【摘要】 目的 采用快速卫生技术评估方法，对医保准入后度拉糖肽治疗2型糖尿病（T2DM）的有效性、安全性与经济性进行证据整合，为医保支付决策和临床合理用药提供依据。方法 计算机检索CNKI、WanFang Data、SinoMed、中华医学期刊全文数据库、PubMed、Web of Science、Cochrane Library和国际卫生技术评估机构（INAHTA）数据库，搜集度拉糖肽注射液治疗我国T2DM患者的相关研究，检索时限均为2021年1月1日至2024年11月5日。由2位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后，进行数据整合分析。结果 共纳入58篇文献，包括46项实用临床研究、4项观察性研究和8项经济学评价研究。有效性方面，度拉糖肽在降低糖化血红蛋白（HbA1c）及体质指数（BMI）方面优于对照药物，Meta分析显示度拉糖肽相较于二甲双胍在HbA1c和BMI改善上具有统计学优势（HbA1c:MD=-1.18,BMI:MD=-0.80）。安全性方面，度拉糖肽低血糖风险低于胰岛素类药物，但胃肠道不良反应发生率相对较高。经济性方面，大多数研究表明度拉糖肽在中国卫生体系视角下具备良好的成本效果，但与其他胰高血糖素样肽-1受体激动剂药物相比经济性优势尚存争议。结论 医保准入后，度拉糖肽在T2DM管理中具有较好的有效性与安全性，经济性亦表现良好，具备医保支付与临床应用价值。建议提高药品上市后的真实世界研究质量，为医保动态调整提供证据。更多还原

【Abstract】 Objective To evaluate the effectiveness, safety, and cost-effectiveness of Dulaglutide for the treatment of type 2 diabetes mellitus(T2 DM) using the rapid health technology assessment(rHTA) method, providing a basis for medical insurance payment decisions and rational clinical use. Methods The CNKI, WanFang Data, SinoMed,Yiigle, PubMed, Web of Science, Cochrane Library and INAHTA databases were electronically searched to collect studies on Dulaglutide for T2 DM from January 1, 2021 to November 5, 2024. Two reviewers independently screened the literature, extracted data, assessed the risk of bias of the included studies and synthesized data. Results A total of 58 studies were included, comprising 46 practical clinical trials, 4 observational studies, and 8 economic evaluations. In terms of effectiveness, Dulaglutide showed superiority over comparator drugs in reducing glycated hemoglobin(HbA1c) and body mass index(BMI). Meta-analysis demonstrated a statistical advantage for Dulaglutide over metformin in improving HbA1c(MD=-1.18) and BMI(MD=-0.80). Regarding safety, Dulaglutide had a lower risk of hypoglycemia compared to insulin, but a relatively higher incidence of gastrointestinal adverse reactions. In terms of economics, most studies indicated that Dulaglutide demonstrated favorable cost-effectiveness from the perspective of Chinese healthcare system,although its economic advantage over other GLP-1 receptor agonists remains debatable. Conclusion After its inclusion in the medical insurance, Dulaglutide demonstrates good effectiveness and safety in T2DM management, along with favorable economic performance, thus possessing value for both medical insurance payment and clinical application. It is recommended to improve the quality of post-marketing real-world studies to provide further evidence for dynamic medical insurance adjustments.更多还原