首选玻璃体腔注射贝伐单抗与曲安奈德对比治疗糖尿病性黄斑水肿疗效及安全性差异的荟萃分析

Comparison of efficacy and complications in treatment of diabetic macular edema by intravitreal bevacizumab with intravitreal triamcinolone acetonide for first priority:a meta-analysis

目的综合评价玻璃体腔注射贝伐单抗(IVB)与曲安奈德(IVT)治疗糖尿病性黄斑水肿(DME)的疗效与安全性差异。设计荟萃分析。研究对象Medline(1966～2011年)、EMbase(1966～2010年)、Cochrane图书馆(2010年)及中国生物医学文献数据库CBM(1979～2010年)有关贝伐单抗与曲安奈德对比治疗DME的临床对照研究文献。方法采用Cochrane系统评价方法检索文献,按照纳入和排除标准限定研究对象,通过Jadad评分量表进行文献质量评估,使用Cochrane协作网提供的RevMan 5.1统计软件进行Meta分析,以获得二者治疗DME的疗效及安全性是否有差异的相关证据。主要指标中央黄斑厚度,最佳矫正视力,不良反应。结果共纳入IVB与IVT对比治疗DME的临床对照研究7项(共417眼)。首选IVB组与首选IVT组的患者中央黄斑厚度降低幅度的差异为-55.34μm(95%CI:-104.51～-6.17μm,P=0.03);提高最佳矫正视力幅度的差异为-0.06(95%CI:-0.13～0.00,P=0.06)。首选IVT组发生眼压升高的比例是首选IVB组的14.3倍(95%CI:4～50倍,P=0.000)。结论 IVT治疗DME在降低中央黄斑厚度方面优于IVB,在提高视力方面二者相似,但安全性方面较IVB差。二者谁更适合作为DME的首选治疗,尚需更多前瞻性大样本临床随机对照试验支持。

To evaluate the efficacy and safety in treatment of diabetic macular edema （DME） by intravitreal beva- cizumab （IVB） with intravitreal triamcinolone acetonide （[VT） for first priority. Design Meta analysis. Participants Published literature in Medline, EMbase, Cochrane library and CBM which comparing IVB with IVT in treatment of DME for first priority. Methods Ac cording to evaluation guidelines of Cochrane collaboration, clinical controlled trials （CCTs） were searched using Medfine, EMbase, the Cochrane Library and CBM. Methodology qualities of literatures were performed by experienced researchers according to the Jadad Score. RevMan 5.1 offered by Coehrane was used to do the rectaanalysis. Main Outcome Measures central macular thickness, best corrected visual acuity and adverse events. Results Only 7 literatures （417 eyes） were selected into metaanalysis. The result of analysis showed that IVT group had a more reduced central macular thickness with 55.34 μm （95%CI： -104.51-6.17 μm, P=0.03） than IVB group. However, no significant difference in visual acuity was observed between IVB and IVT group （1P=0.06）. Adverse event rates （mainly elevation of intraocular pressure） in IVT group was 14.3 times （95%CI： 4-50 times） more than IVB group （P=0.O00）. Conclusion Metaanalysis shows that IVT group had a more reduced central macular thickness and equal visual acuity compared with IVB group in treatment of DME, while the adverse event rates were much more than IVB group. More high quality perspective studies are still required for further analysis. （Ophthalmol CHN, 2012, 21： 60-64）