Exclusive: The paradigm and application of clinical research in traditional Chinese medicine

Construction of clinical practice guidelines for TCM intervention in coronary heart disease and analysis of real world evidence application status

  • WANG Kewen ,
  • LUO Wenye ,
  • ZHANG Jing ,
  • HAO Xiuwei ,
  • KONG Dezhao
Expand
  • 1. The First Clinical College of Liaoning University of Traditional Chinese Medicine, Shenyang 110000, China;
    2. Peking University First Hospital, Beijing 100034, China

Received date: 2024-06-20

  Revised date: 2024-11-07

  Online published: 2024-12-14

Abstract

In order to facilitate clinicians to make faster choices from many clinical guidelines, this paper evaluates the quality of clinical guidelines on Chinese medicine interventions for coronary heart disease using AGREE II and RIGHT reporting standards, and summarises their diagnostic and therapeutic opinions.It also assesses the role played by real world studies in the guidelines for TCM intervention in coronary heart disease and evaluates the quality of real world studies on TCM intervention in coronary heart disease.The results show that of the 10 guidelines included, 8 are evaluated as grade B and 2 as grade C.After summarizing the diagnostic and therapeutic opinions it is found that coronary heart disease is classified into different types of evidence in different guidelines, and the classification criteria have not yet been unified, among which the probabilities of cardioblood stasis and obstruction, qi and yin deficiency, cardio-kidney and yang deficiency, qi and blood stasis and qi and blood stasis are higher, and all of them are recommended in 5 or more guidelines.The recommended GRADE levels for herbal medicines are B, C and D.The former studies on which these guidelines were based were randomized controlled trials, systematic reviews, or expert consensus, and there were no real world studies as the source of evidence, and the evidence-based evidence of the characteristics of TCM was insufficiently reflected.Therefore, this study proposes the following recommendations for the development of guidelines on coronary heart disease in TCM.In the future, emphasis should be placed on constructing guideline evaluation tools that are consistent with the characteristics of TCM, standardising the process of guideline or consensus development, carrying out high-level, high-quality prospective studies, and considering controlling for the effects of bias, confounders, uncertainties, limitations and other influences on the quality of real world studies, in order to obtain high-quality real world research evidence with better quality, higher level of evidence, and more precise and reliable efficacy, focusing on the application of high-quality real world evidence, and also focusing on the promotion of its application, in order to better improve the clinical outcomes of patients with coronary heart disease, enhance clinical efficacy, and promote the long term development of Chinese medicine.

Cite this article

WANG Kewen , LUO Wenye , ZHANG Jing , HAO Xiuwei , KONG Dezhao . Construction of clinical practice guidelines for TCM intervention in coronary heart disease and analysis of real world evidence application status[J]. Science & Technology Review, 2024 , 42(21) : 20 -38 . DOI: 10.3981/j.issn.1000-7857.2024.05.00465

