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    翰森製藥 | 孚來美®再獲國家基層糖尿病防治管理指南推薦
    發布日期：2025/12/22
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    近日，《中華內科雜誌》發布《國家基層糖尿病防治管理指南（2025）》（以下簡稱指南），旨在推動基層糖尿病健康管理工作的規範化[1]。翰森製藥首个中國原研GLP-1RA周製劑孚來美®（聚乙二醇洛塞那肽注射液）被納入指南，這是繼2022年版[2]之後再度獲得這一國家級重磅指南的認可。


    近年來，孚來美®發表了一系列臨床及基礎研究證據，展現出在血糖平穩控制、心腦血管保護、腎臟及肝臟等多方面的綜合獲益。多中心真實世界研究显示，孚來美®在改善葡萄糖目標範圍時間（TIR，一種血糖控制的標準指標）方面相比GLP-1RA日製劑利拉魯肽更具優勢[3]。另一項隨機開放對照試驗證實，二甲雙胍基礎上聯合孚來美®在改善血糖控制及通過持續葡萄糖監測（CGM）評估的血糖變異性方面，效果優於甘精胰島素[4]。這些研究表明孚來美®能夠實現血糖的平穩控制，減少血糖波動及其相關不良事件。

    首個針對中國人群的GLP-1RA心血管結局大型真實世界研究（FLYING研究）證實了孚來美®長期治療能夠帶來顯著的心血管獲益，相比使用非腸促胰島素降糖葯治療能夠顯著降低3P-MACE（包括非致死性心肌梗死、非致死性卒中或心血管死亡）風險32%[5]。隨機對照研究證實孚來美®改善糖尿病腎病（DKD）患者尿蛋白與一線SGLT2抑製劑達格列凈相當，提示其在降糖的同時還有助於延緩腎病進展[6]。一些臨床與基礎研究表明孚來美®能夠有效減少內臟脂肪面積（VFA）、改善脂肪肝並保護肝臟[7-9]。

    從權威指南的持續認可，到改變臨床實踐的心腎肝等獲益證據，孚來美®正憑藉紮實的科研數據，為2型糖尿病治療提供更全面的選擇。隨着在基層醫療機構的廣泛應用，孚來美®有望惠及更廣泛的中國糖尿病患者，為降低糖尿病併發症負擔、助力“健康中國2030”宏偉藍圖貢獻重要力量。

    參考文獻：

    參考文獻：

    [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

    參考文獻：

    [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

    參考文獻：

    [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

    參考文獻：

    [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

    參考文獻

    參考文獻

    參考文獻：

    [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

    參考文獻：

    [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

    參考文獻：

    [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

    參考文獻：

    [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

    參考文獻：

    [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


    參考文獻：

    [1]中華內科雜誌.2025.64(12):1169-1186

    [2]中華內科雜誌,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]山東醫藥,2022,62(25):35-38.

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

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

    關於翰森製藥

    翰森製藥是中國領先的創新驅動型製藥企業，下屬豪森葯業、常州恆邦葯業、翰森生物醫藥等子公司，以「持續創新，提高人類生命質量」為使命，重點關注抗腫瘤、抗感染、中樞神經系統、代謝及自身免疫等重大疾病治療領域。截至目前，公司在中國產生銷售收入的創新葯共7款，形成了豐富的產品管線。翰森製藥連續多年位居全球製藥企業百強、中國醫藥研發產品線最佳工業企業前3強，是國家重點高新技術企業、國家技術創新示範企業。翰森製藥於2019年6月在香港聯交所掛牌上市（股票代碼：03692.HK）。

    免責聲明

    本文僅供醫療衛生專業人士參閱，非廣告用途。翰森製藥不推薦任何未獲批藥品使用和/或未獲批適應症用藥，亦不對任何藥品和/或適應症作推薦。本文中涉及的信息僅供參考，請遵從醫生或其他醫療衛生專業人士的意見或指導。醫療衛生專業人士作出的任何與治療有關的決定應根據患者的具體情況並遵照藥品說明書。如需了解公司任何產品、醫療或疾病的相關信息，請務必諮詢醫療衛生專業人士。

    前瞻性說明

    本新聞稿旨在提供關於翰森製藥集團有限公司及其附屬公司（包括其子公司，統稱為“翰森製藥”）的信息。它不構成對翰森製藥或任何投資建議的信息披露。本新聞稿包含的信息可能包括與翰森製藥業務和產品前景、計劃、信念、預期和策略相關的前瞻性聲明。這些聲明是基於推測性假設的預測，並不保證未來的表現。它們受到諸如科學、商業、政治、經濟、財務、法律因素以及競爭環境和社會條件等風險和不確定性的影響，這些因素很多都是翰森製藥無法控制且難以預測的，因此實際結果可能與此處所述有顯著差異，且過去的證券價格趨勢不應作為未來行情的指導。因此，投資者在使用這些信息進行投資決策時應謹慎行事。“致力於”“預期”“相信”“預測”“意圖”“預計”“可能”“將”“應該”“計劃”“繼續”“目標”“考慮”“估計”“指導”“潛在”“追求”以及於任何未來計劃、行動或事件的討論中使用的類似詞語和術語，均表示前瞻性聲明。翰森製藥不承諾或保證前瞻性信息的準確性、及時性或完整性，並且不承擔更新或修訂這些前瞻性聲明的義務。無論是翰森製藥還是其任何董事、員工或代理人，均不對任何證明不準確或無法實現的前瞻性聲明負責，也不對因依賴本新聞稿中提供的信息而產生的任何損失或損害負責，包括但不限於直接、偶然、間接或懲罰性的損害。

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