雷珠单抗1+PRN和3+PRN治疗湿性年龄相关性黄斑变性的对比研究

Efficacy of ranibizumab 1+PRN and 3+PRN in the treatment of wet age-related macular degeneration

目的探讨雷珠单抗1+按需治疗方案(PRN)和3+PRN治疗湿性年龄相关性黄斑变性(AMD)的疗效和安全性。方法前瞻性随机对照研究。选择2018年3月至2020年4月本院收治的152例(152眼)湿性AMD患者作为研究对象,采用随机数字表法将患者分为1+PRN组(77例77眼)和3+PRN组(75例75眼)。1+PRN组患者在基线治疗期(第0个月)玻璃体内注射雷珠单抗0.5 mg,在第1~12个月采用PRN;3+PRN组患者在核心治疗期(第0、1、2个月)给予玻璃体内注射0.5 mg雷珠单抗(共3次),在延长治疗期采用PRN。统计随访期间两组患者最佳矫正视力(BCVA)、中心凹视网膜厚度(CMT)、平均病灶隆起最高点视网膜厚度(HLT)、平均病灶中央视网膜厚度(CLT),进行视觉电生理检查,统计闪光视网膜电图(FERG)a波、b波潜时及波幅,记录图形视觉诱发电位(PVEP)P100波、闪光视觉诱发电位(FVEP)P100波的潜时及波幅;并统计两组患者的不良反应。结果1+PRN组、3+PRN组患者核心治疗期内玻璃体内注药次数分别为(2.40±0.70)次、3.00次;随访12个月内注药次数分别为(6.22±2.01)次、(6.33±2.01)次,差异均无统计学意义(均为P>0.05)。与注药前相比,两组患者治疗后BCVA均显著升高(均为P<0.05),两组患者不同时间点BCVA比较,差异均无统计学意义(均为P>0.05)。两组患者治疗后CMT、HLT、CLT均显著降低(均为P<0.05),组间比较差异均无统计学意义(均为P>0.05)。两组患者治疗后FERG a波、b波及PVEP P100波的潜时均显著降低(均为P<0.05),FERG a波、b波及PVEP P100波、FVEP P100波的波幅均显著升高(均为P<0.05),两组比较差异均无统计学意义(均为P>0.05)。两组患者均未见严重全身及眼部不良反应。结论雷珠单抗1+PRN及3+PRN治疗湿性AMD疗效相似,临床上可根据患者需求选择合适的治疗方案。

Objective To investigate the efficacy and safety of ranibizumab 1+pro re nata(PRN)and ranibizumab 3+PRN in the treatment of wet age-related macular degeneration(AMD).Methods In this prospective randomized controlled study,152 patients(152 eyes)with wet AMD who were admitted to the hospital between March 2018 and April 2020 were enrolled.Through random number table method,the patients were divided into 1+PRN group(77 patients,77 eyes)and 3+PRN group(75 patients,75 eyes).The 1+PRN group was treated with intravitreal injection of 0.5 mg of ranibizumab at baseline(before treatment)and was then given PRN treatment in the 1st to 12th months.The 3+PRN group was treated with intravitreal injection of 0.5 mg of ranibizumab 3 times during the core treatment period(0,1st,2nd month)and was then given PRN treatment during the extended treatment period.The best corrected visual acuity(BCVA),central macular thickness(CMT),mean retinal thickness at the highest point of eminence lesion(HLT),and mean focal central retinal thickness(CLT)during follow-ups were recorded.Visual electrophysiological examination was performed.The latent time and amplitudes of a and b waves of flash electroretinogram(FERG),as well as P100 waves of pattern visual evoked potential(PVEP)and flash visual evoked potential(FVEP)were recorded.Adverse reactions were also recorded.Results The numbers of injections for 1+PRN group and 3+PRN group during the core treatment period were(2.40±0.70)times and 3 times,respectively.The numbers of injections within 12 months of follow-up were(6.22±2.01)times and(6.33±2.01)times,respectively,without statistically significant difference(P>0.05).The BCVA of the two groups increased significantly after treatment(both P<0.05),but there were no significant differences in BCVA changes between the two groups at different time points(all P>0.05).After treatment,CMT,HLT,and CLT were significantly reduced(all P<0.05),without statistically significant differences between the two groups(all P>0.05).After treatment,the latent time of FERG a wave,FERG b wave,and PVEP P100 wave was significantly reduced in the two groups(all P<0.05).The amplitudes of FERG a wave,FERG b wave,PVEP P100 wave,and FVEP P100 wave were significantly increased(all P<0.05),without statistically significant differences between the two groups(all P>0.05).No serious systemic or ocular adverse reactions were observed in the two groups.Conclusion Ranibizumab 1+PRN and ranibizumab 3+PRN have similar therapeutic effects.Patients can select any of them according to their needs.