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中国药科大学国际医药商学院,南京 211198
硕士研究生。研究方向:药物经济学。E-mail:1041758892@qq.com
副教授,硕士生导师,博士。研究方向:药物经济学、医药企业管理。E-mail:yongjunliu@163.com
收稿日期:2024-10-16,
修回日期:2025-08-28,
录用日期:2025-09-02,
纸质出版日期:2025-09-30
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杨旭,赵一凡,李婉婷,等.达格列净与恩格列净治疗2型糖尿病肾病的药物经济学评价[J].中国药房,2025,36(18):2285-2290.
YANG Xu,ZHAO Yifan,LI Wanting,et al.Pharmacoeconomic evaluation of dapagliflozin and empagliflozin in the treatment of type 2 diabetic kidney disease[J].ZHONGGUO YAOFANG,2025,36(18):2285-2290.
杨旭,赵一凡,李婉婷,等.达格列净与恩格列净治疗2型糖尿病肾病的药物经济学评价[J].中国药房,2025,36(18):2285-2290. DOI: 10.6039/j.issn.1001-0408.2025.18.12.
YANG Xu,ZHAO Yifan,LI Wanting,et al.Pharmacoeconomic evaluation of dapagliflozin and empagliflozin in the treatment of type 2 diabetic kidney disease[J].ZHONGGUO YAOFANG,2025,36(18):2285-2290. DOI: 10.6039/j.issn.1001-0408.2025.18.12.
目的
2
从我国卫生体系角度出发,对达格列净与恩格列净治疗2型糖尿病肾病的经济性进行评价。
方法
2
基于两项多中心临床试验DECLARE-TIMI 58和EMPA-REG OUTCOME的研究数据,根据尿白蛋白与肌酐比值(UACR)划分2型糖尿病肾病患者的疾病状态,构建Markov模型,设循环周期为1年,模拟至99%的患者死亡,模型产出为总成本与质量调整生命年(QALY)。通过比较两种方案的增量成本-效果比(ICER)与意愿支付阈值(WTP,3倍我国2023年人均国内生产总值,即268 074元/QALY)判断方案经济性,并采用单因素敏感性分析和概率敏感性分析检验结果的稳健性。
结果
2
与达格列净相比,恩格列净方案的ICER为44 334.82元/QALY,小于WTP,表明恩格列净方案具有经济性。单因素敏感性分析结果显示,两组非致命性心肌梗死发生率和微量白蛋白尿状态的效用值对结果影响最大,但不会使基础分析结果发生颠覆性变化。概率敏感性分析显示基础分析结果具有稳健性。
结论
2
在以3倍我国2023年人均国内生产总值作为WTP时,与达格列净相比,恩格列净治疗2型糖尿病肾病更具有经济性。
OBJECTIVE
2
To evaluate the cost-effectiveness of dapagliflozin and empagliflozin in the treatment of type 2 diabetic kidney disease from the perspective of healthcare system in China.
METHODS
2
Based on the data from the two multicenter clinical trials, DECLARE-TIMI 58 and EMPA-REG OUTCOME, a Markov model was constructed according to the urinary albumin-to-creatinine ratio (UACR) of the patients with type 2 diabetic kidney disease with a cycle of 1 year, simulating until 99% of patients died. The model outputs were total costs and quality-adjusted life year (QALY). The cost-effectiveness of the two treatment regimens was assessed by comparing their incremental cost-effectiveness ratio (ICER) and the willingness-to-pay threshold (WTP,set at three times China’s 2023 per capita gross domestic product, i.e., 268 074 yuan/QALY). Additionally, oneway sensitivity analysis and probabilistic sensitivity analysis were performed to test the robustness of the base analysis results.
RESULTS
2
Compared with dapagliflozin, the ICER for empagliflozin regimen was 44 334.82 yuan/QALY, which was below the WTP , indicating its cost-effectiveness. The results of the oneway sensitivity analysis indicated that the incidence of non-fatal myocardial infarction in both groups and the utility values associated with the microalbuminuria state had the most significant impact on the outcomes, but did not change the base-case conclusion. The probabilistic sensitivity analysis indicated that the results of the base-case analysis were robust.
CONCLUSIONS
2
With a WTP of three times China’s per capita gross domestic product in 2023, empagliflozin is more cost-effective than dapagliflozin in treating type 2 diabetic kidney disease.
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