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在初发性湿性年龄相关性黄斑变性继发黄斑下出血的情况下,比较阿柏西普、雷珠单抗和贝伐单抗玻璃体切割联合视网膜下空气注入及视网膜下组织型纤溶酶原激活剂治疗的效果。“潜艇研究”

Comparison of subretinal aflibercept vs ranibizumab vs bevacizumab in the context of PPV, pneumatic displacement with subretinal air and subretinal tPA in naïve submacular haemorrhage secondary to nAMD. "The Submarine Study".

作者信息

Iglicki Matias, Khoury Marina, Donato Lucas, Quispe Diego Jose, Negri Hermino Pablo, Melamud Javier Ignacio

机构信息

Private Retina Office, University of Buenos Aires, Buenos Aires, Argentina.

Medical Investigation Institute "Alfredo Lanari", University of Buenos Aires, Buenos Aires, Argentina.

出版信息

Eye (Lond). 2024 Feb;38(2):292-296. doi: 10.1038/s41433-023-02676-9. Epub 2023 Aug 3.

Abstract

OBJECTIVE

To compare efficacy and safety profile of subretinal aflibercept, ranibizumab, and bevacizumab in the context of pars plana vitrectomy, pneumatic displacement with subretinal air and subretinal tPA for subretinal macular haemorrhage (SMH) due to naïve neovascular age-related macular degeneration (nAMD).

DESIGN

Retrospective interventional cohort study.

PARTICIPANTS

123 eyes of 123 patients treated with subretinal aflibercept (n = 41, 33%), ranibizumab (n = 41,33%), and bevacizumab (n = 41, 33%).

METHODS

Review of electronic medical records for best corrected visual acuity (BCVA), central subfoveal thickness (CST), and intraocular pressure (IOP) at baseline and 24 months after treatment.

MAIN OUTCOME MEASURES

BCVA, CST, and number of intravitreal anti VEGF over 24 months.

RESULTS

Mean age of patients was 80.5 ± 5.5 years, 43.9% were female. Mean time from symptom onset until surgery was 1.1 days (range 0-3 days). In all cases, the SMH did not reach the arcades. CST at baseline was 627 ± 140 µ, 739 ± 54 µ, and 793 ± 93 µ (p = 0.0001) for aflibercept, ranibizumab, or bevacizumab, respectively. Baseline BCVA (logMAR) was 0.65 ± 0.13, 0.69 ± 0.96, and 0.74 ± 0.81 (p = 0.0041) for aflibercept, ranibizumab, and bevacizumab, respectively. All three groups showed statistically significant improvement in BCVA and CST (for all groups: p < 0.001). There was no statistically significant difference at the final BCVA (p = 0.789). The mean number of anti VEGF given during follow-up period was 5.2 ± 0.81, 4.4 ± 0.63, and 5.5 ± 0.95 (p = 0.0001) for aflibercept, ranibizumab, and bevacizumab, respectively.

CONCLUSION

This study shows that aflibercept, ranibizumab, and bevacizumab in a subretinal manner in the context of PPV, pneumatic displacement with subretinal air and subretinal tPA for subretinal macular haemorrhage secondary to naïve nAMD work with the same efficacy and safety profile.

摘要

目的

比较在单纯性新生血管性年龄相关性黄斑变性(nAMD)所致黄斑下出血(SMH)的情况下,玻璃体视网膜手术联合视网膜下注射阿柏西普、雷珠单抗和贝伐单抗,以及视网膜下空气注入和气液交换联合视网膜下组织型纤溶酶原激活剂(tPA)的疗效和安全性。

设计

回顾性干预队列研究。

参与者

123例患者的123只眼,其中41只眼(33%)接受视网膜下阿柏西普治疗,41只眼(33%)接受雷珠单抗治疗,41只眼(33%)接受贝伐单抗治疗。

方法

回顾电子病历,记录基线及治疗后24个月时的最佳矫正视力(BCVA)、中心凹下视网膜厚度(CST)和眼压(IOP)。

主要观察指标

BCVA、CST以及24个月内玻璃体内抗血管内皮生长因子(VEGF)药物的注射次数。

结果

患者平均年龄为80.5±5.5岁,女性占43.9%。从症状出现到手术的平均时间为1.1天(范围0 - 3天)。所有病例中,SMH均未累及视网膜血管弓。阿柏西普、雷珠单抗和贝伐单抗组基线时的CST分别为627±140μm、739±54μm和793±93μm(p = 0.0001)。阿柏西普、雷珠单抗和贝伐单抗组基线时的BCVA(logMAR)分别为0.65±0.13、0.69±0.96和0.74±0.81(p = 0.0041)。三组的BCVA和CST均有统计学显著改善(所有组:p < 0.001)。最终BCVA无统计学显著差异(p = 0.789)。随访期间,阿柏西普、雷珠单抗和贝伐单抗组抗VEGF药物的平均注射次数分别为5.2±0.81、4.4±0.63和5.5±0.95(p = 0.0001)。

结论

本研究表明,在玻璃体视网膜手术、视网膜下空气注入和气液交换联合视网膜下tPA治疗单纯性nAMD所致黄斑下出血的情况下,视网膜下注射阿柏西普、雷珠单抗和贝伐单抗具有相同的疗效和安全性。

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