271份注射用粉针剂药品说明书信息分析  

Analysis of package insert information of 271 kinds of powder injections

作　　者：王业民[1] 张永香[1] 张卫国[1] 徐志超 袁红昌 卢乙众[1] WANG Yemin;ZHANG Yongxiang;ZHANG Weiguo;XU Zhichao;YUAN Hongchang;LU Yizhong(Department of Pharmaceutical,the First Affiliated Hospital of Xinxiang Medical University,Xinxiang 453100,China)

机构地区：[1]新乡医学院第一附属医院药学部,新乡453100

出　　处：《西北药学杂志》2020年第5期772-778,共7页Northwest Pharmaceutical Journal

基　　金：中国健康促进基金项目(编号:20160021);河南省医学科技攻关计划联合共建项目(编号:LHGJ20190467)。

摘　　要：目的分析注射用粉针剂药品说明书信息的标注情况,为临床精准用药提供依据。方法收集新乡医学院第一附属医院使用(2019年1~10月)的271份注射用粉针剂药品说明书,分析说明书的项目内容,比较进口和国产药品的标注率以及不同企业生产的同一种药品说明书的差异性。结果进口药品说明书中的孕妇及哺乳期妇女用药、老年用药、药物相互作用、药物过量、毒理研究等项目的标注率高于国产药品(P<0.05)。不同企业生产的同一种药品说明书的差异率为80%(20/25)。结论进口药品说明书中各项目的标注率高于国产药品,不同企业生产的同一种药品的说明书存在差异性,应进一步修订完善。Objective To analyze the record of the information in the instruction of powder injectable drugs and to provide basis for the rational use of drugs in clinic.Methods 271 powder injection drug specifications used in the first affiliated hospital of Xinxiang Medical University from January to October 2019 were collected and analyzed.The items in the specifications,the labeling rates of imported drugs and domestic drugs,and the differences in the specifications of different manufacturers under the same drug names were compared.Results The studies of complete rate of usage and dosage,adverse reactions,contraindications,precautions,drugs for pregnant and nursing women,drugs for the elderly,drug interactions,drug overuse and toxicology of imported drugs was higher than that of domestic drugs(P<0.05).The difference rate of the specification of the same drug produced by different enterprises was 80%(20/25).Conclusion The labeling rate of the imported drugs instruction is higher than that of the domestic drugs.There are differences in the specifications of the same drug produced by different enterprises,which should be further revised and improved.

关 键 词：注射用粉针剂 药品说明书 国产药品 进口药品 生产企业 

分 类 号：R969.3[医药卫生—药理学]