脉血康及血脂康联合院内制剂益心通痹合剂治疗冠心病(气虚血瘀型)随机对照研究

Randomized Study on TCM Preventive Scheme of Maixuekang and Xuezhikang Combined with Yixintongbi Mixture in the Treatment of Coronary Heart Disease(Qi Deficiency and Blood Stasis Type)

目的:评价防治冠心病中医二级预防方案的有效性和安全性。方法:选择已行冠脉造影确定冠心病诊断但未达支架置入标准并至少一支血管狭窄程度为50%~70%的住院患者114例,随机分为试验组、对照组各57例。观察用药后12个月内终点事件的发生率;用药前后西雅图心绞痛积分、中医证候积分及血脂的变化;用药过程中的不良事件发生情况。结果:试验组完成54例,终点事件发生率为5.56%,对照组完成56例,终点事件发生率为8.93%,两组终点事件发生率比较差异无统计学意义(P>0.05)。两组均能有效缓解心绞痛症状及显著改善血脂情况,但两组疗效比较差异无统计学意义(P>0.05)。试验组中医证候疗效明显高于对照组,差异有统计学意义(P<0.05)。两组均未发生与药物相关的不良反应。结论:脉血康、血脂康联合院内制剂益心通痹合剂治疗冠心病的中医预防方案临床疗效不劣于西医二级预防方案,并能明显改善患者的临床症状,安全性高,可作为临床冠心病二级预防方案推广使用。

Objective:To evaluate the efficacy and safety of secondary prevention of coronary heart disease in Chinese medicine.Methods:114hospitalized patients who had received coronary angiography to determine the diagnosis of coronary heart disease but did not meet the criteria for stent implantation and had at least one vessel stenosis of 50%to 70%were randomly divided into the experimental group and the control group with 57cases in each group.The incidence of endpoint events within 12months after administration was observed.Seattle angina points,TCM syndrome points and blood lipid changes before and 12months after medication;Adverse events occurred during the course of medication.Results:54cases were completed in the experimental group,and the incidence of endpoint events was 5.56%;56cases were completed in the control group,and the incidence of endpoint events was 8.93%.There was no significant difference between the two groups(P>0.05).Both groups can effectively alleviate angina symptoms and significantly improve the situation of blood lipid,but there is no significant difference in the efficacy between the two groups(P>0.05).The efficacy of TCM syndromes in the experimental group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).No drug-related adverse reactions occurred in either group.Conclusion:The clinical efficacy of traditional Chinese medicine prevention program of maixuekang and xuezhikang combined with hospital preparations yixintongbi mixture in the treatment of coronary heart disease is not inferior to the secondary prevention program of western medicine,and can significantly improve the clinical symptoms of patients,with high safety,which can be used as a clinical secondary prevention program of coronary heart disease.