A Multicenter,Randomized,Double-Blind,Placebo-Controlled Study of Syndrome Differentiation Combined with Western Medicine in the Treatment of Chronic Heart Failure

ZHU Mingjun; WANG Yongxia; LI Bin; DU Tinghai; ZHU Cuiling; ZHU Chulin; LIU Xincan; CHENG Jiangtao; WANG Zhentao; WANG Shoufu; WANG Liuyi; LUO Qingju; PENG Guangcao; XING Dongmei

doi:10.13288/j.11-2166/r.2019.21.008

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A Multicenter,Randomized,Double-Blind,Placebo-Controlled Study of Syndrome Differentiation Combined with Western Medicine in the Treatment of Chronic Heart Failure

更新时间：2021-11-10

- A Multicenter,Randomized,Double-Blind,Placebo-Controlled Study of Syndrome Differentiation Combined with Western Medicine in the Treatment of Chronic Heart Failure
- Journal of Traditional Chinese Medicine Vol. 60, Issue 21, Pages: 1843-1848(2019)
- 作者机构：
  
  1. 河南中医药大学第一附属医院
  2. 阜外华中心血管病医院
  3. 河南省中医院
  4. 河南省中医药研究院
  5. 河南省人民医院
  6. 郑州市中医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2019.21.008
  CLC： R541.6
- Published：2019
- 稿件说明：
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[1]朱明军,王永霞,李彬,杜廷海,朱翠玲,朱初麟,刘新灿,程江涛,王振涛,王守富,王留义,罗清菊,彭广操,邢冬梅.参附益心颗粒辨证联合西药治疗慢性心力衰竭的多中心、随机、双盲、安慰剂对照研究[J].中医杂志,2019,60(21):1843-1848.

ZHU Mingjun, WANG Yongxia, LI Bin, et al. A Multicenter,Randomized,Double-Blind,Placebo-Controlled Study of Syndrome Differentiation Combined with Western Medicine in the Treatment of Chronic Heart Failure[J]. Journal of Traditional Chinese Medicine2019, 60(21): 1843-1848.
[1]朱明军,王永霞,李彬,杜廷海,朱翠玲,朱初麟,刘新灿,程江涛,王振涛,王守富,王留义,罗清菊,彭广操,邢冬梅.参附益心颗粒辨证联合西药治疗慢性心力衰竭的多中心、随机、双盲、安慰剂对照研究[J].中医杂志,2019,60(21):1843-1848. DOI： 10.13288/j.11-2166/r.2019.21.008.

ZHU Mingjun, WANG Yongxia, LI Bin, et al. A Multicenter,Randomized,Double-Blind,Placebo-Controlled Study of Syndrome Differentiation Combined with Western Medicine in the Treatment of Chronic Heart Failure[J]. Journal of Traditional Chinese Medicine2019, 60(21): 1843-1848. DOI： 10.13288/j.11-2166/r.2019.21.008.

摘要

目的评价参附益心颗粒辨证治疗慢性心力衰竭（CHF）的有效性和安全性。方法采用多中心、随机、双盲、安慰剂对照的方法

将300例CHF患者随机分为治疗组151例和对照组149例。在健康教育基础上

治疗组采用西医规范治疗加中医辨证治疗

分心气（阳）虚、心血瘀阻

心阳亏虚、痰瘀互阻两型

分别给予参附益心颗粒及参附益心颗粒加味

对照组采用西医规范治疗加治疗组中药的模拟药。两组均治疗6个月。比较两组患者治疗前及治疗3、6个月射血分数（EF）、中医证候评分、6分钟步行距离（6MWD）、明尼苏达心力衰竭生活质量调查表（MLHF-Q）评分

并进行心功能疗效和中医证候疗效评价

同时进行安全性评价。结果治疗组心功能疗效总有效率为82. 4%

对照组为54. 26%;治疗组中医证候疗效总有效率为93. 55%

对照组为59. 23%

治疗组心功能疗效及中医证候疗效均优于对照组（P <0. 01）。与本组治疗前比较

两组患者治疗3个月、6个月EF、6MWD均较治疗前增加

中医证候积分、MLHF-Q评分均较治疗前下降（P <0. 01）。治疗6个月

治疗组6MWD长于对照组

中医证候积分低于对照组（P <0. 01）;而EF、MLHF-Q评分与对照组比较差异无统计学意义（P> 0. 05）。治疗组发生18例不良事件

对照组16例不良事件。结论参附益心颗粒辨证治疗加西医规范治疗能进一步提高CHF患者的心功能

提升运动能力

改善患者的临床症状和体征

且安全性较好。

Abstract

Objective To evaluate the efficacy and safety of Shenfu Yixin Granules（参附益心颗粒） in the treatment of chronic heart failure（ CHF）. Methods A multicenter

randomized

double-blind

placebo-controlled approach was used. Totally 300 patients with CHF were randomized into 151 patients in the treatment group and 149 patients in the control group. On the basis of health education

the treatment group used western medicine standard treatment plus traditional Chinese medicine（ TCM） syndrome differentiation treatment

dividing syndromes of heart qi（ yang） deficiency

heart and blood stasis obstruction

heart-yang deficiency with mutual resistance of phlegm and blood stasis. And they were respectively given Shenfu Yixin Granules and modified Shenfu Yixin Granules. The control group was treated with western medicine standard treatment plus TCM simulation drugs. Both groups were treated for6 months. The ejection fraction（ EF）

TCM syndrome score

6-min walking distance（ 6 MWD）

Minnesota living with Heart Failure Questionnaire（ MLHF-Q） scores of the 2 groups were compared before and after 3

6 months treatment

and the cardiac function and TCM syndrome efficacy were evaluated. Safety evaluation was conducted.Results The total effective rate of cardiac function in the treatment group was 82. 4%

and that in the control group was 54. 26%. The treatment group was superior to the control group（ P < 0. 01）. The total effective rate of TCM syndromes in the treatment group was 93. 55%

and that in the control group was 59. 23%. The treatment group was higher than the control group（ P < 0. 01）. After treatment

EF and 6 MWD of both groups were increased and the scores of TCM syndrome and MLHF-Q were decreased（ P < 0. 01）. After 6 months of treatment

the 6 MWD of the treatment group was longer than that of the control group

and the score of TCM syndrome was lower than that of the control group（ P < 0. 01）. The difference of EF and MLHF-Q scores between groups was not statistically significant（ P > 0. 05）. There were 18 cases with adverse events in the treatment group and 16 cases in the control group.Conclusion Shenfu Yixin Granules with TCM syndrome differentiation and western medicine treatment can further improve the cardiac function of patients with chronic heart failure

improving exercise capacity

clinical symptoms and signs

and have better safety.

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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/ National Clinical Research Center for Chinese Medicine

Tianjin University of Traditional Chinese Medicine

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Affiliated Hospital of Shandong University of Traditional Chinese Medicine

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