麝香保心丸联合运动治疗射血分数保留型心力衰竭的疗效：一项单中心，双盲，随机对照试验

LIU Si-pei; ZHOU Jian-guan; JIN Yan; GUO Yan; ZHOU Shi-wei; LIN Mei-lan; ZHANG Jun; WANG Xiao-nv; GUAN Xia-fei; WANG Lei

doi:10.1007/s11655-022-3627-3

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麝香保心丸联合运动治疗射血分数保留型心力衰竭的疗效：一项单中心，双盲，随机对照试验

Original Article | Updated：2023-02-01

- 麝香保心丸联合运动治疗射血分数保留型心力衰竭的疗效：一项单中心，双盲，随机对照试验
- Therapeutic Efficacy of Shexiang Baoxin Pill Combined with Exercise in Patients with Heart Failure with Preserved Ejection Fraction: A Single-Center, Double-Blind, Randomized Controlled Trial
- 中国结合医学杂志（英文版） 2023年29卷第2期页码：99-107
- Affiliations：
  
  1.Nanjing Drum Tower Hospital, Clinical College of Nanjing University of Chinese Medicine, Nanjing (210008), China
  2.Department of Rehabilitation, College of Acupuncture and Moxibustion and Massage Health Preservation and Rehabilitation, Nanjing University of Chinese Medicine, Nanjing(210023), China
  3.Division of Cardiovascular Rehabilitation, Ruian Hospital of Traditional Chinese Medicine, Ruian, Zhejiang Province (325299), China
  4.Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
- Author bio：
  
  Prof. WANG Lei, E-mail: wanglei@njucm.edu.cn
- Funds：
  
  the Chinese Association of Integrative Medicine-Hutchison Research Fund(HMP2005002P)
- DOI：10.1007/s11655-022-3627-3
  中图分类号：
- 纸质出版日期：2023-02，
  
  网络出版日期：2022-12-09，
  
  录用日期：2022-09-21
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麝香保心丸联合运动治疗射血分数保留型心力衰竭的疗效：一项单中心，双盲，随机对照试验[J]. 中国结合医学杂志（英文版）, 2023,29(2):99-107.

LIU Si-pei, ZHOU Jian-guan, JIN Yan, et al. Therapeutic Efficacy of Shexiang Baoxin Pill Combined with Exercise in Patients with Heart Failure with Preserved Ejection Fraction: A Single-Center, Double-Blind, Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2023,29(2):99-107.
麝香保心丸联合运动治疗射血分数保留型心力衰竭的疗效：一项单中心，双盲，随机对照试验[J]. 中国结合医学杂志（英文版）, 2023,29(2):99-107. DOI： 10.1007/s11655-022-3627-3.

LIU Si-pei, ZHOU Jian-guan, JIN Yan, et al. Therapeutic Efficacy of Shexiang Baoxin Pill Combined with Exercise in Patients with Heart Failure with Preserved Ejection Fraction: A Single-Center, Double-Blind, Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2023,29(2):99-107. DOI： 10.1007/s11655-022-3627-3.

摘要

目的:

评价麝香保心丸联合运动治疗射血分数保留型心力衰竭 (Heart Failure with Preserved Ejection Fraction

HFpEF) 的疗效.

方法:

将60例HFpEF患者随机分为A组 (

=20)

在常规药物的基础上接受12周的麝香保心丸联合居家运动训练治疗; B组 (

=20)

接受12周的常规药物联合居家运动训练治疗; C组 (

=20) 仅接受常规药物治疗. 比较各组治疗前后的峰值摄氧量 (Peak oxygen uptake

peakVO2) 、无氧阈 (anaerobic threshold

AT) 、6分钟步行试验 (6-min walking test

6MWT) 、匹兹堡睡眠质量指数 (Pittsburgh Sleep Quality Index

PSQI) 和生活质量量表 (the MOS 36-Item Short-Form Health Survey

SF-36) .

结果:

在12周的干预后

C组患者的peakVO2、AT、6MWT、PSQI、SF-36结果与治疗前相比显著下降 (

0.01)

而A组和B组患者的peakVO2、AT、6MWT、PSQI和SF-36结果与治疗前相比显著改善 (

0.01) . 与C组相比

A组和B组患者的peakVO2、AT、6MWT、PSQI和SF-36显著改善 (

0.01) . 此外

与B组相比

A组患者PSQI以及SF-36量表中生理机能 (physical function) 、生理职能 (role-physical) 、精力 (vitality) 、精神健康 (mental health) 的改善更为显著 (

0.01) .

结论:

运动训练可改善HFpEF患者的运动耐受性、睡眠质量和生活质量. 值得注意的是

麝香保心丸在HFpEF患者的睡眠质量和生活质量方面发挥了积极作用. (该试验在中国临床试验注册中心注册 (注册号: ChiCTR2100054322) )

Abstract

Objective:

To evaluate the therapeutic efficacy of Shexiang Baoxin Pill combined with exercise in heart failure patients with preserved ejection fraction (HFpEF).

