目的 评价达格列净治疗2型糖尿病(T2DM)合并心血管疾病(CVD)的安全性、有效性及经济性，为临床治疗决策提供循证依据。方法 检索PubMed、the Cochrane Library、Embase、Web of Science、中国知网、万方数据、维普网、中国生物医学文献数据库以及国内外卫生技术评估(HTA)相关机构官方网站，收集达格列净治疗T2DM合并CVD的HTA报告、系统评价/Meta分析和药物经济学研究。资料提取、评价质量后，对纳入研究的结果进行描述性分析。结果 共纳入文献13篇，其中系统评价/Meta分析10篇、药物经济学研究3篇。有效性方面，与安慰剂比较，达格列净可显著降低患者的糖化血红蛋白、体重、体重指数及血压水平，且未增加全因病死风险。安全性方面，达格列净未增加患者总体不良反应、主要心血管不良事件、心血管病死、心力衰竭住院、心肌梗死、脑卒中、骨折、肾功能减退的发生风险。经济性方面，英国及中国经济学研究认为，达格列净具有经济学优势;泰国经济学研究认为，该药不具有经济学优势。结论 达格列净治疗T2DM合并CVD的有效性和安全性较好;经济性结论在不同国家存在差异，在我国当前医疗政策及药品价格背景下达格列净具有经济学优势。
Rapid health technology assessment of dapagliflozin in the treatment of type 2 diabetes mellitus combined with cardiovascular disease
OBJECTIVE To evaluate the safety,efficacy and economics of dapagliflozin in the treatment of type 2 diabetes mellitus(T2DM)combined with cardiovascular disease(CVD),and provide an evidence-based basis for clinical treatment decisions.METHODS PubMed,the Cochrane Library,Embase,Web of Science,CNKI,Wanfang data,VIP,SinoMed and official websites of domestic and foreign health technology assessment(HTA)organizations were systematically searched.HTA reports,systematic evaluations/meta-analyses,and pharmacoeconomic studies of dapagliflozin in the treatment of T2DM combined with CVD were searched.After data extraction and quality assessment,the results of the included studies were analyzed descriptively.RESULTS A total of 13 papers were included,of which 10 were systematic evaluations/meta-analyses and 3 were pharmacoeconomic studies.In terms of efficacy,dapagliflozin significantly reduced patients'glycosylated hemoglobin,body weight,body mass index and blood pressure levels compared with placebo,without increasing the risk of all-cause mortality;in terms of safety,dapagliflozin did not increase the risk of overall adverse events,major adverse cardiovascular events,cardiovascular death,hospitalization for heart failure,myocardial infarction,stroke,bone fracture and renal hypoplasia;in terms of economics,the UK and Chinese studies found an economic advantage for dapagliflozin,the Thai study did not.CONCLUSIONS Dagliflozin has better efficacy and safety in the treatment of T2DM combined with CVD,and its economic findings are still controversial in different countries,with economic advantages in the context of current Chinese healthcare policies and drug prices.
dapagliflozintype 2 diabetes mellituscardiovascular diseaserapid health technology assessmenteffectivenesssafetyeconomics
万方数据
维普
