Effect of <italic style="font-style: italic">Jiuxin Pill</italic> （救心丸）on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris：A Randomized，Double-Blind，Placebo-Controlled，Multi-Center Clinical Trial

WANG Xianliang; ZHU Mingjun; NI Daimei; WU Jianguang; XUE Yitao; WANG Chenglong; DAI Xiaohua; LIN Qian; LI Jun; ZHAO Zhiqiang; WANG Shuai; BI Yingfei; LIU Tongzuo; ZHOU Zhou; MAO Jingyuan

doi:10.13288/j.11-2166/r.2024.24.008

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Effect of Jiuxin Pill （救心丸）on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris：A Randomized，Double-Blind，Placebo-Controlled，Multi-Center Clinical Trial

更新时间：2026-02-03

- Effect of Jiuxin Pill （救心丸）on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris：A Randomized，Double-Blind，Placebo-Controlled，Multi-Center Clinical Trial
- Journal of Traditional Chinese Medicine Vol. 65, Issue 24, Pages: 2549-2557(2024)
- 作者机构：
  
  1.天津中医药大学第一附属医院/国家中医针灸临床医学研究中心，天津市西青区昌凌路88号，300381
  2.河南中医药大学第一附属医院
  3.安徽中医药大学附属太和中医院
  4.江西中医药大学附属医院
  5.山东中医药大学附属医院
  6.中国中医科学院西苑医院
  7.安徽中医药大学第一附属医院
  8.北京中医药大学东直门医院
  9.中国中医科学院广安门医院
  10.天津中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2024.24.008
  CLC：
- Received：25 September 2024，
  
  Revised：2024-10-21，
  
  Published：17 December 2024
- 稿件说明：
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王贤良,朱明军,倪代梅等.救心丸对冠心病稳定型心绞痛患者运动耐量及生活质量的影响——一项随机、双盲、安慰剂对照、多中心临床研究[J].中医杂志,2024,65(24):2549-2557.

WANG Xianliang,ZHU Mingjun,NI Daimei,et al.Effect of Jiuxin Pill （救心丸）on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris：A Randomized，Double-Blind，Placebo-Controlled，Multi-Center Clinical Trial[J].Journal of Traditional Chinese Medicine,2024,65(24):2549-2557.
王贤良,朱明军,倪代梅等.救心丸对冠心病稳定型心绞痛患者运动耐量及生活质量的影响——一项随机、双盲、安慰剂对照、多中心临床研究[J].中医杂志,2024,65(24):2549-2557. DOI： 10.13288/j.11-2166/r.2024.24.008.

WANG Xianliang,ZHU Mingjun,NI Daimei,et al.Effect of Jiuxin Pill （救心丸）on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris：A Randomized，Double-Blind，Placebo-Controlled，Multi-Center Clinical Trial[J].Journal of Traditional Chinese Medicine,2024,65(24):2549-2557. DOI： 10.13288/j.11-2166/r.2024.24.008.

摘要

目的

评价救心丸对冠心病稳定型心绞痛患者运动耐量及生活质量的影响和安全性。

方法

采用随机、双盲、安慰剂对照、多中心研究设计，纳入9个中心的冠心病稳定型心绞痛患者170例，按照1∶1比例分为试验组和对照组各85例。两组均维持原西药治疗方案，试验组和对照组分别加用救心丸和救心丸安慰剂口服，每次2粒（0.05 g），每日2次，用药28天。主要疗效指标为运动平板试验总运动时间（TED）、西雅图心绞痛量表（SAQ）评分［包括躯体活动受限程度（PL）、心绞痛稳定状态（AS）、心绞痛发作情况（AF）、治疗满意程度（TS）和疾病认知程度（DP）］；次要疗效指标为运动平板试验其他指标［包括1分钟心率恢复（HRR1）、代谢当量（METs）、ST段压低最大幅度、运动后Borg自感劳累评分］、平均每周心绞痛发作次数、硝酸甘油停减率、中医证候积分、主要不良心血管事件发生率，并进行安全性指标评价，记录试验期间不良事件发生情况。访视时点为治疗前、治疗后即治疗（28±2）天、56天随访时即治疗结束后第（28±2）天。

结果

符合全分析集（FAS）和安全性数据集（SS）试验组和对照组分别有84例和85例。与本组治疗前及与对照组治疗后比较，试验组治疗后TED、HRR1、METs升高，ST段压低最大幅度及Borg自感劳累评分降低（

＜0.01）。与本组治疗前及与对照组治疗后、随访时比较，试验组治疗后及随访时SAQ总评分及AS、AF、TS、DP评分均升高，平均每周心绞痛发作次数及中医证候积分降低（

＜0.01）。两组间硝酸甘油停减率比较差异无统计学意义（

＞0.05）。主要不良心血管事件试验组发生1例（1/84，1.19%），对照组1例（1/85，1.18%），两组比较差异无统计学意义（

＞0.05）。试验组共发生不良事件3例（3/84，3.57%），对照组共发生不良事件6例（6/85，7.06%），两组间不良事件发生率比较差异无统计学意义（

＞0.05）。

结论

在西医常规治疗基础上加用救心丸可进一步提高冠心病稳定型心绞痛患者的运动耐量、改善生活质量，且安全性良好。

Abstract

Objective

To evaluate the effect and safety of

Jiuxin Pill

（救心丸） on exercise tolerance and quality of life in patients with stable angina pectoris （SAP）.

