中医药临床研究病例报告表设计和记录的存在问题及解决策略  

The Problems and Solutions in the Design and Record of TCM Clinical Research Case Report Form

作　　者：韩芳 曹克刚[3,4] 高颖[3,4] 刘宝利[1] 周甜甜[1,5] 胡晶 HAN Fang;CAO Kegang;GAO Ying;LIU Baoli;ZHOU Tiantian;HU Jing(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing Hospital of Traditional Chinese Medicine Huairou Hospital,Beijing 101400,China;Institute for Brain Disorders Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China;Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China;Beijing Institute of Chinese Medicine,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京中医医院怀柔医院,北京101400 [3]北京中医药大学中医脑病研究院,北京100700 [4]北京中医药大学东直门医院,北京100700 [5]北京市中医药研究所,北京100010

出　　处：《世界科学技术-中医药现代化》2025年第2期533-538,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委员会面上项目(81973694):基于中医真实疗效病证结合多个主要终点协同评价方法的构建,负责人:胡晶。

摘　　要：病例报告表(Case report form,CRF)是获取临床研究数据的重要工具,科学设计且规范记录的CRF对于提升临床研究质量具有重要意义。作者总结了目前中医药临床研究CRF设计及记录存在的共性问题,包括(1)设计时点滞后;(2)CRF设计、记录及修改欠规范;(3)合并用药/疗法记录不完善;(4)证候疗效指标量化及舌脉的客观化不足;(5)受试者隐私保护不足;(6)不良事件记录欠规范。与之相应,本文探讨了一些解决策略,以期为其他中医药研究者提供参考,具体包括(1)CRF设计时点前移;(2)规范CRF设计、记录及修改;(3)根据临床数据获取协调标准(Clinical Data Acquisition Standards Harmonization,CDASH)设计合并用药/疗法;(4)证候标准化及舌脉标准化研究;(5)使用受试者鉴认代码保护隐私;(6)不良事件记录要“因研究而异”。Case report form(CRF)is an important tool to obtain clinical research data.Scientifically designed and properly recorded CRF is of great significance to improve the quality of clinical research.The author summarized the common problems existing in the design and recording of CRF in traditional Chinese medicine(TCM)clinical studies,including:(1)Delayed design time point.(2)Unstandardized CRF design,recording and modification.(3)Imperfect records of combined medication/therapy.(4)Insufficient quantification of syndrome efficacy indicators and objectification of tongue and pulse.(5)Insufficient protection of subjects′privacy.(6)Unstandardized records of adverse events.Accordingly,this paper discusses some solutions to provide reference for other TCM researchers,including:(1)Advance CRF design time.(2)Standardize CRF design,recording and modification.(3)Design drug combinations/therapies according to Clinical Data Acquisition Standards Harmonization(CDASH).(4)Standardization of syndrome and tongue and pulse.(5)Use of subject identification codes to protect privacy.(6)AE records should vary from study to study.

关 键 词：中医药 临床研究 病例报告表 设计 记录 

分 类 号：R-058[医药卫生]