瑞替普酶与重组链激酶治疗急性心肌梗死的对照研究

Randomized controlled trial of reteplase with recombinant streptokinase in the venous thrombolytic therapy for acute myocardial infarction

目的观察临床使用瑞替普酶与重组链激酶静脉溶栓治疗急性心肌梗死(AMI)的梗死相关血管开通率、开通时间及不良反应。方法采用随机、双盲、对照、前瞻性研究方法。选取60例AMI患者,根据随机数字表法随机分为瑞替普酶组(30例)及重组链激酶组(30例)。瑞替普酶组给予瑞替普酶20mU,分2次,每次10mU,间隔30min快速静脉推注;重组链激酶组予重组链激酶150×104U溶于5%葡萄糖100ml内60min内静脉滴注。通过临床间接指标和冠状动脉造影观察血管再通率及血管开通时间,并记录不良反应。血管开通率由临床间接指标评价,随后由急诊或补救性经皮冠状动脉介入术(PCI)前冠状动脉造影证实。血管开通时间为从静脉给药结束至ST段回落≥50%时间。结果经冠状动脉造影术证实瑞替普酶组梗死相关血管开通时间明显短于重组链激酶组〔(0.94±0.16)vs(1.20±0.29)h,P<0.05〕,血管开通率略高于重组链激酶组(90.0%vs76.7%,P>0.05),轻度出血率略低于重组链激酶组(6.7%vs10.0%,P>0.05)。结论瑞替普酶溶栓治疗AMI,在缩短血管开通时间上优于重组链激酶,在增加血管开通率、减少出血率上较重组链激酶有更大获益趋势,发病6h内的AMI患者可以首选。

Objective To observe the patency rate and patency time of the infarct-related artery （IRA） and sideeffects of reteplase and recombinant streptokinase in the thrombolytic therapy for acute myocardial infarction（AMI）.Methods The randomized,double-blind,controlled and prospective study was performed.A total of 60 patients with AMI were randomly divided into reteplase group（R group,n=30） and recombinant streptokinase group（S group,n=30）.In R group,reteplase was used with double bolus administration：10 mU at first,subsequently 10mU after 30 min.In S group,recombinant streptokinase of 150 × 104U in 5% glucose solution was administered by intravenous infusion for 60 min.The patency time and patency rates of IRA and adverse effects in two groups were observed.The patency rate was assessed based on clinical indirect indexes and subsequently confirmed by coronary angiography before primary or rescue PCI.The patency time was defined as the time from ending venous medication to ST-segment resolution ≥50%.Results The patency time of IRA in R group was obviously shorter than that in S group 〔（0.94 ± 0.16） vs （1.20 ± 0.29） h,P 〈 0.05） 〕.The patency rate of IRA in R group was slightly higher than that in S group （90.0% vs 76.7%,P 〉 0.05）.The rate of mild bleeding in R group was slightly lower than that in S group （6.7% vs 10.0%,P 〉 0.05）.Conclusions In venous thrombolytic therapy of AMI,reteplase is superior to recombinant streptokinase on shortening patency time of IRA,and it has a tendency of acquiring better fit on increasing patency rate of IRA and decreasing bleeding rate compared with recombinant streptokinase.Reteplase can serve as the first selection within six hours of symptom onset of AMI.