恩格列净在2型糖尿病合并心衰患者中的疗效及安全性研究

doi:10.5246/jcps.2025.11.076

摘要/Abstract

摘要：

本研究聚焦于2型糖尿病合并心力衰竭的特定患者群体, 旨在深入剖析恩格列净原研药与集中采购药品在治疗效果与安全性方面的差异, 以期为临床合理用药及医院药学管理提供极具价值的参考依据。研究采用回顾性调查方法, 纳入2022年6月至2023年6月期间于我院确诊的406例2型糖尿病合并心力衰竭住院患者作为研究对象。依据恩格列净的用药类型(原研药或集中采购药)将患者划分为对照组与观察组。借助科学的统计手段, 对两组患者的各类相关数据予以全面采集、系统梳理与深度分析。于2型糖尿病合并心力衰竭患者中, 应用两类恩格列净药物后, 除观察组与对照组治疗后肌酐清除率呈现显著差异外, 在空腹血糖、糖化血红蛋白、N末端B型利钠肽原、左心室射血分数以及肾小球滤过率等多个关键疗效指标治疗前后的变化情况上, 均未发现具有统计学意义的差异。就药物成本而言, 观察组的总药物成本以及恩格列净的用药总成本均显著低于对照组。综上所述, 在2型糖尿病合并心力衰竭患者群体中, 恩格列净原研药与集中采购药品在治疗效果(肌酐清除率除外)及安全性方面不存在显著统计学差异。然而, 集中采购药品在药物成本方面所展现出的优势, 使其在临床合理用药决策以及医院药学管理中具备关键的参考价值, 在临床应用中结合实际情况值得合理考量。

关键词: 2型糖尿病, 心力衰竭, 恩格列净, 疗效, 安全性

Abstract:

This study focused on a specific cohort of patients with type 2 diabetes mellitus (T2DM) complicated by heart failure (HF), aiming to evaluate the differences in treatment efficacy and safety between the original research formulation and the centralized procurement version of empagliflozin. Conducted as a retrospective study, 406 hospitalized patients with T2DM and HF admitted to our hospital between June 2022 and June 2023 were recruited and divided into two groups: a control group and an observation group, based on the type of empagliflozin administered. Through the application of rigorous statistical methodologies, comprehensive data collection, systematic organization, and detailed analysis were performed for both groups. The findings revealed that, following treatment with the two types of empagliflozin, a significant difference was observed in creatinine clearance rate between the groups. However, no statistically significant changes were detected in other critical efficacy indicators, including fasting blood glucose, glycated hemoglobin, N-terminal pro-B-type natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), and glomerular filtration rate (GFR), before and after treatment. From an economic perspective, the observation group demonstrated a clear cost advantage, with both total drug expenditures and the specific cost of empagliflozin being significantly lower than those in the control group. In conclusion, for patients with T2DM and HF, the centralized procurement version of empagliflozin offered comparable efficacy and safety to the original research formulation, with the exception of differences in creatinine clearance rate. The significant cost advantage of the centralized procurement version highlighted its value in clinical drug selection and hospital pharmacy management. These findings underscored the importance of considering both clinical outcomes and economic factors in optimizing treatment strategies for real-world practice.

Key words: Type 2 diabetes mellitus, Heart failure, Empagliflozin, Efficacy, Safety

Supporting:

王莹, 于欢, 闫婷婷, 潘文斐. 恩格列净在2型糖尿病合并心衰患者中的疗效及安全性研究[J]. 中国药学(英文版), 2025, 34(11): 1024-1032.

Ying Wang, Huan Yu, Tingting Yan, Wenfei Pan. Efficacy and safety of empagliflozin in patients with type 2 diabetes mellitus and concurrent heart failure[J]. Journal of Chinese Pharmaceutical Sciences, 2025, 34(11): 1024-1032.

图/表 6

Table 1. Comparison of gender, age, and BMI between the two groups of patients.

Table 2. Comparison of co-morbid diagnoses between the two groups of patients.

Table 3. Comparison of the medication situation of the "New Quadruple" between the two groups of patients.

Table 4. Comparison of the situation of concomitant anti-diabetic medications between the two groups of patients.

Table 5. Comparison of the changes in the two groups of patients before and after treatment.

Table 6. Comparison of the single-dose and cost of drugs between the two groups of patients (x ± s, Yuan).

参考文献 14

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