Methods

A randomised， double-blind， placebo-controlled， multicentre study design was used to enroll 170 patients of SAP from nine centres， which were divided into 85 patients each in the trial group and control group with 1∶1 ratio. Both groups maintained the original western medicine treatment plan， and added

Jiuxin Pill

or placebo respectively， 2 pills （0.05 g） each time twicely for 28 days. The main outcomes were total exercise time （TED） in the exercise treadmill test and Seattle Angina Questionnaire （SAQ） scores including physical limitation （PL）， angina stability （AS）， angina frequency （AF）， treatment satisfaction （TS）， and disease perception （DP）. The secondary outco

mes were exercise treadmill test indicators including heart rate recovery in 1 min （HRR1）， metabolic equivalents （METs）， maximum magnitude of ST-segment depression， and the Borg rating of perceived exertion scale， the average number of angina attacks per week， withdrawal and reduction rate of nitroglycerin， traditional Chinese medicine syndrome scores， incidence of major adverse cardiovascular events. Safety indicators were evaluated and the occurrence of adverse events during the trial was recorded. Data was collected before treatment， day 28±2 in treatment period， and follow-up at day 56 which is 28±2 days after treatment period finished.

Results

Eighty-four and eighty-five patients respectively from trial group and control group were included to the full analysis set （FAS） and safety analysis set （SS）. Compared with the group before treatment and with the control group after treatment， the trial group had higher TED， HRR1， and METs， and lower maximum magnitude of ST-segment depression and Borg rating of perceived exertion scores after treatment （

＜0.01）. Compared with the group before treatment and with the control group after treatment and at follow-up， the total SAQ score and scores of AS， AF， TS and DP of the trial group after treatment and at follow-up elevated， while the average number of angina attacks per week and traditional Chinese medicine syndrome scores reduced （

＜0.01）. There was no statistically significant difference in the withdrawal and reduction rate of nitroglycerin between groups （

＞0.05）. Major adverse cardiovascular events occurred in 1 case （1/84， 1.19%） in the trial group and 1 case （1/85， 1.18%） in the control group， and the difference between groups was not statistically significant （

＞0.05）. A total of 3 cases of adverse events occurred in the trial group （3/84， 3.57%）， and a total of 6 cases of adverse events occurred in the control group （6/85， 7.06%）， and there was no statistically s

ignificant difference in the incidence of adverse events between groups （

＞0.05）.

Conclusion

In the treatment of SAP，

Jiuxin Pill

combined with conventional western medicine can further enhance exercise tolerance， improve quality of life， and demonstrate great safety.

关键词

Keywords

references

中华医学会心血管病学分会，中华心血管病杂志编辑委员会 . 中国慢性冠脉综合征患者诊断及管理指南［J］. 中华心血管病杂志， 2024 ， 52 （ 6 ）： 589 - 614 .

AGEWALL S . Treating patients with anticoagulants and antiplatelet drugs is always a balance between risk for thrombosis vs. risk for bleeding ［J］. Eur Heart J Cardiovasc Pharmacother ， 2022 ， 8 （ 7 ）： 645 - 647 .

LIU A ， WU Q ， GUO J ， et al . Statins： adverse reactions， oxidative stress and metabolic interactions ［J］. Pharmacol Ther ， 2019 ， 195 ： 54 - 84 . doi： 10.1016/j.pharmthera. 2018.10.004 http://dx.doi.org/10.1016/j.pharmthera.2018.10.004 .

《中成药治疗优势病种临床应用指南》标准化项目组 . 中成药治疗冠心病临床应用指南（2020年）［J］. 中国中西医结合杂志， 2021 ， 19 （ 9 ）： 1409 - 1435 .

毕颖斐，毛静远，王贤良，等．中医药防治冠心病临床优势及有关疗效评价的思考［J］．中医杂志， 2015 ， 56 （ 5 ）： 437 - 440 .

彭全华，王进京 . 华佗救心丸改善冠心病心绞痛患者运动耐量临床观察研究［J/OL］. 中文科技期刊数据库（全文版）医药卫生， 2023 （ 6 ）： 75 - 78 . ［ 2024-09-25 ］. https：//www.cqvip.com/doc/journal/3224127757 https://www.cqvip.com/doc/journal/3224127757 .

