瑞替普酶治疗急性ST段抬高型心肌梗死多中心临床试验分析  

Efficacy of thrombolytic therapy using reteplase in cases with acute ST-segment elevation myocardial infarction：results from a multicenter clinical trial

作　　者：刘馨允 张优[1] 李牧蔚[2] 王宪沛[2] 齐大屯[2] 郝培远[2] 张华[2] 程倩倩[1] 赵洛沙[3] 高传玉[2] 胡大一[4] 

机构地区：[1]河南省人民医院郑州大学人民医院河南省心血管流行病学研究中心,450003 [2]河南省人民医院郑州大学人民医院心内科,450003 [3]郑州大学第一附属医院心内科 [4]北京大学人民医院心内科

出　　处：《中华心血管病杂志》2016年第9期766-770,共5页Chinese Journal of Cardiology

摘　　要：目的 评价瑞替普酶经静脉溶栓治疗急性ST段抬高型心肌梗死的有效性及安全性.方法 2012年10月至2014年10月河南省73家医院参加本临床试验,1 226例急性ST段抬高型心肌梗死患者符合入排标准入选,接受瑞替普酶溶栓治疗,其中男性1 014例（82.7％）,女性212例（17.3％）,年龄59.0（51.0,66.0）岁,溶栓后通过监测临床症状、心电图、心肌酶及心律变化判断溶栓再通率,并观察住院期间心血管事件及出血事件的发生率,出血事件采用全球梗死相关动脉开通策略（GUSTO）分级.同时对发病距溶栓不同时间段（≤6 h和6～12 h）患者进行亚组分析,比较两组患者的血管再通率、心血管事件及出血事件发生率.结果 瑞替普酶溶栓后120 min血管再通率为89.3％（1 089/1 219）,平均再通时间为（59.96±26.86） min.发病距溶栓时间≤6h组的再通率90.3％（988/1 094）高于6～12h组的80.8％（101/125,P=0.001）;但两组住院期间病死率分别为2.6％（28/1 094）和0.8％（1/125）,出血率分别为5.9％ （64/1 094）和5.6％（7/125）,差异均无统计学意义（P均＞0.05）.患者溶栓后住院期间总病死率为2.4％（29/1 219）,血管未开通者的病死率为10.8％（14/130）,高于再通者的1.4％（15/1 089,P＜0.001）;溶栓后住院期间出血总发生率为5.8％（71/1 219）,GUSTO分级严重出血3例（0.2％）,均为脑出血,其中2例死亡.结论 瑞替普酶具有较高的梗死血管再通率及较低的心血管事件及出血发生率,是一种安全有效的溶栓药物.Objective To evaluate the efficacy and safety of intravenous thrombolytic therapy using reteplase in patients with acute ST-segment elevation myocardial infarction （STEMI）.Method A total of 73 hospitals from Henan province took part in this clinical trials during October 2012 to October 2014,1 226 cases （l 014 male （82.7％）,mean age 59.0 （51.0,66.0） years） with acute STEMI received reteplase as thrombolytic agent.Reperfusion rate was judged according to the clinical symptoms,electrocardiogram,myocardial enzymes and heart rhythm,and the rate of cardiovascular events and bleeding events during hospitalization was also observed.Bleeding events were evaluated with global utilization of streptokinase and tissues plasminogen activator for occluded coronary arteries （GUSTO） criteria.Subgroup analysis was performed to compare the effects of various thrombolysis timing （time from onset to thrombolysis≤6 h or 6-12 h） on reperfusion rate,cardiovascular events and bleeding events rate.Results The reperfusion rate was 89.3％ （1 089/1 219） at 120 minutes after the thrombolysis,average recanalization time was （59.96 ± 26.86） minutes.The reperfusion rate of ≤6 h thrombolysis group was significantly higher than in 6-12 hours group （90.3％ （988/1094） vs.80.8％ （101/125）,P =O.001）,while in-hospital mortality （2.6％ （28/1 094） and 0.8％ （1/125）,P =0.352） and rate of bleeding （5.9％ （64/1 094） and 5.6％ （7/125）,P =0.910） were similar between the two groups.The total in-hospital mortality after thrombolysis was 2.4％ （29/1219）,which was significantly higher in failed recanalization group than in recanalization group （10.8％ （14/130） vs.1.4％ （15/1089）,P ＜ 0.001）.The total rate of bleeding after thrombolysis was 5.8％ （71/1219）,there were 3 severe bleeding cases according to GUSTO classification （0.2％）,all of them were cerebral hemorrhage,and 2 out of 3 cases died.Conclusions Reteplase use is related to high recanalization r

关 键 词：心肌梗死 血栓溶解疗法 治疗结果 

分 类 号：R542.22[医药卫生—心血管疾病]