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1.张家港市中医医院药学部,江苏 张家港 215600
2.张家港市中医医院内分泌科,江苏 张家港 215600
副主任药师,硕士。研究方向:临床药学。E-mail:yztalijie@163.com
副主任药师,博士。研究方向:医院药学。E-mail:jzt880521@126.com
收稿:2025-08-04,
修回:2025-10-31,
录用:2025-10-31,
纸质出版:2025-11-30
移动端阅览
李杰,李宏,陈冠吉,等.依柯胰岛素治疗2型糖尿病的快速卫生技术评估 Δ[J].中国药房,2025,36(22):2856-2861.
LI Jie,LI Hong,CHEN Guanji,et al.Rapid health technology assessment of insulin icodec for the treatment of type 2 diabetes mellitus[J].ZHONGGUO YAOFANG,2025,36(22):2856-2861.
李杰,李宏,陈冠吉,等.依柯胰岛素治疗2型糖尿病的快速卫生技术评估 Δ[J].中国药房,2025,36(22):2856-2861. DOI: 10.6039/j.issn.1001-0408.2025.22.18.
LI Jie,LI Hong,CHEN Guanji,et al.Rapid health technology assessment of insulin icodec for the treatment of type 2 diabetes mellitus[J].ZHONGGUO YAOFANG,2025,36(22):2856-2861. DOI: 10.6039/j.issn.1001-0408.2025.22.18.
目的
2
综合评价依柯胰岛素治疗2型糖尿病(T2DM)的有效性、安全性和经济性,为医院新药遴选和临床用药决策提供循证参考。
方法
2
采用快速卫生技术评估方法,检索PubMed、Cochrane Library、Embase、中国知网、万方数据、维普网及国外卫生技术评估(HTA)官方网站,收集依柯胰岛素用于T2DM的系统评价/Meta分析、药物经济学研究和HTA报告,检索时限为建库起至2025年7月15日。经资料提取、质量评价后,对纳入研究的结果进行描述性分析。
结果
2
共纳入10篇系统评价/Meta分析和3篇药物经济学研究,其中4项系统评价/Meta分析为高质量;3项药物经济学研究的质量整体良好。有效性方面,依柯胰岛素在降低糖化血红蛋白(HbA1c)、控制HbA1c<7%的患
者比例方面均显著优于基础胰岛素日制剂(
P
<0.05);在降低空腹血糖方面两者差异无统计学意义(
P
>0.05)。安全性方面,与基础胰岛素日制剂比较,依柯胰岛素未增加所有不良事件(AE)发生率、严重AE发生率、有临床意义的低血糖(随机血糖<3 mmol/L)发生率、注射部位反应发生率、过敏反应发生率(
P
>0.05),但会显著增加使用者的体重(
P
<0.05)。经济性方面,国内的经济学评价结果表明,依柯胰岛素年成本范围为784.90~1 145.96美元或597.66~736.34美元时,分别比甘精胰岛素和德谷胰岛素更具经济性优势。
结论
2
依柯胰岛素用于T2DM的疗效和安全性均较好,但需关注体重增加风险。在我国医疗卫生体系下,当患者每周所需基础胰岛素剂量在特定范围内,依柯胰岛素才更具经济价值,临床应结合个体情况权衡使用。
OBJECTIVE
2
To comprehensively evaluate the efficacy, safety and cost-effectiveness of insulin icodec in treating type 2 diabetes mellitus (T2DM), providing evidence-based guidance for new drug selection in hospital and clinical medication decision-making.
METHODS
2
PubMed, Cochrane Library, Embase, CNKI, Wanfang, VIP and foreign health technology assessment (HTA) websites were searched by using rapid health technology assessment from inception to 15 July 2025 for systematic reviews/meta-analyses, pharmacoeconomic studies, and HTA reports on insulin icodec in the treatment of T2DM. After data extraction and quality assessment, the findings of the included studies were analyzed descriptively.
