1.Comparison of therapeutic effects of aflibercept biosimilar and originator aflibercept on age-related wet macular degeneration
Gaixia ZHAI ; Tianhe LI ; Wenqi SONG ; Shaopeng WANG
Recent Advances in Ophthalmology 2025;45(5):393-397
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.
2.Comparison of therapeutic effects of aflibercept biosimilar and originator aflibercept on age-related wet macular degeneration
Gaixia ZHAI ; Tianhe LI ; Wenqi SONG ; Shaopeng WANG
Recent Advances in Ophthalmology 2025;45(5):393-397
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.
3.Relationship between objective sleep quality and cognitive function in remission depression patients with insomnia
Meng QI ; Fanlei MENG ; Tianhe SONG ; Tingting WANG ; Jinmeng LIU ; Shuangjiang ZHOU ; Jingxu CHEN
Sichuan Mental Health 2022;35(2):126-131
ObjectiveTo discuss the relationship between objective sleep quality and cognitive function in remission depression patients with insomnia. MethodsA total of 47 patients with depression in remission in Beijing Huilongguan Hospital were enrolled. Insomnia Severity Index (ISI) and the sleep efficiency calculated by the first four items of Pittsburgh Sleep Quality Index (PSQI) were defined as insomnia. Among the selected patients, 22 subjects were classified into insomnia group, and 25 subjects in non-insomnia group. The objective sleep status of all subjects was evaluated by polysomnography (PSG), and the cognitive function was evaluated with the Repeatable Battery for Assessment of Neuropsychological Status (RBANS). A regression model was established to explore the relationship between objective sleep quality and cognitive function in remission depression patients with insomnia. ResultsThere was statistically significant difference in immediate memory factor scores of RBANS between depression patients in remission with and without insomnia (t=-2.102, P<0.05). The sleep efficiency (Z=-2.113, P<0.05), the proportion of N3 sleep stage (Z=-3.175, P<0.01) and the duration of N3 sleep stage (Z=-3.196, P<0.01) in insomnia group were all lower than those in non-insomnia group, and the nocturnal awakening (Z=-2.058, P<0.01), the proportion of N1 sleep stage (Z=-2.399, P<0.05) and the duration of N1 sleep stage (Z=-2.463, P<0.05) were higher than those of the insomnia group. Within insomnia group, the increased proportion of REM sleep was correlated with the improvement of attention function (β=0.953, 95% CI: 0.123~2.038, P<0.05), and the increase of nocturnal awakening was correlated with the decline of delayed memory (β=-0.173, 95% CI: -0.325~-0.024, P<0.05). ConclusionObjective sleep is associated with cognitive impairment in remission depression patients with insomnia, the proportion of REM sleep has a positive impact on attention function, and frequent nocturnal awakening at night has a negative impact on delayed memory.

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