益气活血方治疗急性冠脉综合征气虚血瘀证的临床研究

Clinical Efficacy of Yiqi Huoxue Decoction in the Treatment of Patients with Acute Coronary Syndrome(Qi Deficiency and Blood Stasis Syndrome)

目的观察益气活血方治疗急性冠脉综合征气虚血瘀证病人的有效性和安全性。方法选取2014年9月—2017年9月上海中医药大学附属曙光医院心血管科门诊或住院的ACS气虚血瘀证病人100例,采用随机对照设计,分为试验组和对照组,各50例。对照组采取西医常规治疗,试验组在西医常规治疗基础上加用益气活血方治疗8周,随访1年。观察益气活血方干预对ACS病人长期预后的影响,以肝肾功能理化指标及不良事件发生率为安全性指标评价益气活血方的安全性。结果试验组心绞痛量化标准评分、中医胸痹证评分、中医血瘀证评分明显优于对照组(P<0.05或P<0.01);两组终点事件发生率比较差异无统计学意义(P>0.05),试验组有降低终点事件发生率的趋势;两组治疗前后血常规、肝肾功能比较差异均无统计学意义(P>0.05),临床观察也无药物不良反应发生。结论益气活血方能改善ACS气虚血瘀证病人的中医证候,安全性较好。

Objective To analyze the efficacy and safety of Yiqi Huoxue Decoction in the treatment of patients with acute coronary syndrome(Qi deficiency and blood stasis syndrome).Methods One hundred patients with acute coronary syndrome(Qi deficiency and blood stasis syndrome)were randomly selected and randomly divided into two groups:experimental group and control group,with 50 cases in each group.The patients in control group were received conventional Western medicine treatment.On the basis of routine treatment of Western medicine,the patients in experimental group were treated with Yiqi Huoxue Decoction for 8 weeks and followed up for one year.The effect of Yiqi Huoxue Decoction on long-term prognosis of patients with ACS were observed,the safety of Yiqi Huoxue Decoction were evaluated by the physical and chemical indicators of liver and kidney function and the incidence of adverse events as safety indicators.Results The quantitative criteria of angina pectoris,TCM chest syndrome score,TCM blood stasis syndrome score in test group were significantly better than those in control group(P<0.05 or P<0.01);there was no significant statistical significance in the incidence rate of end point event(P>0.05),but there was a downward trend.There was no significant difference in blood routine,liver and kidney function between the experimental group and the control group(P>0.05).No adverse drug reactions occurred.Conclusion Yiqi Huoxue Decoction can improve the TCM syndromes of patients with acute coronary syndrome(qi deficiency and blood stasis syndrome),and is safety.