活心丸(浓缩丸)治疗冠心病慢性稳定性心绞痛(气虚血瘀证)多中心随机双盲临床研究  

Huoxin Pills(Concentrated Pills)in Treatment of Chronic Stable Angina Pectoris of Coronary Heart Disease Patients with Qi Deficiency and Blood Stasis Syndrome:A Multicenter Double–Blind Randomized Controlled Trial

作　　者：吴宗贵 马丽红 段文慧[3] 吕渭辉[4] 杨天伦[5] 林英子[6] 季海刚[7] 宋颖民 翟玉民 郑群[10] 左梅 范恒[12] 于伟仕 王霞 陈可冀[3] WU Zong-gui;MA Li-hong;DUAN Wen-hui;LV Weihui;YANG Tian-lun;LIN Ying-zi;JI Hai-gang;SONG Ying-min;ZHAI Yu-min;ZHENG Qun;ZUO Mei;FAN Heng;YU Wei-shi;WANG Xia;CHEN Ke-ji(Heart Center,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437;Department of Cardiology,Fuwai Hospital,CAMS&PUMC,Beijing 100037;National Clinical Research Center for Chinese Medicine Cardiology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091;Department of Cardiology,Guangdong Province Traditional Chinese Medical Hospital,Guangzhou 510095;Department of Cardiology,XiangYa Hospital Central South University,Changsha 410011;Department of Cardiology,The Fourth Affiliated Hospital of China Medical University,Shenyang 110032;Department of Cardiology,Changzhou TCM Hospital,Jiangsu 213003;Department of Cardiology,Luohe TCM Hospital,Henan 462000;Department of Cardiology,Kaifeng TCM Hospital,Henan 475500;Department of Cardiology,HARRISON International Peace Hospital,Hebei 053000;Department of Cardiology,Xianyang Hospital of Yanan University,Shaanxi 716000;Department of TCM,Tongji Medical College,Huazhong University of Science Technology,Wuhan 430022;YOUCARE Pharmaceutical Group Co.,Ltd,Beijing 100176;Beijing Do.Care Pharmaceutical Technology Co.,Ltd,Beijing 100176)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院心脏中心,上海200437 [2]中国医学科学院阜外医院心内科,北京100037 [3]国家中医心血管病临床医学研究中心,中国中医科学院西苑医院,北京100091 [4]广东省中医院心内科,广州510095 [5]中南大学湘雅医院心内科,长沙410011 [6]中国医科大学附属第四医院心内科,沈阳110032 [7]常州市中医医院心内科,江苏213003 [8]漯河市中医院心内科,河南462000 [9]开封市中医院心内科,河南475500 [10]哈励逊国际和平医院心内科,河北053000 [11]延安大学咸阳医院心内科,陕西716000 [12]华中科技大学同济医学院附属协和医院中医科,武汉430022 [13]悦康药业集团股份有限公司,北京100176 [14]北京科创鼎诚医药科技有限公司,北京100176

出　　处：《中国中西医结合杂志》2022年第6期672-679,共8页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价活心丸(浓缩丸)治疗冠心病慢性稳定性心绞痛(气虚血瘀证)的有效性与安全性。方法采用多中心、随机、双盲、阳性药平行对照临床试验研究,纳入395例冠心病慢性稳定性心绞痛(气虚血瘀证)患者,按1:1:1比例分为芳香温通组132例、活血化瘀组131例和益气活血组132例,分别用麝香保心丸、血塞通滴丸和活心丸(浓缩丸)治疗,疗程24周,评价3组中医证候疗效、硝酸甘油停减率、心绞痛严重程度、西雅图心绞痛量表、心电图疗效及安全性指标情况。以次症基线分数4分为亚组,分析各亚组的中医证候疗效及6 min步行总距离。结果最终纳入分析芳香温通组117例、活血化瘀组113例和益气活血组101例,其中亚组芳香温通组78例、活血化瘀组82例和益气活血组69例。与本组基线比较,3组心绞痛严重度和心绞痛每周发作次数均降低(P<0.01)、西雅图心绞痛量表各维度评分均增加(P<0.01);各亚组6 min步行总距离均增加(P<0.01),且益气活血组6 min步行总距离用药前后差值高于芳香温通组和活血化瘀组(P<0.05)。用药24周后,芳香温通组、活血化瘀组和益气活血组的中医证候积分有效率分别为69.23%、71.68%、87.13%,亚组总有效率分别为58.97%、60.98%、86.96%,组间差异均有统计学意义(χ^(2)=10.77,P<0.05;χ^(2)=16.1348,P<0.01);益气活血组较芳香温通组和活血化瘀组中医证候积分有效率升高(χ^(2)=7.6634,P<0.01;χ^(2)=9.9652,P<0.01)、心电图疗效升高(χ^(2)=7.6142,P<0.01;χ^(2)=6.5211,P<0.05)。益气活血组12、24周硝酸甘油停减率均高于活血化瘀组(χ^(2)分别为8.3624、4.6102,P<0.05)。3组不良反应发生率比较,差异无统计学意义(P>0.05)。结论活心丸(浓缩丸)能明显改善冠心病慢性稳定性心绞痛(气虚血瘀证)患者的中医临床症状、6 min步行总距离、硝酸甘油使用情况和心电图疗效,并且具有良好的安全性。(试验注册编号:No.ChiCTRObjective To evaluate the clinical efficacy and safety of Huoxin Pill(concentrated pill)in treating chronic stable angina pectoris with Qi deficiency and blood stasis syndrome(QDBSS).Methods A multicenter,double-blind,positive drug parallel controlled,randomized controlled trial was conducted.Totally 395 patients of chronic stable angina pectoris with QDBSS were randomly assigned to Fangxiang Wentong group(FXWT,132 cases),Huoxue Huayu group(HXHY,131 cases),and Yiqi Huoxue group(YQHX,132cases)respectively at a ratio of 1:1:1 with Shexiang Baoxin Pill,Xuesaitong dripping Pill,and Huoxin pill(concentrated pill)as treatment,and the course of treatment was 24 weeks.The efficiency of Chinese medicine(CM)syndromes,the nitroglycerin discontinuation rate,the severity of angina,Seattle Angina Scale,ECG efficacy and safety indicators at baseline and 24 weeks after treatment were evaluated in each group.The efficacy of CM syndromes and the total walking distance of 6 minutes of every subgroup were analyzed,whose baseline score of secondary symptom 4 points.Results In the end,117 patients in FXWT,113 patients in HXHY,and 101 patients in YQHX were included in the analysis.Meanwhile,78 patients in FXWT,82patients in HXHY,and 69 patients in YQHX were analyzed as sub-group.Compared with the baseline of this group,the severity of angina pectoris and the frequency of angina pectoris per week of 3 groups decreased(P<0.01),and the scores of all dimensions of the Seattle Angina Scale increased(P<0.01).The total 6-minute walking distance of each subgroup increased(P<0.01).And the difference in total 6-minute walking distance before and after medication in the YQHX was higher than FXWT and the HXHY(P<0.05).After 24 weeks of treatment,the effective rates of CM syndrome scores in FXWT,HXHY,and YQHX were 69.23%,71.68%,and 87.13%,respectively.The effective rates of sub-group in FXWT,HXHY,and YQHX were 58.97%,60.98%,and 86.96%.The differences of CM syndromes scores were both statistically significant(χ^(2)=10.77,P<0.05,χ^(2)=16.1348,P<0.01

关 键 词：活心丸(浓缩丸) 冠心病 益气活血 慢性稳定性心绞痛 气虚血瘀 有效性 安全性 

分 类 号：R259[医药卫生—中西医结合]