School of Pharmacy and Medical Sciences, University of South Australia (UniSA), Adelaide, SA 5000, Australia.
School of Pharmacy and Medical Sciences, University of South Australia (UniSA), Adelaide, SA 5000, Australia.
J Control Release. 2019 Aug 28;308:209-231. doi: 10.1016/j.jconrel.2019.07.001. Epub 2019 Jul 4.
Stents are currently the primary choice for the treatment of both vascular and non-vascular occlusions and/or stenosis. Despite the proven history of clinical safety and efficacy, the benefit of traditional vascular or non-vascular stenting is often limited by in-stent restenosis, resulting in failure of existing stent or reintervention by use of another stent. Coronary drug-eluting stents (DESs) significantly reduce restenosis of vascular stents and have revolutionised the percutaneous coronary intervention (PCI) treatment in coronary stenting patients. Following the similar concept of coronary DESs, non-vascular DESs are being investigated to reduce non-vascular restenosis caused by tumour growth, enhance stenting functions, and increase their effectiveness in the treatment of obstructive gastrointestinal (GI) cancers. This article summarises and updates the outcomes of preclinical and clinical studies on non-vascular DESs for localised management of malignant GI obstructions with emphasis on fabrication techniques and regulatory requirements relevant to development and marketing approval.
支架目前是治疗血管性和非血管性闭塞和/或狭窄的主要选择。尽管传统血管或非血管支架的临床安全性和疗效已得到证实,但支架内再狭窄常常限制了其获益,导致现有支架失效或需要使用另一个支架进行再次介入治疗。冠状动脉药物洗脱支架(DES)显著降低了血管支架的再狭窄率,彻底改变了经皮冠状动脉介入治疗(PCI)中冠状动脉支架置入患者的治疗方法。基于冠状动脉 DES 的相似理念,正在研究非血管性 DES,以减少因肿瘤生长引起的非血管性再狭窄,增强支架功能,并提高其在治疗阻塞性胃肠道(GI)癌症方面的疗效。本文总结和更新了非血管性 DES 用于局部治疗恶性 GI 梗阻的临床前和临床研究结果,重点介绍了与开发和营销批准相关的制造技术和监管要求。