中药有效性评价新策略、新方法:整合证据链法  

Integrated evidence chain:a new strategy and methodology for effectiveness evaluation of traditional Chinese medicines

作　　者：肖小河 罗烨 赵旭 杨洪军[5] 杨忠奇[6] 张俊华[7] 王忠[8] 元唯安[9] 王伽伯 柏兆方 景婧 湛小燕 王睿林 戴爱国 唐健元 XIAO Xiao-he;LUO Ye;ZHAO Xu;YANG Hong-jun;YANG Zhong-qi;ZHANG Jun-hua;WANG Zhong;YUAN Wei-an;WANG Jia-bo;BAI Zhao-fang;JING Jing;ZHAN Xiao-yan;WANG Rui-lin;DAI Ai-guo;TANG Jian-yuan(China Military Institute of Chinese Materia,the Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;Department of Hepatology,the Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital,Beijing 100853,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 100029,China;China Academy of Chinese Medical Sciences,Beijing 100700,China;the First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China;Haihe Laboratory,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200000,China;School of Traditional Chinese Medicine,Capital Medical University,Beijing 100069,China;Hunan University of Chinese Medicine,Changsha 410208,China;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China)

机构地区：[1]解放军总医院第五医学中心全军中医药研究所,北京100039 [2]解放军总医院第五医学中心肝病医学部,北京100039 [3]解放军总医院肾脏疾病全国重点实验室,北京100853 [4]北京中医药大学中药学院,北京100029 [5]中国中医科学院,北京100700 [6]广州中医药大学第一附属医院,广东广州510405 [7]天津中医药大学现代中医药海河实验室,天津301617 [8]中国中医科学院临床基础研究所,北京100700 [9]上海中医药大学附属曙光医院,上海200000 [10]首都医科大学中医药学院,北京100069 [11]湖南中医药大学,湖南长沙410208 [12]成都中医药大学附属医院,四川成都610075

出　　处：《中国中药杂志》2024年第19期5113-5124,共12页China Journal of Chinese Materia Medica

基　　金：中国工程院战略研究与咨询项目(2023-XZ-88);国家自然科学基金重点项目(81721002,82230118);国家自然科学基金区域联合基金重点项目(U23A20519)。

摘　　要：中药疗效评价问题是长期制约中医药发展壮大及国际化的“卡脖子”问题。该文从医学认知的底层逻辑出发,在系统剖析中西医药诊疗理念、药效物质基础、研发范式、疗效认知和评价模式等方面客观差异的基础上,整合临床经验、实验研究和临床试验的证据要素,首次提出并建立中药有效性评价新策略和方法体系——中药有效性评价整合证据链法(integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine,iEC-Eff),形成中药有效性“临床经验-实验研究-临床试验”一体化评价与确证模式。初步应用研究显示,该方法可使中药特别是流传千年、有口皆碑、至今临床常用的经典名方的有效性评价等级得到科学提升,使其有效性证据等级能够更加客观地反映其临床价值和地位,突破了当今中药有效性评价以随机对照试验(RCT)为唯一“金标准”的局面及局限,为破解中药有效性评价难题提供了具有原创性和引领性的策略和方法,为建立中医药理论、人用经验和临床试验相结合的中药注册审评证据体系提供了具有可操作性的新工具。该方法可用于中医药经典名方有效性评价、中药新药研发、上市后中成药有效性再评价等,亦可供国家医保药物目录、国家基本药物目录等中药品种遴选参考。The evaluation of the effectiveness of traditional Chinese medicine(TCM)has long been a"bottleneck"issue that restricts the healthy development and internationalization of TCM.This article systematically analyzes the differences in diagnostic and treatment principles,material composition,new drug development pathways,efficacy cognition,and evaluation methodology between Chinese and Western medicine from the underlying logic of medical perspective.On this basis,it integrates the evidence elements of clinical experience,experimental research,and clinical trials,and for the first time proposes and establishes a new strategy and methodology for the evaluation of the effectiveness of TCM:the integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine(iEC-Eff),forming an integrated evaluation and confirmation model of"clinical experience-experimental research-clinical trial"for the effectiveness of TCM.Preliminary application research shows that this method can scientifically enhance the evaluation level of the effectiveness of TCM,especially for classic prescriptions that have been passed down for thousands of years,have a good reputation,and are commonly used in clinical practice today,making the level of efficacy evidence more objectively reflect their clinical value and status.It breaks through the limitation of the current TCM efficacy evaluation that takes RCT as the only"gold standard",providing a new strategy and method with originality,strategy,and leadership for solving the problem of TCM efficacy evaluation.It provides a new tool with operability for establishing a TCM registration review evidence system that combines TCM theory,human experience,and clinical trials.The iEC-Eff can be used for the efficacy evaluation of classic prescriptions in TCM,the development of new TCM drugs,and the re-evaluation of the effectiveness of TCM after listing,and can also be used as a reference for the selection of TCM varieties in the national medical insurance drug catalog and the national esse

关 键 词：中药 有效性 评价策略 评价方法 底层逻辑 整合证据链 循证医学 

分 类 号：R288[医药卫生—中药学]