尿激酶原和瑞替普酶治疗急性STEMI的疗效和安全性比较  

Efficacy and safety comparison between pro-urokinase and reteplase in the treatment of patients with acute ST elevation myocardial infarction

作　　者：张优[1] 王山 高传玉[1] 刘馨允 程倩倩[1] 张军慧[1] 齐大屯[1] 王宪沛[1] 朱中玉[1] 李牧蔚[1] 胡大一[3] Zhang You;Wang Shan;Gao Chuanyu;Liu Xinyun;Cheng Qianqian;Zhang Junhui;Qi Datun;Wang Xianpei;Zhu Zhongyu;Li Muwei;Hu Dayi(Henan Institute of Cardiovascular Epidemiology,Henan Key Laboratory for Prevention and Control of Coronary Heart Disease,Central China Fuwai Hospital of Zhengzhou University,Fuwai Central China Cardiovascular Hospital,Heart Center of Henan Provincial People′s Hospital,Zhengzhou 451464,China;Big Data Center for Cardiovascular Disease,Henan Key Laboratory for Prevention and Control of Coronary Heart Disease,Central China Fuwai Hospital of Zhengzhou University,Fuwai Central China Cardiovascular Hospital,Heart Center of Henan Provincial People′s Hospital,Zhengzhou 451464,China;Institute of Cardiovascular Disease,Peking University People′s Hospital,Beijing 100044,China)

机构地区：[1]郑州大学华中阜外医院,阜外华中心血管病医院,河南省人民医院心脏中心,河南省冠心病防治重点实验室河南省心血管流行病学研究中心,451464 [2]郑州大学华中阜外医院,阜外华中心血管病医院,河南省人民医院心脏中心,河南省冠心病防治重点实验室,河南省心血管病防治大数据中心,451464 [3]北京大学人民医院心血管病研究所,100044

出　　处：《中华心血管病杂志》2021年第9期866-872,共7页Chinese Journal of Cardiology

基　　金：河南省医学科技攻关普通项目 (201602210,201702218)。

摘　　要：目的:对比尿激酶原和瑞替普酶治疗急性ST段抬高型心肌梗死(STEMI)的临床疗效和安全性。方法:选择2016年9月至2018年8月河南STEMI注册登记研究在河南省66家医院总共入选的5 479例STEMI患者中接受静脉溶栓治疗的患者,根据患者接受溶栓药物情况,分为尿激酶原组( n=638)和瑞替普酶组( n=702)。收集患者的人口统计学资料、危险因素、既往病史、入院时信息、院内治疗情况等。比较两组临床再通率、住院病死率、住院死亡或放弃治疗、住院期间主要不良心脑血管事件(MACCE,包括死亡或放弃治疗、再发心肌梗死、心力衰竭或缺血性卒中)和溶栓后出血情况。出血采用欧美出血学术研究会(BARC)制定的出血分级。 结果:尿激酶原和瑞替普酶两组STEMI患者的年龄分别为61.8(53.2,69.0)和62.6(52.1,69.8)岁,女性分别占23%(147/638)和25.1%(176/702),差异均无统计学意义( P均>0.05)。尿激酶原和瑞替普酶两组患者的临床再通率相似[82.1%(524/638)比84.9%(596/702), P=0.172],两组发病至开始溶栓的时间分别为194.5(135.0,290.0)min和190.0(126.0,292.0)min,溶通的时间分别为95.0(67.5,120.0)min和95.0(71.0,119.0)min。两组以上时间指标的差异均无统计学意义( P均>0.05)。尿激酶原组和瑞替普酶组的住院病死率[5.5%(35/638)比5.1%(36/702), P=0.770],住院死亡或放弃治疗的比例[8.9%(57/638)比7.7%(54/702), P=0.410],住院MACCE的发生率[13.0%(83/638)比10.4%(73/702), P=0.137]相比差异均无统计学意义。然而,瑞替普酶组溶栓后出血的发生率明显高于尿激酶原组[7.8%(55/702)比3.8%(24/638), P=0.002]。进一步分析发现,瑞替普酶组口腔出血和BARC 1~2级出血的比例较尿激酶原组高,差异均有统计学意义( P均<0.001),而两组脑出血的发生率相似[0.6%(4/638)比0.4%(3/702), P=0.715]。采用广义线性混合模型调整基线资料后,两组疗效和安全性指标的比较结果与调整前一致。对于住院病死Objective To compare the efficacy and safety of pro-urokinase and reteplase in the treatment of patients with acute ST elevation myocardial infarction(STEMI).Methods STEMI patients,who received intravenous thrombolytic therapy in Henan STEMI registry between September 2016 and August 2018,were eligible for this study.A total of 5479 patients from 66 hospitals were screened and patients were divided into pro-urokinase group(n=638)and reteplase group(n=702)according to thrombolytic drugs.Data including patient demographics,risk factors,medical histories,patient information at admission,in-hospital treatment,time delays,and clinical events were collected.The clinical recanalization rate,in-hospital mortality,in-hospital death or treatment withdrawal,in-hospital main adverse cardiovascular and cerebrovascular events(MACCE,death or treatment withdrawal,congestive heart failure,reinfarction and ischemic stroke)and post-thrombolysis bleeding were compared between the two groups.Bleeding events were evaluated with Bleeding Academic Research Consortium(BARC)criteria.Results The median age[61.8(53.2,69.0)vs.62.6(52.1,69.8),P=0.833]or the proportion of women[23.0%(147/638)vs.25.1%(176/702),P=0.385]were similar between the pro-urokinase and reteplase groups.Clinical recanalization rates were similar between the pro-urokinase and reteplase groups[82.1%(524/638)vs.84.9%(596/702),P=0.172],and there was no difference in the median time from onset to thrombolysis[194.5(135.0,290.0)min vs.190(126.0,292.0)min,P=0.431]and the median recanalization time[95(67.5,120.0)min vs.95(71.0,119.0)min,P=0.561]between the two groups.There was no significant difference in in-hospital mortality[5.5%(35/638)vs.5.1%(36/702),P=0.770],in-hospital all-cause mortality,treatment withdrawal[8.9%(57/638)vs.7.7%(54/702),P=0.410],and in-hospital MACCE[13.0%(83/638)vs.10.4%(73/702),P=0.137]between pro-urokinase and reteplase groups.However,the incidence of post-thrombolysis bleeding was significantly higher in reteplase group than in pro-urokinase group[7.8%

关 键 词：心肌梗死 血栓溶解疗法 治疗结果 出血 

分 类 号：R542.22[医药卫生—心血管疾病]