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临床实践中抗血管内皮生长因子治疗糖尿病黄斑水肿的视力结果。

Vision Outcomes Following Anti-Vascular Endothelial Growth Factor Treatment of Diabetic Macular Edema in Clinical Practice.

机构信息

Pepose Vision Institute and Washington University School of Medicine, St Louis, Missouri, USA.

Allergan plc, Irvine, California, USA.

出版信息

Am J Ophthalmol. 2018 Jul;191:83-91. doi: 10.1016/j.ajo.2018.04.010. Epub 2018 Apr 21.

Abstract

PURPOSE

To determine monitoring and treatment patterns and vision outcomes in real-world patients initiating anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME).

DESIGN

Retrospective interventional cohort study.

METHODS

Setting: Electronic medical record analysis of Geisinger Health System data.

STUDY POPULATION

A total of 110 patients (121 study eyes) initiating intravitreal ranibizumab or bevacizumab for DME during January 2007‒May 2012, with baseline corrected visual acuity of 20/40 to 20/320, and ≥1 ophthalmologist visit during follow-up.

MAIN OUTCOME MEASURES

Intravitreal injections per study eye during the first 12 months; corrected visual acuity, change in corrected visual acuity from baseline, proportions of eyes with ≥10 or ≥15 approximate Early Treatment Diabetic Retinopathy Study letter gain/loss at 12 months; number of ophthalmologist visits.

RESULTS

Over 12 months, mean number of ophthalmologist visits was 9.2; mean number of intravitreal injections was 3.1 (range, 1-12), with most eyes (68.6%) receiving ≤3 injections. At 12 months, mean corrected visual acuity change was +4.7 letters (mean 56.9 letters at baseline); proportions of eyes gaining ≥10 or ≥15 letters were 31.4% and 24.0%, respectively; proportions of eyes losing ≥10 or ≥15 letters were 10.8% and 8.3%, respectively. Eyes receiving adjunctive laser during the first 6 months (n = 33) showed similar change in corrected visual acuity to non-laser-treated eyes (n = 88) (+3.1 vs +5.3 letters at 12 months).

CONCLUSIONS

DME patients receiving anti-VEGF therapy in clinical practice undergo less frequent monitoring and intravitreal injections, and achieve inferior vision outcomes to patients in landmark clinical trials.

摘要

目的

确定在现实世界中接受抗血管内皮生长因子(抗-VEGF)治疗糖尿病黄斑水肿(DME)的患者的监测和治疗模式以及视力结果。

设计

回顾性干预性队列研究。

方法

背景:对 Geisinger 健康系统数据的电子病历进行分析。

研究人群

共 110 名患者(121 只研究眼),于 2007 年 1 月至 2012 年 5 月期间接受玻璃体腔内雷珠单抗或贝伐单抗治疗 DME,基线矫正视力为 20/40 至 20/320,且在随访期间至少有 1 次眼科就诊。

主要观察指标

在第 1 年中每只研究眼的玻璃体腔内注射次数;矫正视力,从基线开始的矫正视力变化,12 个月时视力提高/降低≥10 或≥15 个早期治疗糖尿病视网膜病变研究字母的眼比例;眼科就诊次数。

结果

在 12 个月内,平均眼科就诊次数为 9.2 次;平均玻璃体腔内注射次数为 3.1(范围,1-12),大多数眼(68.6%)接受≤3 次注射。在 12 个月时,平均矫正视力变化为+4.7 个字母(基线时平均为 56.9 个字母);视力提高≥10 或≥15 个字母的眼比例分别为 31.4%和 24.0%;视力降低≥10 或≥15 个字母的眼比例分别为 10.8%和 8.3%。在第 1 至 6 个月期间接受辅助激光治疗的 33 只眼(n=33)与未接受激光治疗的 88 只眼(n=88)的矫正视力变化相似(12 个月时分别为+3.1 与+5.3 个字母)。

结论

在临床实践中接受抗-VEGF 治疗的 DME 患者的监测和玻璃体腔内注射次数较少,且视力结果比标志性临床试验中的患者差。

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