抗肿瘤类仿制药品与原研药品说明书比较分析  

Comparative Analysis of Instructions for Generic and Original-Patented Anti-Tumor Drugs

作　　者：何蓉 枉前 伍萍 陈和莉 HE Rong;WANG Qian;WU Ping;CHEN Heli(The First Affiliated Hospital of Army Medical University,Chongqing,China 400038)

机构地区：[1]中国人民解放军陆军军医大学第一附属医院,重庆400038

出　　处：《中国药业》2024年第22期44-47,共4页China Pharmaceuticals

基　　金：重庆市临床药学重点专科建设项目[渝卫办发〔2021〕52号]。

摘　　要：目的为规范抗肿瘤类药品说明书及促进其合理使用提供参考。方法参考国家医疗保障局发布的前8批国家组织药品集中带量采购(简称集采)药品目录,通过相关机构官方网站和参考文献,收集抗肿瘤类仿制药品与其原研药品说明书,并对其中的14个主要项目(包括辅料、适应证、用法用量、不良反应等)进行描述性比较分析。结果共纳入抗肿瘤药品26组(包含口服制剂14组,注射制剂12组)、药品说明书52份。药品说明书的主要项目中,临床试验(26组、100.00%)、有效期(23组、88.46%)、贮藏(18组、69.23%)、不良反应(16组、61.54%)存在差异的品种较多。仿制药品与原研药品说明书相同或相似(差异项目≤6个)的有17组(65.38%),差异较大(差异项目≥7个)的有9组(34.62%)。结论抗肿瘤类仿制药品与原研药品说明书项目存在一定差异,医务人员应严格按照药品说明书选用。建议生产厂家按照国家相关法规定期修订药品说明书,为医务人员及患者提供准确的用药指导。Objective To provide a reference for standardizing the instructions of anti-tumor drugs and promoting their rational use.Methods Based on the first eight batches of national-centralized drug procurement(NCDP)drug catalogue released by the National Healthcare Security Administration,the instructions of generic and original-patented anti-tumor drugs were obtained according to the official websites of relevant institutions and literature,and the information on 14 main items in drug instructions(including excipients,indications,usage and dosage,adverse reactions and so on)was collected for descriptive comparative analysis.Results A total of 26 groups of anti-tumor drugs(including 14 groups of oral preparations and 12 groups of injection preparations)and 52 drug instructions were included.There were many varieties with difference in the main instruction items including clinical trials(26 groups,100.00%),expiration date(23 groups,88.46%),storage(18 groups,69.23%),adverse reactions(16 groups,61.54%).There were 17 generic drugs(65.38%)with the same or similar(with differences of≤six items)instructions and nine(3~4.62%)with significant differences(with differences of≥seven items)instructions as original-patented drugs.Conclusion There is a certain difference between the instructions of generic and original-patented anti-tumor drugs,and medical personnel should strictly follow the drug instructions when selecting.It is recommended that manufacturers regularly revise drug instructions in accordance with relevant national regulations to provide accurate medication guidance for medical personnel and patients.

关 键 词：抗肿瘤药品 仿制药品 原研药品 药品说明书 国家组织药品集中带量采购 

分 类 号：R95[医药卫生—药学]