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从设计到临床:心血管纳米医学转化的实用指南。

From design to the clinic: practical guidelines for translating cardiovascular nanomedicine.

机构信息

Cardiovascular Nanomedicine Unit, Section of Experimental Oncology und Nanomedicine (SEON), ENT-Department, University Hospital Erlangen, Glückstr. 10a, Erlangen, Germany.

INSERM U1148, LVTS, Paris Diderot University, Paris 13 University, X. Bichat Hospital, 46 rue H. Huchard, Paris, France.

出版信息

Cardiovasc Res. 2018 Nov 1;114(13):1714-1727. doi: 10.1093/cvr/cvy219.

Abstract

Cardiovascular diseases (CVD) account for nearly half of all deaths in Europe and almost 30% of global deaths. Despite the improved clinical management, cardiovascular mortality is predicted to rise in the next decades due to the increasing impact of aging, obesity, and diabetes. The goal of emerging cardiovascular nanomedicine is to reduce the burden of CVD using nanoscale medical products and devices. However, the development of novel multicomponent nano-sized products poses multiple technical, ethical, and regulatory challenges, which often obstruct their road to successful approval and use in clinical practice. This review discusses the rational design of nanoparticles, including safety considerations and regulatory issues, and highlights the steps needed to achieve efficient clinical translation of promising nanomedicinal products for cardiovascular applications.

摘要

心血管疾病(CVD)在欧洲造成近半数的死亡人数,且占了全球死亡人数的近 30%。尽管临床管理有所改善,但由于老龄化、肥胖和糖尿病的影响日益增加,预计未来几十年心血管死亡率将会上升。新兴的心血管纳米医学的目标是使用纳米级医疗产品和设备来减轻 CVD 的负担。然而,新型多组分纳米级产品的开发带来了多项技术、伦理和监管方面的挑战,这些挑战往往阻碍了它们成功获得批准并在临床实践中使用。这篇综述讨论了纳米颗粒的合理设计,包括安全性考虑和监管问题,并强调了实现有前途的心血管应用纳米药物产品进行有效临床转化所需的步骤。

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