益气凉血生肌方预防冠心病PCI术后气虚血瘀、痰热互结证患者主要不良心血管事件的随机对照试验

Randomize-Controlled Trial of Yiqi Liangxue Shengji Formula(益气凉血生肌方) in Preventing Major Adverse Cardiovascular Events after Percutaneous Coronary Intervention for Coronary Heart Disease

目的观察益气凉血生肌方对冠心病经皮冠状动脉介入治疗(PCI)术后气虚血瘀、痰热互结证患者主要不良心血管事件(MACE)的影响。方法通过前瞻性随机对照试验方法,纳入北京中医药大学东方医院2015年10月至2017年12月成功行PCI术的冠心病气虚血瘀、瘀热互结证住院患者160例,随机分为对照组和治疗组各80例,对照组进行常规西药治疗,治疗组在常规西药治疗基础上加用益气凉血生肌颗粒剂每次5.2 g,每日2次,口服8周。随访至2018年8月,记录并评价两组MACE的发生情况,采用Logistic回归分析进行MACE影响因素探讨,同时进行两组患者生存率比较。结果治疗组患者MACE发生率为17.8%,对照组MACE发生率为38.3%,两组比较差异具有统计学意义(P<0.05);Logistic回归分析结果提示,PCI术后服用益气凉血生肌方与MACE的发生呈负相关(系数β=-1.077,P=0.008)。两组术后生存曲线结果显示生存率差异有统计学意义(P=0.007)。结论与单纯西药治疗相比,在常规西药治疗基础上加用益气凉血生肌方可能减少冠心病PCI术后气虚血瘀、痰热互结证患者MACE的发生。

Objective To explore the effect of Yiqi Liangxue Shengji Formula(益气凉血生肌方)on major adverse cardiovascular events(MACE)in patients with coronary heart disease after percutaneous coronary intervention(PCI).Methods A prospective randomized trail method was used to enroll 160 patients with coronary heart disease(qi deficiency and blood stasis,intermingled blood stasis and heat syndrome)who successfully underwent PCI from October 2015 to December 2017 in Dongfang Hospital Affiliated to Beijing University of Chinese Medicine.They were randomly divided into a control group and a treatment group,with 80 cases in each group.The control group was treated with routine western medicine,and the treatment group was added Yiqi Liangxue Shengji Formula on the basis of routine western medicine treatment for 8 weeks.The incidence of MACE in the 2 groups was recorded and evaluated.Results As of August 2018,the incidence of MACE in the treatment group was 17.8%,and that in the control group was 38.3%.The difference between groups was statistically significant(P<0.05).Logistic regression analysis showed that taking Yiqi Liangxue Shengji Formula after PCI had a negative relationship with the incidence of MACE(β=-1.077,P=0.008).Difference in survival rate of the two groups was statistically significant(P=0.007).Conclusion Compared with treating with western medicine alone,the addition of Yiqi Liangxue Shengji Formula may reduce the occurrence of MACE after PCI.