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雷珠单抗与阿柏西普治疗视网膜分支静脉阻塞性黄斑水肿 12 个月的疗效:FRB!注册研究的数据。

Twelve-month outcomes of ranibizumab versus aflibercept for macular oedema in branch retinal vein occlusion: data from the FRB! registry.

机构信息

Medical Retina, Westmead Hospital, Westmead, New South Wales, Australia

Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia.

出版信息

Br J Ophthalmol. 2022 Aug;106(8):1178-1184. doi: 10.1136/bjophthalmol-2020-318491. Epub 2021 Mar 12.

Abstract

BACKGROUND/AIMS: To compare the efficacy of ranibizumab (0.5 mg) with aflibercept (2 mg) in the treatment of cystoid macular oedema due to branch retinal vein occlusion (BRVO) over 12 months.

METHODS

A multicentre, international, database observational study recruited 322 eyes initiating therapy in real-world practice over 5 years. The main outcome measure was mean change in EDTRS letter scores of visual acuity (VA). Secondary outcomes included anatomic outcomes, percentage of eyes with VA >6/12 (70 letters), number of injections and visits, time to first inactivity, switching or non-completion.

RESULTS

Generalised mixed effect models demonstrated that mean (95% CI) adjusted 12-month VA changes for ranibizumab and aflibercept were similar (+10.8 (8.2 to 13.4) vs +10.9 (8.3 to 13.5) letters, respectively, p=0.59). The mean adjusted change in central subfield thickness (CST) was greater for aflibercept than ranibizumab (-170 (-153 to -187) µm vs -147 (-130 to -164) µm, respectively, p=0.001). The overall median (Q1, Q3) of 7 (4, 8) injections and 9 (7, 11) visits was similar between treatment groups. First grading of inactivity occurred sooner with aflibercept (p=0.01). Switching was more common from ranibizumab (37 eyes, 23%) than from aflibercept (17 eyes, 11%; p=0.002).

CONCLUSION

Visual outcomes at 12 months in this direct comparison of ranibizumab and aflibercept for BRVO in real-world practice were generally good and similar for the 2 drugs, despite a greater effect of aflibercept on CST and time to first grading of inactivity.

摘要

背景/目的:比较雷珠单抗(0.5mg)与阿柏西普(2mg)在治疗分支静脉阻塞(BRVO)引起的黄斑囊样水肿(CME)方面的疗效,随访时间为 12 个月。

方法

一项多中心、国际数据库观察性研究,在 5 年内共招募了 322 只接受治疗的眼。主要观察指标是最佳矫正视力(BCVA)的平均变化(EDTRS 字母评分)。次要观察指标包括解剖学结果、BCVA>6/12(70 个字母)的眼比例、注射次数和访视次数、首次无活动期、转换或未完成时间。

结果

广义混合效应模型显示,雷珠单抗和阿柏西普治疗后 12 个月的平均(95%可信区间)调整后视力变化相似(+10.8(8.2 至 13.4)与+10.9(8.3 至 13.5)个字母,p=0.59)。阿柏西普组中央视网膜神经纤维层厚度(CST)的平均调整后变化大于雷珠单抗组(-170(-153 至-187)µm 与-147(-130 至-164)µm,p=0.001)。两组治疗的总中位数(Q1,Q3)为 7(4,8)次注射和 9(7,11)次访视。阿柏西普组首次无活动期的评分较早(p=0.01)。从雷珠单抗转换为其他药物的情况更为常见(37 只眼,23%),而从阿柏西普转换的情况较少(17 只眼,11%;p=0.002)。

结论

本项在真实世界环境中直接比较雷珠单抗和阿柏西普治疗 BRVO 的研究中,12 个月时的视力结果总体较好,两种药物的结果相似,尽管阿柏西普对 CST 和首次无活动期评分的影响更大。

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