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抗血管内皮生长因子治疗新生血管性年龄相关性黄斑变性后早期和晚期视网膜色素上皮撕裂。

Early and Late Retinal Pigment Epithelium Tears after Anti-Vascular Endothelial Growth Factor Therapy for Neovascular Age-Related Macular Degeneration.

机构信息

Eye Clinic, Department of Biomedical and Clinical Science "Luigi Sacco," Luigi Sacco Hospital, University of Milan, Milan, Italy; Save Sight Institute, University of Sydney, Sydney, Australia.

Save Sight Institute, University of Sydney, Sydney, Australia.

出版信息

Ophthalmology. 2018 Feb;125(2):237-244. doi: 10.1016/j.ophtha.2017.08.039. Epub 2017 Oct 6.

DOI:10.1016/j.ophtha.2017.08.039
PMID:28993010
Abstract

PURPOSE

To investigate when retinal pigment epithelium (RPE) tears occur and their associated treatment patterns and long-term visual outcomes in patients with neovascular age-related macular degeneration (nAMD) during anti-vascular endothelial growth factor (VEGF) treatment.

DESIGN

Case-control analysis from a prospectively designed observational database.

PARTICIPANTS

Treatment-naïve eyes enrolled in the Fight Retina Blindness! observational study that commenced anti-VEGF treatment for nAMD between January 2006 and January 2017 were identified. Cases were defined as eyes in which an RPE tear developed during treatment. Three control eyes per case were matched for age, baseline visual acuity (VA), lesion size, treatment duration before tearing, and duration of follow-up.

METHODS

Cases were classified as having early or late tears using a segmented regression model. Baseline characteristics were compared between the 2 groups. Comparisons of VA and injections received between tear eyes and control eyes were performed at baseline, before and immediately after the tear, and then 12 and 24 months later. Visual acuity also was compared among different visits within each group.

MAIN OUTCOME MEASURES

Visual acuity, time to tear, and injections received.

RESULTS

Fifty-five cases and 165 matched control eyes were included. The segmented regression estimated a breakpoint for the time to tear at 182 days. We therefore defined eyes as having early tears if they tore before the breakpoint (38/55 eyes [69%]), and as late tears if they tore afterward (17/55 eyes [31%]). Baseline VA was significantly lower in early compared with late tears (53.6 vs. 63.4 letters; P = 0.009). Visual acuity had improved in early tears before the tear (+5.6 letters from baseline; P = 0.01), decreased immediately after the tear (-8.3 letters; P = 0.002), then recovered with no difference compared with control eyes 12 and 24 months later (P > 0.05 for both). Late tear eyes had significantly lower VA than control eyes before tearing (55.5 vs. 66.9 letters; P < 0.001). Visual acuity did not decrease significantly after the tear, but continued to decline compared with control eyes at all end points. Both early and late tear eyes received more injections than control eyes after tearing.

CONCLUSIONS

Retinal pigment epithelium tears act differently depending on when they occur. Long-term visual outcomes in eyes affected by RPE tearing may be related more to the patient's response to therapy than to the tear itself.

摘要

目的

研究新生血管性年龄相关性黄斑变性(nAMD)患者在接受抗血管内皮生长因子(VEGF)治疗期间,RPE 撕裂发生的时间及其相关的治疗模式和长期视觉结局。

设计

前瞻性设计观察性数据库中的病例对照分析。

参与者

2006 年 1 月至 2017 年 1 月期间,招募了在 Fight Retina Blindness!观察性研究中开始接受抗 VEGF 治疗的治疗初治眼,并纳入本研究。病例定义为在治疗过程中发生 RPE 撕裂的眼。每例病例匹配 3 只对照眼,以年龄、基线视力(VA)、病变大小、撕裂前治疗持续时间和随访时间进行匹配。

方法

使用分段回归模型对病例进行分类,以确定早发性或迟发性撕裂。比较两组间的基线特征。在撕裂前、撕裂即刻、撕裂后 12 个月和 24 个月比较撕裂眼和对照眼的 VA 和注射次数。比较每组内不同时间点的 VA。

主要结局测量

视力、撕裂时间和注射次数。

结果

纳入 55 例病例和 165 例匹配对照眼。分段回归估计撕裂时间的断点为 182 天。因此,如果眼在该时间点之前撕裂,则定义为早发性撕裂(38/55 眼[69%]),否则为迟发性撕裂(17/55 眼[31%])。早发性撕裂眼的基线 VA 明显低于迟发性撕裂眼(53.6 与 63.4 字母;P=0.009)。早发性撕裂眼在撕裂前 VA 已改善(与基线相比增加 5.6 个字母;P=0.01),撕裂后即刻下降(-8.3 个字母;P=0.002),但在 12 个月和 24 个月后与对照眼无差异(均 P>0.05)。迟发性撕裂眼在撕裂前的 VA 明显低于对照眼(55.5 与 66.9 字母;P<0.001)。撕裂后 VA 无明显下降,但与对照眼相比,所有终点的 VA 持续下降。早发性和迟发性撕裂眼在撕裂后接受的注射次数均多于对照眼。

结论

RPE 撕裂的发生时间不同,其作用也不同。受 RPE 撕裂影响的眼的长期视觉结局可能更多地与患者对治疗的反应有关,而不是与撕裂本身有关。

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