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。
A Real-world Study on the Safety of Oxaliplatin Drugs Selected in the Centralized Procurement
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.
Oxaliplatinreal worldcentralized drug purchasegeneric drugsoriginator drugs
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