中医药治疗冠心病PCI术后心血管复合终点事件的前瞻性临床研究  

The Prospective Clinical Study of Traditional Chinese Medicine on Cardiovascular Composite Endpoint Events in the Treatment of Coronary Heart Disease after Percutaneous Coronary Intervention

作　　者：闫思雨 梁晓鹏[1] 苏燕妮 郭彩霞[1] 陆培培[1] 兰玥[1] 马丽红[1] YAN Siyu;LIANG Xiaopeng;SU Yanni;GUO Caixia;LU Peipei;LAN Yue;MA Lihong(Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China)

机构地区：[1]中国医学科学院/北京协和医学院/阜外医院

出　　处：《中西医结合心脑血管病杂志》2019年第17期2561-2565,共5页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：首都卫生发展科研专项项目(No.2016-2-4032)

摘　　要：目的系统评价中医药干预对冠心病经皮冠状动脉介入(PCI)术后病人心血管复合终点事件的作用,为中医药治疗PCI术后病人的远期疗效及预后提供循证依据。方法采用前瞻性观察性的注册登记研究方法,连续入选2016年9月—2017年2月在中国医学科学院阜外医院确诊为冠心病并进行PCI术治疗的病人,采集基线数据并随访两年。随访结束后根据实际治疗策略的不同将病人分为西药组和中药联合西药组,建立Cox回归模型,以病人两年内心血管复合终点事件(再次血运重建、心肌梗死、全因死亡)为主要疗效指标,以心绞痛症状积分和中医证候量表评分为次要疗效指标,比较不同治疗手段对病人PCI术后的预后影响。结果共入选冠心病PCI术后病人3358例,其中3004例病人完成随访,其中西药组1651例(55.0%),中药联合西药组1353例(45.0%)。Cox回归分析显示,与西药组相比,中药联合西药组心血管复合终点事件风险降低26.5%[HR=0.735,95%CI(0.609,0.887),P=0.001],再次血运重建风险降低19.6%[HR=0.804,95%CI(0.657,0.984),P=0.034],全因死亡风险降低87.1%[HR=0.129,95%CI(0.051,0.324),P=0.000],心肌梗死病人因数目极少未进行Cox回归分析。秩和检验结果显示,西药组和中药联合西药组在心绞痛症状积分方面差异无统计学意义(P=0.909),但是中药联合西药组在中医证候量化评分方面优于西药组,差异有统计学意义(P=0.000)。结论PCI术后病人在常规西药基础上联合中药治疗有利于减少心血管复合终点事件的发生,缓解病人的临床症状,相对于单独使用西药治疗的病人获益更多,尤其以再次血运重建和全因死亡的获益更为明显。Objective To systematically evaluate the impact of traditional Chinese medicine(TCM)on cardiovascular composite endpoint events in patients with coronary heart disease after percutaneous coronary intervention(PCI),so as to provide evidence-based basis for the long-term efficacy.Methods Prospective,observational registration study method was adopted in this study.Patients diagnosed as coronary heart disease and accepted PCI therapy in Fuwai Hospital,Chinese Academy of Medical Sciences from September 2016 to February 2017 were selected.The baseline data was collected and followed-up for 2 years.According to actual treatment strategies,the patients were divided into western medicine group and TCM plus western medicine group.The cox regression model was established.The 2 years of cardiovascular composite endpoint events were used as main efficacy indicators.The angina symptom score and TCM syndrome score were used as secondary efficacy indicators.The efficacy of different treatment groups were compared.Results A total of 3 358 patients with coronary heart disease after PCI were enrolled in this study,among which 3 004 patients were had followed up,1 651 patients(55.0%)in the western medicine group and 1 353 patients(45.0%)in the TCM combined with western medicine group.Cox regression analysis showed that,compared with the western medicine group,the risk of cardiovascular composite end point events in the TCM plus western medicine group was reduced by 26.5%[HR=0.735,95%CI(0.609,0.887),P=0.001],the risk of re-revascularization was reduced by 19.6%[HR=0.804,95%CI(0.657,0.984),P=0.034],the risk of all-cause death was reduced by 87.1%[HR=0.129,95%CI(0.051,0.324),P=0.000].Cox regression analysis was not conducted for the patients with myocardial infarction.The rank-sum test results showed that there was no significant difference in angina symptom score between the western medicine group and the TCM plus western medicine group(P=0.909).TCM syndrome score in the TCM combined western medicine group was significantly lower tha

关 键 词：冠心病 经皮冠状动脉介入术 心血管复合终点事件 再次血运重建 全因死亡 心绞痛症状积分 中医证候量化评分 

分 类 号：R541.4[医药卫生—心血管疾病] R256.2[医药卫生—内科学]