复方鹿角合剂治疗慢性心力衰竭的随机双盲对照研究  

Clinical Effect of “Compound Antler Mixture” in the Treatment of Chronic Heart Failure: A Randomized Double-blinded Controlled Trial

作　　者：王咏[1] 徐基节 刘永明[1] 瞿慧燕 尹琴[1] 周耀中[1] 黄牧华[1] 周华[1] 

机构地区：[1]上海中医药大学附属曙光医院心内科,上海201203

出　　处：《上海中医药大学学报》2016年第4期12-17,共6页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：国家自然科学基金面上项目(81373625);国家自然科学基金青年科学基金资助项目(81403363)

摘　　要：目的:评价复方鹿角合剂治疗慢性心力衰竭(chronic heart failure,CHF)的临床疗效。方法:采用随机、双盲、安慰剂平行对照的方法,将264例心肾阳虚型慢性心力衰竭患者随机分为治疗组(132例)和对照组(132例)。两组均给予西医常规治疗,在此基础上治疗组加用复方鹿角合剂口服,对照组加用安慰剂口服,治疗周期为28 d。评价两组患者的中医证候疗效、美国纽约心脏病协会(New York Heart Association,NYHA)心功能分级疗效,比较两组患者的6 min步行距离(6 minute walk distance,6MWD)、明尼苏达生活质量量表(Minnesota Living With Heart Failure Questionnaire,MLHFQ)评分、左心室射血分数(left ventricular ejection fraction,LVEF)及地高辛和利尿剂减停率。结果:治疗4周末,治疗组的中医证候疗效总有效率为19.8%,对照组为15.3%,两组比较差异无统计学意义(P>0.01);治疗12周末,治疗组的总有效率为65.3%,对照组为18.5%,治疗组疗效优于对照组(P<0.01)。治疗4周末,治疗组的NYHA心功能分级疗效总有效率为19.1%,对照组为6.4%,治疗组疗效优于对照组(P<0.01);治疗12周末,治疗组的总有效率为74.4%,对照组为45.1%,治疗组疗效亦优于对照组(P<0.01)。治疗4周末、12周末,两组患者的6MWD较治疗前均明显延长(P<0.01),且治疗12周末,治疗组患者的6MWD明显长于对照组(P<0.01)。治疗12周末,治疗组患者的MLHFQ评分较治疗前及治疗4周末均明显降低(P<0.01),且治疗组患者的MLHFQ评分明显低于对照组(P<0.01)。治疗12周末,两组患者的LVEF较治疗前均显著升高(P<0.01),但两组的LVEF组间比较,其差异无统计学意义(P>0.01)。治疗12周末,治疗组患者地高辛的减停率为84.0%,对照组为46.9%,两组比较差异有统计学意义(P<0.01);治疗组患者利尿剂的减停率为86.4%,对照组为58.1%,两组比较差异有统计学意义(P<0.01)。结论:复方鹿角合剂结合西医常规疗法治疗CHF可明显缓解患者的临床症状Objective： To evaluate the efficacy of ＂Compound Antler Mixture＂in the treatment of chronic heart failure（ CHF）. Methods： A randomized,double-blinded,placebo controlled trial was performed. 264 patients with CHF of heartkidney yang deficiency syndrome were randomly divided into the treatment group（ 132 cases） and the control group（ 132cases）. All the patients were treated with conventional western medicine,the patients in the treatment group were treated with＂Compound Antler Mixture＂orally and the patients in the control group were treated with placebo orally based on above,with a course of 28 days. The effect of Chinese medical syndrome and the cardiac functional grade effect according to New York Heart Association（ NYHA） were evaluated,the 6 minute walk distance（ 6MWD）,Minnesota Living With Heart Failure Questionnaire（ MLHFQ） scores,left ventricular ejection fraction（ LVEF） and the ratio of dosage reduction and withdrawal of digoxin and diuretics were compared. Results： After treatment of 4 weeks,the total effective rates on the effect of Chinese medical syndrome in the treatment group and the control group were 19. 8% and 15. 3% respectively,with no statistical difference between the two groups（ P 〉 0. 01）; after treatment of 12 weeks,the total effective rates in the treatment group and the control group were 65. 3% and 18. 5% respectively,and the effect of the treatment group was better than that of the control group（ P 〈 0. 01）. After treatment of 4 weeks,the total effective rates on NYHA cardiac functional grade effect in the treatment group and the control group were 19. 1% and 6. 4% respectively,and the effect of the treatment group was better than that of the control group（ P 〈 0. 01）; after treatment of 12 weeks,the total effective rates in the treatment group and the control group were 74. 4% and 45. 1% respectively,and the effect of the treatment group was better than that of the control group（ P 〈 0. 01）. After treatment of 4 weeks and

关 键 词：复方鹿角合剂 慢性心力衰竭 心肾阳虚型 随机对照双盲试验 

分 类 号：R259[医药卫生—中西医结合]