艾托格列净治疗2型糖尿病的快速卫生技术评估

Ertugliflozin in the treatment of type 2 diabetes mellitus:a rapid health technology assessment

目的采用快速卫生技术评估方法,评价艾托格列净治疗2型糖尿病的有效性、安全性和经济性,为临床决策提供依据。方法计算机检索PubMed、Embase、Cochrane Library、CNKI、VIP、WanFang Data数据库和卫生技术评估(HTA)网站,检索时限从建库至2024年1月,由2位研究者独立筛选文献、提取资料、并评价纳入研究的质量后,对结果进行定性描述与分析。结果共纳入27篇文献,包括HTA报告2篇,系统评价/Meta分析24篇和经济学研究2篇。有效性方面,与安慰剂相比,艾托格列净能降低糖化血红蛋白、空腹血糖、心衰住院率、体重和收缩压/舒张压,而全因死亡率、心血管死亡率和肾脏复合终点等指标未显示出优势。安全性方面,艾托格列净导致的泌尿道感染、骨折、截肢、低血糖风险与安慰剂和其他降糖药物差异无统计学意义,但可能引起酮症酸中毒、生殖道感染和和估算肾小球滤过率下降风险增加。经济性方面,艾托格列净对中国2型糖尿病患者具有成本-效果和成本-效用优势。结论艾托格列净治疗2型糖尿病具有良好有效性和安全性,但仍需要进一步开展有效性、安全性的头对头研究和国内经济学评价。

Objective To evaluate the efficacy,safety and cost-effectiveness of ertugliflozin in the treatment of type 2 diabetes mellitus by rapid health technology assessment to provide a basis for clinical decision-making.Methods PubMed,Embase,the Cochrane Library,CNKI,WanFang Data,VIP database and health technology assessment(HTA)related websites and databases were searched from the inception date to January 2024.Two researchers independently screened the literature,extracted the data,assessed the quality and carried out the qualitative analysis.Results A total of 27 articles were included,in which 2 HTA reports,24 systematic reviews/meta-analyses and 2 pharmacoeconomic studies.Compared with placebo,ertugliflozin could significantly lower hemoglobin A1c level,fasting plasma glucose,hospitalization for heart failure,body weight and blood pressure levels,but there were no significant difference in all-cause mortality,cardiovascular mortality and composite renal outcome.In terms of safety,there were no significant difference in the risk of urinary tract infections,fracture,amputation and symptomatic hypoglycemia between ertugliflozin and placebo or other hypoglycemic drugs.However,ertugliflozin increased the risk of ketoacidosis,genital mycotic infections and lowered of estimated glomerular filtration rate.Pharmacoeconomic studies showed that ertugliflozin had better cost-utility and cost-effectiveness in type 2 diabetes in China.Conclusion Ertugliflozin is effective and safety in treating type 2 diabetes mellitus,but it’s necessary to carry out the head to head studies among efficacy,safety and economics research in China.