日本“台帐”模式汉方药真实世界研究方法的启示  

Inspiration from the real world research methods of Chinese prescription medicine under the model of"Drug Seller"and"Ledger"

作　　者：苏雯 彭少衍 西村一郎 SU Wen;PENG Shaoyan;NISHIMURA Ichiro(Guangzhou Huangpu District New Drug Application Service Center,Guangzhou 510670,China;Hin Sang Group(International)Holding Co.,Ltd.,Hongkong 999077,China;Kitanihon Pharmaceutical Co.,Ltd.,Institute,Toyama 9300314,Japan;Guangdong Institute of Traditional Chinese Medicine,Guangzhou 510630,China;World Federation of Chinese Medicine Societies Real-World Research Professional Committee,Beijing 100700,China)

机构地区：[1]广州市黄埔区(广州开发区)新药申报服务中心,广州510670 [2]衍生集团(国际)控股有限公司,中国香港999077 [3]北日本制药研究所,日本富士930031 [4]广东省中药研究所,广州510630 [5]世界中医药学会联合会真实世界研究专业委员会,北京100700

出　　处：《科技导报》2024年第21期180-188,共9页Science & Technology Review

摘　　要：综述了日本的“配置(家庭)药(箱)”及其在多种条件制约下形成的全方位、立体化、多层次“台帐”式信息积聚模式,其对100余种古代经典名方汉方药剂300余年的使用历史、功能检测、效果验证等做出真实记录、数据统计、信息归纳、观察分析和客观判断。该举措为完成数据积累向证据转化和向真实世界研究成果转化,为汉方药剂二次开发、改良提升提供了客观的观察性研究成果和有力支撑,并对“价值医学”理论框架下古代经典名方应用于“未病先防、既病防变、瘥后防复”的“治未病”的价值认知构筑了量化手段。建议加强探究日本的“配置(家庭)药(箱)”真实世界研究形成背景、历史沿革,剖析其模式特征、独特价值,归纳启示意义、借鉴价值,为真实世界研究提质增效提供参考。Since Kaplan et al.first proposed the concept of RWS in 1993,China has become a hot spot in the real world research of traditional Chinese medicine.How to effectively collect value data(RWD)related to patients,and how to make correct,efficient,and accurate statistics,induction,organization,and analysis of the data,making it evidence of use value,potential benefits,and potential risks(RWE)have become important research topics.Japan's"configuration(home)medicine(box)"and its comprehensive,three-dimensional,and multi-level"ledger"information accumulation model formed under various conditions have made real records,data statistics,information induction,observation and analysis,and objective judgments on the usage history,functional testing,and effect verification of more than 100 ancient classic Chinese herbal medicines for more than 300 years.They have completed the transformation of data accumulation into evidence and into real-world research results,providing strong support for the secondary development,improvement,and enhancement of Chinese herbal medicines.Under the theoretical framework of"value medicine",ancient classic Chinese herbal medicines have been used to"prevent diseases before they occur and prevent recurrence after they occur".The value cognition of"treating diseases before they occur"has been constructed as a quantitative means.Given the current situation of limited research in this field,it is recommended to strengthen the exploration of the background and historical evolution of Japan's real-world research on"configuration(home)medicine(box)",analyze its mode characteristics and unique value,summarize its enlightening and reference value,and provide reference for improving the quality and efficiency of real-world research.

关 键 词：台帐 卖药郎 配置药箱 经典名方 汉方药 先用后利 人用经验 价值医疗 

分 类 号：R288[医药卫生—中药学]