摘要
证候是疾病过程中机体综合反应出的症状和体征,辨证论治是中医临床实践中的核心特色。本文参照《中医病证诊断疗效标准》《证候类中药新药临床研究技术指导原则》等文件,综合应用标准化理论和循证医学方法学,引入量表研发和评价指标体系,制定中医证候疗效评估量表研制技术规范。本文确立的中医证候疗效评估量表研制的规范化流程,可以为中医证候疗效评估量表的研制提供技术和方法学参考,指导中医证候疗效评估量表编制和考评相关研究的合理设计与规范实施,对实现中医辨证临床研究的标准化和现代化具有重要意义。
Syndrome refers to the comprehensive manifestation of symptoms and signs during the course of a disease,and syndrome differentiation and treatment is a core feature of clinical practice in traditional Chinese medicine(TCM).Referring to documents such as Standards for Diagnosis and Curative Effect of TCM Diseases and Syndromes and Technical Guidelines for Clinical Research of New Chinese Medicines for Syndrome-related Indications,this article integrates standardization theory and evidence-based medical methodology,introduces the concept of scale development and evaluation index systems and formulates technical specifications for the development of a TCM syndrome efficacy assessment scale.The standardized process established in this study can provide technical and methodological references for the development of TCM syndrome efficacy assessment scales and guide the rational design and standardized implementation of relevant research on scale compilation and evaluation,and has important significance for promoting the standardization and modernization of clinical research on TCM syndrome differentiation.
作者
王瑞平
李斌
WANG Ruiping;LI Bin(Clinical Research&Innovation Center,Shanghai Skin Disease Hospital,Shanghai 200443,China)
出处
《上海医药》
2025年第11期26-29,53,共5页
Shanghai Medical & Pharmaceutical Journal
基金
上海市卫生健康委员会卫生行业临床研究专项(202240371)
上海申康医院发展中心第二轮促进市级医院临床技能与临床创新三年行动计划——研究型医师创新转化能力培训项目(SHDC2022CRS053)
第二轮促进市级医院临床技能与临床创新三年行动计划(2023—2025年)CRU协同数据质量提升项目(SHDC2024CRX032)
上海市皮肤病医院引进人才科研基金项目(2021KYQD01)
上海人才发展基金项目(2021SHRCFZ01)
上海市卫生健康委员会、上海市中医药管理局2025年度中医药标准化项目(2025BZ004)。
关键词
证候
疗效评估
量表
信度
效度
syndrome
efficacy assessment
scale
reliability
validity
