中国医院用药评价与分析2025，Vol.25Issue(8)：924-927,4.DOI:10.14009/j.issn.1672-2124.2025.08.005
2022-2025年我国药品说明书修订情况统计及分析
Statistics and Analysis on Revision of Drug Instructions in China from 2022 to 2025
摘要
Abstract
OBJECTIVE:To analyze the current situation of revision of drug instructions in China and promote the standardization of drug instructions.METHODS:Revision announcements of drug instructions from Jan.2022 to Jan.2025 were collected from the official website of National Medical Products Administration.Statistical methods were applied to analyze revision related to warning statements,adverse drug reactions,contraindications,precautions,and special population usage.RESULTS:A total of 104 revisions were analyzed,covering 63 drugs for injection,83 oral drugs,and 1 rectal administration drug.Revisions were made to warning statements(18),adverse drugs reactions(133),contraindications(86),precautions(120),and special population usage(57).Issues identified included limited revisions to warning statements,vague content in"Other"adverse drug reactions,confusion between contraindications and precautions,and incomplete revisions for special populations.CONCLUSIONS:There is still much room for improvement in drug instructions in China.It is necessary to improve the accuracy and integrity of information to improve the safety of drug use.关键词
药品说明书/修订公告/统计/分析Key words
Drug instructions/Revision announcements/Statistics/Analysis分类
医药卫生引用本文复制引用
张珵,尚德为,党元野,刘欣怡,瞿礼萍,唐冬蕾,陈文林,宋伟琳,蔡俊杰,李承洪,董小诺..2022-2025年我国药品说明书修订情况统计及分析[J].中国医院用药评价与分析,2025,25(8):924-927,4.基金项目
广东省研究生教育创新计划项目(No.2024JGXM_157) （No.2024JGXM_157）
广东省教育科学规划课题(No.2023GXJK444) （No.2023GXJK444）
广州市教育科学规划课题(No.202317478) （No.202317478）
