维格列汀治疗2型糖尿病的卫生技术评估

Vildagliptin in the Treatment of Type 2 Diabetes Mellitus:Health Technology Assessment

目的:明确维格列汀临床使用的获益与风险,为临床治疗和决策者提供循证依据。方法:系统检索Pub Med、EMbase、The Cochrane Library、CNKI等数据库。由2位评价者根据纳入与排除标准独立筛选文献、提取资料和评价质量后,对结果进行定性和定量分析。结果:共纳入2篇卫生技术评估(HTA)报告、10篇Meta分析、67篇随机对照研究(RCT)、1篇观察性研究和8篇经济学研究。维格列汀与安慰剂、伏格列波糖相比可显著降低糖化血红蛋白(Hb A1c)水平,与二甲双胍、磺脲类等阳性对照药比较Hb A1c降低水平的差异无统计学意义;与西格列汀相比可显著降低空腹血糖(FPG)水平。维格列汀不增加低血糖风险,与磺脲类相比显著降低低血糖风险;不增加心力衰竭、心脑血管事件、胰腺炎等不良事件风险。与磺脲类、噻唑烷二酮类药物相比,维格列汀联合二甲双胍可延长患者的质量调整生命年(QALY)并具有良好的成本-效果比。结论:维格列汀治疗2型糖尿病具有良好的有效性、安全性和经济性,建议纳入医保药品目录。

Objective：To evaluate the effectiveness, safety and economy of vildagliptin in type 2 diabetes patients using health technology assessment. Methods： PubMed, EMbase, The Cochrane Library, CNKI were systematically searched. Two reviewers independently identified studies, extracted data and assessed quality of included studies. Qualita- tive and quantitative analysis was performed. Results ： Two HTA reports, 10 Meta-analyses, 67 RCTs, 1 observational study and 8 pharmacoeconomic studies were included. HbAI c levels were significantly decreased in the vildagliptin group than that in placebo and voglibose group, while similar with metformin, sulfonylureas and other active comparators. FPG levels were significantly decreased in the vildagliptin group than the sitagliptin group. Overall and severe adverse events were similar between intervention and control group. Vildagliptin did not increase the risk of hypoglycemia, while lowering the risk compared with sulfonylureas. Vildagliptin also did not increase the risk of heart failure, cardiovascular or cerebro- vascular event and pancreatitis. Addition of vildagliptin to mefformin was associated with improvement in QALYs and medical expenses, compared with sulfonylureas, thiazolidinediones. Conclusion：Vildagliptin was an efficacious, safe and economical choice for type 2 diabetes treatment, and it was recommended to be included in the medical insurance drug list.