理气活血滴丸治疗冠心病慢性稳定型心绞痛Ⅳ期临床研究——糖尿病亚组分析  

A phase Ⅳ clinical study on Liqi Huoxue Gutta Pills for treating chronic stable angina pectoris of coronary heart disease: an analysis in diabetes subgroup

作　　者：王晓峰[1] 张雪娟[2] 王磌 樊瑞红[4] 许东云[5] 赵肖华 徐慧[7] 徐惠梅 沈春富 肖长江 陈玲 吕庆连 徐坡[13] 姜卫东[14] 杨乔淦[15] 刘宝山[16] 沈安明[17] 徐素娥 王振涛 龙明智[20] 周亚滨[21] 刘淑荣[22] 李逢春 王慧智 邓悦[25] 叶穂霖 陈守强[27] 袁晖戍[28] 邓兵[29] 徐新娟[30] 夏碧桦 赵英强[32] 孙刚[33] 刘素堂[34] 肖泓[35] 孙洁[36] 周锐[37] 许勇[38] 张永光 王肖龙[40] 毕育学[41] 孙旭[42] 吴宗贵 Wang Xiaofeng;Zhang Xuejuan;Wang Tian;Fan Ruihong;Xu Dongyun;Zhao Xiaohua;Xu Hui;Xu Huimei;Shen Chunfu;Xiao Changjiang;Chen Ling;Lyu Qinglian;Xu Po;Jiang Weidong;Yang Qiaogang;Liu Baoshan;Shen Anming;Xu Su'e;Wang Zhentao;Long Mingzhi;Zhou Yabin;Liu Shurong;Li Fengchun;Wang huizhi;Deng Yue;Ye Suilin;Chen Shouqiang;Yuan Huishu;Deng Bing;Xu Xinjuan;Xia Bihua;Zhao Yingqiang;Sun Gang;Liu Sutang;Xiao Hong;Sun Jie;Zhou Rui;Xu Yong;Zhang Yongguang;Wang Xiaolong;Bi Yuxue;Sun Xu;Wu Zonggui(Department of Cardiology,Affiliated Hospital of Traditional Chinese Medicine of Xinjiang Medical University,Urumqi 830099,China.)

机构地区：[1]新疆医科大学附属中医医院心内科,乌鲁木齐830099 [2]青岛大学附属医院综合内科,青岛266031 [3]山东省立第三医院心血管内科,济南250031 [4]天津市中医药研究院附属医院心病科,天津300120 [5]昆明医科大学第一附属医院中医科,昆明650032 [6]乌鲁木齐市中医医院心脑血管科,乌鲁木齐830099 [7]济南市中医医院心血管病学科,济南250012 [8]黑龙江省中医药科学院心病科,哈尔滨150036 [9]杭州市富阳区中医医院心血管科,杭州311499 [10]湖南中医药研究院附属医院心血管科,长沙410006 [11]陕西中医药大学附属医院心血管科,西安712021 [12]淮南朝阳医院心脏内科,淮南232002 [13]靖江市中医院老年病科,靖江214599 [14]南通市中医院心血管内科,南通226001 [15]姜堰市中医院心血管病科,姜堰225599 [16]天津医科大学总医院中医科,天津300070 [17]如皋市中医院心血管内科,如皋226599 [18]淮安市中医院心血管科,淮安223001 [19]河南中医学院第二附属医院心病科,郑州450002 [20]南京医科大学第二附属医院心血管内科,南京210011 [21]黑龙江中医药大学附属第一医院心血管病科,哈尔滨150040 [22]吉林省中医药科学院第一临床医院心病科,长春130021 [23]西安市中医院心病科,西安710004 [24]贵阳市第二人民医院心内科,贵阳550081 [25]长春中医药大学附属医院心病中心,长春130021 [26]广州市中医医院心血管科,广州510130 [27]山东中医药大学第二附属医院心血管病科,济南250001 [28]黑龙江中医药大学附属第二医院心病科,哈尔滨150001 [29]上海中医药大学附属龙华医院心病科,上海200032 [30]新疆医科大学第一附属医院心脏中心-高血压科,乌鲁木齐830054 [31]贵州医科大学第二附属医院心血管内科,凯里556000 [32]天津中医药大学第二附属医院心血管科,天津300150 [33]贵阳中医学院第一附属医院心内科,贵阳550001 [34]灌南县人民医院心内科

出　　处：《中国循证心血管医学杂志》2019年第10期1183-1187,共5页Chinese Journal of Evidence-Based Cardiovascular Medicine

基　　金：贵州省重大科技专项资助(黔科合【2016】支撑2911);贵阳市科技计划项目(筑科合同【2017】29-1号)

摘　　要：目的系统阐明理气活血滴丸在冠心病慢性稳定性心绞痛合并糖尿病人群广泛使用条件下的安全性和有效性。方法2016年3月至2017年8月于上海长征医院等全国41家中心随机纳入冠心病慢性稳定型心绞痛患者2433例,口服理气活血滴丸,每次10粒,3/d,连服4周治疗,合并糖尿病患者有效性、安全性和生活质量等指标的分析。结果服用4周后,合并糖尿病患者心绞痛症状有效率70.80%,硝酸甘油停减率83.00%,心电图疗效有效率70.30%。合并糖尿病患者新发生不良事件208例。和筛选期相比,治疗4周后患者生活质量显著提高(P<0.001)。结论理气活血滴丸治疗冠心病稳定性心绞痛合并糖尿病人群疗效可靠,安全性好,患者生活质量明显提高,值得临床推广应用。Objective To clarify the safety and efficacy of Liqi Huoxue Gutta Pills in extensive administration in population with chronic stable angina pectoris(SAP)of coronary heart disease(CHD)complicated by diabetes.Methods The patients with chronic SAP of CHD(n=2433)were randomly chosen from 41 medical units including Shanghai Changzheng Hospital from Mar.2016 to Aug.2017.All patients were treated with Liqi Huoxue Gutta Pills 10 pills a time and 3 times a day for 4 weeks.The indexes of efficacy and safety of Liqi Huoxue Gutta Pills and quality of life(QOL)of patients were analyzed.Results After 4 weeks,the effective rate for symptoms of angina pectoris was 70.80%,stopping or reducing rate of nitroglycerin was 83.00%and effective rate of electrocardiogram curative effect was 70.30%in patients with chronic SAP of CHD complicated by diabetes.There were 208 cases with new adverse events.QOL was significantly improved after treatment for 4 weeks compared with screening period(P<0.001).Conclusion Liqi Huoxue Gutta Pills has reliable curative effect and higher safety in population patients with chronic SAP of CHD complicated by diabetes and patients’QOL is significantly improved,which is well worth clinical application.

关 键 词：理气活血滴丸 Ⅳ期临床研究 稳定型心绞痛 冠心病 糖尿病 

分 类 号：R541.4[医药卫生—心血管疾病]