Effect of <italic style="font-style: italic">Yiqi Liangxue Shengji Formula</italic> （益气凉血生肌方） on Recurrence of Angina Pectoris and Quality of Life after Percutaneous Coronary Intervention in Coronary Heart Disease Patients with <italic style="font-style: italic">Qi</italic> Deficiency and Blood Stasis Syndrome and Binding of Stasis and Heat Syndrome： A Randomized， Triple-blind， Placebo-controlled Parallel Trial

WANG Wujiao; YANG Zhifei; LI Yuxuan; GUO Lingli; WU Yuze; LIN Qian; WAN Jie

doi:10.13288/j.11-2166/r.2023.22.011

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Effect of Yiqi Liangxue Shengji Formula （益气凉血生肌方） on Recurrence of Angina Pectoris and Quality of Life after Percutaneous Coronary Intervention in Coronary Heart Disease Patients with Qi Deficiency and Blood Stasis Syndrome and Binding of Stasis and Heat Syndrome： A Randomized， Triple-blind， Placebo-controlled Parallel Trial

更新时间：2023-11-10

- Effect of Yiqi Liangxue Shengji Formula （益气凉血生肌方） on Recurrence of Angina Pectoris and Quality of Life after Percutaneous Coronary Intervention in Coronary Heart Disease Patients with Qi Deficiency and Blood Stasis Syndrome and Binding of Stasis and Heat Syndrome： A Randomized， Triple-blind， Placebo-controlled Parallel Trial
- Journal of Traditional Chinese Medicine Vol. 64, Issue 22, Pages: 2322-2328(2023)
- 作者机构：
  
  1.北京中医药大学，北京市朝阳区北三环东路11号，100029
  2.北京中医药大学东直门医院
  3.北京中医药大学东方医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2023.22.011
  CLC：
- Received：19 July 2023，
  
  Revised：2023-09-09，
  
  Published：17 November 2023
- 稿件说明：
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汪吴娇,杨志飞,李宇轩等.益气凉血生肌方对冠心病气虚血瘀兼瘀热互结证患者经皮冠状动脉介入治疗术后心绞痛复发和生活质量的影响——一项随机、三盲、安慰剂平行对照试验[J].中医杂志,2023,64(22):2322-2328.

WANG Wujiao,YANG Zhifei,LI Yuxuan,et al.Effect of Yiqi Liangxue Shengji Formula （益气凉血生肌方） on Recurrence of Angina Pectoris and Quality of Life after Percutaneous Coronary Intervention in Coronary Heart Disease Patients with Qi Deficiency and Blood Stasis Syndrome and Binding of Stasis and Heat Syndrome： A Randomized， Triple-blind， Placebo-controlled Parallel Trial[J].Journal of Traditional Chinese Medicine,2023,64(22):2322-2328.
汪吴娇,杨志飞,李宇轩等.益气凉血生肌方对冠心病气虚血瘀兼瘀热互结证患者经皮冠状动脉介入治疗术后心绞痛复发和生活质量的影响——一项随机、三盲、安慰剂平行对照试验[J].中医杂志,2023,64(22):2322-2328. DOI： 10.13288/j.11-2166/r.2023.22.011.

WANG Wujiao,YANG Zhifei,LI Yuxuan,et al.Effect of Yiqi Liangxue Shengji Formula （益气凉血生肌方） on Recurrence of Angina Pectoris and Quality of Life after Percutaneous Coronary Intervention in Coronary Heart Disease Patients with Qi Deficiency and Blood Stasis Syndrome and Binding of Stasis and Heat Syndrome： A Randomized， Triple-blind， Placebo-controlled Parallel Trial[J].Journal of Traditional Chinese Medicine,2023,64(22):2322-2328. DOI： 10.13288/j.11-2166/r.2023.22.011.