RESULTS
2
Ten systematic reviews/meta-analyses and three pharmacoeconomic studies were included. Among them, 4 systematic reviews/meta-analyses were of high quality; the overall quality of the 3 pharmacoeconomic studies was relatively good. Regarding efficacy, insulin icodec was superior to once-daily basal insulin in reducing glycated hemoglobin (HbA1c) and in achieving the target of HbA1c<7% (
P
<0.05). No significant differences were observed between icodec insulin and comparators in lowering fasting plasma glucose (
P
>0.05). For safety, insulin icodec did not increase the incidence of any adverse events (AEs), serious AEs, clinically significant hypoglycemia (random glucose<3 mmol/L), in
jection-site reactions, or allergic reactions, compared with once-daily basal insulin overall (
P
>0.05); however, insulin icodec was associated with a significant increase in body weight (
P
<0.05). Domestic economic evaluations indicated that insulin icodec was more cost-effective than insulin glargine and insulin degludec when its annual costs were in the range of 784.90-1 145.96 and 597.66-736.34 US dollars, respectively.
CONCLUSIONS
2
Insulin icodec demonstrates favorable efficacy and safety profiles in the treatment of T2DM; however, attention should be paid to the risk of weight gain. Under China’s healthcare system, insulin icodec demonstrates greater economic value only when the patient’s weekly required basal insulin dose falls within a specific range,and clinical practice requires individualization.
ZHOU Y C , LIU J M , ZHAO Z P , et al . The national and provincial prevalence and non-fatal burdens of diabetes in China from 2005 to 2023 with projections of prevalence to 2050 [J ] . Mil Med Res , 2025 , 12 ( 1 ): 28 .
WILLIAMS R , KARURANGA S , MALANDA B , et al . Global and regional estimates and projections of diabetes-related health expenditure:results from the International Diabetes Federation Diabetes Atlas,9th edition [J ] . Diabetes Res Clin Pract , 2020 , 162 : 108072 .
ZHONG V W , YU D M , ZHAO L Y , et al . Achievement of guideline-recommended targets in diabetes care in China:a nationwide cross-sectional study [J ] . Ann Intern Med , 2023 , 176 ( 8 ): 1037 - 1046 .
中华医学会糖尿病学分会 . 中国糖尿病防治指南: 2024版 [J ] . 中华糖尿病杂志 , 2025 , 17 ( 1 ): 16 - 139 .
KJELDSEN T B , HUBÁLEK F , HJØRRINGGAARD C U , et al . Molecular engineering of insulin icodec,the first acylated insulin analog for once-weekly administration in humans [J ] . J Med Chem , 2021 , 64 ( 13 ): 8942 - 8950 .
NISHIMURA E , PRIDAL L , GLENDORF T , et al . Molecular and pharmacological characterization of insulin icodec:a new basal insulin analog designed for once-weekly dosing [J ] . BMJ Open Diabetes Res Care , 2021 , 9 ( 1 ): e002301 .
唐惠林 , 门鹏 , 翟所迪 . 药物快速卫生技术评估方法及应用 [J ] . 临床药物治疗杂志 , 2016 , 14 ( 2 ): 1 - 4 .
张方圆 , 沈傲梅 , 曾宪涛 , 等 . 系统评价方法学质量评价工具AMSTAR 2解读 [J ] . 中国循证心血管医学杂志 , 2018 , 10 ( 1 ): 14 - 18 .
HUSEREAU D , DRUMMOND M , AUGUSTOVSKI F , et al . Consolidated health economic evaluation reporting standards 2022(CHEERS 2022) statement:updated reporting guidance for health economic evaluations [J ] . Value Health , 2022 , 25 ( 1 ): 3 - 9 .
DUTTA D , NAGENDRA L , BHAT S , et al . Optimal use of once weekly icodec insulin in type-2 diabetes:an updated meta-analysis of phase-2 and phase-3 randomized controlled trials [J ] . Diabetes Metab Syndr , 2023 , 17 ( 10 ): 102877 .
