芪参益气滴丸对PCI术后患者心肌保护作用及不良心血管事件的防治

Myocardial Protection Effect of Qishen Yiqi Dropping Pills on Patients After PCI and Control Effect and Mechanism on Cardiac Adverse Events

目的:探讨芪参益气滴丸对PCI术后气虚血瘀证患者心肌保护和对心脏不良事件的防治效果,及抗炎、抗氧化损伤机制。方法:将125例PCI术后患者随机分为对照组61例和观察组64例。对照组口服替格瑞洛片,90 mg/次,2次/d;和阿司匹林肠溶片,100 mg/次,1次/d;和富马酸比索洛尔片,5 mg/次,1次/d。观察组西医使用同对照组,并给予芪参益气滴丸,0.5 g/次,3次/d,于术前3 d开始口服。两组疗程均为连续治疗6个月,并进行6个月随访。于用药前、术后24,72 h检测心肌肌钙蛋白I(cTnI),肌酸激酶同工酶(CK-MB);于术后1周内和术后6个月记录左室射血分数(LVEF),每搏输出量(SV),室壁运动积分指数(WMSI),正常心肌百分比和心肌灌注评分指数(PS);记录术后12个月内心绞痛复发、严重心律失常、心力衰竭、再次血运重建、非致死性心肌梗死、心源性死亡、支架内再狭窄(ISR)的发生情况;于术后1周和6个月评价6 min步行试验(6 MWT),西雅图心绞痛量表(SAQ)和气虚血瘀证评分;检测术前、术后48 h和术后6个月肿瘤坏死因子(TNF-α),白细胞介素-6 (IL-6),血浆可溶性细胞间黏附分子-1(sICAM-1),超敏C反应蛋白(hs-CRP),超氧化物歧化酶(SOD),丙二醛(MDA)和内皮素-1(ET-1)水平。结果:观察组在术后24 h和72 h,血清cTnI和CK-MB水平均低于对照组(P<0.05);观察组在术后48 h和术后6个月血清TNF-α,IL-6,sICAM-1,hs-CRP,MDA和ET-1水平均低于对照组,SOD水平高于对照组(P<0.01);观察组在术后6个月LVEF,SV和正常心肌百分比均高于对照组(P<0.05),WMSI和PS均低于对照组(P<0.05);术后12个月内,观察组心绞痛复发率12.5%,低于对照组的29.51%;再次血运重建率4.69%,低于对照组的16.39%;MACE累积发生率37.5%,低于对照组的81.97%(P<0.05,P<0.01);术后6个月,观察组患者6 min步行距离多于对照组(P<0.01),气虚血瘀证评分低于对照组和SAQ评分高于对照组(P<0.01)。结论:对冠心病心绞痛气虚血瘀证患者,于PCI围手术期给予芪参益气滴丸干预,具有持续抗炎、抗氧化损伤和改善皮内功能作用,可以起到防治心肌损伤,减少术后MACE发生率,减轻症状,提高患者活动能力和生活质量的作用。

Objective: To discuss the myocardial protection effect of Qishen Yiqi dropping pills on patients with Qi deficiency and blood stasis syndrome after PCI and the control effect and mechanism on cardiac adverse events.Method: One hundred and twenty-five patients were randomly divided into control group(61 cases) and observation group(64 cases) by random number table after PCI.Patients in control group got Tigrillo tablets,90 mg/time,2 times/days,aspirin enteric-coated tablets,100 mg/time,1 time/day,and bisoprolol fumarate tablets,5 mg/time,1 time/day.In addition to the therapy of control group,patients in observation group were also given Qishen Yiqi dropping pills,0.5 g/time,3 times/days,3 days before operation.A course of treatment was 6 months,and follow-up were carried out for 6 months.Before treatment,and at the 24^th,72^th hour after treatment,cardiac troponin I(cTnI) and creatine kinase isoenzyme(CK-MB) were detected.During the first week after operation,and at the 6^th month after operation,left ventricular ejection fraction(LVEF),settling velocity(SV),wall motion score index(WMSI),percentage of normal myocardium and myocardial perfusion score index(PS) were recorded.After 12 months of the operation, recurrence of angina pectoris, severe arrhythmia,heart failure, revascularization, non-fatal myocardial infarction, cardiogenic death and in-stent restenosis(ISR) were all recorded.During the first week after the operation,and at the 6^th month after operation,six-minute walking test(6 MWT),Seattle angina scale(SAQ) and Qi deficiency and blood stasis syndrome were all scored.Before the operation,and at 48 hours and 6 months after operation,levels of tumor necrosis factor(TNF-α),interleukin-6(IL-6),plasma soluble intercellular adhesion molecule-1(sICAM-1),high-sensitivity C-reactive protein(hs-CRP),superoxide dismutase(SOD),malondialdehyde(MDA) and endothelin-1(ET-1)were all detected.Result: At the 24^th,72^th hour after treatment,levels of cTnI and CK-MB in control group were lower than those in observation group(P<0.05).At the 48^th hour after operation and the 6^th month after operation,levels of TNF-α,IL-6,sICAM-1 hs-CRP,MDA and ET-1 were lower than those in control group(P<0.01).And level of SOD was higher than those in control group(P<0.01).At the 6th months after operation,LVEF,SV and percentage of normal myocardium were higher than those in control group(P<0.05),while levels of WMSI and PS were lower than those in control group(P<0.05).During 12 months after the operation,recurrence rate of angina pectoris was 12.5%, which was lower than 29.15% in control group, and revascularization rate was 4.69%,which was lower than 16.39% in control group.Cumulative incidence of MACE was 37.5%,which was lower than 81.97% in control group(P<0.05 or P<0.01).At the 6^th month after operation,score of six-minute walking test was higher than that in control group(P<0.01).And score of Qi deficiency and blood stasis syndrome was lower than that in control group(P<0.01),while score of SAQ was higher than that in control group(P<0.01).Conclusion: Qishen Yiqi dropping pills has anti-inflammatory and antioxidant effects,and can ameliorate intradermal function,prevent and treat myocardial injury,reduce rate of MACE,relieve symptoms,and improve activity ability and quality of life of patients.