国家集中带量采购中选药品疗效与安全性的真实世界研究  

Efficacy and safety evaluation of selected drugs in the national volume-based procurement: a real-world study

作　　者：岳小林 付娜[2] 赵艳玲 封宇飞 果伟[5] 林阳[6] 郑英丽 战寒秋 冯欣[9] 李国辉[10] 周颖[11] 赵晓彦[12] 张艳华[13] 朱晓虹[14] 张兰[1] YUE Xiao-lin;FU Na;ZHAO Yan-ling;FENG Yu-fei;GUO Wei;LIN Yang;ZHENG Ying-li;ZHAN Han-qiu;FENG Xin;LI Guo-hui;ZHOU Ying;ZHAO Xiao-yan;ZHANG Yan-hua;ZHU Xiao-hong;ZHANG Lan(Xuanwu Hospital Capital Medical University,National Clinical Research Center for Geriatric Diseases,Beijing 100053,China;Beijing Adverse Drug Reaction Monitoring Center,Beijing 100053,China;Department of Pharmacy,Fifth Medical Center of PLA General Hospital,Beijing 100039,China;Department of Pharmacy,Peking University People's Hospital,Beijing 100044,China;Department of Pharmacy,Beijing Anding Hospital of Capital Medical University,Beijing 100088,China;Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;Department of Pharmacy,Fuwai Hospital,Chinese Academy of Medical Sciences,Beijing 100045,China;Department of Pharmacy,Beijing Ditan Hospital,Capital Medical University,Beijing 100102,China;Department of Pharmacy,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing 100026,China;Department of Pharmacy,Cancer Hospital,Chinese Aacademy of Medical Sciences,Beijing 100021,China;Department of Pharmacy,Peking University First Hospital,Beijing 100034,China;Department of Pharmacy,Beijing Huilongguan Hospital,Beijing 102208,China;Department of Pharmacy,Peking University Cancer Hospital,Beijing 100142,China;Department of Pharmacy,Beijing You'an Hospital,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学宣武医院国家老年疾病临床医学研究中心,北京100053 [2]北京市药品不良反应监测中心,北京100053 [3]解放军总医院第五医学中心药学部,北京100039 [4]北京大学人民医院药剂科,北京100044 [5]首都医科大学附属北京安定医院药事部,北京100088 [6]首都医科大学附属北京安贞医院药事部,北京100029 [7]中国医学科学院阜外医院药剂科,北京100045 [8]首都医科大学附属北京地坛医院药学部,北京100102 [9]首都医科大学附属北京妇产医院药事部,北京100026 [10]中国医学科学院肿瘤医院药剂科,北京100021 [11]北京大学第一医院药剂科,北京100034 [12]北京回龙观医院药学部,北京102208 [13]北京大学肿瘤医院药剂科,北京100142 [14]首都医科大学附属北京佑安医院药学部,北京100069

出　　处：《临床药物治疗杂志》2022年第6期43-48,共6页Clinical Medication Journal

基　　金：北京市医院管理中心“登峰”计划专项(DFL20190803);首都科技领军人才培养工程项目(Z191100006119017);重大新药创制国家科技重大专项2017年度(2017ZX09101001-002-044);北京市老年病医疗研究中心老年多重用药风险管控及临床应用研究(1100002222T000000444688);北京药理学会科研扶持基金(KYFC2019001)。

摘　　要：目的分析北京市首批国家集中带量采购(集采)中选药品的临床诊疗、药品不良反应上报及采购数据,评价集采药品的疗效、安全性及使用情况,为政策完善提供参考。方法本研究选取了14个仿制药,收集2019年3月23日至2020年3月22日期间北京市16家医疗机构集采药品的诊疗相关信息,评价集采中选药品与原研药的疗效和安全性;结合北京市药品不良反应上报数据和北京市药品采购数据,进一步分析集采药品的安全性及集采政策对公立医疗机构药品使用的影响。结果集采药品的疗效和安全性与原研药比较无显著性差异,集采前后药品不良反应上报率无显著变化;集采政策执行后,中选药品在北京市公立医疗机构采购量占比显著提升,原研药采购占比普遍下降。结论本研究探索了集采中选仿制药疗效、安全性评价方法,研究结果为集采药品评价、管理和政策推进提供了参考。Objective To analyze the clinical diagnosis and treatment data,adverse drug reaction(ADR)data and procurement data of the first batch of selected drugs in Beijing's national volume-based procurement(VBP),evaluate the implementing effect of the national procurement policy,and provide corresponding suggestions for the refinement of the policy.Methods We collected the diagnosis and treatment related information of the 14 VBP selected drugs in 16 hospitals in Beijing from March 23,2019 to March 22,2020,and analyzed the differences in efficacy and safety between the VBP selected drugs and the brand-name drugs.Also,data on adverse drug reaction reporting and drug procurement data in Beijing were used to analyze the safety of VBP selected drugs and the impact of the VBP policy on the drug proportion in hospitals.Results The results showed that there was no significant difference in the clinical efficacy and safety between the VBP selected drugs and corresponding brand-name drugs.There was no significant change in the reporting rate of adverse drug reactions before and after VBP policy.After the implementation of the VBP policy,the proportion share of the selected drugs has increased significantly,and the proportion of the brand-name drugs has generally declined.Conclusion This study explores the efficacy and safety evaluation methods of VBP selected drugs,and the research results can provide a reference for the drugs evaluation,management and policy promotion of VBP.

关 键 词：集中带量采购 疗效 安全性 仿制药 原研药 

分 类 号：R95[医药卫生—药学]