古代经典名方制剂上市后综合评价指标体系初探  

Preliminary Discussion on Post-marketing Comprehensive Evaluation Indicator System of Ancient Famous Classical Formula Preparations

作　　者：郑丹平 佟琳[1] 张磊[1] 曾子玲 李兵[2] 张华敏[2] ZHENG Danping;TONG Lin;ZHANG Lei;ZENG Ziling;LI Bing;ZHANG Huamin(Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医药信息研究所,北京100700 [2]中国中医科学院中药研究所,北京100700

出　　处：《中国实验方剂学杂志》2023年第18期175-182,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院科技创新工程项目(CI2021A03702);国家药品监督管理局委托研究项目(古代经典名方目录关键信息考证示范性研究);国家中医药管理局委托研究项目(GZY-KJS-2019-011);中央级公益性科研院所基本科研业务费项目(ZZ13-YQ-131);国家科技基础资源调查专项(2018FY100705)。

摘　　要：古代经典名方制剂上市后综合评价指标体系的建构具有理论与实践双重意义。通过检索中国知识基础设施工程(CNKI)、维普网(VIP)、万方数据知识服务平台(WanFang)和中国生物医学文献服务系统(SinoMed)中2000年1月1日至2022年4月30日已发表的与中药复方制剂上市后综合评价研究相关的文献,笔者采用科学计量学软件CiteSpace 6.1.R2对所涉关键词进行可视化呈现,分析该领域动态演进趋势与研究热点。随后筛选并提取现有中药复方制剂上市后综合评价指标体系,并采用数理统计法对研究现状进行系统分析,结果发现存在评估维度与评估要素边界笼统、个别评价指标缺乏数据源、部分指标体系权重未设置、应用度不足等问题。此外,针对古代经典名方的特点展开重视基于病证结合的证据评价、重视古代经典名方制剂的药物警戒、重视古代经典名方制剂的全过程质量控制的探讨,提出以临床价值为导向、证据评价为核心、全过程质量控制为保障的古代经典名方制剂上市后综合评价的构建策略。The construction of the comprehensive evaluation index system of the famous classical formula preparations after the marketing has both theoretical and practical significance.In this study,literature related to the post-marketing comprehensive evaluation of traditional Chinese medicine(TCM)compound preparations was retrieved from China National Knowledge Infrastructure(CNKI),China Science and Technology Journal Database(VIP),Wanfang Data Knowledge Service Platform(WanFang)and SinoMed from January 1,2000 to April 30,2022.CiteSpace 6.1.R2,a scientometrics software,was used to visualize the keywords involved,and to analyze the dynamic evolution trend and research hotspots in this field.Then,the existing comprehensive post-marketing evaluation index system of TCM compound preparations was screened and extracted,and the research status was systematically analyzed by mathematical statistics.It was found that there were problems such as the generalized boundaries between assessment dimensions and assessment elements,the lack of data sources for individual evaluation indexes,unset weight of some index system and insufficient application degree.In addition,according to the characteristics of famous classical formulas,the authors discuss the importance of evidence evaluation based on combination of disease and syndrome,pharmacovigilance of famous classical formulas preparations,and whole-process quality control of famous classical formulas,and put forward the construction strategy of comprehensive post-marketing evaluation of the famous classical formula preparations,which is oriented by clinical value,centered on evidence evaluation,and guaranteed by the whole-process quality control.

关 键 词：古代经典名方 上市后评价 指标体系 文献计量 药物警戒 质量控制 中药制剂 

分 类 号：R22[医药卫生—中医基础理论] R24[医药卫生—中医学] R28R94