Javanović Sandra, Canadanović Vladimir, Sabo Ana, Grgić Zorka, Mitrović Milena, Rakić Dušan
Vojnosanit Pregl. 2015 Oct;72(10):876-82. doi: 10.2298/vsp140402074j.
BACKGROUND/AIM: Within diabetic retinopathy (DR), diabetic macular edema DIE) is one of the leading causes of the loss of visual acuity. The aim of this study was to determine the efficacy of the intravitreal vascular endothelial growth factor (VEGF) inhibitor application alone or combined with macular focal/grid lasephotocoagulation compared with laser treatment alone.
This prospective randomized clinical trial included 72 patients (120 treated eyes) with varying degrees of DR and DME. The DME treatment included intravitreal VEGF inhibitor bevacizumab (Avasting) application, with and without laser treatment. Bevacizumab (1.25 mg/0.05 mL) was administered intravitreally in 4-6-week intervals. Laser is applied 4-6 weeks after last dose of the drug as a part of combined treatment, or as the primary treatment.
The mean reduction in central macular thickness (CMT) for the eyes (n = 31) treated with bevacizumab alone was 162.23 .rm, for the eyes (n = 53) treated with combined treatment the mean reduction in CMT was 124.24 pm, both statistically significant at p < 0.001. Laser macular photocolagulation as a part of combined treatment (in 53 eyes) significantly contributed to the CMT reduction, based on the paired t-test results (366.28 vs. 323.0 pLm at p < 0.05). In our study, the mean visual acuity improvement of 0.161 logMAR was achieved in the group of eyes treated with bevacizumab alone, and 0.093 logMAR in the group with combined treatment, both statistically significant atp < 0.05. The effect of laser photocolagulation alone on visual acuity and'CMT was not statistically significant.
Treatment with bevacizumab alone or within combined treatment is more effective in treating DME than conventional macular laser treatment alone, both anatomically and functionally.
背景/目的:在糖尿病视网膜病变(DR)中,糖尿病性黄斑水肿(DME)是导致视力丧失的主要原因之一。本研究的目的是确定玻璃体内注射血管内皮生长因子(VEGF)抑制剂单独应用或联合黄斑局部/格栅激光光凝与单纯激光治疗相比的疗效。
这项前瞻性随机临床试验纳入了72例(120只治疗眼)不同程度DR和DME的患者。DME治疗包括玻璃体内注射VEGF抑制剂贝伐单抗(阿瓦斯汀),有或没有激光治疗。贝伐单抗(1.25mg/0.05mL)每4至6周玻璃体内注射一次。作为联合治疗的一部分,在最后一剂药物注射后4至6周进行激光治疗,或作为主要治疗方法。
单独使用贝伐单抗治疗的眼(n = 31)中心黄斑厚度(CMT)平均降低162.23μm,联合治疗的眼(n = 53)CMT平均降低124.24μm,两者在p < 0.001时均具有统计学意义。根据配对t检验结果,作为联合治疗一部分的激光黄斑光凝(53只眼)对CMT降低有显著贡献(p < 0.05时,分别为366.28μm和323.0μm)。在我们的研究中,单独使用贝伐单抗治疗的眼组平均视力提高0.161 logMAR,联合治疗组为0.093 logMAR,两者在p < 0.05时均具有统计学意义。单纯激光光凝对视力和CMT的影响无统计学意义。
单独使用贝伐单抗治疗或联合治疗在治疗DME方面在解剖学和功能上均比传统的黄斑激光治疗更有效。