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.
[1] 刘昌孝, 张铁军, 朱强. 经典名方中药新药研发关键技术与示范研究[M]. 北京: 中国医药科技出版社, 2023: 3- 4.
[2] 小曾戶洋. 漢方の歴史~中国·日本の伝統医学[M]. 东京: 大修館書店, 1999: 170-178.
[3]《中医 药发 展“ 十三 五”规划》[A/OL]. (2016-08-11)[2023-12-24]. https://www.gov.cn/xinwen/2016-08/11/content_5098925.htm.
[4] 郭然, 曾典, 胡裕涵, 等. 价值医疗视角下的中医药优势评价思路与方法[J]. 科技导报, 2023, 41(14): 14-21.
[5] Concato J, Corrigan-Curay J. Real-world evidence—Where are we now?[J]. New England Journal of Medicine, 2022, 386(18): 1680-1682.
[6] 董斐, 刘建平. 从“经验”到“证据”: 循证医学促进中医药传承创新发展[J]. 南京中医药大学学报, 2021, 37(5): 642-647.
[7] Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and real-world data for evaluating drug safety and effectiveness[J]. JAMA, 2018, 320(9): 867.
[8] Basch E, Schrag D. The evolving uses of "real-world" data[J]. JAMA, 2019, 321(14): 1359.
[9] 富山县药业联合会. 薬都飛翔[M]. 富山: 薬日新聞社, 2002: 20-29.
[10] 薛益明. 中医药传入日本与朝鲜[J]. 中医文献杂志, 2009, 27(4): 47-48.
[11] 高橋眞太郎. 漢方薬とその発展史[M]. 东京: 故高橋眞太郎先生を偲ぶ会, 1976: 13-15.
[12] 石原保秀. 東洋医学通史[M]. 东京: 自然社, 1979: 87- 90.
[13] 玉川信明. 反魂丹の文化史~越中富山の薬売り[M]. 富山: 社会評論社, 2005: 168-194.
[14] 全国配置薬協会. 全国配置薬業鑑[M]. 第3 版. 富山: 薬日新聞社, 2002: 1-9.
[15] 作道洋太郎. 富山県薬業史~資料集成(上)[M]. 富山: 丸善出版社, 1983: 617-675.
[16] 成川一郎. 現代科学と漢方製剤: 漢方の主張[M]. 东京: 健友館, 1991: 84-97.
[17] Sherman R E, Anderson S A, Dal Pan G J, et al. Realworld evidence: What is it and what can it tell us?[J]. New England Journal of Medicine, 2016, 375(23): 2293- 2297.
[18] 長沢元夫. 漢方の諸問題[M]. 东京: 健友館, 1980: 48- 52.
[19] 作道洋太郎. 富山県薬業史: 通史[M]. 富山: 丸善出版社, 1987: 30-37.
[20] Porter M E, Teisberg E O. Redefining health care: Creating value-based competition on results[M]. Cambridge: Harvard Business Press, 2006.
[21] Institute of Medicine. Crossing the quality chasm: A new health system for the 21st century[M]. Washington, D C: National Academy Press, 2001.
[22] 吉見達三. 五十年つれづれ[M]. 东京: 薬日新聞社, 1992: 87-88.
[23] 西山由美, 南恵理子, 谷典義, 等. 薬局薬剤師へのア ンケ-トから分かる漢方薬における問題点と課題に ついて》[C]. 东京: 第56回日本薬剤師学術大会, 2023.
[24] 周雪忠, 王世华, 张迪, 等. 构建中医药特色真实世界临床研究新模式的实践与思考[J]. 科技导报, 2023, 41(14): 22-31.
[25] 大塚敬節. 漢方ひとすじ[M]. 东京: 日本経済新聞社, 1976: 141-152.