李玉耕，林红丽 . 华佗救心丸治疗冠心病稳定性劳累性心绞痛的临床研究［J/OL］. 中文科技期刊数据库（全文版）医药卫生， 2023 （ 7 ）： 56 - 59 . ［ 2024-09-25 ］. https：//www.cqvip.com/doc/journal/3247235687 https://www.cqvip.com/doc/journal/3247235687 .

张希廉，王雪民，张健 . 华佗救心丸改善冠心病心绞痛患者心功能临床观察分析［J/OL］. 中文科技期刊数据库（引文版）医药卫生， 2023 （ 6 ）： 70 - 73 .［ 2024-09-25 ］. https：//www.cqvip.com/doc/journal/3198359868 https://www.cqvip.com/doc/journal/3198359868 .

中华医学会心血管病分会 . 稳定性冠心病诊断与治疗指南［J］. 中华心血管杂志， 2018 ， 46 （ 9 ）： 680 - 694 .

ARNOLD JM ， LIU P ， DEMERS C ， et al . Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006： diagnosis and management ［J］. Can J Cardiol ， 2006 ， 22 （ 1 ）： 23 - 45 .

MÜNZEL T ， THOMAS M ， ULRICH T ， et al . Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers： a 12-week， randomized， double-blind， placebo-controlled trial ［J］. Eur Heart J ， 2014 ， 14 ： 895 - 903 . doi： 10.1093/eurheartj/eht384 http://dx.doi.org/10.1093/eurheartj/eht384 .

梁晓鹏，郭彩霞，马杰，等 . 活心丸（浓缩丸）治疗冠心病稳定性心绞痛的多中心、随机、双盲、安慰剂对照临床研究［J］. 中国中西医结合杂志， 2018 ， 38 （ 3 ）： 289 - 294 .

王慧，陈瑶，郭勇娟，等 . 浙江省心电图平板运动试验操作与诊断规范（试用版）［J］. 心电与循环， 2015 ， 34 （ 3 ）： 149 - 151，164 .

FLETCHER GF ， ADES PA ， KLIGFIELD P ， et al . Exercise standards for testing and training： a scientific statement from the American Heart Association ［J］. Circulation ， 2013 ， 128 （ 8 ）： 873 - 934 .

SPERTUS JA ， WINDER JA ， DEWHURST TA ， et al . Monitoring the quality of life in patients with coronary artery disease ［J］. Am J Cardiol ， 1994 ， 74 （ 12 ）： 1240 - 1244 .

毕颖斐，王贤良，毛静远，等 . 基于临床流行病学调查的冠心病心绞痛中医证候诊断建议［J］. 中医杂志， 2018 ， 59 （ 22 ）： 1977 - 1980 .

毕颖斐，王贤良，赵志强，等 . 冠心病现代中医证候特征的临床流行病学调查［J］. 中医杂志， 2017 ， 58 （ 23 ）： 2013 - 2019 .

周文莉，钟勤霜，李龙飞，等 . 华佗救心丸抗心肌缺血及活血化瘀作用的初步药效研究［J］. 中南药学， 2020 ， 18 （ 3 ）： 402 - 406 .

许菲，王桐生，李龙飞，等 . 华佗救心丸对异丙肾上腺素诱导小鼠急性心肌缺血的作用［J］. 中成药， 2023 ， 45 （ 7 ）： 2359 - 2363 .

JENG C ， YANG MH ， CHEN PL ， et al . The influence of exercise tolerance on quality of life among patients with heart failure ［J］. Qual Life Res ， 2004 ， 13 （ 5 ）： 925 - 932 .

CHRISTENSEN SB ， DALL CH ， PRESCOTT E ， et al . A high-intensity exercise program improves exercise capacity，self-perceived health， anxiety and depression in heart transplant recipients： a randomized， controlled trial ［J］. J Heart Lung Transplant ， 2012 ， 31 （ 1 ）： 106 - 107 .

张菊花 . 运动平板试验及动态心电图、CTA在诊断冠心病中的应用研究［J］. 中国CT和MRI杂志， 2019 ， 17 （ 4 ）： 62 - 64 .

MCKAVANAGH P ， LUSK L ， BALL PA ， et al . A comparison of cardiac computerized tomography and exercise stress electrocardiogram test for the investigation of stable chest pain： the clinical results of the CAPP randomized prospective trial ［J］. Eur Heart J Cardiovascu Imag ， 2015 ， 16 （ 4 ）： 441 - 448 .

GARRATT AM ， HUTCHINSON A ， RUSSELL I ， et al . The UK version of the seattle angina questionnaire（SAQ-UK）： reliability，validity and responsiveness ［J］. J Clin Epidemiol ， 2001 ， 54 （ 9 ）： 907 - 915 .

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Effect of Jiuxin Pill （救心丸）on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris：A Randomized，Double-Blind，Placebo-Controlled，Multi-Center Clinical Trial

DOI：10.13288/j.11-2166/r.2024.24.008

摘要

Abstract

关键词

Keywords

references