中国药物警戒 ›› 2025, Vol. 22 ›› Issue (5): 575-579.
DOI: 10.19803/j.1672-8629.20241015

• 安全与合理用药 • 上一篇    下一篇

丹参饮治疗冠心病疗效及安全性的系统评价

王凤鑫1, 李磊1, 黄徐睿1, 赵芸2, LING Ruby1, 杨阳1, 梁昌昊3, 曾韵桃1, 郑颖君1, 唐元辰1, 刘嘉涛1, 王成祥1, 文天才2#, 李平1,*   

  1. 1北京中医药大学第三临床医学院,北京 100029;
    2中国中医科学院中医药数据中心,北京 100091;
    3北京中医药大学循证医学中心,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: *李平,女,博士,主任医师,中医药防治心系病研究。E-mail：Pearll2008@126.com;#为共同通信作者。
  • 作者简介:王凤鑫,女,在读博士,中医药防治心肺疾病研究。
  • 基金资助:
    国家自然科学基金资助项目（81960852、82374624）

Efficacy and Safety of Danshen Decoction in Treatment of Coronary Heart Disease

WANG Fengxin1, LI Lei1, HUANG Xurui1, ZHAO Yun2, LING Ruby1, YANG Yang1, LIANG Changhao3, ZENG Yuntao1, ZHENG Yingjun1, TANG Yuanchen1, LIU Jiatao1, WANG Chengxiang1, WEN Tiancai2#, LI Ping1,*   

  1. 1The Third Clinical Medical College of Beijing University of Chinese Medicine, Beijing 100029, China;
    2National Data Center of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100091, China;
    3Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2024-12-20 Online:2025-05-15 Published:2025-05-19

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摘要： 目的 系统评价丹参饮治疗冠心病的疗效和安全性。方法 检索Cochrane、PubMed、Embase、Web of Science及中国知网等中英文数据库,收集自建库始至2023年8月1日应用丹参饮治疗冠心病的随机对照试验。采用Cochrane Handbook5.1推荐的偏倚风险评估工具评价纳入研究的方法学质量;使用Review Manager5.3进行数据分析;运用GRADE评价结局指标的证据质量。结果 共纳入16项研究,1 388例患者。Meta分析显示,丹参饮治疗组在总有效率[RR=1.31,95%CI（1.24,1.39）,P<0.000 01]、提高心电图改良率[RR=1.28,95%CI（1.19,1.38）,P<0.000 01]、降低心绞痛发作次数[SMD=-1.27,95%CI（-2.12,-0.41）,P=0.004]、降低中医证候积分[SMD= -2.22, 95%CI（-2.62, -1.82）,P<0.000 01]、降低不良反应发生率[RR=0.25,95%CI（0.09, 0.75）,P=0.001]明显优于对照组。亚组分析发现,疗程2~4周疗效最佳。GRADE评价结果显示,总有效率、心电图改良率和中医证候积分为中等质量证据。结论 现有证据表明,丹参饮联合常规药物治疗冠心病的疗效和安全性明显优于常规药物,推荐疗程2~4周。受纳入研究的数量和质量限制,尚需更多高质量RCT进行验证。

关键词: 丹参饮, 冠心病, 系统评价, Meta分析, 有效性, 安全性, GRADE评价

Abstract: Objective To assess the efficacy and safety of Danshen decoction (DSD) in treating coronary heart disease (CHD). Methods Cochrane, PubMed, Embase, Web of Science, and CNKI were searched for literature about RCTs related to the use of DSD in treating CHD that was published from the inception to August 1, 2023. The Cochrane Handbook 5.1 tool was used to evaluate the methodological quality of the included studies, Review Manager 5.3 was adopted to analyze the data, and GRADE was employed to assess the quality of evidence for indexes of outcomes. Results Sixteen studies involving 1,388 patients were included. Meta-analysis showed that DSD compared favorably with the controls in terms of the total efficacy [RR=1.31,95%CI(1.24,1.39), P<0.000 01], ECG improvements [RR=1.28, 95%CI(1.19,1.38), P<0.000 01], frequency of angina onsets[SMD=-1.27,95%CI(-2.12,-0.41), P=0.004], TCM symptom scores[SMD=-2.22, 95%CI(-2.62,-1.82), P<0.000 01], and adverse reactions [RR=0.25%, 95%CI (0.09,0.75), P=0.001]. Subgroup analysis found that 2 to 4 weeks of treatment with DSD were the most effective. GRADE assessment indicated that the evidence for efficacy and ECG improvement was of medium quality. Conclusion There is evidence to suggest that DSD combined with conventional medications is more effective and safer than conventional medications alone for CHD, and a 2-to 4-week course of treatment is recommended. However, more high-quality RCTs are needed to confirm these findings.

Key words: Danshen Decoction, Coronary Heart Disease, Systematic Review, Meta-Analysis, Efficacy, Safety, GRADE Assessment

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