南京中医药大学学报2026，Vol.42Issue(1)：90-97,8.DOI:10.14148/j.issn.1672-0482.2026.0090
基于人用经验的医疗机构中药制剂临床实践数据采集要点探讨
Analysis of Key Points in Clinical Practice Data Collection for Hospital-Prepared Traditional Chinese Medicine Formulations Based on Human Use Experience
摘要
Abstract
Against the backdrop of promoting the inheritance,innovation,and development of traditional Chinese medicine(TCM)and the establishment of the"three-combination"review evidence system integrating"TCM theory,human use experience,and clinical trials",hospital-prepared TCM formulations have become a vital source for transforming new TCM drugs.Standardized collection of clinical practice data from human use experience of these formulations plays a key role in summarizing such experience and facilitating research and development transformation.Based on policy requirements and methodological guidelines,this paper identifies the core elements of data collection,covering key dimensions such as target population characteristics,study factors,outcome variables,and co-variates.It also proposes the use of causal directed acyclic graphs(DAG)to guide variable identification and collection.Additionally,this study emphasizes key methodological requirements including a focus on regulatory compliance in information gathering and struc-tured processes in data acquisition,ensuring the standardization of TCM diagnostic information collection,and promoting the routine documentation of out-of-hospital outcomes and competing endpoints,along with the dimensional integration of the biopsychosocial medical model.This provides methodological support for constructing high-quality human use experience datasets,thereby facilitating evidence-based transformation of hospital-prepared TCM formulations and the development of new TCM drugs.关键词
人用经验/医疗机构中药制剂/临床实践数据/中药新药/"三结合"审评证据体系/有向无环图/标准化Key words
human use experience/hospital-prepared traditional Chinese medicine formulations/clinical practice data/new tradi-tional Chinese medicine drugs/"three-combination"review evidence system/directed acyclic graph/standardization分类
医药卫生引用本文复制引用
王威,王晓骁,贾玉龙,王家莹,俞曼殊,王志超,张春烽,于茜,王卯,吴文忠..基于人用经验的医疗机构中药制剂临床实践数据采集要点探讨[J].南京中医药大学学报,2026,42(1):90-97,8.基金项目
2023年度预防医学及血地寄防科研课题(Ym2023103) （Ym2023103）
江苏省中医疫病研究中心开放课题(JSYB2024KF17) （JSYB2024KF17）
科主任学术提升专项课题(Y2022ZR14) （Y2022ZR14）
江苏省中药特色制剂融合创新中心课题(k2024J02) （k2024J02）
南京江北新区生物医药公共服务平台项目 （）
