吲哚布芬联合氯吡格雷治疗老年冠心病PCI术后患者的临床研究

Clinical trial of indobufen combined with clopidogrel in treating elderly patients with coronary heart disease after PCI

目的探究吲哚布芬结合氯吡格雷在伴阿司匹林禁忌证老年冠心病患者经皮冠状动脉介入治疗(PCI)术后的应用价值。方法入选伴阿司匹林禁忌症老年冠心病患者作为研究对象,用随机数字表法将其分为2组,对照组给予口服硫酸氢氯吡格雷片75 mg,qd;试验组在对照组治疗的基础上,给予口服吲哚布芬片200 mg,qd,2组患者均治疗3个月。比较2组治疗前后心功能指标及凝血-纤溶系统指标、血小板功能指标、血管内皮功能指标、微循环功能指标,并统计MACE发生率及药物不良反应发生情况。结果本研究中试验组和对照组最终均有39例纳入统计分析。试验组和对照组的总有效率分别为94.87%和79.49%,在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的左室射血分数(LVEF)分别为(57.13±3.16)%和(55.65±3.01)%,左心室舒张末期容积指数(LVEDVI)分别为(61.29±3.46)和(63.78±3.12)mL·m^(-2),心脏指数分别为(3.68±0.31)和(3.41±0.28)L·min^(-1)·m^(-2),每搏输出量指数(SVI)分别为(57.37±2.57)和(55.29±2.74)mL·m^(-2),纤溶酶原活化剂抑制物-1(PAI-1)水平分别为(46.29±4.18)和(49.37±5.24)ng·mL^(-1),抗凝血酶Ⅲ(AT-Ⅲ)分别为(131.04±10.65)%和(120.95±9.73)%,组织型纤溶酶原激活物(t-PA)水平分别为(0.54±0.09)和(0.46±0.10)U·mL^(-1),纤维蛋白原(FIB)水平分别为(3.52±0.61)和(4.03±0.59)g·L^(-1),PT分别为(15.43±0.65)和(14.92±0.57)s,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的心血管不良事件(MACE)有恶性心律失常1例,对照组的MACE有急性心肌梗死2例、恶性心律失常3例、靶血管再次血运重建2例、支架内发生急性血栓事件1例,试验组、对照组的MACE发生率分别为2.56%和20.51%,在统计学上差异有统计学意义(P<0.05)。结论在伴阿司匹林禁忌症老年冠心病患者PCI术后给予吲哚布芬结合氯吡格雷治疗,可提高患者心功能及微循环功能,改善凝血-纤溶功能,并能减轻血管内皮功能损伤,降低MACE发生率。

Objective To investigate the application value of indobufen combined with clopidogrel in elderly patients with coronary heart disease after percutaneous coronary intervention(PCI)with aspirin contraindications.Methods Elderly patients with coronary heart disease with aspirin contraindications were selected as study subjects and divided into 2 groups by random number table method.The control group was giv en oral clopidogrel bisulfate tablet 75 mg,qd;the treatment group was additionally given oral indobufen tablet 200 mg,qd,and both groups were treated for 3 months.Cardiac function indexes,coagulation-fibrinolytic system indexes,platelet function indexes,vascular endothelial function indexes and microcirculation function indexes were compared between the two groups before and after treatment,and the incidence of MACE and adverse drug reactions were analyzed.Results In this trial,39 cases in both the treatment group and the control group were included in the statistical analysis.The total effective rate of treatment group and control group were 94.87%and 79.49%,respectively,and the total effective rate of treatment group were higher than that of control group(P<0.05).After treatment,the left ventricular ejection fraction(LVEF)of treatment group and control group were(57.13±3.16)%and(55.65±3.01)%,and the left ventricular end-diastolic volume index(LVEDVI)were(61.29±3.46)and(63.78±3.12)mL·m^(-2),respectively;the cardiac index were(3.68±0.31)and(3.41±0.28)L·min^(-1)·m^(-2),and the stroke output index(SVI)were(57.37±2.57)and(55.29±2.74)mL·m^(-2),respectively;plasminogen activator inhibitor-1(PAI-1)levels were(46.29±4.18)and(49.37±5.24)ng·mL^(-1);antithrombinⅢ(AT-Ⅲ)levels were(131.04±10.65)%and(120.95±9.73)%,respectively;tissue plasminogen activator(t-PA)levels were(0.54±0.09)and(0.46±0.10)U·mL^(-1);fibrinogen(FIB)levels were(3.52±0.61)and(4.03±0.59)g·L^(-1),respectively;PT were(15.43±0.65)and(14.92±0.57)s,respectively.Compared with control group,the above indexes in treatment group were statistically significant(all P<0.05).In the treatment group,there were 1 case of malignant arrhythmia in the cardiovascular adverse event(MACE),and in the control group,there were 2 cases of acute myocardial infarction,3 cases of malignant arrhythmia,2 cases of target vessel revascularization,and 1 case of acute thrombus in the stent.The incidence of MACE in the treatment group and the control group were 2.56%and 20.51%,respectively;the difference were statistically significant(P<0.05).Conclusion In elderly patients with coronary heart disease contraindicated with aspirin after PCI,indobufen combined with clopidogrel can improve the cardiac function and microcirculation function,improve coagulation and fibrinolysis function,reduce vascular endothelial function injury,and reduce the incidence of MACE.