<italic style="font-style: italic">Qishen Yiqi Dripping Pill</italic> （芪参益气滴丸） for Ischemic Heart Failure： a Multicenter Prospective Cohort Study

Shuai WANG; Zhiqiang ZHAO; Xianliang WANG; Xiaoyan YAN; Chengliang ZHONG; Meixia SHANG; Cong WANG; Shanshan LIN; Siyuan HU; Jingyuan MAO; Boli ZHANG

doi:10.13288/j.11-2166/r.2022.07.007

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Qishen Yiqi Dripping Pill （芪参益气滴丸） for Ischemic Heart Failure： a Multicenter Prospective Cohort Study

更新时间：2022-03-29

- Qishen Yiqi Dripping Pill （芪参益气滴丸） for Ischemic Heart Failure： a Multicenter Prospective Cohort Study
- Journal of Traditional Chinese Medicine Vol. 63, Issue 7, Pages: 635-643(2022)
- 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.北京大学临床研究所
  3.北京大学第一医院
  4.天津中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2022.07.007
  CLC：
- Received：02 August 2021，
  
  Revised：2021-10-30，
  
  Published：02 April 2022
- 稿件说明：
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王帅,赵志强,王贤良等.芪参益气滴丸治疗缺血性心力衰竭的多中心、前瞻性队列研究[J].中医杂志,2022,63(07):635-643.

WANG Shuai,ZHAO Zhiqiang,WANG Xianliang,et al.Qishen Yiqi Dripping Pill （芪参益气滴丸） for Ischemic Heart Failure： a Multicenter Prospective Cohort Study[J].Journal of Traditional Chinese Medicine,2022,63(07):635-643.
王帅,赵志强,王贤良等.芪参益气滴丸治疗缺血性心力衰竭的多中心、前瞻性队列研究[J].中医杂志,2022,63(07):635-643. DOI： 10.13288/j.11-2166/r.2022.07.007.

WANG Shuai,ZHAO Zhiqiang,WANG Xianliang,et al.Qishen Yiqi Dripping Pill （芪参益气滴丸） for Ischemic Heart Failure： a Multicenter Prospective Cohort Study[J].Journal of Traditional Chinese Medicine,2022,63(07):635-643. DOI： 10.13288/j.11-2166/r.2022.07.007.

摘要

目的

基于真实世界评价芪参益气滴丸治疗缺血性心力衰竭（IHF）的临床疗效和安全性。

方法

采用多中心、前瞻性队列研究设计，纳入全国84家医院的IHF患者1228例，根据患者意愿分为治疗组644例和对照组584例。两组患者均参照相关规范接受西药治疗方案，治疗组在西药治疗基础上加服芪参益气滴丸（每次0.5 g，每日3次）。两组疗程均为90天，访视点为治疗后30天、60天、90天，以美国纽约心脏病协会（NYHA）心功能分级、明尼苏达心力衰竭生存质量量表（MLHFQ）评分为主要疗效指标，以中医四诊信息积分、左室射血分数（LVEF）及复合终点事件为次要疗效指标，并采用安全性数据集分析两组患者治疗期间不良事件的发生情况。

结果

治疗组最终纳入分析641例，对照组584例。治疗后30天治疗组与对照组NYHA心功能分级总有效率分别为50.55%（324例/641例）与35.10%（205例/584例），治疗后60天分别为58.66%（376例/641例）与40.07%（234例/584例），治疗后90天分别为71.45%（458例/641例）与48.63%（284例/584例），治疗组NYHA心功能分级总有效率均高于对照组（

