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年龄相关性黄斑变性患者玻璃体内注射后感染性和非感染性眼内炎的发生率和结局。

Incidence and Outcomes of Infectious and Noninfectious Endophthalmitis after Intravitreal Injections for Age-Related Macular Degeneration.

机构信息

The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales; Department of Ophthalmology, Gui De Chauliac Hospital, Montpellier, France; Inserm, U1061, Montpellier, France.

The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales.

出版信息

Ophthalmology. 2018 Jan;125(1):66-74. doi: 10.1016/j.ophtha.2017.07.005. Epub 2017 Aug 8.

Abstract

PURPOSE

To assess the incidence, cumulative rate, and long-term outcomes of infectious and noninfectious endophthalmitis after intravitreal injections (IVTs) of anti-vascular endothelial growth factor (VEGF) agents.

DESIGN

Database study, prospectively designed.

PARTICIPANTS

Treatment-naïve eyes with neovascular age-related macular degeneration (nAMD) tracked by the Fight Retinal Blindness! (FRB!) registry that commenced anti-VEGF therapy between January 1, 2006, and November 30, 2016.

METHODS

Cumulative rate of endophthalmitis and survival curves were measured using Cox-proportional hazards models. Locally weighted scatterplot smoothing curves were used to display visual acuity (VA).

MAIN OUTCOME MEASURES

Incidence and cumulative rate of endophthalmitis, and change in VA 12 months after endophthalmitis.

RESULTS

Infectious endophthalmitis developed in 18 of 88 150 injections (1/4897 injections [0.020%]; 95% confidence interval [CI], 0.012-0.032) with no difference found between types of anti-VEGF medications (P = 0.896). The cumulative rate of infectious endophthalmitis per patient was 0.055%, 0.183%, 0.360%, 0.360%, 0.555%, and 0.843% after 10, 20, 30, 40, 50, and 60 IVTs, respectively. However, the "risk" of infectious endophthalmitis did not increase with each successive injection (P = 0.202). Noninfectious endophthalmitis developed in 11 of 88 150 injections (1/8013 injections [0.012%]; 95% CI, 0.006-0.022). The cumulative rate of noninfectious endophthalmitis per patient was 0.087% and 0.228% after 10 and 20 IVTs, respectively, and then remained stable up to 60 IVTs. The incidence of noninfectious endophthalmitis was higher for bevacizumab (8/9931, 0.081%) compared with ranibizumab (3/54 776, 0.005%; P = 0.005) and aflibercept (0/23 425; P = 0.016), and no differences were observed between ranibizumab and aflibercept (P = 1.0). The 12-month VA in infectious and noninfectious endophthalmitis was within ±2 lines of before endophthalmitis in 53% and 75% of eyes, respectively; a loss >2 lines was observed in 31% and 25% of eyes, respectively.

CONCLUSIONS

The incidences of infectious and noninfectious endophthalmitis after IVT were low, and the risk did not increase with each successive injection. We found higher rates of noninfectious endophthalmitis with bevacizumab compared with ranibizumab or aflibercept. Three quarters of cases with infectious and two thirds of cases with noninfectious endophthalmitis retained vision within 10 letters of the pre-endophthalmitis level.

摘要

目的

评估抗血管内皮生长因子(VEGF)药物玻璃体内注射(IVT)后感染性和非感染性眼内炎的发生率、累积率和长期结局。

设计

数据库研究,前瞻性设计。

参与者

自 2006 年 1 月 1 日至 2016 年 11 月 30 日,Fight Retinal Blindness!(FRB!)注册中心开始抗 VEGF 治疗的未经治疗的伴有新生血管性年龄相关性黄斑变性(nAMD)的治疗-naive 眼。

方法

使用 Cox 比例风险模型测量眼内炎的累积发生率和生存曲线。使用局部加权散点平滑曲线显示视力(VA)。

主要观察指标

眼内炎的发生率和累积率,以及眼内炎发生后 12 个月 VA 的变化。

结果

18 例(1/4897 次注射[0.020%];95%置信区间[CI],0.012-0.032)88150 次 IVT 中发生感染性眼内炎,不同类型的抗 VEGF 药物之间无差异(P=0.896)。每位患者感染性眼内炎的累积发生率分别为 0.055%、0.183%、0.360%、0.360%、0.555%和 0.843%,分别为 10、20、30、40、50 和 60 次 IVT 后。然而,每次连续注射的“风险”并未增加(P=0.202)。88150 次 IVT 中发生 11 例(1/8013 次注射[0.012%];95%CI,0.006-0.022)非感染性眼内炎。每位患者非感染性眼内炎的累积发生率分别为 0.087%和 0.228%,分别为 10 和 20 次 IVT 后,然后在 60 次 IVT 后保持稳定。贝伐单抗(8/9931,0.081%)的非感染性眼内炎发生率高于雷珠单抗(3/54776,0.005%;P=0.005)和阿柏西普(0/23425;P=0.016),雷珠单抗和阿柏西普之间无差异(P=1.0)。感染性和非感染性眼内炎发生后 12 个月的 VA 在 53%和 75%的眼中分别在眼内炎之前的±2 行内,分别有 31%和 25%的眼中观察到>2 行的损失。

结论

IVT 后感染性和非感染性眼内炎的发生率较低,且风险不会随每次连续注射而增加。我们发现贝伐单抗引起的非感染性眼内炎发生率高于雷珠单抗或阿柏西普。感染性眼内炎和非感染性眼内炎的三分之二病例保留了 10 个字母以内的视力。

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