芪苈强心胶囊治疗心肾阳虚证慢性心力衰竭的临床研究  

Clinical Study of Qili Qiangxin Capsule in the Treatment of Chronic Heart Failure Patients with Heart-kidney Yang Deficiency Syndrome

作　　者：王菲[1] 阮小芬[1] 邓兵[2] 邓中龙[3] 关敬树 李益萍[1] 王肖龙[1] WANG Fei;RUAN Xiaofen;DENG Bing;DENG Zhonglong;GUAN Jingshu;LI Yiping;WANG Xiaolong(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Branch of National Clinical Research Center for Chinese Medicine Cardiology,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院,国家中医心血管病临床医学研究中心分中心,上海201203 [2]上海中医药大学附属龙华医院 [3]上海中医药大学附属岳阳中西医结合医院 [4]上海市宝山中西医结合医院

出　　处：《中西医结合心脑血管病杂志》2021年第9期1436-1440,共5页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：国家自然科学基金面上项目(No.81573647,82074222);国家自然科学基金青年科学基金项目(No.81803887);上海市中医临床重点实验室(No.14DZ2273200);上海市科委引导类项目(No.19401934300);上海市卫健委中医药事业发展三年行动计划[No.ZY(2018-2020)-CCCX-2003-07];上海市临床重点专科(中医心病科)(No.shslczdzk05301)。

摘　　要：目的观察芪苈强心胶囊治疗心肾阳虚证慢性心力衰竭的临床疗效。方法采用随机、双盲、多中心、安慰剂对照的研究方法,将72例中医辨证为心肾阳虚证的慢性心力衰竭病人随机分为芪苈强心胶囊组(试验组)、安慰剂组(对照组),每组36例。两组均给予治疗慢性心力衰竭的标准药物,在此基础上,试验组加用芪苈强心胶囊,对照组加用安慰剂,用药6个月并继续随访6个月,观察治疗前后病人中医证候积分、中医证候疗效、纽约心脏病协会(NYHA)心功能分级、6 min步行距离(6MWD)、明尼苏达生活质量评分(MLHFQ)、左心室射血分数(LVEF)、B型脑钠肽(BNP);6个月后电话随访因心力衰竭加重的再住院人数和再住院次数。结果治疗后,两组中医证候积分均较治疗前降低(P<0.01),且试验组治疗后3个月、6个月中医证候积分均低于对照组(P<0.05);试验组3个月、6个月中医证候疗效总有效率高于对照组(P<0.05);试验组治疗后6个月MLHFQ评分、NYHA分级、BNP水平低于对照组(P<0.05),6MWD高于对照组(P<0.05);试验组治疗后LVEF高于治疗前(P<0.05);试验组因心力衰竭加重住院率明显低于对照组(χ^(2)=4.126,P<0.05)。结论在常规西药治疗基础上加用芪苈强心胶囊,可以降低慢性心力衰竭病人中医证候积分,提高病人生活质量及活动耐量,降低血浆BNP水平,改善病人心脏功能,减少因心力衰竭加重再住院的次数。Objective To observe the intervention effect of Qili Qiangxin Capsule(QL)in the treatment of chronic heart failure(CHF)patients with heart-kidney Yang deficiency syndrome.Methods A randomized,doubled-blind,placebo-controlled,multicenter clinical trial was operated.CHF patients with traditional Chinese medicine(TCM)syndrome of heart-kidney yang deficiency were randomly divided into the QL intervention group(experimental group)and the placebo group(control group),with 36 cases in each group.All patients undertook routine therapy of CHF,while the patients in experimental group was given QL,the patients in control group was given placebo.After 6 months treatment and another 6 months of follow-up,TCM symptoms scores,the efficacy of TCM syndromes,New York Heart Association(NYHA)functional class,6 minutes walking distance(6MWD),Minnesota Living with Heart Failure Questionnaire Index(MLHFQ)scores,left ventricular ejection fraction(LVEF),B-type natriuretic peptide(BNP),and the number of re-hospitalizations due to aggravation of heart failure were observed.Results After treatment,the TCM symptoms scores in the two groups were lower than those before treatment(P<0.01),and the TCM symptoms scores in experimental group were lower than those in control group after 3 months and 6 months treatment(P<0.05).The total effective rate of TCM symptoms in experimental group was higher than that in control group after 3 months and 6 months(P<0.05).MLHFQ scores,NYHA functional class,and the level of BNP in the two groups were lower than those before treatment,and the indexes in experimental group were lower than those in control group(P<0.05).6MWD in the two groups was higher than that before treatment,and 6MWD in experimental group was higher than that in control group(P<0.05).After treatment,LVEF in experimental group was higher than that before treatment(P<0.05).During the follow-up visit,the rate of re-hospitalizations due to aggravation of heart failure in experimental groups was lower than that in control group(χ^(2)=4.126,P<0.05)

关 键 词：慢性心力衰竭 心肾阳虚证 芪苈强心胶囊 中医证候 心功能 B型脑钠肽 

分 类 号：R54[医药卫生—心血管疾病]