Department of Ophthalmology, Miguel Servet University Hospital, Aragon Health Science Institute, IIS Aragon, Isabel la Católica 1-3, 50009, Zaragoza, Spain,
Drugs. 2015 Sep;75(13):1461-9. doi: 10.1007/s40265-015-0447-1.
Diabetes mellitus (DM) is a chronic disease that affects 387 million people worldwide. Diabetic retinopathy (DR), a common complication of DM, is the main cause of blindness in the active population. Diabetic macular edema (DME) may occur at any stage of DR, and is characterized by vascular hyperpermeability accompanied by hard exudates within the macula. Medical and surgical therapies have dramatically reduced the progression of DR, and timely intervention can reduce the risk of severe vision loss by more than 90 %. In 2012, intravitreal ranibizumab became the first antivascular endothelial growth factor (anti-VEGF) agent approved for DME and, since then, many reports of the use of ranibizumab for DME have been promising. Randomized, prospective, multicenter clinical trials-most notably, RESOLVE, READ-2, RISE/RIDE, RESTORE, DRCR.net protocol I, and RETAIN-reported improvements in best-corrected visual acuity and decreased central retinal thickness as measured with optical coherence tomography in patients with DME. Similar treatment benefits have also been noted in clinical trials evaluating intravitreal aflibercept and bevacizumab (DAVINCI, VISTA/VIVID, and BOLT) and more recently DRCR.net protocol T. Intravitreal steroids (dexamethasone intravitreal implant and fluocinolone acetonide), particularly in refractory cases, also play a significant role in the management of DME (MEAD/CHAMPLAIN and FAMOUS/FAME studies). In summary, over the last 5 years, blocking VEGF and inflammation has been shown to improve visual outcomes in patients with macular edema due to DM, revolutionizing the treatment of center-involved DME and establishing a new standard of care.
糖尿病(DM)是一种全球性疾病,影响全球 3.87 亿人。糖尿病视网膜病变(DR)是 DM 的常见并发症,是活跃人群失明的主要原因。糖尿病黄斑水肿(DME)可能发生在 DR 的任何阶段,其特征是血管通透性增加,黄斑内伴有硬性渗出物。医学和手术治疗极大地降低了 DR 的进展速度,及时干预可将严重视力丧失的风险降低 90%以上。2012 年,玻璃体内雷珠单抗成为首个获批用于 DME 的抗血管内皮生长因子(anti-VEGF)药物,此后,许多关于雷珠单抗治疗 DME 的报告都很有前景。随机、前瞻性、多中心临床试验——尤其是 RESOLVE、READ-2、RISE/RIDE、RESTORE、DRCR.net 方案 I 和 RETAIN——报道称 DME 患者的最佳矫正视力和中心视网膜厚度(通过光学相干断层扫描测量)有所改善。在评估玻璃体内阿柏西普和贝伐单抗(DAVINCI、VISTA/VIVID 和 BOLT)的临床试验中也观察到了类似的治疗益处,最近 DRCR.net 方案 T 也观察到了类似的治疗益处。玻璃体内皮质类固醇(地塞米松玻璃体内植入物和氟轻松醋酸酯),特别是在难治性病例中,在 DME 的管理中也发挥着重要作用(MEAD/CHAMPLAIN 和 FAMOUS/FAME 研究)。总之,在过去 5 年中,阻断 VEGF 和炎症已被证明可改善糖尿病性黄斑水肿患者的视力结果,彻底改变了中心性 DME 的治疗方法,并确立了新的治疗标准。