目的 評(píng)估德谷門冬雙胰島素注射液（IDegAsp）用于2型糖尿病的有效性、安全性及經(jīng)濟(jì)性。方法 系統(tǒng)檢索PubMed、Embase、中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（Wanfang Data）等數(shù)據(jù)庫和國(guó)外衛(wèi)生技術(shù)評(píng)估（HTA）機(jī)構(gòu)官網(wǎng)，經(jīng)文獻(xiàn)篩選、數(shù)據(jù)提取及質(zhì)量評(píng)估對(duì)相關(guān)研究結(jié)果進(jìn)行綜合評(píng)價(jià)。結(jié)果 最終納入11篇SR/Meta分析、8篇藥物經(jīng)濟(jì)學(xué)研究。有效性方面，多數(shù)研究表明IDegAsp相比基礎(chǔ)胰島素在控制糖化血紅蛋白（HbA1c）及減少胰島素劑量方面可能具有非劣效性，在HbA1c達(dá)標(biāo)率（<7%）、空腹血糖（FPG）方面無明顯差異（P>0.05）。而IDegAsp與預(yù)混胰島素相比能夠更好地降低FPG并減少胰島素使用劑量（P<0.05）。安全性方面，多數(shù)研究表明IDegAsp在嚴(yán)重低血糖發(fā)生率、低血糖發(fā)生率、總不良事件發(fā)生率方面與其他胰島素安全性相似（P>0.05），而IDegAsp相比其他胰島素可顯著降低夜間低血糖的發(fā)生率（P<0.05）。經(jīng)濟(jì)性方面，在中國(guó)醫(yī)療保障體系內(nèi)，使用IDegAsp相比其他胰島素是更具有經(jīng)濟(jì)性的治療方案。結(jié)論 IDeg Asp與其他常規(guī)胰島素治療方案相比，更加有效、安全且具有經(jīng)濟(jì)學(xué)優(yōu)勢(shì)。因此，IDegAsp是可供替代的治療方案。

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

四川省中醫(yī)藥管理局面上項(xiàng)目(2024MS600); 成都市醫(yī)學(xué)科研課題項(xiàng)目(2022562)