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用于糖尿病视网膜病变的氟轻松醋酸酯植入装置。

Fluocinolone acetonide implantable device for diabetic retinopathy.

机构信息

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, FL, USA.

出版信息

Curr Pharm Biotechnol. 2011 Mar 1;12(3):347-51. doi: 10.2174/138920111794480651.

DOI:10.2174/138920111794480651
PMID:20939799
Abstract

Diabetic retinopathy remains a major worldwide cause of preventable visual loss. Although photocoagulation and improved metabolic control are effective for patients with diabetic macular edema and proliferative diabetic retinopathy, some patients continue to lose vision despite treatment. Various classes of pharmacotherapy have shown promise in the treatment of diabetic retinopathy, including corticosteroids, anti-vascular endothelial growth factor agents, and others. Off-label intravitreal corticosteroids are associated with short-term anatomic and visual improvement in some patients, but these patients may require repeated intravitreal injections with cumulative risks of cataract formation, intraocular pressure elevation, and endophthalmitis. Various sustained-release corticosteroid delivery systems have been investigated for this purpose. The first to become widely available is the fluocinolone acetonide intravitreal implant (Retisert, Bausch & Lomb, Rochester, NY), which received U.S. Food and Drug Administration approval to treat chronic, noninfectious posterior segment uveitis in 2005. This device also has been investigated as a treatment for diabetic macular edema. Multiple randomized clinical trials have demonstrated medium-term anatomic and visual improvement, but the device is associated with high risks of cataract formation and intraocular pressure elevation. At this time, the device is not widely used in the treatment of diabetic retinopathy. A smaller device, designed to be injected in a clinic setting (Iluvien, Alimera Sciences, Alpharetta, GA) is currently being investigated for the treatment of diabetic macular edema. Results from a phase 3 randomized controlled trial have recently reported medium-term efficacy and safety in the treatment of diabetic macular edema. Combination photocoagulation and pharmacotherapy with these devices has not yet been reported.

摘要

糖尿病性视网膜病变仍然是全球范围内导致可预防视力丧失的主要原因。虽然光凝术和改善代谢控制对糖尿病性黄斑水肿和增生性糖尿病性视网膜病变患者有效,但一些患者尽管接受了治疗仍继续丧失视力。各种类别的药物治疗在治疗糖尿病性视网膜病变方面显示出了希望,包括皮质类固醇、抗血管内皮生长因子药物等。未经批准的玻璃体内皮质类固醇在一些患者中与短期解剖和视觉改善相关,但这些患者可能需要反复玻璃体内注射,累积发生白内障、眼压升高和眼内炎的风险。为此目的,已经研究了各种缓释皮质类固醇递送系统。第一个广泛应用的是氟轻松醋酸酯玻璃体植入物(Retisert,Bausch & Lomb,罗彻斯特,NY),该植入物于 2005 年获得美国食品和药物管理局批准用于治疗慢性、非传染性后节葡萄膜炎。该装置也被研究用于治疗糖尿病性黄斑水肿。多项随机临床试验表明中期解剖和视觉改善,但该装置与白内障形成和眼压升高的高风险相关。目前,该装置在糖尿病性视网膜病变的治疗中并未广泛应用。一种较小的装置,设计用于在诊所环境中注射(Iluvien,Alimera Sciences,阿尔法利塔,GA),目前正在研究用于治疗糖尿病性黄斑水肿。最近报告了一项 3 期随机对照试验的中期疗效和安全性结果。这些装置联合光凝术和药物治疗尚未报道。

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