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本文引用的文献

1
Naïve subretinal haemorrhage due to neovascular age-related macular degeneration. pneumatic displacement, subretinal air, and tissue plasminogen activator: subretinal vs intravitreal aflibercept-the native study.由于新生血管性年龄相关性黄斑变性导致的单纯性视网膜下出血。 气动移位、视网膜下空气和组织纤溶酶原激活物: 视网膜下与玻璃体内阿柏西普——原生研究。
Eye (Lond). 2023 Jun;37(8):1659-1664. doi: 10.1038/s41433-022-02222-z. Epub 2022 Aug 29.
2
Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative Age-Related macular degeneration (TIGER): study protocol for a phase 3, pan-European, two-group, non-commercial, active-control, observer-masked, superiority, randomised controlled surgical trial.玻璃体切除术、视网膜下组织纤维蛋白溶酶原激活物和眼内气体治疗渗出性年龄相关性黄斑变性继发的黄斑下出血(TIGER):一项 3 期、泛欧、2 组、非商业、活性对照、观察者设盲、优效性、随机对照手术试验的研究方案。
Trials. 2022 Jan 31;23(1):99. doi: 10.1186/s13063-021-05966-3.
3
Multicenter study of pars plana vitrectomy for optic disc pit maculopathy: MACPIT study.玻璃体切割术治疗视盘小凹黄斑病变的多中心研究:MACPIT研究
Eye (Lond). 2017 Sep;31(9):1266-1273. doi: 10.1038/eye.2017.142. Epub 2017 Jul 21.
4
Early treatment of acute submacular haemorrhage secondary to wet AMD using intravitreal tissue plasminogen activator, C3F8, and an anti-VEGF agent.使用玻璃体内组织型纤溶酶原激活剂、C3F8和抗血管内皮生长因子药物对湿性年龄相关性黄斑变性继发的急性黄斑下出血进行早期治疗。
Eye (Lond). 2016 Jul;30(7):952-7. doi: 10.1038/eye.2016.67. Epub 2016 Apr 15.
5
Compatibility of recombinant tissue plasminogen activator (rtPA) and aflibercept or ranibizumab coapplied for neovascular age-related macular degeneration with submacular haemorrhage.重组组织型纤溶酶原激活剂(rtPA)与阿柏西普或雷珠单抗联合应用于伴有黄斑下出血的新生血管性年龄相关性黄斑变性的兼容性。
Br J Ophthalmol. 2015 Jun;99(6):864-9. doi: 10.1136/bjophthalmol-2014-306454. Epub 2015 Mar 4.
6
Management of thick submacular hemorrhage with subretinal tissue plasminogen activator and pneumatic displacement for age-related macular degeneration.应用组织型纤溶酶原激活物(subretinal tissue plasminogen activator, srt-PA)和空气动力学移位(subretinal tissue plasminogen activator, srt-PA)治疗年龄相关性黄斑变性的厚型脉络膜下出血的管理。
Am J Ophthalmol. 2014 Jun;157(6):1250-7. doi: 10.1016/j.ajo.2014.02.007. Epub 2014 Feb 13.
7
Subretinal pneumatic displacement of subretinal hemorrhage.视网膜下气体移位对视网膜下出血的影响。
JAMA Ophthalmol. 2013 Dec;131(12):1632-5. doi: 10.1001/jamaophthalmol.2013.5464.
8
Ranibizumab and bevacizumab for neovascular age-related macular degeneration.雷珠单抗和贝伐单抗治疗新生血管性年龄相关性黄斑变性。
N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.
9
Analysis of forces acting upon submacular hemorrhage in pneumatic displacement.气体置换时作用于黄斑下出血的力的分析
Retina. 2007 Mar;27(3):370-4. doi: 10.1097/IAE.0b013e3180439bc9.
10
The retinal tolerance to bevacizumab in co-application with a recombinant tissue plasminogen activator.贝伐单抗与重组组织型纤溶酶原激活剂联合应用时视网膜的耐受性。
Br J Ophthalmol. 2007 Aug;91(8):1077-82. doi: 10.1136/bjo.2006.111260. Epub 2007 Mar 23.

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.

DOI:10.1038/s41433-023-02676-9
PMID:37537388
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10810790/
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。