目的 快速评价恩格列净治疗 2 型糖尿病的有效性、安全性和经济性,为临床决策提供循证医学证据.方法 检索PubMed,Embase、the Cochrane Library、中国国家知识基础设施、万方数据库、维普中文科技期刊数据库及各大卫生技术评估网站,检索时限从建库至 2022 年 11 月 30 日.由 2 位研究者根据纳入和排除标准独立筛选文献,提取资料,质量评价及综合分析.结果 共纳入文献 23 篇,包括 3 篇HTA报告,10 篇系统评价/Meta分析和 10 篇药物经济学研究.有效性分析结果显示,与对照组相比,恩格列净可有效控制血糖、降低血压、体质量以及全因死亡率.安全性分析结果显示,恩格列净与安慰剂或其他口服降糖药相比,总体耐受性良好,能显著降低主要心血管不良事件(MACE)和肾脏结局的相对风险,但增加生殖系统感染和电解质水平异常风险.经济性分析结果提示恩格列净对于合并心血管或肾脏疾病的高危人群具有成本-效果优势.结论 恩格列净治疗 2 型糖尿病具有良好的有效性和安全性,亟需开展中国人群的药物经济学研究.
Objective To rapidly evaluate the efficacy,safety and economics of empagliflozin in the treatment of type 2 diabetes mellitus(T2DM)and to provide evidence-based medical evidence for clinical decision.Methods PubMed,Embase,the Cochrane Library,CNKI,Wangfang,VIP database and major health technology assessment(HTA)websites were searched from the construction of the databases to Nov 30th,2022.Two researchers independently screened,extracted the data,evaluated the quality and analyzed the results according to inclusion and exclusion criteria.Results A total of 23 literatures were included,including 3 HTA reports,10 systematic review/Meta-analyses and 10 pharmacoeconomic studies.The results of efficacy showed that empagliflozin reduced HbA1c,blood pressure,body weight and all-cause mortality compared with the control group.Safety studies showed that empagliflozin was generally well tolerated,and significantly reduced MACEs and the relative risk of the renal primary outcomes,but increased the risk of genital infections and electrolyte abnormality compared with placebo and other oral antidiabetic drugs.The economic evaluation results showed that empagliflozin was more cost-effective in high risk patients with comorbid cardiovascular or kidney disease.Conclusion Empagliflozin is effective and safe in the treatment of T2DM,but the pharmacoeconomic studies focusing on chinese populations are urgently needed.