玻璃体腔注射地塞米松植入物与抗血管内皮生长因子药物治疗视网膜静脉阻塞并发黄斑水肿比较的Meta分析

摘要

目的：比较玻璃体腔注射地塞米松植入物（ dexamethasone implant， DEX）与抗血管内皮生长因子（ anti－vas－cular epithelial growth factor， anti－VEGF）药物在治疗视网膜静脉阻塞（retinal vein occlusion， RVO）并发黄斑水肿（macu－lar edema， ME）时的有效性及安全性。方法以“retinal vein occlusion”、“macular edema”、“anti－VEGF”、“pegaptanib”、“Macugen”、“bevacizumab”、“Avastin”、“ranibizumab”、“Lucentis”、“aflibercept”、“Trap－eye”、“Ozurdex”、“dexametha－sone invitreal implant”、“clinical trial”为关键词，检索1948年1月至2015年6月外文生物医学数据库Cochrane图书馆、Pubmed、 EMBASE、 Ovid Medline及ClinicalTrials．gov关于两种药物对RVO并发ME比较治疗的临床试验。采用Cochrane或Newcastle－Ottawa scale评价方法评价所纳入研究的文献质量，并提取有效数据后用RevMan 5．3软件进行Meta分析。结果随访1个月时，玻璃体腔注射DEX与anti－VEGF治疗前后最佳矫正视力差值的差异无统计学意义[ MD＝0．04糖尿病视网膜病变早期治疗研究字母视力表（ Early Treatment Diabetic Retinopathy Study， ETDRS）字母，95％ CI：－2．07～2．15 ETDRS字母， P＝0．97]。但在随访3、4、6个月时， anti－VEGF药物能获得更好的治疗前后最佳矫正视力差值，两组间差异有统计学意义（ MD＝－6．98，－12．18，－11．84 ETDRS字母，95％ CI：－10．39～－3．58，－20．34～－4．03，－19．66～－4．02 ETDRS字母， P＜0．0001， P＝0．003， P＝0．003）。随访6个月时， anti－VEGF药物较DEX能更有效地降低中央视网膜厚度变化值（MD＝135．86μm，95％ CI：57．07～214．64μm， P＝0．0007）。 anti－VEGF组眼压升高的人数比例也较DEX组低（OR＝3．54，95％ CI：1．64～7．66， P＝0．001）。结论在治疗RVO引起的ME时， anti－VEGF药物较DEX可更有效改善最佳矫正视力、减少ME，同时对眼内压的影响较小，其有效性及安全性均优于DEX。%Objective To compare the efficacy and safety of intravitreal injections of dexamethasone im -plants (DEX) with anti-vascular endothelial growth factor (VEGF) in the treatment of macular edema (ME) secondary to retinal vein occlusion (RVO).Methods The databases of Cochrane Library , PubMed, EMBASE, Ovid Medline, and ClinicalTrial.gov between January 1948 and June 2015 were searched for studies comparing DEX with anti-VEGF for the treatment of ME caused by RVO with key words “retinal vein occlusion”,“macular ede-ma”,“anti-VEGF”, “pegaptanib”, “Macugen”, “bevacizumab”, “Avastin”, “ranibizumab”, “Lucentis”,“aflibercept”,“Trap-eye”,“Ozurdex”,“dexamethasone invitreal implant”, and “clinical trial”.We evaluated the quality of selected studies using Cochrane or Newcastle-Ottawa scale .Data were extracted and analyzed by Rev-Man 5.3 for Meta-analysis.Results The mean difference in the mean changes of best corrected visual acuity (BC-VA) in Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters comparing DEX with anti-VEGF was 0.04 [95%confidence interval (CI): -2.07~2.15;P=0.97] at 1 month, -6.98 (95%CI: -10.39~-3.58;P<0.0001) at 3 months, -12.18 (95%CI: -20.34~-4.03;P=0.003) at 4 months, and -11.84 (95%CI: -19.66~-4.02;P=0.003) at 6 months.A greater reduction of central retinal thickness at 6 months was observed in the anti-VEGF group than in the DEX group ( mean difference 135.86 μm; 95% CI: 57.07 ~214.64 μm;P=0.0007 ) .The incidence of intraocular pressure increase in the DEX group was significantly higher than that in the anti-VEGF group ( OR=3.54 , 95%CI:1.64~7.66 , P=0.001 ) .Conclusions Anti-VEGF showed better effect than DEX in improving BCVA , reducing ME , and less influence on intraocular pressure for ME secondary to RVO .Therefore , anti-VEGF may have higher efficacy and safety than DEX for this condition .