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真实世界环境下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的疗效。

Outcome of anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration in real-life setting.

机构信息

Tays Eye Centre, Tampere University Hospital, Tampere, Finland.

Department of Ophthalmology, University of Tampere, Tampere, Finland.

出版信息

Br J Ophthalmol. 2018 Jul;102(7):959-965. doi: 10.1136/bjophthalmol-2017-311055. Epub 2017 Oct 26.

Abstract

AIMS

To evaluate outcome of anti-vascular endothelial growth factor (VEGF) therapy for the treatment of neovascular age-related macular degeneration (nAMD) in the real-life setting and to compare incidence of ocular serious adverse events (SAE) after injections administered by nurses and physicians.

METHODS

Retrospective, single-centre study. Medical records of patients receiving anti-VEGF treatment for nAMD between 2008 and 2013 with three-loading-dose regimen were evaluated. Outcome measures were baseline visual acuity (VA), change in VA, number of intravitreal injections, incidence of ocular SAE and patients' baseline characteristics affecting VA change. In addition, the number of injections per 1000 citizens living in the serving area and per individuals over 65 years old were estimated.

RESULTS

1349 eyes in 1117 patients received a total of 11 562 intravitreal anti-VEGF injections. Twenty-one per cent of patients received treatment for both eyes. The mean baseline Snellen VA was 0.32. The mean change of VA from baseline was +2, +2 and ±0 Early Treatment Diabetic Retinopathy Study letters and the mean numbers of injections were 5.7, 4.7 and 4.9 at years 1, 2 and 3, respectively. There was a negative correlation between baseline VA and change of VA. Incidence of endophthalmitis was 0.086%. No difference in the incidence of ocular SAE was identified between injections given by nurses or by physicians. The number of intravitreal injections per all citizens was 9 per 1000 inhabitants and 45 per 1000 inhabitants over 65 years.

CONCLUSION

The VA was maintained at the baseline level (±0 letters) with the mean of 15.3 anti-VEGF injections in real-world clinical practice during 3-year follow-up.

摘要

目的

评估血管内皮生长因子(VEGF)拮抗剂治疗新生血管性年龄相关性黄斑变性(nAMD)的真实世界疗效,并比较护士和医生注射后的眼部严重不良事件(SAE)发生率。

方法

回顾性、单中心研究。评估了 2008 年至 2013 年间接受抗 VEGF 治疗 nAMD 的患者(采用三剂量负荷疗法)的医疗记录。主要观察指标为基线视力(VA)、VA 变化、眼内注射次数、眼部 SAE 发生率以及影响 VA 变化的患者基线特征。此外,还估计了服务区域内每 1000 名居民和每 1000 名 65 岁以上居民的注射次数。

结果

1117 例患者的 1349 只眼共接受了 11562 次眼内抗 VEGF 注射。21%的患者接受了双眼治疗。平均基线 Snellen VA 为 0.32。从基线开始 VA 的平均变化为+2、+2 和±0 个早期治疗糖尿病视网膜病变研究字母,平均注射次数分别为 5.7、4.7 和 4.9 个,分别在第 1、2 和 3 年。基线 VA 与 VA 变化呈负相关。眼内炎发生率为 0.086%。护士和医生注射的眼部 SAE 发生率无差异。所有居民的眼内注射次数为每 1000 人 9 次,65 岁以上居民每 1000 人 45 次。

结论

在 3 年随访期间,真实世界临床实践中平均使用 15.3 次抗 VEGF 注射,VA 保持在基线水平(±0 个字母)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9029/6047152/519a6c2128e7/bjophthalmol-2017-311055f01.jpg

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