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·循证药学·


          依柯胰岛素治疗2型糖尿病的快速卫生技术评估                                                      Δ


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          李 杰 ,李 宏 ,陈冠吉 ,常晓艳 ,杨 祥 ,蒋志涛 (1.张家港市中医医院药学部,江苏 张家港 215600;
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                                                            1 #
                 1*
          2.张家港市中医医院内分泌科,江苏 张家港 215600)
          中图分类号  R977.1+5      文献标志码  A      文章编号  1001-0408(2025)22-2856-06
          DOI  10.6039/j.issn.1001-0408.2025.22.18
          摘   要  目的  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  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  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  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。
          关键词  依柯胰岛素;2型糖尿病;疗效;安全性;经济性;快速卫生技术评估


          Rapid health technology assessment of insulin icodec for the treatment of type 2 diabetes mellitus
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          LI Jie ,LI Hong ,CHEN Guanji ,CHANG Xiaoyan ,YANG Xiang ,JIANG Zhitao(1.  Dept.  of  Pharmacy,
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          Zhangjiagang  Hospital  of  Traditional  Chinese  Medicine,  Jiangsu  Zhangjiagang  215600,  China;2.  Dept.  of
          Endocrinology, Zhangjiagang Hospital of Traditional Chinese Medicine, Jiangsu Zhangjiagang 215600, China)
          ABSTRACT      OBJECTIVE  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  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  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),  injection-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  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
              Δ 基金项目 江苏省卫生健康委医学科研项目(No. 苏卫科教
                                                              required  basal  insulin  dose  falls  within  a  specific  range,and
          〔2022〕14号)
             *第一作者 副主任药师,硕士。研究方向:临床药学。E-mail:                 clinical practice requires individualization.
          yztalijie@163.com                                   KEYWORDS    insulin  icodec;  type  2  diabetes  mellitus;
              # 通信作者 副主任药师,博士。研究方向:医院药学。E-mail:               efficacy;  safety;  cost-effectiveness;  rapid  health  technology
          jzt880521@126.com                                   assessment


          · 2856 ·    China Pharmacy  2025 Vol. 36  No. 22                            中国药房  2025年第36卷第22期
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