集采背景下恩格列净完整临床综合评价实践与思考  

Practice and reflection on the comprehensive clinical evaluation of empagliflozin under the background of centralized procurement

作　　者：张歆 周婧 译丽则热·司马义 沈静 张裴[1] ZHANG Xin;ZHOU Jing;YILIZERE·Simayi(Department of Pharmacy,Fifth Affiliated Hospital of Xinjiang Medical University,Urumqi 830000,China;不详)

机构地区：[1]新疆医科大学第五附属医院药学部,乌鲁木齐830000 [2]新疆医科大学药学院,乌鲁木齐830000 [3]新疆医科大学第一附属医院药学部,乌鲁木齐830000

出　　处：《中国处方药》2025年第2期1-5,共5页Journal of China Prescription Drug

基　　金：新疆维吾尔自治区卫生健康委药品临床综合评价项目(XJWJYZ202411);中国医药教育协会(药教协项字〔2022〕第045号)。

摘　　要：目的在国家集中带量采购背景下,探讨基于真实世界数据完整临床综合评价的方法与可行性,为方法学建立提供参考。开展集采与原研恩格列净片在2型糖尿病合并心力衰竭治疗中的完整临床综合评价,为政策实施后恩格列净的临床疗效评价提供数据支持。方法通过文献综述法,建立完整临床综合评价方法学。通过文献综述与高质量的真实世界研究对集采和原研恩格列净进行完整的临床综合评价。结果临床综合评价相关指南与专家共识陆续出台,但快速评价与真实世界研究的结合与权重分配相关资料欠缺。对集采与原研恩格列净片进行快速临床综合评价,原研恩格列净片评分74.6分,集采恩格列净片71.6分。真实世界数据研究结果显示,集采与原研恩格列净片治疗后,患者血糖水平(空腹血糖、糖化血红蛋白)以及对心功能(NT-proBNP)的改善均有显著差异,平均空腹血糖水平分别由(9.56±3.64)mmol/L、(9.39±3.64)mmol/L降至(7.02±1.59)mmol/L、(7.70±2.18)mmol/L,糖化血红蛋白水平分别由(8.50±1.87)%、(8.10±1.37)%降至(7.47±1.13)%、(7.41±1.19)%,NT-proBNP分别由[818.55(595.3,2143.75)]pg/ml、[754.00(591.00,5707.00)]pg/ml降至[340.15(192.3,838.88)]pg/ml、[332.00(124.00,2020.00)]pg/ml,差异有统计学意义(P<0.05)。结论基于真实世界数据的完整临床综合评价方法学仍待完善。集采与原研恩格列净片临床快速评价评分均在70分以上,在医疗机构药品使用目录品种引进时均为“强推荐”。真实世界研究表明两者在安全性与有效性方面未见显著差异,集采恩格列净片具有价格优势。Objective To explore the method and feasibility of comprehensive clinical evaluation based on real-world data in the context of national centralized quantity procurement,and provide reference for methodological establishment.Carry out a complete clinical comprehensive evaluation of intensive procurement and the original research of empagliflozin in the treatment of type 2 diabetes with heart failure,providing data support for the clinical efficacy evaluation of empagliflozin after the implementation of the policy.Methods Establish a comprehensive clinical evaluation methodology through literature review.Conduct a comprehensive clinical evaluation of centralized procurement and original empagliflozin through literature review and high-quality real-world research.Results Clinical comprehensive evaluation guidelines and expert consensus have been gradually introduced,but there is a lack of information on the combination of rapid evaluation and real-world research,as well as weight allocation.A rapid clinical comprehensive evaluation was conducted on the combination of centralized procurement and original research empagliflozin,with the original empagliflozin scoring 74.6 points and the centralized procurement empagliflozin scoring 71.6 points.The results of real-world data research show that there are significant differences in patients'blood glucose levels(fasting blood glucose,glycated hemoglobin)and improvement in heart function(NT-proBNP)before and after treatment with centralized procurement and original empagliflozin.The average fasting blood glucose levels decreased from(9.56±3.64)mmol/L and(9.39±3.64)mmol/L to(7.02±1.59)mmol/L and(7.70±2.18)mmol/L,respectively.The glycosylated hemoglobin levels decreased from(8.50±1.87)%,(8.10±1.37)%to(7.47±1.13)%,(7.41±1.19)%,and NT-proBNP levels decreased from[818.55(595.3,2143.75)]pg/ml,[754.00(591.00,5707.00)]pg/ml decreased to[340.15(192.3,838.88)]pg/ml,[332.00(124.00,2020.00)]pg/ml,and the difference was statistically significant(P<0.05).However,there is no sta

关 键 词：集中带量采购 临床综合评价 恩格列净 2型糖尿病合并心力衰竭 真实世界研究 

分 类 号：R977.15[医药卫生—药品]