References

[1] World Health Organization. World health statistics 2021: Monitoring health for the SDGs, sustainable development Goals[EB/OL]. (2021-05-20)[2024-02-06]. https://www. who.int/publications/i/item/9789240027053.
[2] Roth G A, Mensah G A, Johnson C O, et al. Global burden of cardiovascular diseases and risk factors, 1990-2019 update from the GBD 2019 study[J]. Journal of the American College of Cardiology, 2020, 76(25): 2982-3021.
[3] 王增武, 胡盛寿.《中国心血管健康与疾病报告2019》要点解读[J]. 中国心血管杂志, 2020, 25(5): 401-410.
[4] 葛均波, 徐永健, 王辰. 内科学[M]. 第9 版. 北京: 人民卫生出版社, 2018: 218-219.
[5] 国家卫生计生委合理用药专家委员会, 中国药师协会. 冠心病合理用药指南(第2版)[J]. 中国医学前沿杂志(电子版), 2018, 10(6): 1-130.
[6] Cardiovascular Prevention and Rehabilitation Committee of Integrative Medicine, Chinese Association for Research and Advancement of Chinese Medicine. 稳定性冠心病中西医结合康复治疗专家共识[J]. 中西医结合心脑血管病杂志, 2019, 17(3): 321-329.
[7] 李金根, 徐浩, 史大卓. 冠心病中西医结合随机对照临床研究: 进展与展望[J]. 中国中西医结合杂志, 2017, 37(5): 517-521.
[8] 徐香梅, 陈旋, 孔艺璇, 等. 基于AGREEⅡ工具评价冠心病中西医临床实践指南的质量[J]. 中西医结合心脑血管病杂志, 2021, 19(8): 1233-1237.
[9] 李承羽, 陈耀龙, 胡嘉元, 等. 冠心病中西医结合临床实践指南研制现状及思考[J]. 世界科学技术-中医药现代化, 2018, 20(12): 2101-2108.
[10] 杨颖, 毕颖斐, 王贤良, 等. 基于AGREE Ⅱ的中医药治疗心血管病指南/共识质量评价[J]. 中西医结合心脑血管病杂志, 2020, 18(7): 1030-1038.
[11] 李逸雯, 刘艳飞, 崔京, 等. 冠心病中医药诊疗指南的方法学质量评价[J]. 中国循证医学杂志, 2021, 21(6): 696-702.
[12] 韦当, 王聪尧, 肖晓娟, 等. 指南研究与评价(AGREE II)工具实例解读[J]. 中国循证儿科杂志, 2013, 8(4): 316- 319.
[13] 陈耀龙, 胡嘉元, 李承羽, 等. 中国临床实践指南的发展与变革[J]. 中国循证医学杂志, 2018, 18(8): 787- 792.
[14] 朱政, 胡雁, 周英凤, 等. 推动证据向临床转化(五)证据临床转化研究中的文献质量评价[J]. 护士进修杂志, 2020, 35(11): 996-1000.
[15] 夏韵. 基于RIGHT声明的中医药指南报告规范研究[D]. 广州: 广州中医药大学, 2019.
[16] 陈薇, 方赛男, 刘建平, 等. 国际循证医学证据分级体系的发展与现状[J]. 中国中西医结合杂志, 2017, 37(12): 1413-1419.
[17] Sherman R E, Anderson S A, Dal Pan G J, et al. Realworld evidence-what is it and what can it tell us?[J]. The New England Journal of Medicine, 2016, 375(23): 2293-2297.
[18] Knottnerus J A, Tugwell P. Real world research[J]. Journal of Clinical Epidemiology, 2010, 63(10): 1051-1052.
[19] 刘少芳, 黄国东, 陈峰, 等. 真实世界研究应用于中医药领域近况[J]. 中国中医药现代远程教育, 2023, 21(24): 200-202.
[20] Field M J, Lohr K N. Clinical practice guidelines: directions for a new program[M]. Washington, D C: National Academy Press, 1990.
[21] Graham R. Clinical practice guidelines we can trust[M]. Washington, D C: National Academies Press, 2011.
