益心通痹合剂联合双联抗栓药物治疗房颤合并ACS气虚血瘀型PCI术后的临床研究

Clinical Study of Yixintongbi Mixture combined with Dual Antithrombotic Drugs in the Treatment of Atrial Fibrillation Patients with ACS Qi deficiency and Blood stasis after PCI

目的:观察运用益心通痹合剂联合双联抗栓药物治疗心房颤动(AF)合并急性冠脉综合征(ACS)气虚血瘀型经皮冠状动脉介入治疗(PCI)术后患者的临床疗效。方法:60例入选患者随机分为试验组与对照组各30例。试验组在双联抗栓治疗基础上加益心通痹合剂治疗,对照组予以双联抗栓治疗,用药时间各为2周,观察对比两组患者用药前后心功能分级、西雅图心绞痛量表评分(SAQ)、中医症状评分以及cTnT、NT-proBNP和脂蛋白(a)水平;随访6个月,比较两组患者的再住院率及不良事件发生情况。结果:两组用药前心功能分级、SAQ评分和中医症状评分无统计学差异(P>0.05);两组用药后心功能I级病人数较用药前均增加,而心功能II级病人数与用药前相比均有所减少(P<0.05),且试验组较对照组更甚(P<0.05);用药2周后,试验组SAQ评分比对照组高(P<0.05),试验组中医症状评分比对照组低(P<0.05)。用药前两组cTnT、NT-proBNP和脂蛋白(a)水平均无统计学差异(P>0.05);用药2周后,两组cTnT、NT-proBNP和脂蛋白(a)均较用药前降低(P<0.05),且试验组较对照组更甚(P<0.05)。在2周用药期间,两组间不良反应发生率无统计学差异(P>0.05)。随访6个月,试验组的再住院率,以及发生脑梗死、急性心肌梗死、顽固性心绞痛甚至心源性死亡等事件的几率均比对照组更低(P<0.05)。结论:益心通痹合剂联合双联抗栓药物治疗方案能降低AF合并ACS气虚血瘀型PCI术后栓塞风险,而不增加出血风险,并且可能具有抗动脉粥样硬化作用。

Objective:To observe the clinical efficacy of Yixintongbi mixture combined with dual antithrombotic drugs in the treatment of patients with atrial fibrillation(AF)complicated with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI)with Qi deficiency and blood stasis.Methods:60subjects were randomly divided into an experimental group with 30cases and a control group with 30cases.The experimental group was treated with Yixintongbi mixture on the basis of dual antithrombotic therapy,while the control group was treated with dual antithrombotic therapy.The treatment time was 2weeks in each group,to observe and compare the cardiac function grading,Seattle angina pectoris scale score(SAQ),traditional Chinese medicine(TCM)symptom score,and cardiac troponin T(cTnT),N-terminal pro-B-type natriuretic peptide(NT-proBNP)and lipoprotein(a)levels of patients in the two groups before and after treatment.The patients were followed up for 6months,the readmission rate and adverse events were compared between the two groups.Results:There was no significant difference in cardiac function,SAQ score and TCM symptom score between the two groups before treatment(P<0.05).After treatment,the number of patients with cardiac function grade I increased,while the number of patients with cardiac function grade II decreased in both groups(P<0.05),and the experimental group was more significant than the control group(P<0.05).After 2weeks of treatment,the SAQ score of the experimental group was higher than that of the control group(P<0.05),and the TCM symptom score of the experimental group was lower than that of the control group(P<0.05).Before treatment,there were no significant differences in the levels of cTnT,NT-proBNP and lipoprotein(a)between the two groups(P<0.05).After 2weeks of treatment,cTnT,NT-proBNP and lipoprotein(a)in both groups were decreased compared with before treatment(P<0.05),and the experimental group was more significant than the control group(P<0.05).During 2weeks of treatment,there was no significant difference in the incidence of adverse reactions between the two groups(P<0.05).After 6months of follow-up,the experimental group had lower rates of rehospitalization,cerebral infarction,acute myocardial infarction,intractable angina,and even cardiac death than the control group(P<0.05).Conclusion:Yixintongbi mixture combined with dual antithrombotic drugs can reduce the risk of embolism after PCI for patients with AF and ACS with Qi deficiency and blood stasis,without increasing the risk of bleeding,and may have anti-atherosclerotic effect.