中国药房2025，Vol.36Issue(17)：2092-2096,5.DOI:10.6039/j.issn.1001-0408.2025.17.02
基于说明书修订公告及药品国家不良反应监测报告的中药安全性内容管控现状与对策分析
Analysis of the current status and countermeasures of safety content control of traditional Chinese medicine based on the revision announcement of the instruction and the national adverse drug reaction monitoring report
摘要
Abstract
OBJECTIVE To provide a reference for revising the safety content of traditional Chinese medicine(TCM)instructions.METHODS A systematic analysis was conducted on the relevant announcements on the revision of TCM instruction from 2013 to 2024,including the year of publication,drug name,drug formulation,announcement release time,and the average number of revisions made to three safety contents(contraindication,adverse drug reaction,and precaution).According to the report data of national adverse drug reaction monitoring from 2013 to 2024,analyze the proportion of TCM in all adverse drug reactions,the composition ratio of adverse drug reaction of different dosage forms of drugs[TCM injection,oral TCM,other(topical)TCM].RESULTS From 2013 to 2024,the National Medical Products Administration issued a total of 101 notices on the revision of TCM instruction,involving 241 types of TCM.Among them,there were 163 types of oral TCM,25 types of TCM injection,and 53 types of other(topical)TCM.There were 3,10 and 0 types of TCM injection,oral TCM,and other(topical)TCM with missing safety content,respectively.The main source of adverse drug reaction data for TCM injections was post-marketing monitoring data(accounting for 48.00%);the main source of adverse drug reaction data for oral TCM was monitoring data(accounting for 71.17%);73.58%of other(topical)TCM did not mention the source of adverse drug reaction data.The report on national adverse drug reaction monitoring showed that the proportion of all adverse drug reactions of TCM had decreased from 17.3%in 2013 to 12.1%in 2024.Among them,the proportion of adverse drug reaction of TCM injection in the three dosage forms of TCM had decreased from 61.3%in 2015 to 24.6%in 2024,while the proportion of adverse drug reaction of oral TCM in the three dosage forms of TCM had increased from 34.7%in 2015 to 64.0%in 2024.CONCLUSIONS The risk management of TCM safety content has achieved results in China,but still faces three major challenges:strong dependence on passive monitoring,insufficient data traceability,and missing key content.It is urgent to improve safety content by dosage form,optimize data sources,and fully utilize real-world evidence to supplement safety content.关键词
中药说明书/说明书修订/安全性内容/不良反应Key words
traditional Chinese medicine instruction/revision of the instruction/safety content/adverse drug reaction分类
医药卫生引用本文复制引用
朱健,王忠,武红莉,荆志伟..基于说明书修订公告及药品国家不良反应监测报告的中药安全性内容管控现状与对策分析[J].中国药房,2025,36(17):2092-2096,5.基金项目
国家自然科学基金项目(No.82074584) （No.82074584）
中国中医科学院中药监管科学研究项目(No.ZYJGKX202409) （No.ZYJGKX202409）
