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新生血管性年龄相关性黄斑变性数据库:报告 2:第二只治疗眼的发病率、治疗方法和视力结果。

The neovascular age-related macular degeneration database: report 2: incidence, management, and visual outcomes of second treated eyes.

机构信息

Moorfields Eye Hospital NHS Trust, London, United Kingdom.

Moorfields Eye Hospital NHS Trust, London, United Kingdom.

出版信息

Ophthalmology. 2014 Oct;121(10):1966-75. doi: 10.1016/j.ophtha.2014.04.026. Epub 2014 Jun 20.

DOI:10.1016/j.ophtha.2014.04.026
PMID:24953791
Abstract

PURPOSE

To study the characteristics of second treated eyes in patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab in the United Kingdom National Health Service.

DESIGN

Multicenter national nAMD database study.

PARTICIPANTS

Twelve thousand nine hundred fifty-one treatment-naïve eyes of 11,135 patients receiving 92,976 ranibizumab injections.

METHODS

Up to 5 years of routinely collected, anonymized data within electronic medical record systems were extracted remotely from 14 centers. Participating centers exclusively used ranibizumab to treat nAMD (loading phase of 3 monthly injections followed by monthly visits and pro re nata re-treatment). The minimum data set included: age, logarithm of the minimum angle of resolution (logMAR) visual acuity (VA) at baseline and at all subsequent visits, and injection episodes.

MAIN OUTCOME MEASURES

Baseline, change and actual VA over 3 years, and number of treatments and clinic visits.

RESULTS

During the study, 1816 (16.3%) of the 11 135 patients received treatment to the fellow eye. Mean baseline and final VA were 0.66 (standard deviation, 0.32) and 0.65 (0.40) for first treated eyes and 0.41 (0.34) and 0.56 (0.40) for second treated eyes. The rate of VA loss after the loading phase was similar in first and second treated eyes (0.03 and 0.05 logMAR units/year). When fellow eyes with baseline VA worse than 20/200 were excluded to restrict analyses to eyes at risk of nAMD, the rate of second-eye involvement was 14.0% per year (42%/3 years). Mean number of injections/visits in years 1, 2, and 3 were similar for first and second treated eyes (5.6/8.2, 3.9/8.0, 3.8/8.2 and 5.5/8.7, 3.6/9.4, and 3.8/9.1, respectively).

CONCLUSIONS

Second treated eyes with nAMD commence treatment with better baseline VA, do not show significant vision gain but maintain better VA than first treated eyes at all time points for at least 3 years, making them the more important eye functionally. These data highlight the high burden of second eye involvement, with almost half of all eyes at risk requiring bilateral treatment by 3 years, and the need for regular monitoring of fellow eyes for best visual outcomes which theoretically may reduce the benefits of extended monitoring regimens.

摘要

目的

研究在英国国民保健制度下接受雷珠单抗治疗的新生血管性年龄相关性黄斑变性(nAMD)患者中,第二只治疗眼的特征。

设计

多中心全国 nAMD 数据库研究。

参与者

11135 名患者的 12951 只未经治疗的眼睛,共接受 92976 次雷珠单抗注射。

方法

从 14 个中心远程提取常规收集的、匿名的电子病历系统内长达 5 年的数据。参与中心专门使用雷珠单抗治疗 nAMD(3 个月注射负荷期,随后每月就诊和按需治疗)。最小数据集包括:年龄、最小角分辨率(logMAR)视力基线和所有后续就诊时的对数(log)、注射次数。

主要观察指标

3 年的基线、变化和实际视力,以及治疗和就诊次数。

结果

在研究期间,11135 名患者中有 1816 名(16.3%)接受了对另一只眼的治疗。第一只治疗眼的平均基线和最终视力分别为 0.66(标准差 0.32)和 0.65(0.40),第二只治疗眼分别为 0.41(0.34)和 0.56(0.40)。在负荷期后视力丧失的速度在第一只和第二只治疗眼相似(每年 0.03 和 0.05 logMAR 单位)。当排除基线视力低于 20/200 的对侧眼,将分析限制在有 nAMD 风险的眼中时,对侧眼的发病率为每年 14.0%(3 年 42%)。第 1、2 和 3 年每只眼的平均注射/就诊次数在第一只和第二只治疗眼相似(分别为 5.6/8.2、3.9/8.0、3.8/8.2 和 5.5/8.7、3.6/9.4、3.8/9.1)。

结论

nAMD 的第二只治疗眼开始治疗时基线视力较好,在至少 3 年内,所有时间点均未显示出显著的视力改善,但视力保持优于第一只治疗眼,这使其在功能上成为更重要的眼睛。这些数据突出了第二只眼受累的高负担,近一半的高危眼在 3 年内需要双侧治疗,需要定期监测对侧眼以获得最佳视力结果,这理论上可能会降低延长监测方案的益处。

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