基于真实世界数据的阿托伐他汀集采仿制药对原研药的可替代性研究  

Study on the Substitutability of Atorvastatin Centralized Procurement to the Originator Drug Based on Real-world Data

作　　者：何静 蒲强红[1] 刘易陇 李燕 蒋兴 周建 HE Jing;PU Qianghong;LIU Yilong;LI Yan;JIANG Xing;ZHOU Jian(The People’s Hospital of Leshan,Leshan Sichuan 614099,China;Emeishan People’s Hospital,Emeishan Sichuan 614299,China)

机构地区：[1]乐山市人民医院,四川乐山614099 [2]峨眉山市人民医院,四川峨眉山614299

出　　处：《药品评价》2024年第12期1461-1464,共4页Drug Evaluation

基　　金：乐山市重点科技计划项目(20SZD105)。

摘　　要：目的本研究旨在真实诊疗环境中,比较阿托伐他汀集采仿制药与原研药的有效性与安全性,以评估仿制药对原研药的可替代性。方法通过回顾性的收集2020—2021年乐山市人民医院门诊使用阿托伐他汀的患者的病例数据,根据用药情况将患者分为集采仿制药组、原研药组和转换组(由原研药转换为集采仿制药),收集患者的一般信息和血脂数据,比较集采仿制药组和原研药组的血脂达标率和不良反应发生率,以及药物转换前后的血脂水平。结果集采仿制药组与原研药组的一般资料差异无统计学意义,不良反应发生率、血脂达标率二者差异无统计学意义,从原研药向集采药物进行转化以后的血脂水平[甘油三酯、胆固醇、低密度脂蛋白胆固醇]差异无统计学意义(P>0.05),转换后高密度脂蛋白胆固醇(HDL-C)降低(P<0.05)。结论阿托伐他汀集采仿制药的临床疗效和安全性与原研药一致,具有临床可替代性,使用集采仿制药能降低患者药费,减轻患者负担。Objective This study is to compare the efficacy and safety of atorvastatin centralized procurement of generic drugs and original drugs in a real diagnosis and treatment environment,in order to evaluate the substitutability of generic drugs to original drugs.Methods Retrospective data were collected from outpatient medical records of patients using atorvastatin at The People’s Hospital of Leshan between 2020 and 2021.Patients were categorized into three groups:the centralized procurement of generic drugs group,the originator drug group,and the switching group(conversion from original research drugs to centralized procurement of generic drugs).General information and lipid profiles were collected,the lipid target achievement rate and incidence of adverse reactions were compared between the centralized procurement of generic drugs and originator drug groups,along with lipid levels before and after drug switching.Results No statistically significant differences were observed in baseline characteristics between the centralized procurement of generic drugs and originator drug groups.The incidence of adverse reactions and lipid target achievement rates showed no significant differences(P>0.05).After switching from the originator to the centralized procurement of generic drugs,lipid levels(triglycerides,total cholesterol,and LDL-C)remained comparable(P>0.05),while HDL-C levels decreased significantly(P<0.05).Conclusion The centralized procurement of generic drugs demonstrated clinical equivalence in efficacy and safety to the originator drug,supporting its substitutability.The use of centralized procurement of generic drugs can reduce medication costs and alleviate financial burdens for patients.

关 键 词：集中采购 仿制药 原研药 可替代性 阿托伐他汀 

分 类 号：R969.3[医药卫生—药理学]