参桂胶囊治疗冠心病稳定型心绞痛(心阳不振、气虚血瘀证)随机、双盲双模拟、阳性药平行对照、多中心临床研究  

A study on treating stable angina pectoris of coronary heart disease of the Xinyang Buzhen type and Qixu Xueyu type with the Shengui capsule

作　　者：林谦[1] 张东耀 魏俊平[3] 翟理黄[4] 杨明[5] 罗清菊 宋颖民 孙艳玲 

机构地区：[1]北京中医药大学东方医院,北京100078 [2]上海玉丹药业有限公司,上海201601 [3]上海中医药大学附属曙光医院松江分院,上海201600 [4]河南中医药大学第一附属医院,河南郑州450001 [5]河南省人民医院,河南郑州450003 [6]郑州市中医院,河南郑州450007 [7]漯河市中医院,河南漯河462000 [8]洛阳市第一中医院,河南洛阳461000

出　　处：《中医临床研究》2018年第23期7-10,共4页Clinical Journal Of Chinese Medicine

基　　金：上海市科委生物医药产业转化基金项目(编号:09DZ190288)

摘　　要：目的:以阳性药为对照,按照优效性检验临床试验设计,评价参桂胶囊治疗冠心病稳定型心绞痛(心阳不振、气虚血瘀证)的安全性和临床疗效。方法:本研究为区组随机、双盲双模拟、阳性药平行对照、多中心临床研究。结果:试验组在心绞痛疗效、中医证候疗效及西雅图量表等方面,与对照组比较均有明显差异(P<0.05)。基于主要疗效指标心绞痛疗效评估,用药28天后,试验组总有效率为86.72%,对照组为68.51%,两组间总有效率比较差异有统计学意义(P<0.05),两组间总有效率差值(试验组-对照组)及95%可信区间为18.21%(8.70%~27.72%)。试验组均优于对照组,PPS与FAS结论一致。总的不良事件及不良反应发生率两组比较均无统计学意义。结论:参桂胶囊治疗各种原因引起的冠心病稳定型心绞痛(心阳不振、气虚血瘀证)安全、有效,其疗效明显优于对照药活心丸。Objective:To investigate clinical efficacy of the Shengui capsule(参桂胶囊)on stable angina pectoris of coronary heart disease(Xinyang Buzhen type,Qixu Xueyu type)(心阳不振、气虚血瘀证).Methods:All patients were divided into 2 groups.The control group was given Huoxin Wan(活心丸),and the study group was given the Shengui capsule.Results:There were significant differences in efficacy,TCM syndrome score and Seattle scale between the two groups(P<0.05).In 28 days,the total efficiency was 86.72%in the study group,better than 68.51%in the control group(P<0.05).There was no statistical difference in the incidence of adverse reactions between the two groups.Conclusion:The Shengui capsule on stable angina pectoris of coronary heart disease of Xinyang Buzhen Qixu Xueyu type shows a good effect.

关 键 词：参桂胶囊 冠心病心绞痛 中医药疗法 

分 类 号：R541.4[医药卫生—心血管疾病]