冠状动脉内注射重组人TNK组织型纤溶酶原激活剂及腺苷注射液对急性ST段抬高型心肌梗死的疗效分析

Efficacy of recombinant human TNK tissue-type plasminogen activator and adenosine injection for acute ST-segment elevation myocardial infarction

目的评价急诊直接经皮冠脉介入(PPCI)治疗中经指引导管冠状动脉内注射重组人TNK组织型纤溶酶原激活剂及腺苷注射液对急性ST段抬高型心肌梗死(ASTEMI)的疗效。方法选择行急诊PPCI的ASTEMI患者,按照随机数字表法分为对照组和治疗组。对照组给予PPCI术常规治疗,若PPCI后梗死相关动脉(IRA)达到TIMI血流3级,则终止手术;若TIMI血流≤2级,则应用指引导管于冠脉内注射硝普钠、硝酸甘油、替罗非班改善冠状动脉微循环功能障碍(CMD),直到IRA达到TIMI血流3级。治疗组是在PPCI术常规治疗基础上,术中开通IRA后应用指引导管于冠状动脉内注射重组人TNK组织型纤溶酶原激活剂8 mg及腺苷注射液200μg,若IRA达到TIMI血流3级,则终止手术;若TIMI血流≤2级,则再次注射腺苷注射液改善CMD,直到IRA达到TIMI血流3级。观察指标,①心肌损伤指标:术前及术后12、24、36、48 h的血浆肌钙蛋白I(cTnI)、肌酸激酶同工酶(CK-MB)、N端B型脑钠肽(NT-pro BNP)水平;②心肌灌注指标:术后校正的TIMI帧数(CTFC)、术后90 min IRA导联ST段回落值(STR);③心肌缺血的程度:术后3 d行静息D-SPECT+腺苷负荷D-SPECT检查,观察心肌17节段分布下心肌灌注总积分、心肌缺血总节段数情况;④术后30 d的药物不良反应:皮下瘀斑、牙龈出血、消化道出血、泌尿系出血、血红蛋白下降、脑出血;⑤术后30 d的主要不良心血管事件(MACE):心脏死亡、心肌梗死、心力衰竭、靶血管再次血运重建情况。结果①心肌损伤指标:术前的cTnI、CK-MB、NT-pro BNP水平两组患者差异均无统计学意义(均P>0.05),心肌损伤指标治疗组均在术后12 h显著低于对照组(均P<0.05),之后均趋势下降,术后48 h两组差异均无统计学意义(均P>0.05)。②心肌灌注指标:治疗组术后CTFC均显著优于对照组(P<0.05)。应用秩和检验,治疗组术后90 min STR显著优于对照组(Z=2.437,P=0.014)。③心肌缺血的程度:两组患者在术后3 d行静息D-SPECT+腺苷负荷D-SPECT检查,在心肌17节段分布下心肌灌注总积分、心肌缺血总节段数情况,治疗组在负荷缺血节段数、静息灌注总评分、负荷灌注总评分均显著优于对照组(均P<0.05)。④术后30 d的药物不良反应:两组患者在皮下瘀斑、牙龈出血、消化道出血、泌尿系出血、血红蛋白下降、脑出血发生率均无统计学差异(P>0.05)。⑤术后30 d的MACE情况:两组患者在心脏死亡、心肌梗死、心力衰竭、靶血管再次血运重建情况以及总MACE发生率均无统计学差异(P>0.05)。结论急诊PPCI中经指引导管冠状动脉内注射重组人TNK组织型纤溶酶原激活剂及腺苷注射液对ASTEMI患者安全、有效,可改善心肌损伤、心肌灌注和心肌缺血。

Objective To evaluate the efficacy of recombinant human TNK tissue-type plasminogen activator and adenosine injection through guiding in treating acute ST-segment elevation myocardial infarction(ASTEMI)in e mergency primary percutaneous coronary intervention(PPCI).Methods Patients with ASTEMI who chose to receive emergency PPCI were randomly divided into control group and treatment group according to a digital random table method.The control group received conventional treatment of PPCI.If the infarct-related artery(IRA)reached TIMI flow grade 3 after PPCI,the operation was terminated.If TIMI flow was≤2,then a guide catheter to inject sodium nitroprusside,nitroglycerin,and tirofiban into the coronary artery to improve coronary microcirculation dysfunction(CMD)was applied until the IRA reached TIMI flow grade 3.The treatment group received the conventional treatment of PPCI,and after opening of the IRA during the operation,a guide catheter to inject recombinant human TNK tissue-type plasminogen activator(8 mg)and adenosine(200μg)into the coronary artery was applied.If the IRA reached TIMI flow grade 3,the operation was terminated.If TIMI flow was≤2,then adenosine injection was re-applied to improve CMD until the IRA reached TIMI flow grade 3.Observation indicators were as follows:①myocardial injury indicators:cardiac troponin I(cTnI),creatine kinase isoenzyme(CK-MB),and N-Terminal pro-brain natriuretic peptide(NT-pro BNP)levels before and 12 h,24 h,36 h,and 48 h after surgery;②myocardial perfusion indicators:corrected TIMI frame count(CTFC)after surgery and ST segment regression value(STR)at 90 min after surgery;③degree of myocardial ischemia:rest D-SPECT+adenosine stress D-SPECT examination at day 3 after surgery,observation of myocardial perfusion total score under 17 segment distribution and myocardial ischemia total segment number;④adverse drug reactions at day 30 after surgery:subcutaneous ecchymosis,gingival bleeding,gastrointestinal bleeding,urinary bleeding,hemoglobin decline,and cerebral hemorrhage;⑤major adverse cardiovascular events(MACE)at day 30 after surgery:cardiac death,myocardial infarction,heart failure,and target vessel revascularization.Results①Myocardial injury indicators:There was no significant difference in the levels of cTnI,CK-MB,or NT-pro BNP before surgery between the two groups(all P>0.05).The myocardial injury indicators were significantly lower in the treatment group than in the control group at 12 hours after surgery(all P<0.05),and then showed a downward trend.There was no significant difference between the two groups at 48 hours after surgery(all P>0.05).②Myocardial perfusion indicators:CTFC in the treatment group was significantly better than that in the control group after surgery(P<0.05).Using the rank sum test,the STR was significantly better in the treatment group than in the control group at 90 minutes after surgery(Z=2.437,P=0.014).③myocardial ischemia:Both groups underwent rest D-SPECT+adenosine stress D-SPECT examination at 3 days after surgery.Under the distribution of 17 myocardial segments,the total score of myocardial perfusion and the total number of myocardial ischemia segments in the treatment group were significantly better than those in the control group(all P<0.05).④Adverse drug reactions 30 days after surgery:There was no significant difference in subcutaneous ecchymosis,gingival bleeding,gastrointestinal bleeding,urinary system bleeding,hemoglobin decline,or cerebral hemorrhage between the two groups(P>0.05).⑤MACE 30 days after surgery:There was no significant difference in cardiac death,myocardial infarction,heart failure,target vessel revascularization,or total MACE between the two groups(P>0.05).Conclusion The intra-coronary injection of recombinant human TNK tissue-type plasminogen activator and adenosine injection through a guiding catheter in emergency PPCI is safe and effective for the treatment of ASTEMI.It can improve myocardial injury,myocardial perfusion,and myocardial ischemia.