RIBEIRO E SILVA R , DE MIRANDA GAUZA M , GUISSO M E S , et al . Once-weekly insulin icodec vs. once-daily insulin glargine U100 for type 2 diabetes:a systematic review and meta-analysis of phase 2 randomized controlled trials [J ] . Arch Endocrinol Metab , 2023 , 67 ( 5 ): e000614 .
ABUELAZM M , IBRAHIM A A , KHLIDJ Y , et al . Once-weekly insulin icodec versus once-daily long-acting insulin for type Ⅱ diabetes:a meta-analysis of randomized controlled trials [J ] . J Endocr Soc , 2023 , 8 ( 2 ): bvad177 .
AHMED M , SHAFIQ A , JAVAID H , et al . Clinical outcomes with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naïve and previously insulin-treated individuals with type 2 diabetes:a meta-analysis of randomised controlled trials [J ] . Endocrinol Diabetes Metab , 2024 , 7 ( 3 ): e00480 .
BAJAJ H S , ÁSBJÖRNSDÓTTIR B , BARI T J , et al . Once-weekly insulin icodec compared with daily basal insulin analogues in type 2 diabetes:participant-level meta-analysis of the ONWARDS 1-5 trials [J ] . Diabetes Obes Metab , 2024 , 26 ( 9 ): 3810 - 3820 .
崔智程 , 凤心雨 , 鲁一兵 , 等 . 胰岛素Icodec治疗2型糖尿病的疗效及安全性的Meta分析 [J ] . 中华糖尿病杂志 , 2024 , 16 ( 2 ): 226 - 232 .
MUKHOPADHYAY P , CHATTERJEE P , PANDIT K , et al . Once-weekly insulin icodec as compared to once-daily basal insulins:a meta-analysis [J ] . Endocr Pract , 2024 , 30 ( 2 ): 128 - 134 .
SALEEM S Z , FAREED A , AKHTAR S M M , et al . Efficacy and safety of once-weekly insulin icodec compared to once-daily insulin g U-100 in patients with type Ⅱ diabetes:a systematic review and meta-analysis [J ] . Diabetol Metab Syndr , 2024 , 16 ( 1 ): 80 .
SHETTY S , SUVARNA R . Efficacy and safety of once-weekly insulin icodec in type 2 diabetes:a meta-analysis of ONWARDS phase 3 randomized controlled trials [J ] . Diabetes Obes Metab , 2024 , 26 ( 3 ): 1069 - 1081 .
ZUHAIR V , OBAID M A , MUSTAFA M S , et al . Evalua-ting the efficacy and safety of weekly insulin icodec vs. daily insulin glargine in type 2 diabetes mellitus:a syste-matic review and meta-analysis [J ] . J Diabetes Metab Disord , 2024 , 23 ( 1 ): 1337 - 1349 .
DAI N , SU X R , WANG Y . Cost-utility analysis of once-weekly insulin icodec and once-daily insulin glargine in patients with type 2 diabetes receiving basal-bolus insulin therapy in China [J ] . Diabetes Obes Metab , 2025 , 27 ( 1 ): 377 - 386 .
HU S S , WANG S W , GU S Y , et al . Cost-utility analysis and drug pricing of once-weekly insulin icodec versus once-daily insulin degludec for type 2 diabetes patients treated with basal insulin in China [J ] . Diabetes Obes Metab , 2024 , 26 ( 12 ): 5995 - 6006 .
TORRE E , DI MATTEO S , BRUNO G M , et al . Economic evaluation of once-weekly insulin icodec from Italian NHS perspective [J ] . Clinicoecon Outcomes Res , 2024 , 16 : 799 - 811 .
BAJAJ H S , ABERLE J , DAVIES M , et al . Once-weekly insulin icodec with dosing guide app versus once-daily basal insulin analogues in insulin-naive type 2 diabetes(ONWARDS 5):a randomized trial [J ] . Ann Intern Med , 2023 , 176 ( 11 ): 1476 - 1485 .
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