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钇-90 放射性标记树脂微球和玻璃微球的研发、商业化及临床应用背景

The development, commercialization, and clinical context of yttrium-90 radiolabeled resin and glass microspheres.

作者信息

Westcott Mark A, Coldwell Douglas M, Liu David M, Zikria Joseph F

机构信息

Department of Radiology, Lenox Hill Hospital, New York, New York.

Department of Radiology, University of Louisville, Louisville, Kentucky.

出版信息

Adv Radiat Oncol. 2016 Aug 18;1(4):351-364. doi: 10.1016/j.adro.2016.08.003. eCollection 2016 Oct-Dec.

Abstract

Selective internal radiation therapy has emerged as a well-accepted therapeutic for primary and metastatic hepatic malignancies. This therapeutic modality requires the combined efforts of multiple medical disciplines to ensure the safe delivery of yttrium-90 (Y)-labeled microspheres. The development of this therapy followed decades of clinical research involving tumor vascularity and microsphere development. Today, it is essential that treating physicians have a thorough understanding of hepatic tumor vascularity and Y microsphere characteristics before undertaking this complex intervention. This review explores the contributions of early investigators of this therapy, as well as the development, US Food and Drug Administration approval, manufacturing process, and attributes of the 2 commercially available Y radiolabeled microsphere device to clarify the key physical differences between the products.

摘要

选择性体内放射疗法已成为一种被广泛接受的原发性和转移性肝脏恶性肿瘤的治疗方法。这种治疗方式需要多个医学学科的共同努力,以确保钇-90(Y)标记微球的安全输送。这种疗法的发展历经了数十年涉及肿瘤血管和微球开发的临床研究。如今,治疗医生在进行这种复杂干预之前,必须对肝脏肿瘤血管和Y微球特征有透彻的了解。本综述探讨了该疗法早期研究者的贡献,以及两种市售Y放射性标记微球装置的开发、美国食品药品监督管理局批准、制造工艺和特性,以阐明产品之间的关键物理差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c31/5514171/21b5a1bdbe0d/gr1.jpg

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