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[急性ST段抬高型心肌梗死患者治疗中尿激酶原与瑞替普酶的疗效及安全性比较]

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

作者信息

Zhang Y, Wang S, Gao C Y, Liu X Y, Cheng Q Q, Zhang J H, Qi D D, Wang X P, Zhu Z Y, Li M W, Hu D Y

机构信息

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.

出版信息

Zhonghua Xin Xue Guan Bing Za Zhi. 2021 Sep 24;49(9):866-872. doi: 10.3760/cma.j.cn112148-20201103-00877.

Abstract

To compare the efficacy and safety of pro-urokinase and reteplase in the treatment of patients with acute ST elevation myocardial infarction (STEMI). 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 (=638) and reteplase group (=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. The median age [61.8 (53.2, 69.0) vs. 62.6 (52.1, 69.8), =0.833] or the proportion of women [23.0% (147/638) vs. 25.1% (176/702), =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), =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, =0.431] and the median recanalization time [95 (67.5,120.0) min vs. 95 (71.0,119.0) min, =0.561] between the two groups. There was no significant difference in in-hospital mortality [5.5% (35/638) vs. 5.1% (36/702), =0.770], in-hospital all-cause mortality, treatment withdrawal [8.9% (57/638) vs.7.7% (54/702), =0.410], and in-hospital MACCE [13.0% (83/638) vs. 10.4% (73/702), =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% (55/702) vs. 3.8% (24/638), =0.002]. Further analysis found that the incidence of oral bleeding and the BARC grades 1-2 bleeding were significantly higher in reteplase group than in pro-urokinase group, whereas the incidence of cerebral hemorrhage was similar between the two groups [0.6% (4/638) vs. 0.4% (3/702), =0.715]. The comparison of efficacy and safety outcomes between the two groups after adjusting for baseline characteristics using general linear mixed models was consistent with those before the adjustment. There was no significant difference in in-hospital mortality, in-hospital death or treatment withdrawal, in-hospital MACCE after adjusting for baseline characteristics and post-thrombolysis bleeding between the two groups. Pro-urokinase and reteplase have similar clinical efficacy in the treatment of STEMI. In terms of safety, the incidence of cerebral hemorrhage is similar, while the incidence of BARC grades 1-2 bleeding and oral bleeding is higher in reteplase group than in pro-urokinase group, which has no impact on in-hospital outcomes.

摘要

比较尿激酶原和瑞替普酶治疗急性ST段抬高型心肌梗死(STEMI)患者的疗效和安全性。2016年9月至2018年8月在河南STEMI注册研究中接受静脉溶栓治疗的STEMI患者符合本研究条件。共筛选了来自66家医院的5479例患者,并根据溶栓药物将患者分为尿激酶原组(n = 638)和瑞替普酶组(n = 702)。收集了包括患者人口统计学、危险因素、病史、入院时患者信息、住院治疗、时间延迟和临床事件等数据。比较两组的临床再通率、住院死亡率、住院死亡或治疗退出、住院主要心血管和脑血管不良事件(MACCE,死亡或治疗退出、充血性心力衰竭、再梗死和缺血性卒中)以及溶栓后出血情况。出血事件采用出血学术研究联盟(BARC)标准进行评估。尿激酶原组和瑞替普酶组的中位年龄[61.8(53.2,69.0)对62.6(52.1,69.8),P = 0.833]或女性比例[23.0%(147/638)对25.1%(176/702),P = 0.385]相似。尿激酶原组和瑞替普酶组的临床再通率相似[82.1%(524/638)对84.9%(596/702),P = 0.172],两组从发病到溶栓的中位时间[194.5(135.0,290.0)分钟对190(126.0,292.0)分钟,P = 0.431]和中位再通时间[95(67.5,120.0)分钟对95(71.0,119.0)分钟,P = 0.561]无差异。尿激酶原组和瑞替普酶组在住院死亡率[5.5%(35/638)对5.1%(36/702),P = 0.770]、住院全因死亡率、治疗退出[8.9%(57/638)对7.7%(54/702),P = 0.410]以及住院MACCE[13.0%(83/638)对10.4%(73/702),P = 0.137]方面无显著差异。然而,瑞替普酶组溶栓后出血的发生率显著高于尿激酶原组[7.8%(55/702)对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级出血的发生率显著高于尿激酶原组,而两组脑出血的发生率相似[0.6%(4/638)对0.4%(3/702),P = 0.715]。使用一般线性混合模型调整基线特征后,两组疗效和安全性结果的比较与调整前一致。调整基线特征和溶栓后出血情况后,两组在住院死亡率、住院死亡或治疗退出、住院MACCE方面无显著差异。尿激酶原和瑞替普酶在治疗STEMI方面具有相似的临床疗效。在安全性方面,脑出血的发生率相似,而瑞替普酶组BARC 1 - 2级出血和口腔出血的发生率高于尿激酶原组,但这对住院结局无影响。

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