Clinical Trials Branch, Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD 20892-1204, USA.
Retina. 2010 Mar;30(3):459-67. doi: 10.1097/IAE.0b013e3181bcf1a0.
Inflammation may play an important role in the pathogenesis of diabetic macular edema, a major cause of vision loss in persons with diabetes. The purpose of this study was to evaluate combined antiinflammatory therapy and laser approaches for treating patients with diabetic macular edema.
In this prospective, factorial, randomized, multicenter trial, we compared cyclo-oxygenase-2 inhibitor (celecoxib) with placebo and diode grid laser with standard Early Treatment Diabetic Retinopathy Study focal laser treatment in 86 participants with diabetic macular edema. The primary outcome is change in visual acuity of > or = 15 letters from baseline, and the secondary outcomes include a 50% reduction in the retinal thickening of diabetic macular edema measured by optical coherence tomography and a 50% reduction in leakage severity on fluorescein angiography.
Visual acuity and retinal thickening data from >2 years of follow-up did not show evidence of differences between the medical and laser treatments. However, participants assigned to the celecoxib group were more likely to have a reduction in fluorescein leakage when compared with the placebo group (odds ratio = 3.6; P < 0.01).
This short-term study did not find large visual function benefits of treatment with celecoxib or diode laser compared with those of standard laser treatment. A suggestive effect of celecoxib in reducing fluorescein leakage was observed.
炎症可能在糖尿病性黄斑水肿的发病机制中起重要作用，这是糖尿病患者视力丧失的主要原因。本研究旨在评估联合抗炎治疗和激光方法治疗糖尿病性黄斑水肿患者的疗效。
在这项前瞻性、析因、随机、多中心试验中，我们比较了环氧化酶-2 抑制剂（塞来昔布）与安慰剂以及二极管格栅激光与标准早期糖尿病视网膜病变研究的点状激光治疗在 86 例糖尿病性黄斑水肿患者中的疗效。主要结局是从基线开始视力提高 > 或 = 15 个字母，次要结局包括光学相干断层扫描测量的糖尿病性黄斑水肿视网膜增厚减少 50%，荧光素血管造影显示渗漏严重程度减少 50%。
超过 2 年的随访视力和视网膜增厚数据均未显示药物和激光治疗之间存在差异。然而，与安慰剂组相比，接受塞来昔布治疗的患者更有可能减少荧光素渗漏（比值比=3.6；P < 0.01）。
这项短期研究未发现塞来昔布或二极管激光治疗与标准激光治疗相比在改善视力功能方面有显著益处。观察到塞来昔布在减少荧光素渗漏方面有一定效果。
