摘要
目的观察并比较玻璃体内注射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(AMD)的疗效差异。方法回顾性研究。纳入2024年1月至5月于淄博市中心医院眼科诊治的60例60眼AMD患者的临床资料,其中30例30眼玻璃体内注射阿柏西普原研药(原研药组),30例30眼玻璃体内注射阿柏西普生物类似药(类似药组),所有患者均采用3+PRN治疗方案,随访时间至少6个月。治疗前后均完善最佳矫正视力(BCVA)、光学相干断层扫描、角膜内皮镜检查、多焦视网膜电图(mfERG)检查。比较两组患者治疗前后BCVA、黄斑中心视网膜厚度(CRT)、色素上皮脱离(PED)高度、角膜内皮细胞密度、六角形细胞的比例、角膜内皮细胞变异系数、环1 P1波振幅密度、玻璃体内注射次数及并发症发生情况。结果两组患者年龄、性别比以及病史天数比较,差异均无统计学意义(均为P>0.05)。两组患者治疗后BCVA均下降,CRT均变薄,PED高度均下降,而环1 P1波振幅密度均提高,与治疗前相比,差异均有统计学意义(均为P<0.05)。原研药组患者治疗后角膜内皮细胞密度、六角形细胞比例以及角膜内皮细胞变异系数均上升,类似药组患者治疗后角膜内皮细胞密度与六角形细胞比例下降,而角膜内皮细胞变异系数上升,但与治疗前相比,差异均无统计学意义(均为P>0.05)。原研药组与类似药组患者注射次数比较,差异无统计学意义(P>0.05)。原研药组及类似药组患者病史时间与治疗后BCVA(logMAR)相关分析结果显示,二者均呈正相关(r=0.901、0.905,均为P<0.0001)。所有患者均未出现眼部严重并发症及心脑血管疾病。结论阿柏西普原研药和阿柏西普生物类似药对湿性AMD患者的短期疗效无明显差异。
Objective To observe and compare the therapeutic effects of aflibercept biosimilar and originator aflibercept through intravitreal injection in patients with age-related wet macular degeneration(AMD).Methods This retrospective 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 patients(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 acuity(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 detachment(PED)height,corneal endothelial cell density,hexagonal cell ratio,coefficient of variation(CV)of corneal endothelial 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 significant differences compared with baseline values(all P<0.05).In the originator group,the corneal endothelial cell density,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<0.0001).No severe ocular complications or cardiovascular/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.
作者
翟改霞
李天贺
宋文琦
王少鹏
ZHAI Gaixia;LI Tianhe;SONG Wenqi;WANG Shaopeng(Department of Ophthalmology,Zibo Central Hospital,Zibo City Key Laboratory,Zibo 255000,Shandong Province,China)
出处
《眼科新进展》
北大核心
2025年第5期393-397,共5页
Recent Advances in Ophthalmology
基金
山东省医药卫生科技项目(编号:202407020840)。
