奥沙利铂集采药品安全性的真实世界研究  

A Real⁃world Study on the Safety of Oxaliplatin Drugs Selected in the Centralized Procurement

作　　者：杨燕妮 黎曙霞[2] 张晓娟[3] 金伟军[4] 陈明浩 YANG Yanni;LI Shuxia;ZHANG Xiaojuan;JIN Weijun;CHEN Minghao(Guangzhou Adverse Drug Reaction Monitoring Center,Guangzhou,Guangdong 510160,China;Department of Pharmacy,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong 510080,China;Department of Pharmacy,Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences),Southern Medical University,Guangzhou,Guangdong 510080,China;Department of Pharmacy,The First Affiliated Hospital of Jinan University,Guangzhou,Guangdong 510630,China)

机构地区：[1]广州市药品不良反应监测中心,广东广州510160 [2]中山大学附属第一医院药学部,广东广州510080 [3]南方医科大学附属广东省人民医院(广东省医学科学院)药学部,广东广州510080 [4]暨南大学附属第一医院药学部,广东广州510630

出　　处：《今日药学》2024年第6期451-454,共4页Pharmacy Today

基　　金：广州市科技计划项目(202201011805)。

摘　　要：目的本研究旨在比较第五批国家药品集中带量采购中选的奥沙利铂仿制药与非中选奥沙利铂原研药在真实世界中的安全性。方法采用主动监测研究方法,收集2022年10月~2023年9月期间某地3家三甲医院使用奥沙利铂集采药品及其非中选原研药的不良反应报告,并分别统计中选集采药品及其原研药的药物不良反应(adverse drug reaction,ADR)发生率。结果共监测到奥沙利铂注射剂172例不良反应报告,中选集采药品与其原研药的ADR发生率无显著性差异(P>0.05)。结论奥沙利铂集采药品与原研药在安全性方面的差异无统计学意义。OBJECTIVE This study aims to compare the safety of generic oxaliplatin drugs selected in the fifth batch of national drug centralized bulk procurement with those of non-selected original oxaliplatin drugs in the real world.METHODS Using active monitoring research methods,we collected adverse reaction reports of oxaliplatin drugs selected in the centralized procurement and non-selected original drugs in three first-class hospitals in a certain area from October 2022 to September 2023,and separately counted the incidence of ADRs of the selected centralized procurement drugs and their original drugs.RESULTS A total of 172 adverse reaction reports of oxaliplatin injection were monitored.There was no significant difference in the incidence of ADRs between the selected centralized procurement drugs and their original drugs(P>0.05).CONCLUSION There was no significant difference in safety between oxaliplatin drugs selected in the centralized procurement and their original drugs.

关 键 词：奥沙利铂 真实世界 集采药品 仿制药 原研药 

分 类 号：R969[医药卫生—药理学]