益气通脉口服液治疗冠心病心绞痛的多中心随机双盲临床研究  

Multicentric randomized double blinded clinical study of Yiqi Tongmai Oral Liquid against angina pectoris in patients with coronary heart disease

作　　者：张硕[1] 宋衍芹[2] 岳旺[1] 毛兴荣 鞠传霞[1] 董梦久[4] 郑琼莉[5] 戴小华[6] 李忠业[7] 王莎萍 

机构地区：[1]青岛大学医学院药学系 [2]青岛市市立医院东部医院,山东青岛266071 [3]四川奇力药物研究所临床研究部,四川成都610031 [4]湖北中医学院附属医院心内科,湖北武汉430065 [5]武汉市中西医结合医院心内科,湖北武汉430000 [6]安徽中医学院第一医院心内科,安徽合肥230031 [7]广西中医学院第一医院心内科,广西南宁530000 [8]陕西省中医研究院附属医院心内科,陕西西安710000

出　　处：《中西医结合学报》2007年第4期383-391,共9页Journal of Chinese Integrative Medicine

摘　　要：目的:评价益气通脉口服液治疗冠心病心绞痛的临床疗效及其安全性。方法:采用多中心、随机、双盲、平行对照的方法,选择冠心病心绞痛气虚血瘀证型患者110例为试验组,予以益气通脉口服液治疗;109例为阳性对照组,予以舒心口服液治疗。疗效性指标为:临床显效率、有效率;心绞痛发作次数、持续时间;心电图;血脂指标;血流变学指标;于第0、1、2、3、4周定期观察气虚血瘀证型中医症候指征。安全性指标为:一般体格检查项目;血、尿、大便常规;肝、肾功能检查;不良反应监测。结果:试验组和阳性对照组的总有效率分别为91.82%和85.32%,差异无统计学意义(P>0.05);从显效、有效、无效的分布看,试验组的疗效明显优于阳性对照组(P<0.01)。两药均明显降低心绞痛发作次数和持续时间(P<0.01)、冠状动脉造影阳性率(P<0.05)以及平板运动试验阳性率(P<0.01);试验药物降低心绞痛发作次数和持续时间的效果优于阳性对照药(P<0.05);而两药降低冠状动脉造影阳性率、平板运动试验阳性率的效果差异无统计学意义(P>0.05)。两组心电图疗效及分布无明显差别(P>0.05)。两药均明显降低血清胆固醇、甘油三酯和低密度脂蛋白水平(P<0.05);试验药控制血清胆固醇、甘油三酯和低密度脂蛋白的效果优于阳性对照药(P<0.05)。两药均明显降低全血黏度、高切还原黏度、低切还原黏度、红细胞聚集指数、红细胞刚性指数、纤维蛋白原、血沉(P<0.05);试验药降低全血黏度、高切还原黏度、低切还原黏度、红细胞聚集指数、纤维蛋白原的作用优于阳性对照药(P<0.05)。对于胸痛、胸闷、气短、心悸、疲倦乏力、面色紫黯和自汗等中医症候指征,两组均表现出明显的改善作用和趋势(P<0.05);对于改善胸闷、心悸、疲倦乏力和自汗等症状,试验组的效果优于阳性对照组(P<0.05);试验组具有更明显降低症候�Objective： To study the efficacy and safety of Yiqi Tongmai Oral Liquid （YQTM）, a traditional compound Chinese herbal medicine, in treating angina pectoris in patients with coronary heart disease. Methods： A multicentric, randomized, double blinded and paralleled controlled trial was conducted on 110 patients in trial group treated with YQTM, and 109 patients in control group treated with Shuxin Oral Liquid （SX）. Cure and effective rates in both groups were evaluated. Frequency and duration of angina attack were counted and measured. Coronary angiography （CAG）, electrocardiogram （ECG） and flat exercise test were taken in both groups. Blood lipid indexes, such as cholesterol （CH）, triglyceride （TG）, low-density lipoprotein （LDL）, high density lipoprotein （HDL）, were determined at pre- and post-treatment. The hemodynamic indexes, such as whole blood viscosity （J2）, high-shear reduced viscosity （Eh）, low-shear reduced viscosity （El）, red cell aggregation index （Lb）, red cell rigidity index （Rh）, fibrinogen （Fb）, blood sedimentation rate （BSR） and hematocrit （HCT）, were determined at pre-and post-treatment. The indicated scores of symptoms and signs of traditional Chinese medicine （TCM） pattern, such as chest pain, chest constriction, breath shortness, palpitation, fatigue, dim complexion, spontaneous perspiration and tongue proper, tongue coating were evaluated in week 0, 1, 2, 3, 4 during the treatment course. The safety indexes, such as body temperature, pulse, respiration and blood pressure were observed. Routine tests of blood, urine and stool, hepatic function test and renal function test were taken at pre- and post-treatment. Results： There was no significant difference between the total effective rate of the trial group and that of the control group, which were 91.82% and 85.32%, respectively （P〉0.05）. Trial group＇s percentile of cure rate is significantly higher than that of the control group （P〈0.01）. The frequency and

关 键 词：冠心病 心绞痛 多中心研究 随机对照试验 双盲法 

分 类 号：R259[医药卫生—中西医结合]