芪参桃红颗粒辅助治疗改善慢性心力衰竭患者心功能和生活质量的随机对照试验

Xing-xing LI; Yang WU; Zong-jing FAN; Jie CUI; Dong LI; Quan LIN; Rui ZHUANG; Rong-kun YAN; Qian LIN; Yan LI

doi:10.1007/s11655-021-2866-z

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芪参桃红颗粒辅助治疗改善慢性心力衰竭患者心功能和生活质量的随机对照试验

Original Article | Updated：2022-03-18

- 芪参桃红颗粒辅助治疗改善慢性心力衰竭患者心功能和生活质量的随机对照试验
- Qishen Taohong Granule as Adjuvant Therapy for Improving Cardiac Function and Quality of Life in Patients with Chronic Heart Failure: A Randomized Controlled Trial
- Chinese Journal of Integrative Medicine 2022年28卷第1期页码：12-19
- Affiliations：
  
  1.Department of Graduate School, Beijing University of Chinese Medicine, Beijing (100029), China
  2.Department of Cardiology,Dongfang Hospital, Beijing University of Chinese Medicine, Beijing(100078), China
  3.Department of Cardiology, Xiyuan Hospital,China Academy of Chinese Medical Sciences, Beijing (100091),China
  4.Department of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing (100700), China
- Author bio：
  
  Dr. LI Yan, E-mail: 15801434320@163.com
- Funds：
  
  Beijing Science and Technology Planning Project(Z171100001017225);National Natural Science Foundation of China(81703902);Beijing University of Chinese Medicine 1166 Development Program for Junior Scientists(030903010331)
- DOI：10.1007/s11655-021-2866-z
  中图分类号：
- 纸质出版日期：2022-01-01，
  
  网络出版日期：2021-08-13，
  
  录用日期：2020-12-03
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Xing-xing LI, Yang WU, Zong-jing FAN, 等. 芪参桃红颗粒辅助治疗改善慢性心力衰竭患者心功能和生活质量的随机对照试验[J]. Chinese Journal of Integrative Medicine, 2022,28(1):12-19.

Xing-xing LI, Yang WU, Zong-jing FAN, et al. Qishen Taohong Granule as Adjuvant Therapy for Improving Cardiac Function and Quality of Life in Patients with Chronic Heart Failure: A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(1):12-19.
Xing-xing LI, Yang WU, Zong-jing FAN, 等. 芪参桃红颗粒辅助治疗改善慢性心力衰竭患者心功能和生活质量的随机对照试验[J]. Chinese Journal of Integrative Medicine, 2022,28(1):12-19. DOI： 10.1007/s11655-021-2866-z.

Xing-xing LI, Yang WU, Zong-jing FAN, et al. Qishen Taohong Granule as Adjuvant Therapy for Improving Cardiac Function and Quality of Life in Patients with Chronic Heart Failure: A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(1):12-19. DOI： 10.1007/s11655-021-2866-z.

摘要

目的:

证实芪参桃红颗粒能够改善慢性心力衰竭 (CHF) 患者的心功能和生活质量.

方法:

本研究是一项单中心、前瞻性、随机、对照临床试验. 将76例27-84岁New York Heart Association (NYHA) Ⅱ或Ⅲ级、CHF分期C期的CHF患者随机等比例分配接受芪参桃红颗粒或曲美他嗪治疗

两组患者均服用治疗CHF的西医常规药物. 研究周期为4周. 主要结局指标为心功能 (NYHA分级和左室射血分数) 、CHF患者中西医结合生存量表评估生活质量. 次要结局指标包括6分钟步行试验 (6MWT) 、中医证候积分、症状和体征积分以及N端B型利钠肽原 (NT-proBNP). 所有指标均在入组时和试验结束时测量.

结果:

4周随访时

芪参桃红颗粒组NYHA分级有效率优于曲美他嗪组 (74.29% vs. 54.29%

0.05) . 但两组治疗后左室射血分数比较

差异无统计学意义 (

0.05) . 芪参桃红颗粒组和曲美他嗪组患者中西医结合生存量表评分分别提高了 (13.82±6.04) 分和 (7.49±2.28) 分 (

0.05) . 亚组分析显示

芪参桃红颗粒组在生理功能、角色限制和活力方面评分明显优于曲美他嗪组[ (15.76±7.85) vs. (7.40±3.36)

0.05; (16.00±8.35) vs. (10.53±4.64)

0.05; (15.31±8.09) vs. (7.89±4.60)

0.05]. 与曲美他嗪组比较

芪参桃红颗粒治疗组患者在6MWT、中医证候积分、气短、乏力、气喘、水肿和NT-proBNP方面也表现出优势性. 两组治疗期间均未发生明显的不良反应或不良心血管事件.

结论:

芪参桃红颗粒联合西医常规治疗可明显改善NYHA Ⅱ或Ⅲ级、ACC/AHA CHF分期C期患者的心功能及生活质量 (临床研究注册号: ChiCTR 1900022036)

Abstract

Objective:

To confirm the improvement of cardiac function and quality of life (QoL) in patients with chronic heart failure (CHF) via Chinese medicine (CM) Qishen Taohong Granule (QTG).

Methods:

This study was a single-center

prospective

randomized

controlled clinical trial. Seventy-six patients from 27 to 84 years old diagnosed with CHF New York Heart Association (NYHA) class Ⅱ or Ⅲ in stage C were enrolled and randomly assigned at a 1:1 ratio to receive QTG or trimetazidine (TMZ)

in addition to their standard medications for the treatment of CHF. The study period was 4 weeks. The primary outcomes included cardiac function evaluated by NYHA classification and left ventricular ejection fraction (LVEF)

as well as QoL evaluated by CHF Integrated Chinese and Western Medicine Survival Scale (CHFQLS). The secondary outcomes included 6-min walking test (6MWT)

CM syndrome score

symptom and sign scores and N-terminal pro-B-type natriuretic peptide level (NT-proBNP). All indices were measured at baseline and the end of the trial.

Results:

At the 4-week follow-up period

the effective rate according to NYHA classification in the QTG group was better than that in the TMZ group (74.29% vs. 54.29%

0.05). But there was no significant difference in posttreatment level of LVEF between the two groups (

0.05). The CHFQLS scores improved by 13.82±6.04 vs. 7.49±2.28 in the QTG and TMZ groups

respectively (

0.05). Subgroup analysis of the CHFQLS results showed that physiological function

role limitation and vitality were significantly higher in the QTG group than in the TMZ group (15.76±7.85 vs. 7.40±3.36

0.05; 16.00±8.35 vs. 10.53±4.64

0.05; 15.31±8.09 vs. 7.89±4.60

0.05). Compared with TMZ group

treatment with QTG also demonstrated superior performance with respect to 6MWT

CM syndrome

shortness of breath

fatigue

gasping

general edema and NT-proBNP level. No significant adverse reactions or adverse cardiac events occurred during treatment in either group.

Conclusion:

In addition to conventional treatments

the use of QTG as an adjuvant therapy significantly improved cardiac function and QoL in patients with CHF class Ⅱ or Ⅲ in stage C. [Registration No. ChiCTR1900022036 (retrospectively registered)]

关键词

Keywords

chronic heart failureChinese medicineQishen Taohong Granulecardiac functionquality of life

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