参术冠心方治疗冠心病稳定型心绞痛临床研究  

Double-blind, Randomized, Controlled Clinical Trial of Shenzhu Guanxin Prescription for Treatment of Stable Angina Due to Coronary Heart Disease

作　　者：徐丹苹[1,2] 王侠[3] 盛小刚[4] 林宇[5] 李松[6] 郑朝阳[5] 吴焕林[1,2] 

机构地区：[1]广东省中医院心脏中心 [2]广东省中医药科学院,广东广州510006 [3]广东省中医院二沙岛分院,广东广州510105 [4]广东省中医院大德路总院,广东广州510120 [5]广东省中医院大学城分院,广东广州510006 [6]广东省中医院芳村分院,广东广州510370

出　　处：《广州中医药大学学报》2014年第2期173-177,182,共6页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金："十一.五"国家科技支撑计划资助项目(编号:2007BAI10B02)

摘　　要：【目的】观察参术冠心方治疗冠心病稳定型心绞痛的疗效。【方法】采用多中心、随机、双盲、安慰剂对照的临床研究方法,共纳入病例120例,随机分为试验组和对照组。2组均给予相同的西医标准治疗,试验组同时给予参术冠心方中药复方颗粒剂,对照组给予参术冠心方安慰剂,2组疗程均为90 d。观察各时点的心绞痛发作情况、中医证候计分、西雅图心绞痛量表评分的变化情况。【结果】(1)完成随访114例,其中试验组55例,对照组59例。(2)心绞痛发作情况比较:治疗后第30、60、90天3个时点试验组心绞痛发作次数的改善作用优于对照组,差异均有统计学意义(P<0.05);治疗后第30、60天2个时点试验组的心绞痛发作持续时间的改善作用优于对照组,差异均有统计学意义(P<0.05);试验组第30天硝酸甘油的使用总量少于对照组,差异有统计学意义(P<0.05)。试验组治疗后第30、90天诱发心绞痛的体力活动程度的改善作用优于对照组,差异有统计学意义(P<0.05);试验组治疗后第30、60、90天3个时点心绞痛疼痛程度的改善作用优于对照组,差异均有统计学意义(P<0.01)。(3)试验组治疗后各时点中医证候计分和西雅图心绞痛量表各维度积分的改善均优于对照组,差异均有统计学意义(P<0.05)。【结论】参术冠心方能改善冠心病稳定型心绞痛患者的心绞痛症状,改善中医证候计分,提高患者的日常活动耐量。Objective To observe the therapeutic effect of Shenzhu Guanxin Prescription for stable angina pectoris due to coronary heart disease. Methods A multi-center, randomized, double-blind, placebo-controlled trial was carried out in 120 patients with stable angina pectoris due to coronary heart disease. The patients were divided into observation group and control group, and all were given conventional western medicine. Additionally, the observation group was treated with Shenzhu Guanxin Prescription, and the control group was treated with placebo formula. The treatment course was 90 days for both groups. Before and after treatment, outcomes including angina pectoris attack, traditional Chinese medical symptom scores, and Seattle angina scores were observed. Results （1） A total of 114 patients were followed up, which consisted of 55 patients in the observation group and 59 patients in the control group. （2） On post-treatment day 30, 60, 90, the improvement of attack frequency of angina pectoris in the observation group was superior to that in the control group （P〈0.05） . On post-treatment day 30, 60, the improvement of duration of angina pectoris in the observation group was better than that in the control group （P〈0.05）, and on post-treatment day 30, the dosage of nitroglycer in the observation group was less than that in the control group （P〈0.05） . In comparison with the control group, the angina-inducing physical activity level was much decreased on post-treatment day 30, 90 （P〈0.05）, and angina was much relieved on post-treatment day 30, 60, 90 （P〈0.01） in the observation group. （3） Traditional Chinese medical symptom scores and Seattle angina scores were much improved in the observation group on post-treatment day 30, 60, 90, the differences being significant compared with those in the control group （P〈0.05） . Conclusion Shenzhu Guanxin Prescription is effective on relieving angina symptoms, improving traditional Chinese medical symptom scores, and increasing tolera

关 键 词：参术冠心方 治疗应用 冠心病 中西医结合疗法 稳定型心绞痛 中西医结合疗法 

分 类 号：R541.4[医药卫生—心血管疾病]