摘要
^(90)Y微球将放射性微球通过微创介入灌注至肿瘤供血动脉,放射性微球随血流分散并滞留在肿瘤末端小血管,通过持续释放高能射线实现高选择性地杀伤肿瘤细胞,对中晚期肝癌的局部治疗具有重要价值。目前全球已上市两款^(90)Y微球产品(SIR-Spheres和TheraSpheres),在国外已开展近二十年临床应用,纳入多个权威肝癌诊疗规范和指南。自2018年开始,SIR-Spheres和TheraSpheres逐步进入我国,引起国内临床专家的关注,并被纳入我国最新的肝癌诊疗相关指南。2022年,SIR-Spheres作为进口药品通过国家药监局审批上市,用于标准治疗失败且不可手术切除的结直肠癌肝转移患者的治疗。同期完成首例TheraSpheres治疗原发性肝癌。我国自主研发的^(90)Y炭微球显示良好的临床转化潜力。为更好开展^(90)Y微球产品在我国临床研究与应用,推动同类产品研发创新,本文对^(90)Y微球的种类与研发现状、临床应用,以及在国内的发展情况和展望进行综述,以期为我国^(90)Y微球药物的研发与应用提供参考。
With ^(90)Y microspheres,radioactive microspheres are perfused to tumor feeding arteries through minimally invasive intervention,and then diffused and retained in small vessels of tumor terminals along with blood flow,so as to high selectively kill tumor cells by means of sustained release of high energy rays.^(90)Y microspheres are of important value in the local treatment of advanced liver cancer.At present,two types of ^(90)Y microsphere products(SIR-Spheres and TheraSpheres)which have appeared on the market globally,have been clinically applied abroad for nearly twenty years,and have been incorporated into many authoritative norms and guidelines for the diagnosis and treatment of liver cancer.Since 2018,SIR-Spheres and TheraSpheres have gradually entered China and attracted the attention of domestic clinical experts,and have been incorporated into the latest relevant guidelines for the diagnosis and treatment of liver cancer in China.In 2022,SIR-Spheres,as imported drugs,passed the approval of the National Medical Products Administration(NMPA)and were approved for listing to treat patients with surgically unresectable liver metastases of colorectal cancer after failure in standard treatment.At the same time,the first case of primary liver cancer has been treated by TheraSpheres.^(90)Y carbon microspheres independently researched and developed in China show good clinical conversion potential.In order to more effectively carrying out clinical research and application of ^(90)Y microsphere products in China and promote research and development innovation of similar products,this paper reviews types,the research and development status,clinical application and domestic development and outlook of ^(90)Y microspheres,so as to provide reference for the research,development and application of ^(90)Y microsphere drugs in China.
作者
高洁
刘晓明
周文华
王红亮
赵小生
葛强
李建国
GAO Jie;LIU Xiaoming;ZHOU Wenhua;WANG Hongliang;ZHAO Xiaosheng;GE Qiang;LI Jianguo(China Institute for Radiation Protection/Research and Development Center of Nuclear Technology(Non Clinical Evaluation of Radioactive Drugs)of National Atomic Energy Agency/CNNC Key Laboratory on Radiotoxicology and Radiopharmaceutical Preclinical Evaluation/Shanxi Key Laboratory of Drug Toxicology and Drug for Radiation Injury,Taiyuan 030006,China;First Hospital of Shan Xi Medical University,Taiyuan 030001,China;Cheng Du New Radiomedicine Technology Co Ltd,Chengdu 610200,China)
出处
《同位素》
CAS
2022年第3期189-199,共11页
Journal of Isotopes
基金
中核集团青年英才项目“90Y微球临床前内照射对肝脏耐受剂量的研究”
核能开发后补助项目“治疗晚期肝癌Ⅰ类创新型放射性药物钇[90Y]炭微球的工艺优化与非临床评价研究”。
关键词
^(90)Y
微球
原发性肝癌
转移性肝癌
研发现状
Yttrium-90
microspheres
primary liver cancer
metastatic liver cancer
research and development status
