带量采购中标仿制药利奈唑胺片与原研药有效性及安全性的真实世界研究  

Real-world study of the efficacy and safety of generic linezolid tablets and branded one

作　　者：王琲 应寅清 张亮 张雨霏 张令春[2] 张迪 马春来 马培志[2] 钟明康 WANG Bei;YING Yinqing;ZHANG Liang;ZHANG Yufei;ZHANG Lingchun;ZHANG Di;MA Chunlai;MA Peizhi;ZHONG Mingkang(Department of Pharmacy,Huashan Hospital Affiliated to Fudan University,Shanghai 200040,China;Department of Pharmacy,Henan Provincial People’s Hospital,Zhengzhou 450003,China)

机构地区：[1]复旦大学附属华山医院药剂科,上海200040 [2]河南省人民医院药剂科,郑州450003

出　　处：《中国临床药学杂志》2023年第1期18-22,共5页Chinese Journal of Clinical Pharmacy

基　　金：上海市临床重点专科项目-临床药学专业(编号shslczdzk06502);上海市优秀青年临床药师培养计划(编号:沪卫计药政[2018]1号)。

摘　　要：目的比较利奈唑胺片仿制药与原研药的有效性和安全性,为利奈唑胺片中标后再评价提供真实世界的临床研究数据,为临床医师用药决策时提供证据支撑。方法采用多中心真实世界回顾性研究,采集真实世界使用利奈唑胺片的患者住院处方和检查检验信息,病例收集期从2020年5月1日至2021年12月31日,共纳入病例154例,分为原研药组(59例)和仿制药组(95例),经倾向性评分匹配后比较原研药和仿制药的临床有效性和安全性。结果原研药和仿制药的使用平均总量、疗程以及临床疗效差异均无统计学意义(P>0.05);原研利奈唑胺片在用药过程中肝功能损伤发生率高于集采品种(P<0.05),全血细胞减少、恶心呕吐、皮疹以及腹泻在2组之间的发生率差异均无统计学意义(P>0.05)。结论利奈唑胺片“4+7”带量采购政策中标品种在临床有效性及安全性上不劣于原研品种。AIM To compare the efficacy and safety of the branded drug with the generic linezolid tablets,and to provide real world clinical research data for the re-evaluation of linezolid tablets after the bid,and provide evidence support for clinicians when making treatment decisions.METHODS This was a multi-center real world retrospective study.The collection period was from May 1,2020 to December 31,2021.The inpatient prescriptions and inspection information of real-world patients using linezolid tablets were collected and divided into the branded drug group(n=59)and the generic drug group(n=95).After analyzed by the propensity score matching to make the baseline characteristics balanced,the efficacy and safety of the branded drug and generic drug were compared.RESULTS There was no statistical significance in the dosage,course of treatment and clinical efficacy between the branded drug and the generic drug(P>0.05).The incidence of hepatic injury of the branded drug was slightly higher than that of generic drug with statistically significant(P<0.05).There was no statistical significance between 2 groups in the incidence of pancytopenia,nausea,vomiting,rash and diarrhea(P>0.05).CONCLUSION This study finds that the generic linezolid tablets which won the bid in"4+7"volume-based purchasing policy are not inferior to the branded drug in clinical effectiveness and safety.

关 键 词：利奈唑胺 原研药 仿制药 带量采购 真实世界研究 

分 类 号：R95[医药卫生—药学]