摘要背景 视网膜中央静脉阻塞(CRVO)可导致黄斑水肿,影响视力,且治疗方法有限,近年虽有随机对照临床试验(RCTs)研究抗血管内皮生长因子(VEGF)对CRVO的疗效,但还缺乏循证评价. 目的 对VEGF玻璃体腔内注射治疗CRVO并发黄斑水肿进行循证医学评价. 方法 采用Meta分析的方法和Cochrane系统评价方法,检索有关抗VEGF玻璃体腔内注射治疗CRVO合并黄斑水肿的RCTs文献进行二次分析,检索文献范围包括Cochrane Library、Pubmed、Embase、万方数据库、会议记录等,文献不限定发表语言及时间,由2位作者独立决定入选文献,对纳入文献进行质量评价,分析指标为治疗前后最佳矫正视力(BCVA)提高≥15个字母的人数比例、BCVA LogMAR提高值及光学相干断层扫描(OCT)测得的视网膜中心凹厚度(CFT)变化值.使用Cochrane协作网Review Manager 5.1软件对连续变量进行合并效应量的检测,6篇文献间经I2检验无显著异质性,故采用固定效应模型对治疗后不同时间抗VEGF治疗组与假治疗组间的BCVA、BCVA LogMAR视力和CFT进行分析. 结果 共纳入RCTs文献6篇,总样本量为948眼,纳入的文献中包括5个多中心研究和1个单中心研究.其中1篇文献用哌加他尼钠(pegaptanib)作为治疗组,2篇文献用雷珠单抗(ranibizumab)作为治疗组,1篇文献采用贝伐单抗(bevacizumab)作为治疗组,2篇文献采用VEGF TrapEye作为治疗组.1年随访时间中抗VEGF药物治疗组BCVA提高≥15个字母的人数比例明显高于假治疗组,6个月时差值最明显(Z=8.43,P＜0.000 01);6个月随访时间中BCVA LogMAR提高均大于假治疗组,第6个月时差值最大(Z=28.27,P＜O.000 01).6个月随访时间中抗VEGF治疗组患眼CFT下降值明显大于假治疗组,其中第3个月时差值最明显(Z=35.38,P＜0.000 01).抗VEGF治疗组玻璃体腔内注射后偶发眼部并发症,主要为玻璃体出血19眼、白内障16眼、眼内炎8眼、虹膜新生血管2眼等,而用药后全身不良事件罕见. 结论 抗VEGF药物治疗CRVO并发黄斑水肿效果明显,不良反应较少,但疗效维持时间较短.发病早期及时注射抗VEGF药物对患者更有益,但晚期注射仍能取得一定疗效.

abstractsBackground Central retinal vein occlusion (CRVO) causes macular edema.The treatment options are limited.There have been a series of randomized controlled trials (RCTs) to investigate the effectiveness of anti-vascular endothelial growth factor (VEGF),but the systematic review of the literature to assess the strength of evidence supporting the interventions is lack.Objective This study was to evaluate the effectiveness of anti-VEGF therapy for improving vision and reducing macular edema in patients with CRVO associated with macular edema.Methods A systematic review and Meta-analysis was performed.According to guidelines of Cochrane collaboration,the literature of RCTs for anti-VEGF therapy treating CRVO with macular edema was searched from Cochrane Library,Pubmed,Embase,Wanfang databases and conference documents without the limiting of language or date.The literature was screened independently by two searchers,and the methodology quality of the included papers was estimated.The proportion of patients with the best corrected visual acuity (BCVA) ≥ 15 ETDRS letters,the change ranges of BCVA (LogMAR) and central fovea thickness (CFT) were analyzed.The overall effect size was analyzed using Review Manager 5.1 in The Cochrane Collaboration as weighted mean difference (WSD).Fixed effect mode was used to evaluate and compare the treating effectiveness between the anti-VEGF group and sham treating group.Results Six RCTs were incorporated with 948 eyes and generated 3 comparisons in the study,including 5 multi-central studies and 1 single central study.Pegaptanib was administered in 1 study,and ranibizumab was used in 2 studied,bevacizumab in 1 study and VEGF Trap-Eye in 2 studies.The results demonstrated that anti-VEGF therapy resulted in more patients who gained 15 ETDRS letters or more during one-year duration (Z =8.43,P＜0.000 01) in the 6th month after intravitreous injection.BCVA logMAR was significantly improved in the anti-VEGF therapy group in comparison with sham treating group during the initial 6 months of trial (Z=28.27,P＜0.000 01) with the maximal difference in the 6th month.CFT value was significantly lower in the anti-VEGF therapy group than that of the sham treating group during the first 6 months (Z=35.38,P＜0.000 01) in the 3rd month.Topical adverse events occurred occasionally,including vitreous hemorrhage in 19 eyes,cataract in 16 eyes,endophthalmitis in 8 eyes and iris neovascularization in 2 eyes.No system adverse event was found after administration of the drugs.Conclusions Anti-VEGF therapy is efficient in CRVO with macular edema with little side effect.However,in order to maintain the effect,multiple injections are needed.Early onset treatment of anti-VEGF drugs is recommended,but the delayed onset is still beneficial.