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    翰森制药 | 孚来美®再获国家基层糖尿病防治管理指南推荐
    发布日期：2025/12/22
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    近日，《中华内科杂志》发布《国家基层糖尿病防治管理指南（2025）》（以下简称指南），旨在推动基层糖尿病健康管理工作的规范化[1]。翰森制药首个中国原研GLP-1RA周制剂孚来美®（聚乙二醇洛塞那肽注射液）被纳入指南，这是继2022年版[2]之后再度获得这一国家级重磅指南的认可。


    近年来，孚来美®发表了一系列临床及基础研究证据，展现出在血糖平稳控制、心脑血管保护、肾脏及肝脏等多方面的综合获益。多中心真实世界研究显示，孚来美®在改善葡萄糖目标范围时间（TIR，一种血糖控制的标准指标）方面相比GLP-1RA日制剂利拉鲁肽更具优势[3]。另一项随机开放对照试验证实，二甲双胍基础上联合孚来美®在改善血糖控制及通过持续葡萄糖监测（CGM）评估的血糖变异性方面，效果优于甘精胰岛素[4]。这些研究表明孚来美®能够实现血糖的平稳控制，减少血糖波动及其相关不良事件。

    首个针对中国人群的GLP-1RA心血管结局大型真实世界研究（FLYING研究）证实了孚来美®长期治疗能够带来显著的心血管获益，相比使用非肠促胰岛素降糖药治疗能够显著降低3P-MACE（包括非致死性心肌梗死、非致死性卒中或心血管死亡）风险32%[5]。随机对照研究证实孚来美®改善糖尿病肾病（DKD）患者尿蛋白与一线SGLT2抑制剂达格列净相当，提示其在降糖的同时还有助于延缓肾病进展[6]。一些临床与基础研究表明孚来美®能够有效减少内脏脂肪面积（VFA）、改善脂肪肝并保护肝脏[7-9]。

    从权威指南的持续认可，到改变临床实践的心肾肝等获益证据，孚来美®正凭借扎实的科研数据，为2型糖尿病治疗提供更全面的选择。随着在基层医疗机构的广泛应用，孚来美®有望惠及更广泛的中国糖尿病患者，为降低糖尿病并发症负担、助力“健康中国2030”宏伟蓝图贡献重要力量。

    参考文献：

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献

    参考文献

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321

    参考文献：

    [1]Jun Chen,et al.Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retroprospective observational study. EASL 2025.Abstract No: SAT-258.

    [2]Xiaochuan Diao,et al.Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study. EASL 2025.Abstract No: WED-295

    [3]Shu Xiong,et al.Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment.EASL 2025.Abstract No: SAT-321


    参考文献：

    [1]中华内科杂志.2025.64(12):1169-1186

    [2]中华内科杂志,2022,61(3):249-262.

    [3]Front Pharmacol. 2024 Mar 7;15:1370594.

    [4]Front Pharmacol. 2023 May 4;14:1171399.

    [5]MedComm (2020). 2025;6(2):e70094.

    [6]Front. Endocrinol. 2024.15:1387993.

    [7]山东医药,2022,62(25):35-38.

    [8]Front Endocrinol (Lausanne). 2023 Jan 26;14:1106868.

    [9]Front Pharmacol. 2021 Dec 6;12:781856.

    关于翰森制药

    翰森制药是中国领先的创新驱动型制药企业，下属豪森药业、常州恒邦药业、翰森生物医药等子公司，以「持续创新，提高人类生命质量」为使命，重点关注抗肿瘤、抗感染、中枢神经系统、代谢及自身免疫等重大疾病治疗领域。截至目前，公司在中国产生销售收入的创新药共7款，形成了丰富的产品管线。翰森制药连续多年位居全球制药企业百强、中国医药研发产品线最佳工业企业前3强，是国家重点高新技术企业、国家技术创新示范企业。翰森制药于2019年6月在香港联交所挂牌上市（股票代码：03692.HK）。

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