中药有效性评价新策略、新方法:整合证据链法

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中文摘要：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。

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

外文摘要：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 essential drug catalog.

外文关键词：

traditional Chinese medicineeffectivenessevaluation strategyevaluation methodologyunderlying logicintegrated evidence chainevidence-based medicine

作者：

肖小河、罗烨、赵旭、杨洪军、杨忠奇、张俊华、王忠、元唯安、王伽伯、柏兆方、景婧、湛小燕、王睿林、戴爱国、唐健元

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作者单位：

解放军总医院第五医学中心全军中医药研究所,北京 100039

解放军总医院第五医学中心肝病医学部,北京 100039

解放军总医院肾脏疾病全国重点实验室,北京 100853

北京中医药大学中药学院,北京 100029

中国中医科学院,北京 100700

广州中医药大学第一附属医院,广东广州 510405

天津中医药大学现代中医药海河实验室,天津 301617

中国中医科学院临床基础研究所,北京 100700

上海中医药大学附属曙光医院,上海 200000

首都医科大学中医药学院,北京 100069

湖南中医药大学,湖南长沙 410208

成都中医药大学附属医院,四川成都 610075

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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

基金：

中国工程院战略研究与咨询项目国家自然科学基金重点项目国家自然科学基金重点项目国家自然科学基金区域联合基金重点项目

项目编号：

2023-XZ-888172100282230118U23A20519

出版年：

2024

DOI：

10.19540/j.cnki.cjcmm.20240709.601

中国中药杂志

中国药学会

中国中药杂志

CSTPCD北大核心

影响因子：1.718

ISSN：1001-5302

年,卷(期)：2024.49(19)