Methods:

Sixty patients with HFpEF were randomly divided into group A (

=20)

receiving Shexiang Baoxin Pill combined with home-based exercise training based on conventional drugs for 12 weeks; group B (

=20)

receiving conventional drugs combined with home-based exercise training for 12 weeks; and group C (

=20)

receiving conventional drug treatment only. Peak oxygen uptake (peakVO 2)

anaerobic threshold (AT)

6-min walking test (6MWT)

Pittsburgh Sleep Quality Index (PSQI)

and SF-36 questionnaire (SF-36) results before and after treatment were compared among groups.

Results:

After the 12-week intervention

patients in group C showed significant declines in peakVO 2

6MWT

PSQI

and SF-36 compared with pre-treatment (

0.01)

while groups A and B both showed significant improvements in peakVO

6MWT

PSQI

and SF-36 results compared with pre-treatment (

0.01). Compared with group C

patients in groups A and B showed significant improvements in peakVO

6MWT

PSQI

and SF-36 (

0.01). In addition

patients in group A showed more significant improvements in physical function

role-physical

vitality

and mental health scores on the SF-36 questionnaire

and PSQI scores than those in group B (

0.01).

Conclusions:

Exercise training improved exercise tolerance

sleep quality and quality of life (QoL) in patients with HFpEF. Notably

Shexiang Baoxin Pill played an active role in sleep quality and QoL of patients with HFpEF. (The trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2100054322))

关键词

心力衰竭保留射血分数运动训练麝香保心丸

Keywords

heart failurepreserved ejection fractionexercise trainingShexiang Baoxin Pill

references

Zhuang CC, Luo XF, Wang QY, Wang WJ, Sun RM, Zhang XF, et al. The effect of exercise training and physiotherapy on diastolic function, exercise capacity and quality of life in patients with heart failure with preserved ejection fraction: a systematic review and meta-analysis.Kardiol Pol 2021;7910:1107-1115.

Zakeri R, Cowie MR. Heart failure with preserved ejection fraction: controversies, challenges and future directions.Heart 2018;1045:377-384.

Naing P, Forrester D, Kangaharan N, Muthumala A, Myint SM, Playford D. Heart failure with preserved ejection fraction: a growing global epidemic. Aust J Gen Pract 2019;487:465-471.

Oktay AA, Shah SJ. Diagnosis and management of heart failure with preserved ejection fraction: 10 key lessons. Curr Cardiol Rev 2015;111:42-52.

Tucker WJ, Nelson MD, Beaudry RI, Halle M, Sarma S, Kitzman DW, et al. Impact of exercise training on peak oxygen uptake and its determinants in heart failure with preserved ejection fraction. Cardiac Fail Rev 2016;22:95-101.

Lee KS, Lennie TA, Heo S, Song EK, Moser DK. Prognostic importance of sleep quality in patients with heart failure. Am J Crit Care 2016;256:516-525.

Fu TC, Huang SC, Hsu CC, Wang CH, Wang JS. Cardiac rehabilitation in patients with heart failure. Acta Cardiol Sin 2014;305:353-359.

Haykowsky MJ, Daniel KM, Bhella PS, Sarma S, Kitzman DW. Heart failure: exercise-based cardiac rehabilitation: who, when, and how intense? Can J Cardiol 2016;3210:S382-S387.

Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice. Rev Espan de Cardiol (English) 2016;6910:939.

Fukuta H, Goto T, Wakami K, Kamiya T, Ohte N. Effects of exercise training on cardiac function, exercise capacity, and quality of life in heart failure with preserved ejection fraction: a meta-analysis of randomized controlled trials. Heart Fail Rev 2019;244:535-547.

Fukuta H, Goto T, Wakami K, Ohte N. Effects of drug and exercise intervention on functional capacity and quality of life in heart failure with preserved ejection fraction: a meta-analysis of randomized controlled trials. Eur J Prev Cardiol 2016;231:78-85.

Wang JP, Yang R, Zhang FL, Jia CX, Wang PP, Liu JJ, et al. The effect of Chinese herbal medicine on quality of life and exercise tolerance in heart failure with preserved ejection fraction: a systematic review and meta-analysis of randomized controlled trials. Front Physiol 2018;9:15.

Fang HY, Zeng HW, Lin LM, Chen X, Shen XN, Fu P, et al.A network-based method for mechanistic investigation of Shexiang Baoxin Pill's treatment of cardiovascular diseases. Sci Rep 2017;7:11.

Lu L, Sun XD, Chen C, Qin YT, Guo XM. Shexiang Baoxin Pill, Derived from the traditional Chinese medicine, provides protective roles against cardiovascular diseases. Front Pharmacol 2018;9:10.

Fukuta H. Effects of exercise training on cardiac function in heart failure with preserved ejection fraction. Cardiac Fail Rev 2020;6:e27.

Leggio M, Fusco A, Loreti C, Limongelli G, Bendini MG, Mazza A, et al. Effects of exercise training in heart failure with preserved ejection fraction: an updated systematic literature review. Heart Fail Rev 2020;255:703-711.

