心可舒片对冠心病心功能不全的疗效非劣效随机对照试验  

Effect of Xinkeshu on Cardiac Dysfunction in Coronary Heart Disease

作　　者：曹瑞 徐梓铭 朱晓睿 周建冠 张君 王小女 管霞飞 郭艳[2] CAO Rui;XU Ziming;ZHU Xiaorui;ZHOU Jianguan;ZHANG Jun;WANG Xiaonyv;GUAN Xiafei;GUO Yan(Nanjing Pukou District Hospital of Traditional Chinese Medicine,Nanjing 210000,Jiangsu,China;Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences,Beijing 100091,China;Ruian Hospital of Traditional Chinese Medicine,Ruian 325200,Zhejiang,China)

机构地区：[1]南京市浦口区中医院,南京210000 [2]中国中医科学院西苑医院,北京100091 [3]瑞安市中医院,浙江瑞安325200

出　　处：《中西医结合心脑血管病杂志》2024年第20期3675-3681,共7页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：2022年度沃华科研基金-重点项目(No.BYPDF2212218)。

摘　　要：目的:探讨心可舒片治疗冠心病心功能不全的疗效。方法:将确诊冠心病心功能不全病人30例按完全随机数字表法随机分为对照组(15例)与试验组(15例)。对照组接受常规药物治疗加安慰剂,试验组接受常规药物治疗联合心可舒片,共治疗8周。检测血清脑钠肽(BNP)、左心室射血分数(LVEF)、6 min步行试验(6MWT)。比较治疗前、中、后两组心功能。采用明尼苏达州心功能不全生命质量评价表(MLHFQ)评价生活质量,并观察安全性。结果:治疗前,两组一般资料、6MWT、MLHFQ评分、BNP水平、LVEF比较差异均无统计学意义(P>0.05)。治疗4周时,两组6MWT、MLHFQ评分均较治疗前改善,对照组治疗前后比较差异无统计学意义(P>0.05),试验组治疗前后比较差异有统计学意义(P<0.05),且试验组6MWT较对照组更优(P<0.05)。治疗8周后两组6MWT、MLHFQ评分均较治疗前改善(P<0.05),试验组6MWT、MLHFQ评分较对照组更优(P<0.05);对照组BNP较治疗前无明显下降(P>0.05),试验组BNP较治疗前下降(P<0.05),且试验组低于对照组(P<0.05);两组LVEF较治疗前无明显提高(P>0.05),两组组间比较差异无统计学意义(P>0.05)。与对照组相比,试验组治疗8周后血常规、肝肾功能指标无明显变化,两组均未见明显不良反应。结论:冠心病心功能不全病人采用常规药物治疗联合心可舒片,相比常规药物治疗,能够在更短时间内更好地改善以心血瘀阻为主要病机的冠心病心功能不全病人的心功能,提高生命质量,且具有较好安全性。Objective:To investigate the effect of Xinkeshu on cardiac dysfunction in patients with coronary heart disease.Methods:Thirty patients with cardiac insufficiency diagnosed as coronary heart disease were randomly divided into control group(15 cases)and observation group(15 cases)according to the complete random number method.The patients in control group received conventional drug treatment combined with placebo,while the patients in observation group received conventional drug treatment combined with Xinkeshu tablets for 8 weeks.The cardiac function of the two groups before,during,and after treatment was compared:serum brain natriuretic peptide(BNP),left ventricular ejection fraction(LVEF),and 6-minute walk test(6MWT).The Minnesota Living with Heart Failure Questionnaire(MLHFQ)were used to evaluate the quality of life,and the safety was observed.Results:Before treatment,there was no significant difference in general information,6MWT,MLJFQ score,BNP level,and LVEF between the two groups of patients(P>0.05).During 4 weeks of treatment,the 6MWT and MLJFQ scores of both groups were improved compared to those before treatment,these data were no significant difference in the control group(P>0.05),while,these data were significant difference in the observation group(P<0.05).The 6MWT score of the observation group was better than that of the control group(P<0.05).After 8 weeks of treatment,the 6MWT and MLJFQ scores of both groups were improved compared to that before treatment(P<0.05),and the 6MWT and MLJFQ scores of the observation group were better than those of the control group(P<0.05).After 8 weeks of treatment,there was no significant decrease in BNP in the control group compared to before treatment(P>0.05).However,BNP in the observation group decreased significantly compared to those before treatment(P<0.05)and was lower than that in the control group(P<0.05).After 8 weeks of treatment,there was no significant improvement in LVEF in two groups compared to that before treatment(P>0.05),and there was no statisticall

关 键 词：冠心病 心功能不全 心可舒片 血清脑钠肽 左心室射血分数 6 min步行试验 

分 类 号：R541.4[医药卫生—心血管疾病]