阿柏西普T&E方案与雷珠单抗3+prn方案治疗初发DME的回顾性对照研究

A comparative study of aflibercept T&E regimen and ranibizumab 3+PRN regimen in the treatment of primarydiabetic macular edema:a retrospective case study

目的:回顾性对照研究阿柏西普T&E方案与雷珠单抗3+prn方案治疗初发糖尿病黄斑水肿(DME)的有效性、安全性和治疗成本。方法:采用回顾性方法对比初发DME患者61只眼。31只接受阿柏西普T&E方案,30只接受雷珠单抗3+prn方案。评估基线、3个月、6个月、12个月的最佳矫正视力(BCVA)、黄斑中心厚度(CMT)、不良反应。对比2组随访期末的注射次数和治疗成本。结果:在12个月随访期末,2组平均BCVA均提高(P<0.01),组间相比无统计学差异(P=0.498);2组CMT均改善(P<0.01),组间相比无统计学差异(P=0.140)。阿柏西普T&E方案组注射次数(7.3±1.5)低于雷珠单抗3+prn方案组(8.2±1.7),差异有统计学意义(P=0.02)。阿柏西普T&E方案组治疗成本低于雷珠单抗3+prn方案组。结论:在真实世界中,阿柏西普T&E方案与雷珠单抗3+prn方案治疗初发DME均有效安全,但阿柏西普T&E方案需要的注射次数更少,治疗成本更低。

OBJECTIVE To compare the clinical efficacy,safety and treatment expenditure of aflibercept using treat-and-extend regimen versus ranibizumab followed by 3+prn regimen for the treatment of diabetic macular edema(DME).METHODS In this retrospective study,there were 61 naive DME patients receiving either intravitreal aflibercept using treat-and-extend regimen(n=31)or ranibizumab followed by 3+prn regimen(n=30).Demographic features,best-corrected visual acuity(BCVA),central macular thickness(CMT)and adverse reactions were evaluated at baseline and at Month 3/6/12 post-treatment.At Month 12,number of injections and treatment expenditure were compared between two groups.RESULTS At Month 12,final BCVA showed statistically significant improvement in both groups(P<0.01).However,there was no statistically significant inter-group difference(P=0.498).Significant reduction in CMT occurred in both groups(P<0.01).Yet there was no inter-group statistical difference(P=0.140).The number of injections was significantly lower in group A than that in group B(7.3±1.5 vs 8.2±1.7,P=0.02).In neither groups,no complications occurred.Treatment expenditure was lower in group A.CONCLUSION In a real world,both aflibercept using treat-and-extend regimen and ranibizumab followed by 3+prn regimen are both safe and effective for DME.However,aflibercept using treat-and-extend regimen decreases the frequency of injections and lowers the treatment expenditure.