90Y微球的研发现状与应用研究

Study on Research and Development Status and Application of 90Y Microspheres

  • 摘要: 90Y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90Y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90Y炭微球显示良好的临床转化潜力。为更好开展90Y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90Y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90Y微球药物的研发与应用提供参考。

     

    Abstract: With 90Y 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. 90Y microspheres are of important value in the local treatment of advanced liver cancer. At present, two types of 90Y 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-. 90Y 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 90Y 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 90Y microspheres, so as to provide reference for the research, development and application of 90Y microsphere drugs in China.

     

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