栓塞微球的临床应用和临床评价相关思考  

Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres

作　　者：刘菁 郭佳莹 LIU Jing;GUO Jiaying(Yangtze River Delta Center for Medical Device Evaluation and Inspection,NMPA,Shanghai,201210)

机构地区：[1]国家药品监督管理局医疗器械技术审评检查长三角分中心,上海市201210

出　　处：《中国医疗器械杂志》2024年第6期694-698,共5页Chinese Journal of Medical Instrumentation

摘　　要：栓塞微球可通过血管栓塞的方法使富血管型实质型器官恶性肿瘤发生缺血性坏死,也可作为外科手术辅助治疗的方法,通过术前肿瘤血管内栓塞减少围手术期出血。该研究总结了与栓塞微球临床应用有关的临床指南和共识,并介绍了美国食品药品管理局(Food and Drug Administration, FDA)发布的关于栓塞微球的指南文件。该研究还总结了作者对于栓塞微球临床评价的一些思考,以期为该类产品的临床评价和技术审评提供思路。Embolization microspheres can be used for the embolization of hypervascular malignant tumors of parenchymal organs.They can also be used as an adjuvant therapy for surgery to reduce perioperative bleeding through preoperative intravascular embolization of tumors.This study summarizes the clinical guidelines and consensus on embolization microspheres and introduces the guidance document for embolization microspheres issued by the Food and Drug Administration(FDA).Additionally,this study presents the authors'thoughts on clinical review of embolization microspheres,aiming to provide insights for the clinical evaluation and technical review of such products.

关 键 词：栓塞微球 临床应用 临床评价 

分 类 号：R318[医药卫生—生物医学工程] F203[医药卫生—基础医学]