Schmidt C, Moreira-Goncalves D, Santos M, Leite-Moreira A, Oliveira J. Physical activity and exercise training in heart failure with preserved ejection fraction: gathering evidence from clinical and pre-clinical studies. Heart Fail Rev 2022;272:573-586.

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg 2012;101:28-55.

Turri-Silva N, Vale-Lira A, Verboven K, Quaglioti Durigan JL, Hansen D, Cipriano G. High-intensity interval training versus progressive high-intensity circuit resistance training on endothelial function and cardiorespiratory fitness in heart failure: a preliminary randomized controlled trial. PLoS One 2021;1610:25.

Liao YH, Yang JF, Zhang J, Cheng X, Xie MX, Li XL, et al.An expert consensus for diagnosis and treatment of diastolic heart failure. J Clin Cardiol (Chin) 2020;3601:1-10.

Wang LM, Shen YQ. Chinese expert consensus on exercise rehabilitation in chronic stable heart failure. Chin Circ J (Chin) 2014;z2:113-119.

Salzano A, De Luca M, Israr MZ, Crisci G, Eltayeb M, Debiec R, et al. Exercise intolerance in heart failure with preserved ejection fraction. Heart Fail Clin 2021;173:397-413.

Parati G, Lombardi C, Castagna F, Mattaliano P, Filardi PP, Agostoni P, et al. Heart failure and sleep disorders. Nat Rev Cardiol 2016;137:389-403.

Awotidebe TO, Adeyeye VO, Adedoyin RA, Ogunyemi SA, Oke KI, Ativie RN, et al. Assessment of functional capacity and sleep quality of patients with chronic heart failure. Hong Kong Physiother J 2017;36:17-24.

Suna JM, Mudge A, Stewart I, Marquart L, O'Rourke P, Scott A. The effect of a supervised exercise training programme on sleep quality in recently discharged heart failure patients. Eur J Cardiovasc Nurs 2015;143:198-205.

Esnaasharieh F, Dehghan M, Shahrbabaki PM. The relationship between sleep quality and physical activity among patients with heart failure: a cross-sectional study. BMC Sports Sci Med Rehabil 2022;141:8.

Hassanpour Dehkordi A, Khaledi Far A. Effect of exercise training on the quality of life and echocardiography parameter of systolic function in patients with chronic heart failure: a randomized trial. Asian J Sport Med 2015;61:e22643.

Dallas K, Dinas PC, Chryssanthopoulos C, Dallas G, Maridaki M, Koutsilieris M, et al. The effects of exercise on VO2peak, quality of life and hospitalization in heart failure patients: a systematic review with meta-analyses. Eur J Sport Sci 2021;219:1337-1350.

Wang ZX, Liu ZC, Gao SW, WANG BH. Research progress on the mechanism of Shexiang Baoxin Pill. J Emerg Trad Chin Med (Chin) 2020;2907:1309-1312.

Wu ZX, Jang ZT, Luo J, Zhou SB, Xiao T, Li F, et al. Effect of Shexiang Baoxin Pill on myocardial remodeling and gap junction proteins Cx43 and Cx45 in heart failure rats. Chin Trad Patent Med (Chin) 2015;3706:1329-1332.

Wu BW, Li J, Jin B, Li HY, Shi HM, Luo XP. Mechanism of promoting angiogenesis by Shexiang Baoxin Pill. Chin Trad Patent Med (Chin) 2018;4006:1384-1388.

Zhang BL, Wang YL, Jing XM. Advances of sleep disorder in heart failure patients. J North Sichuan Med Coll (Chin)2017;3203:471-474.

Zhou XD, Shi DD, Zhang ZJ. Antidepressant and anxiolytic effects of the proprietary Chinese medicine Shexiang Baoxin Pill in mice with chronic unpredictable mild stress. J Food Drug Anal 2019;271:221-230.

LI YZ, Ou YL, Zhang YN, Jin C, Gong S, Yu GL.Observation on the efficacy of Shexiang Baoxin Pill on coronary heart disease with angina pectoris and mild to moderate anxiety and depression. Modern J Integ Trad Chin West Med (Chin) 2022;3108:1062-1066.

Lu YS, Liu M. Efficacy of escitalopram combined with Shexiang Baoxin Pill in chronic heart failure complicated by depression. Hubei J Trad Chin Med (Chin) 2015;3711:49-50.

Wang KB. Effect of Shexiang Baoxin Pill on chronic heart failure. Cardiovasc Dis J Integr Chin West Med (Chin) 2015; 323: 85-86.

Yao HL, Xu MW, Wu Q. Effect of Shexiang Baoxin Pill combined with sacubitril valsartan sodium Tablets on cardiac function and SF-36 scores in chronic heart failure patients. J North Pharm (Chin) 2020;1710:27-28.

Zhu YH. Clinical observation of Shexiang Baoxin Pill in the treatment of chronic heart failure. Med J Chin People Health (Chin) 2014;2607:86-87.

Zhang KJ. Effect of exercise rehabilitation combined with Shexiang Baoxin Pill on cardiac function and daily living ability of chronic heart failure patients with coronary heart disease. Chin J Convalesc Med (Chin) 2019;2807:722-723.

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