玻璃体内注射贝伐单抗和贝伐单抗/曲安奈德联合用药治疗糖尿病性黄斑水肿疗效及安全性差异的荟萃分析

Efficacy and safety of intravitreal bevacizumab alone and intravitreal bevacizumab combined with triamcinolone acetonide in treatment of diabetic macular edema:a meta-analysis

目的综合评价玻璃体内注射贝伐单抗(IVB)和贝伐单抗/曲安奈德联合用药(IVB/IVT)两种方案治疗糖尿病性黄斑水肿的疗效与安全性的差异。方法检索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)有关贝伐单抗和贝伐单抗/曲安奈德联合用药对比治疗糖尿病性黄斑水肿的临床对照研究文献资料。采用Cochrane系统评价的方法 ,按照纳入和排除标准限定,通过Jadad评分量表进行文献质量评估后,使用RevMan5.1统计软件进行Meta分析,以获得二者治疗糖尿病性黄斑水肿的疗效及安全性是否有差异的相关证据。结果本研究纳入IVB和IVB/IVT对比治疗糖尿病性黄斑水肿的临床对照研究共4篇(321眼)。Meta分析结果显示,IVB组与IVB/IVT组患者的中央黄斑厚度降低幅度的差异为-28.72μm(95%CI,-90.68～33.25μm),差异无统计学意义(P=0.36);最佳矫正视力(以LogMAR视力计算)提高幅度的差异为-0.03(95%CI,-0.14～0.09),差异也无统计学意义(P=0.65)。IVB/IVT治疗组发生不良反应的比例是单纯IVB治疗组的2.44倍(95%CI,1.28～4.55倍),差异有显著统计学意义(P=0.006)。结论两种方案治疗糖尿病性黄斑水肿时,在降低中央黄斑厚度和提高最佳矫正视力方面疗效相仿;而单纯IVB治疗的安全性优于IVB/IVT联合治疗,但尚需更多前瞻性大样本的临床随机对照试验数据支持。

Objective To evaluate the efficacy and safety of intravitreal bevaci- zumab （1VB） alone and intravitreal bevacizumab combined with intravitreal triamcin- olone acetonide （IVB/IVT） in treatment of diabetic macular edema （DME）. Methods A meta-analysis. According to evaluation guidelines of Cochrane collaboration, clinical controlled trials were searched using Medline （from 1966 to 2011 ） ,EMbase （from 1966 to 2010） ,Cochrane Library （2010） and CBM （from 1979 to 2010）. Methodology quali- ties of literatures were performed by experienced researchers according to the Jadad Score. RevMan 5.1 offered by Cochrane was used to do the meta-analysis. Results Only 4 literatures came into meta-analysis （321 eyes）. The result of analysis showed that the difference of reduced central macular thickness between IVB group and IVB/ IVT group was -28.72 μm （95% CI,from -90.58 μm to 33.25 μm） ,there was no sig- nificant difference （P-0.35） ;Difference of improved best corrected visual acuity （Log- MAR） between IVB group and IVB/IVT group was - 0.03 （95% CI, from - 0. 14 to 0. 09 ）, there was no significant difference （ P = 0.65 ）. Adverse event rates in IVB/IVT group was 2.44 times （95% CI, from 1.28 times to 4.55 times） more than IVB group, there was significant difference （P = 0. 006）. Conclusion Meta-analysis shows that IVB/IVT group has the equal reduced central macular thickness and visual acuity com- pared with IVB group in treatment of DME, while the adverse event rates are much morethan IVB group. However, more high quality perspective studies should be still required for further analysis.