同品种不同厂家中药注射剂说明书不良反应项差异调查  

Investigation on the Adverse Reaction Items in the Instructions of Traditional Chinese Medicine Injections with the Same Species and Different Manufacturers

作　　者：韩相坤 王昱智 刘欣雅 张雪[1] HAN Xiangkun;WANG Yuzhi;LIU Xinya;ZHANG Xue(Liaoning University of Traditional Chinese Medicine,Shenyang 110847,Liaoning,China)

机构地区：[1]辽宁中医药大学,辽宁沈阳110847

出　　处：《中国药物滥用防治杂志》2025年第2期228-232,共5页Chinese Journal of Drug Abuse Prevention and Treatment

基　　金：2021年辽宁中医药大学人文社科项目(编号:2021LNZYZZ005)。

摘　　要：目的:统计中药注射剂说明书“不良反应”项的标注现状以及同品种不同厂家说明书的差异,对“不良反应”项内容及相关法律法规的修订完善提出思考与建议。方法:通过文献检索的方式,收集我国已上市中药注射剂同品种不同厂家的药品说明书,提取分析说明书“不良反应”项信息,对比不同厂家同一品种的差异并进行统计分析。结果:纳入说明书219份,涉及55个品种、92家企业,发现同一品种不同厂家中药注射剂不良反应项存在较大差异(ICC=0.657)且书写内容欠规范;51份说明书标注“尚不明确”;不良反应信息丰富,偶有、少数、罕见描述多样等。结论:建议生产厂家发挥主体责任,重视药品上市后研究,及时完善更新说明书不良反应项内容,国家相关部门加大监管力度,加快修订相关法律法规,以减少用药风险。Objective:To analyze the labeling status of adverse reactions in the instructions of traditional Chinese medicine injections and the differences in the instructions of different manufacturers of the same variety,and to put forward thoughts and suggestions on the revision and improvement of the contents of adverse reactions and relevant laws and regulations.Methods:Through literature retrieval,the drug instructions of listed traditional Chinese medicine injections from different manufacturers were collected,and the information of adverse reactions in the instructions was extracted and analyzed.The differences of the same varieties from different manufacturers were compared and statistically analyzed.Results:Including 219 manuals,involving 55 varieties and 92 enterprises,it was found that there were large differences in the adverse reaction items of traditional Chinese medicine injections of different manufacturers of the same variety(ICC=0.657)and the writing content was not standardized;51 manuals were labeled with“unclear”;the information on adverse reactions was abundant,with various descriptions of occasional,few,rare and etc.Conclusion:It is recommended that manufacturers play the main responsibility,pay attention to post-marketing research,improve and update the content of the adverse reaction items of the manual in a timely manner,and the relevant state departments to increase supervision and accelerate the revision of relevant laws and regulations to reduce the risk of medication.

关 键 词：中药注射剂 药品说明书 不良反应 调查分析 

分 类 号：R288[医药卫生—中药学]