<italic style="font-style: italic">Bushen Huoxue Formula</italic> （补肾活血方） Combined with Conventional Western Medicine for 129 Patients of Heart Failure with Mid-range Ejection Fraction with Syndrome of <italic style="font-style: italic">Qi</italic> Deficiency and Blood Stasis：A Randomized Controlled Trial

ZHANG Yan; HE Jia; ZHANG Wei; SONG Tingting

doi:10.13288/j.11-2166/r.2024.04.008

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Bushen Huoxue Formula （补肾活血方） Combined with Conventional Western Medicine for 129 Patients of Heart Failure with Mid-range Ejection Fraction with Syndrome of Qi Deficiency and Blood Stasis：A Randomized Controlled Trial

更新时间：2024-02-08

- Bushen Huoxue Formula （补肾活血方） Combined with Conventional Western Medicine for 129 Patients of Heart Failure with Mid-range Ejection Fraction with Syndrome of Qi Deficiency and Blood Stasis：A Randomized Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 65, Issue 4, Pages: 376-381(2024)
- 作者机构：
  
  1.辽宁中医药大学附属医院，辽宁省沈阳市皇姑区北陵大街33号，110032
  2.辽宁中医药大学附属第四医院
  3.辽宁中医药大学
  4.辽宁中医药大学附属第二医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2024.04.008
  CLC：
- Received：30 September 2023，
  
  Revised：2023-11-26，
  
  Published：17 February 2024
- 稿件说明：
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张艳,何佳,张伟等.补肾活血方联合常规西药治疗射血分数中间值心衰气虚血瘀证患者129例随机对照临床观察[J].中医杂志,2024,65(04):376-381.

ZHANG Yan,HE Jia,ZHANG Wei,et al.Bushen Huoxue Formula （补肾活血方） Combined with Conventional Western Medicine for 129 Patients of Heart Failure with Mid-range Ejection Fraction with Syndrome of Qi Deficiency and Blood Stasis：A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2024,65(04):376-381.
张艳,何佳,张伟等.补肾活血方联合常规西药治疗射血分数中间值心衰气虚血瘀证患者129例随机对照临床观察[J].中医杂志,2024,65(04):376-381. DOI： 10.13288/j.11-2166/r.2024.04.008.

ZHANG Yan,HE Jia,ZHANG Wei,et al.Bushen Huoxue Formula （补肾活血方） Combined with Conventional Western Medicine for 129 Patients of Heart Failure with Mid-range Ejection Fraction with Syndrome of Qi Deficiency and Blood Stasis：A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2024,65(04):376-381. DOI： 10.13288/j.11-2166/r.2024.04.008.

摘要

目的

评价补肾活血方治疗射血分数中间值心衰（HFmrEF）气虚血瘀证的临床疗效。

方法

将HFmrEF气虚血瘀证患者277例随机分为治疗组139例、对照组138例，对照组给予常规西药治疗，治疗组在对照组基础上加用补肾活血方，两组均治疗8周。比较治疗前后两组患者左心室射血分数（LVEF）、N末端B型利钠肽原（NT-pro BNP）水平、心功能分级、明尼苏达心力衰竭生活质量评分、焦虑评分、抑郁评分，以及治疗后6个月主要不良心血管事件发生率、再住院率情况。

结果

治疗组脱落10例、对照组脱落6例，实际完成治疗组129例、对照组132例。与本组治疗前比较，两组患者治疗后LVEF升高、NT-pro BNP水平降低（

＜0.05）；治疗后治疗组与对照组比较，LVEF升高、NT-pro BNP水平降低（

＜0.05）。治疗组心功能分级改善总有效率（97.67%，126例/129例）高于对照组（84.09%，111例/132例）（

＜0.05）。治疗后两组患者明尼苏达心力衰竭生活质量评分、焦虑评分、抑郁评分均较治疗前降低（

＜0.05），且治疗组上述评分均低于对照组（

＜0.05）。治疗后6个月两组患者均无死亡事件发生，治疗组主要不良心血管事件发生率（25.58%，33例/129例）与对照组（33.33%，44例/132例）比较差异无统计学意义（

＞0.05）；治疗组再住院率（14.73%，19例/129例）低于对照组（30.30%，40例/132例）（

＜0.05）。

结论

补肾活血方可增加HFmrEF气虚血瘀证患者的LVEF，降低NT-pro BNP，提高生活质量，改善患者焦虑抑郁状态，降低再住院率。

Abstract

Objective

To evaluate the clinical effectiveness of

Bushen Huoxue Formula

（补肾活血方） in the treatment of heart failure with mid-range ejection fraction.

Methods

A total of 277 patients of heart failure with mid-range ejection fraction with syndrome of

deficiency and blood stasis were randomly divided into the treatment group （139 cases） and the control group （138 cases）. The control group was given conventional western medicine， and the treatment group was given

Bushen Huoxue Formula

on the basis of the control group. Both groups were treated for 8 weeks. Left ventricular ejection fraction （LVEF）， N-terminal B-type natriuretic peptide （NT-pro BNP） level， cardiac function grade， Minnesota heart failure quality of life score， anxiety score， depression score， and the major incidence of cardiovascular adverse events and re-hospitalization rate after 6-month treatment were compared between the two groups before and after treatment.

Results

There were 10 withdrawals in the treatment group and 6 withdrawals in the control group， so 129 cases in the treatment group and 132 cases in the control group completed the trial. After treatment， LVEF increased and NT-pro BNP level decreased in both groups （

＜0.05）； compared with those in the control group， LVEF increased and NT-pro BNP level decreased in the treatment group （

＜0.05）. The total rate of graded improvement of cardiac function in the treatment group （97.67%， 126/129 cases） was higher than that in the control group （84.09%， 111/132 cases）（

＜0.05）. After treatment， the Minnesota heart failure quality of life score， anxiety score， and depression score were lower in both groups （

＜0.05）， and the above scores in the treatment group were lower than those in the control group （

＜0.05）. After 6-month treatment， there was no death event in both groups， and there was no significant difference in the major incidence of cardiovascular adverse events between the treatment group （25.58%， 33/129 cases） and the control group （33.33%， 44/132 cases）（

＞0.05）. The rate of re-hospitalization in treatment group （14.73%， 19/129 cases） was lower than that in control group （30.30%， 40/132 cases）（

＜0.05）.

Conclusion

Bushen Huoxue Formula

can increase LVEF， reduce NT-pro BNP， improve quality of life， improve anxiety and depression， and reduce the rate of re-hospitalization in patients of heart failure with mid-range ejection fraction with syndrome of

deficiency and blood stasis.

关键词

Keywords

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Bushen Huoxue Formula （补肾活血方） Combined with Conventional Western Medicine for 129 Patients of Heart Failure with Mid-range Ejection Fraction with Syndrome of Qi Deficiency and Blood Stasis：A Randomized Controlled Trial

DOI：10.13288/j.11-2166/r.2024.04.008

摘要

Abstract

关键词

Keywords

references