313份注射液药品说明书标注信息调查分析  

Analysis of 313 Instructions for Injectable Drugs

作　　者：张永恒[1] 韩晨 杨宵 韩秀奇[1] 袁红昌 邓智建[1] ZHANG Yongheng;HAN Chen;YANG Xiao;HAN Xiuqi;YUAN Hongchang;DENG Zhijian(Department of Pharmacy,the First Affiliated Hospital of Xinxiang Medical University,Xinxiang Henan 453100,China)

机构地区：[1]新乡医学院第一附属医院药学部,河南新乡453100

出　　处：《中国药物警戒》2021年第7期669-673,682,共6页Chinese Journal of Pharmacovigilance

基　　金：中国健康促进基金项目(20160021)。

摘　　要：目的分析注射液药品说明书信息标注情况,为规范完善说明书内容提供参考。方法收集313份注射液药品说明书,统计分析项目内容,比较进口和国产注射液药品说明书的标注率以及不同企业生产同一种注射液药品说明书标注的差异性。结果与国产相比,进口注射液药品说明书中的药物相互作用、药物过量、毒理研究等标注率较高,差异有统计学意义(P<0.05);不同企业生产同一种注射液药品说明书标注的差异率为42.86%(9/21)。结论进口注射液药品说明书中部分项目的标注率高于国产药品说明书;不同企业同一种注射液药品说明书的标注存在差异性。Objective To investigate the labeled information in the instructions of injectable drugs and provide reference for the improvement of instructions.Methods A total of 313 instructions for injectable drugs used in the First Affiliated Hospital of Xinxiang Medical University from January 2018 to November 2019 were collected before the items and contents in the instructions were statistically analyzed.The labeling rates were compared between imported drugs and home-made ones,and the difference in the specifications of the same type of injectable drug by different manufacturers was also studied.Results The labeling rate of drug interactions,drug overdose and toxicology in the instructions of imported drugs was higher than that of domestic drugs,with statistically significant differences(P<0.05).The difference rate in the specifications of the same type of drug produced by different enterprises was 42.86%(9/21).Conclusion The labeling rate of instructions of imported drugs is higher than that of home-made drugs.There are differences in the specifications of the same type of injectable drug produced by different enterprises.

关 键 词：注射液 药品说明书 完整性 差异性 合理用药 

分 类 号：R95[医药卫生—药学]