Nguyen Quan Dong, Tatlipinar Sinan, Shah Syed Mahmood, Haller Julia A, Quinlan Edward, Sung Jennifer, Zimmer-Galler Ingrid, Do Diana V, Campochiaro Peter A
The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9277, USA.
Am J Ophthalmol. 2006 Dec;142(6):961-9. doi: 10.1016/j.ajo.2006.06.068. Epub 2006 Aug 2.
The role of vascular endothelial growth factor (VEGF) in diabetic macular edema (DME) was tested with ranibizumab, a specific antagonist of VEGF.
A nonrandomized clinical trial.
Ten patients with chronic DME received intraocular injections of 0.5 mg of ranibizumab at baseline and at one, two, four, and six months. The primary outcome was change in foveal thickness between baseline and seven months, and the secondary outcome measures were changes from baseline in visual acuity and macular volume.
Mean values at baseline were 503 microm for foveal thickness, 9.22 mm3 for macular volume, and 28.1 letters (20/80) read on an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. At seven months (one month after the fifth injection), the mean foveal thickness was 257 microm, which was a reduction of 246 microm (85% of the excess foveal thickness present at baseline; P = .005 by Wilcoxon signed-rank test for likelihood that this change is due to ranibizumab rather than chance). The macular volume was 7.47 mm3, which was a reduction of 1.75 mm3 (77% of the excess macular volume at baseline; P = .009). Mean visual acuity was 40.4 letters (20/40), which was an improvement of 12.3 letters (P = .005). The injections were well-tolerated with no ocular or systemic adverse events.
Intraocular injections of ranibizumab significantly reduced foveal thickness and improved visual acuity in 10 patients with DME, which demonstrated that VEGF is an important therapeutic target for DME. A randomized, controlled, double-masked trial is needed to test whether intraocular injections of ranibizumab provide long-term benefit to patients with DME.
使用血管内皮生长因子（VEGF）的特异性拮抗剂雷珠单抗来检验VEGF在糖尿病性黄斑水肿（DME）中的作用。
一项非随机临床试验。
10例慢性DME患者在基线时以及第1、2、4和6个月接受了0.5毫克雷珠单抗的眼内注射。主要结局是基线至7个月时黄斑中心凹厚度的变化，次要结局指标是视力和黄斑体积相对于基线的变化。
基线时黄斑中心凹厚度的平均值为503微米，黄斑体积为9.22立方毫米，在早期糖尿病性视网膜病变研究（ETDRS）视力表上读出的视力为28.1个字母（20/80）。在7个月时（第5次注射后1个月），黄斑中心凹平均厚度为257微米，减少了246微米（占基线时黄斑中心凹增厚部分的85%；通过Wilcoxon符号秩检验，此变化归因于雷珠单抗而非偶然因素的可能性P = 0.005）。黄斑体积为7.47立方毫米，减少了1.75立方毫米（占基线时黄斑体积增加部分的77%；P = 0.009）。平均视力为40.4个字母（20/40），提高了12.3个字母（P = 0.005）。注射耐受性良好，未出现眼部或全身不良事件。
眼内注射雷珠单抗可使10例DME患者的黄斑中心凹厚度显著降低，视力提高，这表明VEGF是DME的重要治疗靶点。需要进行一项随机、对照、双盲试验来检验眼内注射雷珠单抗是否能为DME患者带来长期益处。
