维药养心达瓦依米西克蜜膏治疗稳定型心绞痛气滞血瘀证279例——一项随机、双盲、阳性药对照、多中心临床研究  

Uyghur Medicine Yangxin Dawayimixike Honey Paste(养心达瓦依米西克蜜膏)in Treatment of 279 Cases Stable Angina Pectoris Patients with Qi Stagnation and Blood Stasis Syndrome:A Multi-center,Double-blind,Positive-controlled Randomized Clinical Trial

作　　者：姜丙华[1] 范立华 王晓峰 宋颖民 张彦来 乔松彦 董静 靳丽华 丁艳萍 买尼沙·买买提[10] 赵继先[11] 高东升 赵秋平 关玲霞 孙鸿彬 林梅瑟[16] 王恒亮 李军[18] JIANG Binghua;FAN Lihua;WANG Xiaofeng;SONG Yingmin;ZHANG Yanlai;QIAO Songyan;DONG Jing;JIN Lihua;DING Yanping;Mainisha·Maimaiti;ZHAO Jixian;GAO Dongsheng;ZHAO Qiuping;GUAN Lingxia;SUN Hongbin;LIN Meise;WANG Hengliang;LI Jun(The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan,250001;Third Affiliated Hospital of Henan University of Traditional Chinese Medicine;Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine;Luohe City Hospital of Chinese Medicine,Henan Province;Zhoukou City Hospital of Traditional Chinese Medicine,Henan Province;Nanyang City Hospital of Traditional Chinese Medicine,Henan Province;The Second Affiliated Hospital of Shanxi University of Chinese Medicine;Dandong First Hospital,Liaoning Province;Luoyang Hospital of Traditional Chinese Medicine,Henan Province;Hospital of Xinjiang Traditional Uyghur Medicine;Shiyan Renmin Hospital,Hubei Province;Luoyang Second Hospital of Traditional Chinese Medicine,Henan Province;Fuwai Central China Cardiovascular Hospital,Henan Province;Zhumadian TCM Hospital,Henan Province;The Second People's Hospital of Pingdingshan,Henan Province;Wenzhou Traditional Chinese Medicine Hospital,Zhejiang Province;Xinxiang Central Hospital,Henan Province;Guang'anmen Hospital,China Academy of Chinese Medical Sciences)

机构地区：[1]山东中医药大学第二附属医院,山东省济南市250001 [2]河南中医药大学第三附属医院 [3]新疆维吾尔自治区中医医院 [4]河南省漯河市中医院 [5]河南省周口市中医院 [6]河南省南阳市中医院 [7]陕西中医药大学第二附属医院 [8]辽宁省丹东市第一医院 [9]河南省洛阳市中医院 [10]新疆维吾尔自治区维吾尔医医院 [11]湖北省十堰市人民医院 [12]河南省洛阳市第二中医院 [13]河南省阜外华中心血管病医院 [14]河南省驻马店市中医院 [15]河南省平顶山市第二人民医院 [16]浙江省温州市中医院 [17]河南省新乡市中心医院 [18]中国中医科学院广安门医院

出　　处：《中医杂志》2024年第21期2225-2233,共9页Journal of Traditional Chinese Medicine

基　　金：国家科技重大专项(民口)课题(2018ZX09303-021)。

摘　　要：目的 观察维药养心达瓦依米西克蜜膏治疗稳定型心绞痛气滞血瘀证的临床疗效和安全性。方法采用随机、双盲、阳性药对照、多中心的临床研究方法,将370例稳定型心绞痛气滞血瘀证患者按照3∶1比例分为治疗组279例,对照组91例。治疗组给予养心达瓦依米西克蜜膏(每次3 g)和血府逐瘀胶囊模拟剂(每次2.4 g)口服,对照组给予血府逐瘀胶囊(每次2.4 g)和养心达瓦依米西克蜜膏模拟剂(每次3 g)口服,均每天2次,疗程为12周。两组主要疗效指标为心绞痛症状疗效,次要疗效指标包括治疗前后心绞痛单项症状评分(发作次数、发作持续时间、疼痛程度及硝酸甘油服用量评分)和心绞痛症状总积分,硝酸甘油服用量,平板运动试验的运动持续时间及DUKE (杜克)评分的患者分布情况,西雅图心绞痛量表评分(包括躯体活动受限程度、心绞痛稳定状态、心绞痛发作情况、治疗满意程度、疾病认知程度5个维度),并观察治疗后中医证候疗效和中医单项症状疗效,通过血常规、尿常规、肝功能、肾功能、空腹血糖、心电图、不良事件发生情况等评估安全性。结果 治疗组心绞痛症状疗效总有效率为71.68%(200/279),明显高于对照组的总有效率51.65%(47/91,P<0.01);治疗组中医证候疗效愈显率为53.05%(148/279),明显高于对照组的愈显率25.27%(23/91,P<0.01)。与本组治疗前比较,治疗后两组心绞痛发作次数评分、发作持续时间评分及疼痛程度评分,心绞痛症状总积分,硝酸甘油服用量均降低,且治疗组治疗后上述指标改善程度均优于对照组;治疗后两组躯体活动受限程度、心绞痛稳定状态、心绞痛发作情况、治疗满意程度、疾病认知程度评分均升高,且治疗组治疗后在升高心绞痛稳定状态、心绞痛发作情况、治疗满意程度评分方面优于对照组(P<0.05或P<0.01)。治疗后治疗组中医单项症状胸痛、胸闷、心悸、气Objective To observe the efficacy and safety of Uyghur medicine Yangxin Dawayimixike Honey Paste(养心达瓦依米西克蜜膏,YDMHP)in the treatment of stable angina pectoris(SAP)of qi stagnation and blood stasis syndrome.Methods A randomized,double-blind,positive-controlled,multi-center clinical trial was conducted,in which 370 patients with SAP of qi stagnation and blood stasis syndrome were randomly divided into treatment group(279 cases)and control group(91cases)at a ratio of 3∶1.The treatment group was orally administered with YDMHP,3 g each time,and placebo of Xuefu Zhuyu Capsule(血府逐瘀胶囊),2.4 g each time,while the control group was treated with Xuefu Zhuyu Capsule,2.4 g each time,and placebo of YDMHP,3 g each time,both twice a day for a course of 12 weeks.The primary outcome was the effect of angina pectoris symptom.The secondary outcomes include single angina symptom scores such as number of attacks,duration of attacks,pain intensity and usae of nitroglycerin scores,the total angina symptom score before and after the treatment,the usage of nitroglycerin,the exercise duration in treadmill exercise test(TET)and the Duck treadmill score among patients,the scores of Seattle Angina Questionnaire(SAQ)on five dimensions including physical limitations,anginal stability,anginal frequency,treatment satisfaction,and disease perception,and efficacy of TCM syndrome and of each single TCM symptom after treatment.The safety were evaluated by examine blood routine,urine routine,liver and kidney function,fasting blood sugar,electrocardiogram,adverse events.Results The total effective rate of angina symptom in the treatment group was 71.69%(200/279),significantly higher than 51.64%(47/91)in the control group(P<0.01).The curative and markedly effective rate of TCM syndrome in the treatment group was 53.05%(148/279),which was significantly higher than 25.27%(23/91)in the control group(P<0.01).After treatment,scores of the number as well as duration of angina attacks and pain severity,the total score of angina s

关 键 词：稳定型心绞痛 气滞血瘀证 养心达瓦依米西克蜜膏 平板运动试验 西雅图心绞痛量表 

分 类 号：R259[医药卫生—中西医结合]