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重组人促甲状腺激素临床应用中国专家共识(2025年版)

Chinese expert consensus on the clinical application of recombinant human thyroid-stimulating hormone (2025 edition)

  • 摘要: 重组人促甲状腺激素(recombinant human thyroid-stimulating hormone, rhTSH)可应用于分化型甲状腺癌(differentiated thyroid cancer, DTC)手术后随访、131I治疗前准备和131I治疗后随访。该药物自1998年由美国食品药品监督管理局(Food and Drug Administration, FDA)批准上市以来,在欧美等国家已临床应用近30年。2024年4月,中国首个自主研发的创新型rhTSH药物获批上市。国内专家基于临床经验,整合国内外证据,组织研讨并形成rhTSH临床应用中国专家共识,并根据现有证据作相应推荐,旨在规范rhTSH的临床应用场景。

     

    Abstract: The recombinant human thyroid-stimulating hormone (rhTSH) can be used for differentiated thyroid cancer (DTC) preparation before 131I therapy, and follow-up. Since its approval by the American Food and Drug Administration (FDA) in 1998, rhTSH has been clinically used in European countries, the United States, and other countries for nearly 30 years. In April 2024, the first independently developed rhTSH agent in China was approved. Based on clinical experience and integrating evidence from domestic and international studies, an expert consensus on the application of rhTSH has been developed following thorough consultations among experts. The consensus offers evidence-based recommendations designed to guide the appropriate use of rhTSH in clinical practice.

     

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