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在真实世界环境中,玻璃体内注射阿柏西普治疗湿性年龄相关性黄斑变性的日本患者的视觉相关生活质量。

Vision-related quality of life in Japanese patients with wet age-related macular degeneration treated with intravitreal aflibercept in a real-world setting.

机构信息

Hyogo College of Medicine Hospital, Hyogo, Japan.

Bayer Yakuhin, Osaka, Japan.

出版信息

Jpn J Ophthalmol. 2019 Nov;63(6):437-447. doi: 10.1007/s10384-019-00687-2. Epub 2019 Oct 31.

Abstract

PURPOSE

To evaluate vision-related quality of life (QoL) in wet age-related macular degeneration (wAMD) patients receiving intravitreal aflibercept (IVT-AFL).

STUDY DESIGN

Prospective, observational Japanese postmarketing surveillance study.

METHODS

All decisions were made by the treating physician. QoL was assessed using the 25-item National Eye Institute-Visual Functioning Questionnaire (NEI-VFQ-25) composite score administered at baseline, 6 months, and 12 months (primary assessment). Secondary assessments included NEI-VFQ-25 subscale scores, resource use, and best-corrected visual acuity (BCVA; logarithm of the minimum angle of resolution [logMAR]).

RESULTS

In total, 576 patients (baseline), 555 patients (6 months), and 446 patients (12 months) were included. The mean (SD) number of IVT-AFL injections was 3.5 (1.2) at 6 months and 4.6 (2.2) at 12 months. The mean (SD) improvement from baseline in the NEI-VFQ-25 composite score was 3.1 (11.1) at 6 months and 2.7 (12.3) at 12 months (P < .0001). For the NEI-VFQ-25 subscale scores, the mean change was ≥ 4 (minimally important difference) for general vision, near vision, and mental health at 6 months, and for general vision and mental health at 12 months (all P < .0001). A significant improvement from baseline was found in mean BCVA (logMAR) at 6 months (-0.1) and 12 months (-0.1) (P < .0001). The mean change from baseline in the NEI-VFQ-25 scores was greatest in patients with improved BCVA (gain of ≤ -0.3 logMAR units or ≥ 15 letters) after treatment.

CONCLUSION

IVT-AFL was associated with significant improvements in QoL and visual acuity in Japanese patients with wAMD in a real-world setting.

摘要

目的

评估接受玻璃体内注射阿柏西普(IVT-AFL)的湿性年龄相关性黄斑变性(wAMD)患者的视觉相关生活质量(QoL)。

研究设计

前瞻性、观察性的日本上市后监测研究。

方法

所有决策均由主治医生做出。在基线、6 个月和 12 个月(主要评估)时使用 25 项国家眼科研究所视觉功能问卷(NEI-VFQ-25)综合评分评估 QoL。次要评估包括 NEI-VFQ-25 子量表评分、资源利用和最佳矫正视力(BCVA;最小分辨角对数[logMAR])。

结果

共有 576 名患者(基线)、555 名患者(6 个月)和 446 名患者(12 个月)纳入研究。6 个月时 IVT-AFL 注射的平均(SD)次数为 3.5(1.2),12 个月时为 4.6(2.2)。与基线相比,6 个月时 NEI-VFQ-25 综合评分的平均(SD)改善为 3.1(11.1),12 个月时为 2.7(12.3)(P<0.0001)。对于 NEI-VFQ-25 子量表评分,6 个月时,一般视力、近视力和心理健康的平均变化≥4(最小有意义差异),12 个月时一般视力和心理健康的平均变化≥4(均 P<0.0001)。6 个月时和 12 个月时 BCVA(logMAR)的平均变化均较基线显著改善(均 P<0.0001)。治疗后 BCVA(logMAR)改善(≤-0.3 logMAR 单位或≥15 个字母)的患者的 NEI-VFQ-25 评分基线变化最大。

结论

在真实世界环境中,IVT-AFL 可显著改善日本 wAMD 患者的 QoL 和视力。

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