摘要

目的

观察益气凉血生肌方对经皮冠状动脉介入治疗（PCI）术后患者8周内心绞痛复发和生活质量的影响。

方法

纳入行PCI术的冠心病气虚血瘀兼瘀热互结证患者82例，随机分为治疗组及对照组各41例。治疗组在PCI术后西医常规治疗的基础上加用益气凉血生肌方颗粒口服，对照组在PCI术后西医常规治疗的基础上加用安慰剂颗粒口服，两组均每日1剂，疗程为8周。记录PCI术后8周内患者心绞痛复发率及再入院率，并于治疗前后记录患者中医证候总积分、西雅图心绞痛量表（SAQ）评分（包括躯体活动受限程度、心绞痛稳定状态、心绞痛发作情况、治疗满意程度及疾病认识程度5项）、健康调查简表（SF-36）评分（包括躯体健康评价评分、精神健康评价评分）；观察并记录两组患者服药期间不良反应情况。

结果

PCI术后8周内，治疗组心绞痛复发率为9.76%（4/41），低于对照组的26.83%（11/41，

＜0.05）。治疗组心绞痛再入院率为2.44%（1/41），对照组为12.20%（5/41），两组比较差异无统计学意义（

＞0.05）。与本组治疗前比较，两组治疗后中医证候总积分均明显降低，两组术后生活质量方面，SAQ中心绞痛稳定状态、心绞痛发作情况、疾病认识程度评分均提高，SF-36总分及躯体健康评价评分、精神健康评价评分均提高（

＜0.05或

＜0.01）。治疗后两组间比较，治疗组中医证候积分较对照组明显降低（

＜0.01），SAQ各项评分及SF-36总分及躯体健康评价评分、精神健康评价评分两组间比较差异无统计学意义（

＞0.05）。治疗期间两组均未出现不良反应。

结论

益气凉血生肌方可减少冠心病PCI术后气虚血瘀兼瘀热互结证患者8周内心绞痛的复发率，改善中医证候，且服药后安全性较好，但在改善术后短期内生活质量方面与安慰剂疗效相当。

Abstract

Objective

To observe the clinical effect of

Yiqi Liangxue Shengji Formula

（益气凉血生肌方， YLSF） on recurrence of angina pectoris and quality of life at eight weeks after perecutaneous coronary intervention （PCI）.

Methods

Eighty-two coronary artery disease （CAD） patients with

deficiency and blood stasis and binding of stasis and heat syndrome who had underwent PCI were randomly divided into two groups with 41 patients each in the treatment group and the control group. Based on conventional western medicine after PCI， patients in the treatment group orally took YLSF granules while those in the control group were administered with placebo， one dose daily for 8 weeks. The recurrence rate of angina pectoris and readmission rate within eight weeks after PCI were recorded. Before and after treatment， total traditional Chinese medicine （TCM） syndrome score， Seattle Angina Questionnaire （SAQ） scores （physical limitation， angina stability， angina frequency， treatment satisfaction and disease perception）， and the SF-36 scores for quality of life （physical and mental health） were evaluated. The adverse reactions during medication in both groups were recorded.

Results

Within eight weeks after PCI， the recurrence rate of angina pectoris in the treatment group （4/41， 9.76%） was significantly lower than that in the control group （11/41， 26.83%，

＜0.05）. The readmission rate in the treatment group was 2.44% （1/41）， while that in the control group was 12.20% （5/41）， with no significantly statistical difference （

＞0.05）. After treatment， total TCM syndrome score significantly decreased in both groups， while in terms of quality of life， the SAQ scores on domains of angina stability， angina frequency and disease perception as well as SF-36 total scores， physical health and mental health scores significantly increased （

＜0.05 or

＜0.01）. Compared between the two groups， total TCM syndrome score was significantly lower in the treatment group than the control group （

＜0.01）， while no significant differences were found in SAQ scores and SF-36 total， physical and mental health scores （

＞0.05）. No adverse reactions occurred in both groups during the treatment period.

Conclusion

YLSF can reduce the recurrence rate of angina pectoris within eight weeks after PCI for coronary artery disease， and can improve the TCM syndrome score， and have sound safety， with comparable effect to that of placebo in improving postoperative short-term quality of life.

关键词

Keywords

references

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DOI：10.13288/j.11-2166/r.2023.22.011

摘要

Abstract

关键词

Keywords

references