注射用赖氨匹林安全性风险分析及思考  

Analysis and Consideration on Risks of Lysine Acetylsalicylate for Injection

作　　者：王涛 刘松东 王丹 WANG Tao;LIU Songdong;WANG Dan(Center for Drug Reevaluation,NMPA,Beijing 100022,China;Linyi Center for ADR Monitoring,Shandong Linyi 276000,China)

机构地区：[1]国家药品监督管理局药品评价中心,北京100022 [2]临沂市药品不良反应监测中心,山东临沂276000

出　　处：《中国药物警戒》2019年第5期281-284,共4页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项项目(2017ZX09101001-001-003):药品再评价政策法规及实施策略研究

摘　　要：目的分析注射用赖氨匹林的安全性风险,为临床合理用药提供参考。方法对世界卫生组织药品不良反应监测数据库、我国药品不良反应监测数据库、国内文献数据库中的不良反应报告及国内风险控制措施等相关资料进行整理与分析。结果WHO及我国监测数据库和国内文献显示,过敏性休克、严重皮肤损害、儿童用药等相关严重不良反应为本品较为突出的风险。结论应加强注射用赖氨匹林的安全性监测,及时完善产品说明书,促进药品的临床合理使用。Objective To analyze the risk of lysine acetylsalicylate for injection in china,in order to provide reference for clinical rational drug use.Methods The individual adverse drug reaction cases in WHO Vigilyze and China adverse drug reaction database,domestic literatures,and the domestic risk management measures were analyzed.Results The Data from WHO Vigilyze^TM,China adverse drug reaction database and domestic literatures showed that the serious adverse drug reactions related to anaphylactic shock,severe cutaneous damage,and use of medicines in children were the major risks of lysine acetylsalicylate.ConclusionWe should reinforce the safety monitoring of lysine acetylsalicylate for injection,timely update the drug labeling and promote the rational application of medicine.

关 键 词：赖氨匹林 过敏性休克 儿童用药 说明书 

分 类 号：R994.11[医药卫生—毒理学]