[22] 周芬, 郝玉芳, 丛雪, 等. 指南研究与评价工具AGREE II及各领域分值的补充解释及思考[J]. 护理学报, 2018, 25(18): 56-58.
[23] Chen Y L, Yang K H, Marušic A, et al. A reporting tool for practice guidelines in health care: The RIGHT statement[J]. Annals of Internal Medicine, 2017, 166(2): 128- 132.
[24]《药学与临床研究》编辑部. 如何正确运用组内相关系数进行一致性检验: 药物研究中的统计学(一)[J]. 药学与临床研究, 2018, 26(1): 7-8.
[25] 王阶, 陈光. 冠心病稳定型心绞痛中医诊疗专家共识[J]. 中医杂志, 2018, 59(5): 447-450.
[26] China Association of Chinese Medicine Cardiovascular Disease Branch. 冠心病稳定型心绞痛中医诊疗指南[J]. 中医杂志, 2019, 60(21): 1880-1890.
[27] 毛静远, 吴永健, 史大卓. 中成药治疗冠心病临床应用指南(2020年)[J]. 中西医结合心脑血管病杂志, 2021, 19(9): 1409-1435.
[28] 中华医学会, 中华医学会临床药学分会, 中华医学会杂志社, 等. 稳定性冠心病基层合理用药指南[J]. 中华全科医师杂志, 2021, 20(4): 423-434.
[29] Liao P D, Chen K J, Ge J B, et al. Clinical practice guideline of integrative Chinese and western medicine for acute myocardial infarction[J]. Chinese Journal of Integrative Medicine, 2020, 26(7): 539-551.
[30] 张敏州, 丁邦晗, 林谦. 急性心肌梗死中医临床诊疗指南[J]. 中华中医药杂志, 2021, 36(7): 4119-4127.
[31] 张瑞芬, 苏和, 黄新生, 等. 不稳定型心绞痛中医诊疗专家共识[J]. 中医杂志, 2022, 63(7): 695-700.
[32] 陈可冀, 史大卓. 冠心病及急性心肌梗死中医临床辨证标准及防治指南[M]. 北京: 人民卫生出版社, 2014: 29-50.
[33] 王阶, 邢雁伟. 冠心病心绞痛证候要素诊断标准[J]. 中医杂志, 2018, 59(6): 539-540.
[34] Guyatt G, Oxman A D, Akl E A, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables[J]. Journal of Clinical Epidemiology, 2011, 64(4): 383-394.
[35] Guyatt G H, Ebrahim S, Alonso-Coello P, et al. GRADE guidelines 17: Assessing the risk of bias associated with missing participant outcome data in a body of evidence[J]. Journal of Clinical Epidemiology, 2017, 87: 14-22.
[36] 刘振飞, 刘爽, 张世亮. 基于网络药理学及分子对接探讨冠心2 号方治疗冠心病的作用机制[J]. 中西医结合心脑血管病杂志, 2022, 20(11): 1929-1939.
[37] 曹雪, 孟祥然, 王馨, 等. 真实世界观察性研究的质量评价工具ArRoWS解读[J]. 中国循证医学杂志, 2023, 23(2): 227-232.
[38] Coles B, Tyrer F, Hussein H, et al. Development, content validation, and reliability of the Assessment of Real-World Observational Studies (ArRoWS) critical appraisal tool[J]. Annals of Epidemiology, 2021, 55: 57-63.
[39] 国家药品监督管理局. 用于产生真实世界证据的真实世界数据指导原则(试行)[EB/OL]. (2021-04-13)[2024- 02-06]. https://www. cde. org. cn/main/news/viewInfoCommon/2a1c437ed54e7b838a7e86f4ac21c539.
[40] 耿洪娇, 刘峘, 谢雁鸣, 等. 刺五加注射液治疗4680例脑血管病的真实世界应用特征及联合用药分析[J]. 辽宁中医杂志, 2021, 48(6): 156-159.
