号：R743.3[医药卫生—神经病学与精神病学]