中国药物警戒 ›› 2025, Vol. 22 ›› Issue (5): 570-574.
DOI: 10.19803/j.1672-8629.20241011

• 安全与合理用药 • 上一篇    下一篇

西洋参茎叶总皂苷辅助治疗冠心病心绞痛的有效性和安全性Meta分析

范丽萍1, 鲁姝1, 孙慧媛2,*   

  1. 1北京中医药大学第三附属医院药学部,北京 100029;
    2北京中医药大学第三附属医院互联网诊疗办公室,北京 100029
  • 收稿日期:2024-12-20 出版日期:2025-05-15 发布日期:2025-05-19
  • 通讯作者: *孙慧媛,女,博士,副主任医师,中医药防治呼吸循环系统疾病的基础与临床研究。E-mail: doctorelegance@126.com
  • 作者简介:范丽萍,女,硕士,主管药师,药事管理与临床药学。
  • 基金资助:
    国家自然科学基金资助项目（82174203、82374413）; 第七批全国老中医药专家学术经验继承工作项目（国中医药人教函[2022]76号）

Efficacy and Safety of Panax Quinquefolium Saponin in Adjuvant Treatment of Angina Pectoris of Coronary Heart Disease: a Meta-Analysis

FAN Liping1, LU Shu1, SUN Huiyuan2,*   

  1. 1Department of Pharmacy, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China;
    2Office of Internet Diagnosis and Treatment, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China
  • Received:2024-12-20 Online:2025-05-15 Published:2025-05-19

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摘要： 目的 系统评价西洋参茎叶总皂苷治疗冠心病心绞痛的有效性和安全性。方法 基于Cochrane、PubMed、Embase、Web of Science、ClinicalTrials、中国生物医学文献数据库、中国知网、万方数据和维普网等数据库,检索有关西洋参茎叶总皂苷辅助治疗冠心病心绞痛的随机对照试验（RCTs）。检查时间为建库至2025年2月28日应用Cochrane偏倚风险评估工具RoB 2.0对纳入研究的质量进行评价,应用Revman5.3进行Meta分析和敏感性分析,应用Stata12.0分析发表偏倚,应用GRADE评价体系对结局指标进行质量评价。结果 最终纳入11项RCTs,Meta结果显示西洋参茎叶总皂苷组在临床有效率{[RR=1.24,95%CI（1.16,1.32）,P<0.000 01]}、心绞痛症状改善情况{心绞痛持续时间[MD=-2.45,95%CI(-3.54,-1.37),P<0.000 01]和心绞痛发作频次[MD=-1.22,95%CI(-1.80,-0.65),P<0.000 1]}、心肌损伤改善情况{BNP[MD=-52.36,95%CI(-87.35,-17.37),P=0.003]}、CK-MB{[MD=-4.56,95%CI(-0.74,-0.08),P=0.000 7]}、cTnI{[MD=-0.41,95%CI(-87.35,-17.37),P=0.01]}和H-FABP{[MD=-1.86,95%CI(-3.35,-0.37),P=0.01]}方面优于西医常规治疗组,在头晕头痛、面色潮红、消化道、肝功能、肾功能等不良反应方面2组差异均不具有统计学意义。结论 西洋参茎叶总皂苷可有效改善冠心病心绞痛疗效、症状和心肌损伤指标,且不增加不良反应。但受纳入研究数量、样本量和质量的限制,仍需要开展更多、更高质量的RCTs予以验证。

关键词: 西洋参茎叶总皂苷, 心悦胶囊, 冠心病心绞痛, 随机对照试验, 有效性, 安全性, Meta分析

Abstract: Objective To evaluate the efficacy and safety of Panax quinquefolium saponin (Xinyue capsules) in treating angina pectoris of coronary heart disease. Methods Cochrane, PubMed, Embase, Web of Science, ClinicalTrials, SinoMed, CNKI, Wanfang and VIP Data Knowledge Service Platform were searched for literature on randomized controlled trials (RCTs) related to the efficacy and safety of Panax quinquefolium saponin in treating angina pectoris of coronary heart disease. Literature bias risk was assessed using the Cochrane risk of bias 2.0 tool (RoB 2.0) from the inception to Feb 28, 2025. RevMan 5.3 software was used for Meta-analysis and sensitivity analysis while GRADE was employed for quality evaluation of outcome indicators. Results A total of 11 articles were included in this study. Meta-analysis results showed that the clinical effective rate[RR=1.24, 95%CI(1.16, 1.32), P<0.000 01], improvement of angina symptoms(duration of angina pectoris[MD=-2.45, 95%CI(-3.54, -1.37), P<0.000 01] and frequency of angina pectoris[MD=-1.22, 95%CI(-1.80, -0.65), P<0.000 1], myocardial injury indexes{BNP[MD=-52.36, 95%CI(-87.35,-17.37), P=0.003]、CK-MB[MD=-4.56, 95%CI(-0.74,-0.08), P=0.000 7]、cTnI[MD=-0.41, 95%CI(-87.35,-17.37), P=0.01] and H-FABP[MD=-1.86, 95%CI (-3.35,-0.37), P=0.01]} in the panax quinquefolium saponin (Xinyue capsule) group were better than in the Western medicine group. However, there were no significant differences between the two groups in incidence of adverse reactions, such as dizziness, headache, flushing or those involving the digestive tract, liver function and kidney function. Conclusion Panax quinquefolium saponin (Xinyue capsules) can effectively improve the curative effect, symptoms and myocardial injury indexes in the treatment of angina pectoris of coronary heart disease without increasing adverse reactions. However, due to the limitation of the number, sample size and quality of the included studies, more high-quality studies are needed.

Key words: Panax Quinquefolium Saponin, Xinyue Capsule, Angina Pectoris of Coronary Heart Disease, Randomized Controlled Trials(RCTs), Efficacy, Safety, Meta-Analysis

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