芪附益心方治疗慢性心力衰竭心气虚证患者的临床疗效  

Clinical Effect of Qifu Yixin Prescription on Chronic Heart Failure in Patients with Syndrome of Heart Qi Deficiency

作　　者：徐朝辉 钟逸航 史天云 杨佳慧 柳智瑞 万琪琪 刘永明[1,2] XU Zhaohui;ZHONG Yihang;SHI Tianyun;YANG Jiahui;LIU Zhirui;WAN Qiqi;LIU Yongming(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(TCM),Shanghai 201203,China;Anhui Provincial Hospital of Integrated Medicine,Anhui Hospital of Shuguang Hospital Affiliated to Shanghai University of TCM,Hefei 230011,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]安徽省中西医结合医院,上海中医药大学附属曙光医院安徽医院,合肥230011

出　　处：《中国实验方剂学杂志》2023年第23期98-105,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(81973611);西医学习中医优秀人才研修项目(国中医药人教教育便函[2020]184号);安徽省中医药管理局中医优势病种诊疗能力建设项目;安徽省中医药管理局长三角名中医工作室建设项目;上海市卫生健康委员会科研项目(202340158)。

摘　　要：目的:探讨芪附益心方治疗慢性心力衰竭(简称慢性心衰)心气虚证患者的临床疗效及安全性,为芪附益心方治疗慢性心衰提供客观的、科学的临床证据,旨在推动芪附益心方的临床应用和转化。方法:选取上海中医药大学附属曙光医院2022年9月至2023年5月符合标准的慢性心衰心气虚证患者106例,随机分为观察组及对照组(每组各53例)。两组均予以慢性心衰西医常规治疗,观察组在此基础上予以芪附益心方加载治疗,对照组则予以安慰剂,治疗疗程为12周。通过观察患者治疗前后纽约心脏协会(NYHA)心功能分级、N末端B型脑钠肽前体(NT-proBNP)、可溶性生长刺激表达基因蛋白2(sST2)、左室射血分数(LVEF)、舒张早期二尖瓣血流最大流速(E)与舒张早期二尖瓣环运动速度(e')的比值(E/e')、左心室舒张末期内径(LVEDD)、中医证候积分、运动耐量评价指标6 min步行试验(6MWT)、生活质量评价指标明尼苏达心力衰竭生活质量调查表(MLHFQ)和堪萨斯心肌病患者生活质量量表(KCCQ)及其他安全性指标。结果:最终完成试验观察病例102例,观察组和对照组各51例;观察组治疗后心功能分级改善显效及有效患者42例,总有效率为82.35%;对照组治疗后心功能分级改善显效及有效患者32例,总有效率为62.75%,观察组治疗后心功能疗效总有效率明显优于对照组(χ^(2)=4.923,P<0.05);观察组降低NT-proBNP水平明显优于对照组(P<0.05);观察组升高LVEF及降低E/e'程度明显优于对照组(P<0.05);观察组降低LVEDD及sST2水平明显优于对照组(P<0.05);观察组中医证候改善程度明显优于对照组(P<0.05);观察组对于运动耐量(6MWT)及生活质量(MLHFQ评分、KCCQ评分)的改善程度均明显优于对照组(P<0.05)。两组患者治疗前后各项安全性指标均未出现明显异常,未发现不良事件。结论:芪附益心方能显著改善慢性心衰心气虚证患者的心功能、中医证候、运�Objective:To explore the clinical efficacy and safety of Qifu Yixin prescription in treating chronic heart failure in the patients with the syndrome of heart Qi deficiency,so as to provide clinical evidence for the treatment of chronic heart failure with this prescription and promote the clinical application and transformation of this prescription.Method:A total of 106 chronic heart failure patients with the syndrome of heart Qi deficiency who met the criteria in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(TCM)from September 2022 to May 2023 were selected and randomized into an observation group(53 cases)and a control group(53 cases).Both groups received routine Western medicine treatment.In addition,the observation group received Qifu Yixin prescription,while the control group received placebo.The treatment course for both groups was 12 weeks.The New York heart association(NYHA)cardiac function grading,N-terminal pro-B-type natriuretic peptide(NT-proBNP),soluble growth-stimulating expression gene 2(sST2),left ventricular ejection fraction(LVEF),the ratio of early diastolic maximum mitral flow velocity(E)to early diastolic mitral annular motion velocity(e')(E/e'),left ventricular end diastolic diameter(LVEDD),TCM syndrome scores,6-minute walking test(6MWT),Minnesota Living with Heart Failure Questionnaire(MLHFQ),and Kansas City Cardiomyopathy Questionnaire(KCCQ)were determined before and after treatment.Result:Finally,102 patients were included for analysis,including 51 patients in the observation group and 51 patients in the control group.After treatment,42 patients in the observation group showed improved cardiac function grading,with a total response rate of 82.35%,and 32 patients in the control group showed improved cardiac function grading,with a total response rate of 62.75%.The total response rate regarding the cardiac function in the observation group was higher than that in the control group(χ^(2)=4.923,P<0.05).The observation group outperformed the control group

关 键 词：慢性心力衰竭 心气虚证 芪附益心方 心肌纤维化 临床疗效 

分 类 号：R2-0[医药卫生—中医学] R22R242R287