眼科新进展2025，Vol.45Issue(5)：393-397,5.DOI:10.13389/j.cnki.rao.2025.0069
阿柏西普生物类似药与阿柏西普原研药对湿性年龄相关性黄斑变性的疗效对比
Comparison of therapeutic effects of aflibercept biosimilar and originator aflibercept on age-related wet macular degeneration
摘要
Abstract
Objective To observe and compare the therapeutic effects of aflibercept biosimilar and originator afliber-cept through intravitreal injection in patients with age-related wet macular degeneration(AMD).Methods This retro-spective study enrolled 60 AMD patients(60 eyes)who were diagnosed and treated at the Department of Ophthalmology,Zibo Central Hospital,from January 2024 to May 2024.These patients were divided into two groups.Specifically,30 pa-tients(30 eyes)(the originator group)received the intravitreal injection of originator aflibercept,while another 30 patients(30 eyes)(the biosimilar group)received the intravitreal injection of aflibercept biosimilar.All patients followed a 3+PRN treatment regimen with a follow-up period of at least 6 months.Relevant examinations including best-corrected visual acui-ty(BCVA),optical coherence tomography,corneal endothelial microscopy,and multifocal electroretinogram(mfERG)were performed before and after treatment.Moreover,the BCVA,central retinal thickness(CRT),pigment epithelial de-tachment(PED)height,corneal endothelial cell density,hexagonal cell ratio,coefficient of variation(CV)of corneal en-dothelial cells,P1 wave amplitude density of the first ring,number of intravitreal injections,and incidence of complications were compared between both groups.Results No statistically significant differences were observed in the age,sex ratio,or disease duration between both groups(all P＞0.05).After treatment,the BCVA,CRT,and PED height of patients in both groups decreased,and the P1 wave amplitude density of the first ring increased in both groups,with statistically sig-nificant differences compared with baseline values(all P＜0.05).In the originator group,the corneal endothelial cell den-sity,hexagonal cell ratio,and CV of corneal endothelial cells of patients in both groups increased after treatment,while the biosimilar group showed a decrease in the corneal endothelial cell density and hexagonal cell ratio,alongside an increase in the CV of corneal endothelial cells;however,these changes were not statistically significant compared with baseline values(all P＞0.05).No significant difference was observed in the number of intravitreal injections between both groups(P＞0.05).The correlation analysis results revealed positive associations between disease duration and post-treatment BCVA(logMAR)in both groups(r=0.901 and 0.905,respectively;both P＜0.000 1).No severe ocular complications or cardio-vascular/cerebrovascular events occurred in all patients.Conclusion There is no significant difference in the short-term efficacy between originator aflibercept and aflibercept biosimilar in the treatment of patients with wet AMD.关键词
阿柏西普原研药/阿柏西普生物类似药/年龄相关性黄斑变性/多焦视网膜电图/角膜内皮细胞Key words
originator aflibercept/aflibercept biosimilar/age-related macular degeneration/multifocal electroretino-gram/corneal endothelial cell分类
医药卫生引用本文复制引用
翟改霞,李天贺,宋文琦,王少鹏..阿柏西普生物类似药与阿柏西普原研药对湿性年龄相关性黄斑变性的疗效对比[J].眼科新进展,2025,45(5):393-397,5.基金项目
山东省医药卫生科技项目(编号:202407020840) （编号:202407020840）
