目的 评估德谷门冬双胰岛素注射液（IDegAsp）用于2型糖尿病的有效性、安全性及经济性。方法 系统检索PubMed、Embase、中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）等数据库和国外卫生技术评估（HTA）机构官网，经文献筛选、数据提取及质量评估对相关研究结果进行综合评价。结果 最终纳入11篇SR/Meta分析、8篇药物经济学研究。有效性方面，多数研究表明IDegAsp相比基础胰岛素在控制糖化血红蛋白（HbA1c）及减少胰岛素剂量方面可能具有非劣效性，在HbA1c达标率（<7%）、空腹血糖（FPG）方面无明显差异（P>0.05）。而IDegAsp与预混胰岛素相比能够更好地降低FPG并减少胰岛素使用剂量（P<0.05）。安全性方面，多数研究表明IDegAsp在严重低血糖发生率、低血糖发生率、总不良事件发生率方面与其他胰岛素安全性相似（P>0.05），而IDegAsp相比其他胰岛素可显著降低夜间低血糖的发生率（P<0.05）。经济性方面，在中国医疗保障体系内，使用IDegAsp相比其他胰岛素是更具有经济性的治疗方案。结论 IDeg Asp与其他常规胰岛素治疗方案相比，更加有效、安全且具有经济学优势。因此，IDegAsp是可供替代的治疗方案。

Objective To evaluate the effectiveness, safety and cost-effectiveness of Insulin Degludec and Insulin Aspart（IDegAsp） for type 2 diabetes mellitus. Methods Systematic search of databases such as PubMed, Embase, CNKI, Wanfang, and the official websites of foreign health technology assessment（HTA） agencies. Comprehensive evaluation of relevant research results through literature screening, data extraction, and quality assessment. Results A total of 11 SR/Meta-analyses and eight pharmacoeconomic studies were ultimately included. In terms of effectiveness, most studies had shown that IDegAsp might have non inferiority in controlling glycated hemoglobin（HbA1c） and reducing insulin dosage compared to basal insulin, with no significant differences in HbA1c achievement rate（＜ 7%）, fasting plasma glucose（FPG）（P＞0.05）. However, IDegAsp was more effective than premixed insulin in lowering FPG and reducing insulin dosage（P＜0.05）. For the safety of IDegAsp, in terms of the incidence of severe hypoglycemia, hypoglycemia incidence, and overall adverse event incidence, most studies indicated that IDegAsp had similar safety profiles to other insulins（P＞0.05）. However, compared to other insulins, IDegAsp can significantly reduce the incidence of nocturnal hypoglycemia（P＜0.05）. For the cost-effectiveness of IDegAsp, IDegAsp is a more cost-effective treatment option compared to other insulins within China’s healthcare system. Conclusion Compared with other conventional insulin treatment regimens, IDegAsp is more effective, safer, and offers economic advantages. Therefore, IDegAsp can be an alternative treatment option.

R977

四川省中医药管理局面上项目(2024MS600); 成都市医学科研课题项目(2022562)