[41] 孙粼希, 高阳, 谢雁鸣, 等. 丹参川芎嗪注射液治疗冠心病合并高血压的临床用药特征: 一项真实世界研究[J]. 海南医学院学报, 2022, 28(17): 1320-1326.
[42] 黎元元, 程豪, 谢雁鸣. 灯盏细辛注射液治疗脑梗死合并用药的真实世界研究[J]. 中国中药杂志, 2014, 39(18): 3551-3554.
[43] 赖润民, 林骞, 张贺, 等. 活血解毒中药对稳定性冠心病再发心血管事件影响的真实世界研究[J]. 中国中西医结合杂志, 2023, 43(9): 1069-1074.
[44] 邵淑玲, 谢雁鸣, 黎元元, 等. 基于倾向评分法探讨真实世界注射用灯盏花素治疗冠心病的临床实效研究[J]. 浙江中医药大学学报, 2022, 46(3): 300-308.
[45] 孙粼希, 谢雁鸣, 黎元元, 等. 基于真实世界分析注射用灯盏花素治疗冠心病的临床用药特征[J]. 新中医, 2021, 53(19): 35-40.
[46] 王连心, 谢雁鸣, 杨薇, 等. 基于HIS真实世界的参麦注射液临床实效研究[J]. 中国中药杂志, 2012, 37(18): 2710-2713.
[47] 杨薇, 程豪, 谢雁鸣, 等. 基于HIS灯盏细辛注射液“真实世界”临床用药特点分析[J]. 中国中药杂志, 2012, 37(18): 2718-2722.
[48] 孙春全, 谢雁鸣, 侯恒悦. 生脉注射液治疗冠心病心绞痛临床特征及合并用药的真实世界研究[J]. 世界中医药, 2022, 17(1): 123-128.
[49] 成冯镜茗, 谢雁鸣, 王连心, 等. 真实世界刺五加注射液治疗2046例冠心病患者的临床用药特征分析[J]. 中国中医基础医学杂志, 2021, 27(10): 1588-1594.
[50] 王明霞, 王淑梅, 刘明, 等. 真实世界中30012例参麦注射液使用情况与安全性评价[J]. 中国循证医学杂志, 2021, 21(2): 133-138.
[51] 张丹丹, 韩振蕴, 秦绍林, 等. 真实世界中通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证疗效的多因素分析[J]. 中国中医基础医学杂志, 2022, 28(12): 2001-2006.
[52] 毕颖斐, 王贤良, 王聪, 等. 中医药辨治稳定性冠心病的病、证、症-疗效-用药规律的真实世界研究[J]. 中医杂志, 2023, 64(7): 702-709.
[53] 蒋燕君. 基于真实世界下活血化瘀类中成药干预稳定性冠心病的观察性研究[D]. 北京: 北京中医药大学, 2022.
[54] 张蕾, 黎元元, 谢雁鸣, 等. 注射用灯盏花素治疗心绞痛真实世界研究[J]. 中国药物警戒, 2022, 19(8): 857- 861.
[55] 陈雅馨, 梁宁, 晏利姣, 等. 中成药临床实践指南制定方法(二): 指南工作组的建立及利益冲突管理[J]. 中医杂志, 2024, 65(1): 50-54.
[56] 柴月. 从利益冲突看医药产品推广行为之规制[J]. 北京化工大学学报(社会科学版), 2015(2): 22-28.
[57] 郭然, 曾典, 胡裕涵, 等. 价值医疗视角下的中医药优势评价思路与方法[J]. 科技导报, 2023, 41(14): 14-21.
[58] 刘道践, 陈俊国, 李源, 等. 一个中国化医学临床指南评价工具的研发[J]. 中国医学装备, 2012, 9(9): 11-14.
[59] Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and real-world data for evaluating drug safety and effectiveness[J]. JAMA, 2018, 320(9): 867-868.
[60] Basch E, Schrag D. The evolving uses of "real-world" data[J]. JAMA, 2019, 321(14): 1359-1360.
[61] 刘保延. 真实世界的中医临床科研范式[J]. 中医杂志, 2013, 54(6): 451-455.
[62] Roche N, Reddel H, Martin R, et al. Quality standards for real-world research. Focus on observational database studies of comparative effectiveness[J]. Annals of the American Thoracic Society, 2014, 11(Suppl 2): S99-S104.
[63] 刘保延, 文天才. 从信息科学与物质科学及其范式认识中西医学体系的科学原理[J]. 科技导报, 2023, 41(14): 5-13.
[64] 周雪忠, 王世华, 张迪, 等. 构建中医药特色真实世界临床研究新模式的实践与思考[J]. 科技导报, 2023, 41(14): 22-31.
Outlines

/