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.
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)
关键词
参桂胶囊
冠心病心绞痛
中医药疗法
The Shengui capsule
Stable angina pectoris of coronary heart disease
TCM
