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地塞米松药物输送系统:适应证和证据。

The dexamethasone drug delivery system: indications and evidence.

机构信息

Retina Service, Wills Eye Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA.

出版信息

Adv Ther. 2011 May;28(5):351-66. doi: 10.1007/s12325-011-0019-z. Epub 2011 Mar 12.

Abstract

INTRODUCTION

The Ozurdex(®) (Allergan Inc., Irvine, CA, USA) dexamethasone drug delivery system (DDS) was recently developed as a biodegradable intravitreal implant to provide sustained delivery of 700 μg of preservativefree dexamethasone to the retina and vitreous, and is approved by the United States Food and Drug Administration (FDA) for the treatment of macular edema associated with retinal vein occlusion, as well as for noninfectious posterior uveitis. This review summarizes the rationale behind the development of the dexamethasone DDS, evidence for its use in various clinical scenarios, and compares its efficacy to other available treatment options.

METHODS

Published data regarding the dexamethasone DDS as well as unpublished data that has been presented at national meetings were reviewed.

RESULTS

The dexamethasone DDS has evidence for efficacy in multiple clinical situations, including macular edema associated with retinal vein occlusion (RVO), macular edema associated with uveitis or Irvine-Gass syndrome, diabetic macular edema in vitrectomized eyes, persistent macular edema, noninfectious vitritis, and as adjunctive therapy for age-related macular degeneration. Safety concerns include cataract formation and intraocular pressure elevation that is most often temporary and amenable to medical management.

CONCLUSIONS

The dexamethasone DDS is one of the most recent additions to the armamentarium against macular edema, and is intriguing for its potency, dose consistency, potential for extended duration of action, and favorable safety profile. Early evidence shows clinical utility for several conditions, the most well established being for macular edema associated with RVO. Future studies and, in particular, head-to-head comparisons with other treatment modalities will elucidate the precise role for the dexamethasone DDS in clinical practice.

摘要

简介

Ozurdex(®)(艾尔建公司,欧文,加利福尼亚州,美国)地塞米松药物输送系统(DDS)最近被开发为一种可生物降解的眼内植入物,以向视网膜和玻璃体提供 700μg 无防腐剂地塞米松的持续输送,并且已获得美国食品和药物管理局(FDA)的批准,用于治疗与视网膜静脉阻塞相关的黄斑水肿,以及非感染性后葡萄膜炎。本综述总结了地塞米松 DDS 开发背后的原理,其在各种临床情况下使用的证据,并将其疗效与其他可用的治疗选择进行了比较。

方法

审查了关于地塞米松 DDS 的已发表数据以及在全国会议上提出的未发表数据。

结果

地塞米松 DDS 在多种临床情况下具有疗效证据,包括与视网膜静脉阻塞(RVO)相关的黄斑水肿、与葡萄膜炎或 Irvine-Gass 综合征相关的黄斑水肿、玻璃体切割术后糖尿病性黄斑水肿、持续性黄斑水肿、非感染性眼内炎和年龄相关性黄斑变性的辅助治疗。安全问题包括白内障形成和眼内压升高,这通常是暂时的,且易于进行医学管理。

结论

地塞米松 DDS 是对抗黄斑水肿的最新武器之一,其效力、剂量一致性、潜在的延长作用时间和良好的安全性特征令人着迷。早期证据表明,它对几种疾病具有临床效用,最确定的是与 RVO 相关的黄斑水肿。未来的研究,特别是与其他治疗方式的头对头比较,将阐明地塞米松 DDS 在临床实践中的确切作用。

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