＜0.01）；采用Logistic回归分析校正基线中潜在混杂因素后，结果显示加载芪参益气滴丸可明显提高患者NYHA心功能分级疗效（

＜0.01）。治疗后30、90天时两组MLHFQ评分均较本组治疗前降低（

＜0.01），且治疗后90天治疗组MLHFQ评分明显低于对照组（

＜0.01）；经多重线性回归分析校正基线中潜在混杂因素后，结果显示加载芪参益气滴丸可明显改善患者MLHFQ评分（

＜0.01）。治疗前治疗组患者中医四诊信息积分高于对照组、LVEF低于对照组（

＜0.05）；治疗后两组中医四诊信息积分均降低、LVEF均提高（

＜0.01），且治疗组中医四诊信息积分明显低于对照组（

＜0.01）。治疗组发生复合终点事件患者20例（3.12%），对照组27例（4.62%），两组复合终点事件发生率比较差异无统计学意义（

＞0.05）；研究过程中治疗组发生不良事件36例、对照组发生不良事件34例，均未判断为研究药物相关不良反应。

结论

在西药治疗基础上加服芪参益气滴丸可进一步改善IHF患者的心功能和生存质量，且临床应用安全性良好。

Abstract

Objective

To evaluate the clinical effectiveness and safety of

Qishen Yiqi Dripping Pill

（芪参益气滴丸， QYDP） in the treatment of ischemic heart failure （IHF） based on a real-world study.

Methods

In this prospective cohort study， 1

228 IHF patients from 84 hospitals across the country were enrolled， and they were divided into treatment group （644 cases） and control group （584 cases） according to patients' preference. Both groups received western medicine as required by the guidelines， and the treatment group was additionally administered with QYDP， 0.5 g each time， three times per day. The course of treatment for both groups was 90 days. The follow-up time was 30 days， 60 days， and 90 days after enrollment. The primary outcomes were New York Heart Association （NYHA） functional class and Minnesota Living with Heart Failure Questionnaire （MLHFQ） score. The secondary outcomes were the scores of the four examinations information in traditional Chinese medicine （TCM）， left ventricular ejection fraction （LVEF）， and composite endpoint events. The safety data set was used to analyze the occurrence of adverse events in the two groups during treatment.

Results

A total of 641 cases in the treatment group and 584 cases in the control group were included in the analysis. When measured 30 days， 60 days and 90 days after enrollment， the total effective rates regarding NYHA functional class in the treatment group and control group were 50.55% （324/641）

versus

35.10% （205/584）（

＜0.01）， 58.66% （376/641）

versus

40.07% （234/584）（

＜0.01）， and 71.45% （458/641）

versus

48.63% （284/584）（

＜0.01）， respectively. Logistic regression analysis was used to correct for potential confounding factors at baseline， and the results showed that the addition of QYDP significantly improved the total effective rate regarding NYHA functional class （

＜0.01）. At 30 days and 90 days after enrollment， the MLHFQ scores of both groups significantly decreased as compared with those before treatment （

＜0.01）， and lower score was found in the treatment group than in the control group after 90 days treatment （

＜0.01）. After adjusting for potential confounding factors at baseline by multiple linear regression analysis， the results showed that the addition of QYDP significantly improved the MLHFQ score （

＜0.01）. Before treatment， the scores of the four examination information in TCM were higher， and the LVEF was lower in the treatment group than in the control group （

＜0.05）. The scores of the four examination information significantly decreased， and the LVEF significantly increased in both groups after treatment （

＜0.01）， and the treatment group had lower score of four examination information （

＜0.01）. There were 20 patients （3.12%） with composite endpoint events in the treatment group and 27 patients （4.62%） in the control group （

＞0.05）. Totally， 36 adverse events in the treatment group and 34 in the control group occurred， and none was judged to be drug-related adverse reactions.

Conclusion

The addition of QYDP to western medicine can further improve the cardiac function and quality of life of IHF patients， and the safety in clinical application is good.

关键词

Keywords

references

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Qishen Yiqi Dripping Pill （芪参益气滴丸） for Ischemic Heart Failure： a Multicenter Prospective Cohort Study

DOI：10.13288/j.11-2166/r.2022.07.007

摘要

Abstract

关键词

Keywords

references