直接经皮冠状动脉介入治疗术前预注射替罗非班对冠状动脉前向血流和心肌组织灌注的影响及其安全性

目的探讨直接经皮冠状动脉介入治疗(PPCI)术前预注射替罗非班对急性ST段抬高心肌梗死(STEMI)患者冠状动脉前向血流和心肌组织灌注的影响及安全性。方法研究对象为2010年1月至2011年12月因STEMI在北京安贞医院住院拟行PPCI术的患者,采用随机数字表法分为替罗非班组和对照组。2组患者冠状动脉造影术前均嚼服阿司匹林300 mg及氯吡格雷300～600 mg,术中均给予标准剂量肝素(100 U/kg)。替罗非班组造影后通过指引导管在3 min内缓慢推注替罗非班10μg/kg,随后用微量注射泵以0.15μg/(kg·min)的速度持续静脉输注36 h;对照组未经指引导管注射任何药物。PPCI术后2组均给予常规抗凝处理。收集并比较2组患者的一般资料、冠状动脉造影特征、临床预后及轻、中、重度出血、血小板减少发生率及院内病死率,分析冠状动脉内预先应用替罗非班的有效性与安全性。结果纳入研究的患者共737例。替罗非班组324例,男性233例,女性91例,平均年龄(62±10)岁;对照组413例,男性301例,女性112例,平均年龄(60±11)岁。2组患者性别、年龄分布、合并高血压病、糖尿病、吸烟情况、前壁心肌梗死占比、发病至就诊时间、术前心肌梗死溶栓(TIMI)试验0级血流者占比、PPCI术中血栓抽吸导管使用率、中度出血及血小板减少发生率的差异均无统计学意义(均P>0.05)。2组患者均未发生重度出血。替罗非班组患者术后TIMI 3级血流者占比、心肌呈色分级3级者占比、ST段回落率和轻度出血发生率高于对照组[分别为96.0%(311/324)比91.3%(377/413),92.3%(299/324)比87.2%(360/413),91.4%(296/324)比85.7%(354/413),6.8%(22/324)比2.7%(11/413)],院内病死率低于对照组[0.9%(3/324)比3.1%(13/413)],差异均有统计学意义(均P<0.05)。Logistic回归分析表明,冠状动脉内预注射替罗非班是术后TIMI 3级血流独立影响因素(OR=1.947,95%:1.156～4.022,P=0.036)。结论 PPCI术前预注射替罗非班能改善STEMI患者冠状动脉前向血流及心肌组织灌注,可增加轻度出血发生率,但不需要临床干预,具有较好的疗效与安全性。

Effects of pre-injection of tirofiban before primary percutaneous coronary intervention on the coronary forward blood flow and myocardial tissue perfusion as well as its safety

Objective To study the effects of intracoronary pre-injection of tirofiban before primary percutaneous coronary intervention （PPCI） on coronary forward blood flow and myocardial tissue perfusion in patients with acute ST-segment elevation myocardial infarction（STEMI）.Methods The STEMI patients who were scheduled for PPCI from January 2010 to December 2011 in Beijing Anzhen Hospital were enrolled in the study as the subjects and were divided into the tirofiban group and the control group by random number table.The patients in both groups chewed aspirin 300mg and clopidogrel 300-600 mg before coronary angiography,and received heparin at the standard dosage （100 U/kg） during the operation.The patients in the tirofiban group were given a slow Ⅳ push of tirofiban（10 μg/kg）within three minutes through a guiding catheter after coronary angiography,followed by a continuous Ⅳ infusion of tirofiban 0.15 μg/kg per minute for 36 hours via a mini pump,while the patients in the control group did not received any drugs.The patients in both groups received the same routine anticoagulant treatment after PPCI.The data including baseline characteristics of patients features of coronary angiogram,clinical prognosis,incidences of mild,moderate and severe hemorrhage,thrombocytopenia and in hospital mortality were collected and compared between the 2 groups.The efficacy and safety of intracoronary pre-injection of tirofiban were analyzed.Results A total of 737 patients enrolled in the study.There were 324 patiens in the tirofiban group comprising 233 male and 91 female with average age of （62 ± 10）years.There were 413 patients in the control group comprising 301 male and 112 female with average age of （60 ± 11） years.The differences in sex and age distribution,cases complicated with hypertension and diabetes mellitus,smoking status,percentage of anterior myocardial infarction,the time from disease onset to treatment,the percentage of patients with thrombolysis in myocardial infarction （TIMI） grade 0 flow before PPCI,utilization rate of thrombus aspiration catheter during PPCI,incidence of moderate hemorrhage and thrombocytopenia between the 2 groups were not statistically significant （all P 〉 0.05）.No severe hemorrhage occurred in both groups.The percentage of patients with TIMI grade 3 flow after PPCI,percentage of grade 3 myocardial blush grade （MBG）,rate of ST-segment decline and rate of mild hemorrhage were significantly higher in the tirofiban group than in the control group,they were 96.0% （311/324）vs 91.3% （377/413）,92.3% （299/324）vs 87.2% （360/413）,91.4% （296/324）vs 85.7% （354/413）,6.8% （22/324）vs 2.7% （11/413）,respectively,but the in hospital mortality was lower than that in the control group [0.9% （3/324）vs 3.1%（13/413）] （all P 〈 0.05）.Logistic regression analysis indicated that intracoronary pre-injection of tirofiban was the independent factor affecting TIMI grade 3 flow after PPCI（OR =1.947,95% CI：l.156-4.022,P =0.036）.Conclusions [ntracoronary pre-injection of tirofiban before PPCI may improve the coronary forward blood flow and myocardial tissue perfusion,and it may also increase the mild haemorrhage rate,but there is no need for clinical intervention.It has better efficacy and safety to patients with STEMI.