速效救心丸干预ACS血管重建术后病人的随机、双盲、安慰剂对照临床研究  

Intervention of Suxiao Jiuxin Pill in Patients with Acute Coronary Syndrome after Revascularization: a Randomized,Doubled-blind,Placebo-controlled Clinical Trial

作　　者：阮小芬[1] 沈智杰[1] 薛金贵[1] 张春伶[1] 李益萍[1] 王肖龙[1] RUAN Xiaofen;SHEN Zhijie;XUE Jingui;ZHANG Chunling;LI Yiping;WANG Xiaolong(Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203

出　　处：《中西医结合心脑血管病杂志》2019年第9期1286-1290,共5页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：国家自然科学基金项目(No.81573647;81803887);上海申康医院发展中心市级医院临床研究培育项目(No.SHDC12018X29);上海市高级中西医结合人才计划[No.ZY(2018-2020)-RCPY-2004]

摘　　要：目的观察速效救心丸干预急性冠脉综合征(ACS)血管重建术后病人的临床疗效。方法应用随机、双盲和安慰剂对照临床研究的方法,将124例急性冠脉综合征病人随机分为对照组和治疗组,各62例,冠状动脉造影后行早期经皮冠状动脉介入手术(PCI),治疗组、对照组病人在常规西药治疗基础上分别给予速效救心丸及速效救心丸模拟剂,每次8粒,每日3次,疗程24周,随访1年。比较两组临床终点事件发生率,并观察两组治疗前后中医证候积分、纤维蛋白原含量(Fib)、血小板聚集率(PAG)、炎性指标、左室射血分数(LVEF)变化。结果治疗组临床终点事件的发生率明显低于对照组(8.62%与21.31%,P<0.05),治疗后治疗组Fib、PAG、胱抑素C水平显著低于对照组(P<0.01)。结论速效救心丸可以改善ACS病人血管重建术后的临床症状,减少临床终点事件发生,显著抑制炎症反应,降低血浆纤维蛋白原水平,降低病人的血小板聚集率。Objective To observe the clinical effect of Suxiao Jiuxin pill(SJP)in patients with acute coronary syndrome(ACS)after revascularization.Methods A randomized,double-blind,placebo-controlled clinical trial was performed.One hundred and twenty-four patients with ACS were randomized into control group and treatment group.After coronary angiography,early PCI was performed.Patients were treated with SJP in the treatment group and placebo in the the control group for 24 weeks of treatment,followed up for 1 year.The incidence of clinical endpoints was compared between the two groups.The changes of traditional Chinese medicine(TCM)syndrome scores,fibrinogen(Fib)content,platelet aggregation rate(PAG),inflammatory index,and left ventricular ejection fraction(LVEF)before and after treatment were observed.Results The incidence of clinical endpoints in the treatment group was significantly lower than that in the control group(8.62%versus 21.31%,P<0.05).The levels of Fib,PAG and cystatin C in the treatment group was significantly lower than that in the control group(P<0.01).Conclusion SJP can improve the clinical symptoms,reduce the incidence of clinical endpoints,significantly inhibit the inflammatory response,reduce plasma fibrinogen levels and the platelet aggregation rate in patients with ACS after revascularization.

关 键 词：急性冠脉综合征 血管重建术 速效救心丸 临床终点事件 中医证候 

分 类 号：R541[医药卫生—心血管疾病] R289.5[医药卫生—内科学]