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.
Abstract
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.
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
Key words
traditional Chinese medicine/effectiveness/evaluation strategy/evaluation methodology/underlying logic/integrated evidence chain/evidence-based medicine
维普
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