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BRAMD 试验:抗血小板和抗凝药物对新生血管性年龄相关性黄斑变性的视觉结局无影响。

Antiplatelet and Anticoagulant Drugs Do Not Affect Visual Outcome in Neovascular Age-Related Macular Degeneration in the BRAMD Trial.

机构信息

Department of Ophthalmology, Erasmus Medical Center, Rotterdam, Netherlands; Department of Epidemiology, Erasmus Medical Center, Rotterdam, Netherlands.

Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.

出版信息

Am J Ophthalmol. 2018 Mar;187:130-137. doi: 10.1016/j.ajo.2018.01.003. Epub 2018 Jan 9.

Abstract

PURPOSE

To determine if use of antiplatelet or anticoagulant (AP/AC) medication influences visual acuity in patients with active neovascular age-related macular degeneration (N-AMD).

DESIGN

Retrospective analysis of data from a randomized controlled trial.

METHODS

Setting: Multicenter.

STUDY POPULATION

Total of 330 patients with active N-AMD from the BRAMD study, a comparative trial between bevacizumab and ranibizumab in the Netherlands.

OBSERVATION PROCEDURES

Patients underwent an extensive ophthalmic examination. Visual acuity was categorized into functional vision (best-corrected visual acuity [BCVA] ≥ 0.5), visual impairment (BCVA < 0.5), and severe visual impairment (BCVA < 0.3). Fundus photographs were graded for presence of retinal or subretinal hemorrhages. Information on AP/AC medication was obtained through interview. Logistic regression analysis was used to determine associations between AP/AC medication and outcomes. Frequency of hemorrhages in users and non-users stratified for visual acuity categories was analyzed with ANCOVA.

MAIN OUTCOME MEASURES

BCVA and presence of hemorrhages.

RESULTS

In total, 40.9% of the patients used AP/AC medication, of which 73.3% was aspirin. AP/AC use was not associated with visual impairment (adjusted odds ratio [OR] 0.79; 95% confidence interval [CI] 0.43-1.44) or severe visual impairment (adjusted OR 0.75; 95% CI 0.40-1.43). Patients on AP/AC presented with comparable frequencies of hemorrhages (27% vs 32%, P = .32, respectively). Similar results were found when analyses were restricted to aspirin users only.

CONCLUSION

In our study, use of AP/AC medication was associated neither with visual decline nor with the occurrence of hemorrhages in patients with active N-AMD.

摘要

目的

确定抗血小板或抗凝(AP/AC)药物的使用是否会影响活动性新生血管性年龄相关性黄斑变性(N-AMD)患者的视力。

设计

对一项随机对照试验数据的回顾性分析。

方法

地点:多中心。

研究人群

来自 BRAMD 研究的 330 名活动性 N-AMD 患者,这是荷兰贝伐单抗和雷珠单抗的比较试验。

观察程序

患者接受了全面的眼科检查。视力分为功能性视力(最佳矫正视力[BCVA]≥0.5)、视力障碍(BCVA<0.5)和严重视力障碍(BCVA<0.3)。眼底照片根据视网膜或视网膜下出血的存在进行分级。通过访谈获得 AP/AC 药物信息。使用逻辑回归分析确定 AP/AC 药物与结果之间的关联。对按视力类别分层的使用者和非使用者的出血频率进行分析,采用协方差分析(ANCOVA)。

主要观察指标

BCVA 和出血情况。

结果

共有 40.9%的患者使用了 AP/AC 药物,其中 73.3%为阿司匹林。AP/AC 使用与视力障碍(调整后的优势比[OR]0.79;95%置信区间[CI]0.43-1.44)或严重视力障碍(调整后的 OR 0.75;95% CI 0.40-1.43)无关。服用 AP/AC 的患者出血频率相似(分别为 27%和 32%,P=0.32)。当仅分析阿司匹林使用者时,也得到了类似的结果。

结论

在我们的研究中,AP/AC 药物的使用与活动性 N-AMD 患者的视力下降或出血发生均无关。

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