我国超说明书用药情况的现状分析  

Situation analysis of off-label drug use in China

作　　者：胡瑞学 莫美 于丹丹[1] 李慧敏 廖星[1] 段笑娇 郭宇博[2] HU Rui-xue;MO Mei;YU Dan-dan;LI Hui-min;LIAO Xing;DUAN Xiao-jiao;GUO Yu-bo(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Standards and Guideline Developing Office,China Association of Chinese Medicine,Beijing 100029,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中华中医药学会标准化办公室,北京100029

出　　处：《中国中药杂志》2020年第17期4277-4284,共8页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金面上项目(81774159);中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(ZZ13-YQ-075);中国中医科学院中央级公益性科研院所基本科研业务费自主选题(第十三批)(Z0650)。

摘　　要：该研究介绍目前临床超说明书用药的文献报告情况。通过检索中英文7大数据库获取我国发表超说明书用药的相关文献,并对文献进行资料提取和分析。最终对667篇文献进行了分析,医院超说明书用药数据分析325篇,超说明书用药临床研究329篇,其中病例系列及个案报告最多(69.91%),还有13篇超说明书用药专家共识以及56篇基于真实世界用药数据特征及影响因素分析的研究。结果显示报告超说明书用药的文献量逐年增多,现有文献中超说明书用药西药报告较中药文献多,主要为超剂量使用。医院超说明书用药数据分析多局限于某地区一家或几家三级医院,报告的超说明书用药类型不统一。临床研究主要为在临床对照试验与病例系列或个案报告,但报告结果存在矛盾,超说明书用药专家共识数量较少且推荐分级不统一。真实世界用药数据特征及影响因素的分析多关注中药注射剂,分析结果也不尽相同。今后应进一步关注并加强超说明书用药的报告和分析,明确其研究目的,统一报告内容和报告标准,促进我国超说明书用药数据的整合利用,从而真实反映其实际情况。To introduce current literature reporting situations of the off-label drug use(OLDU)by analyzing relevant literatures published in China,this study comprehensively focused on literatures about OLDU in China in seven Chinese and English databases,then extracted and analyzed the data by different literature types.A total of 667 papers were analyzed.The number of literatures about OLDU data analyzed in hospitals was 325,and the number of clinical studies relating to OLDU was 329,in which case series and case reports were the majority(69.91%).In addition,there were 13 expert consensuses of OLDU and another 56 studies about drug use based on the real-world data characteristics and influencing factors.The number of OLDU data studies has increased year by year.Based on the existing studies,there were more western medicine reports than traditional Chinese medicines,and OLDU types were mainly for over-dosage use.The literatures from OLDU data in hospital were mostly limited to one or several tertiary hospitals in a certain area,and the OLDU types were not uniform.Clinical studies were mainly clinical control trials and case series/reports,but with contradictory reporting results.There were fewer OLDU consensus,and the recommended classification was not uniform.The characteristics and analysis of influencing factors of drug using data in real-world focused on traditional Chinese medicine injections,and the results were not the same.In the future,we shall pay more attention to and strengthen reporting and analysis of OLDU,define study objectives,and unify the content and reporting standards,so as to promote the integrated utilization of OLDU data and reflect real situations in our country.

关 键 词：中国 超说明书用药 现状分析 

分 类 号：R95[医药卫生—药学]