摘要
2022年1月1日,中国国际科技促进会发布了《医用锗[^(68)Ge]/镓[^(68)Ga]发生器及镓[^(68)Ga]放射性药物质量标准》(T/CI 046⁃2021)和《医用镥[177 Lu]及其放射性药物的质量标准》(T/CI 047⁃2021),对放射性药物的质量控制、临床规范应用等提出了新要求,标志着我国在放射性药物标准化管理领域取得进一步发展。本文结合核医学发展现状,对该两项标准的技术背景、质量控制以及临床应用等核心内容进行解读,同时基于我国核医学发展现状,指出标准实施面临的挑战及对策,以促进我国放射性药物质量控制体系的完善与发展。
On January 1,2022,the China International Association for the Promotion of Science and Technology(CIAPST)officially implemented two pivotal standards:Quality Standards for Medical Germanium⁃^(68)/Gallium⁃^(68)(^(68)Ge/^(68)Ga)Generators and Gallium⁃^(68)Radiopharmaceuticals(T/CI 046⁃2021)and Quality Standards for Medical Lutetium⁃177(177 Lu)and Its Radiopharmaceuticals(T/CI 047⁃2021).These standards introduce innovative requirements for quality control and clinical application of radiopharmaceuticals,marking a significant advancement in China's regulatory framework for nuclear medicine.This article provides a compre⁃hensive analysis of the technical rationale,QC protocols,and clinical implications outlined in the standards.Against the backdrop of China's evolving nuclear medicine landscape,we further identify challenges in imple⁃mentation(e.g.,production consistency,regulatory compliance)and propose actionable strategies to optimize radiopharmaceutical quality management systems.Our perspective aims to support the standardization and global integration of China's radiopharmaceutical industry.
作者
赖毓昕
彭雨萌
王国昌
LAI Yuxin;PENG Yumeng;WANG Guochang(Department of Nuclear Medicine,the First Affiliated Hospital,Fujian Medical University,Fuzhou 350005,China;Department of Nuclear Medicine,National Regional Medical Center,Binhai Campus of the First Affiliated Hospital,Fujian Medical University,Fuzhou 350212,China)
出处
《协和医学杂志》
北大核心
2025年第4期867-873,共7页
Medical Journal of Peking Union Medical College Hospital
基金
国家自然科学基金(82402315)
福建省自然科学基金(2024J08171)
福建省科技创新联合资金项目(2023Y9084)
福建省级临床重点专科建设项目(2023SZDZK⁃HYXK)。
