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玻璃体内抗血管内皮生长因子药物对眼压的真实世界影响:利用 IRIS 注册研究进行的分析。

The Real-World Effect of Intravitreous Anti-Vascular Endothelial Growth Factor Drugs on Intraocular Pressure: An Analysis Using the IRIS Registry.

机构信息

Department of Ophthalmology, Rush University Medical Center, Chicago, Illinois.

American Academy of Ophthalmology, San Francisco, California.

出版信息

Ophthalmology. 2018 May;125(5):676-682. doi: 10.1016/j.ophtha.2017.11.027. Epub 2018 Jan 11.

DOI:10.1016/j.ophtha.2017.11.027
PMID:29336897
Abstract

PURPOSE

To identify sustained differences in intraocular pressure (IOP) after intravitreous injections of anti-vascular endothelial growth factor (VEGF) drugs.

DESIGN

Database study.

PARTICIPANTS

Patients seeing an ophthalmic provider who contributes to the database.

METHODS

We identified a total of 23 776 unique patients who received only a single type of anti-VEGF medication (bevacizumab, aflibercept, or ranibizumab) by injection in the right eye in the American Academy of Ophthalmology Intelligent Research in Sight Registry. Subgroups included patients with age-related macular degeneration only and patients who had not received an anti-VEGF injection for at least 1 year before the study. We examined those with at least 12, 18, and 25 injections for each of these 3 medications. For all groups, we used fellow, untreated eyes for comparison.

MAIN OUTCOME MEASURES

The mean change in IOP from baseline at a minimum of 1 year of follow-up and the proportion of eyes with a clinically significant IOP increase (defined as sustained rise of at least 6 mmHg to an IOP of more than 21 mmHg).

RESULTS

All patients in all groups receiving all drugs showed a decrease in IOP from baseline, with a mean of 0.9 mmHg in treated eyes compared with an average decrease of 0.2 mmHg in fellow untreated eyes, a statistically significant difference. A generalized linear model accounting for confounders associated bevacizumab with slightly less lowering of IOP than aflibercept and ranibizumab in most subgroups. A clinically significant IOP increase was seen in 2.6% of eyes receiving injections compared with 1.5% in the associated untreated fellow eyes. Clinically significant IOP increases occurred at a rate of 1.9%, 2.8%, and 2.8% for aflibercept, ranibizumab, and bevacizumab, respectively, which was significantly higher than untreated fellow eyes for bevacizumab and ranibizumab, but not for aflibercept.

CONCLUSIONS

These analyses from real-world data indicate that anti-VEGF intravitreous injections are associated with a small but statistically significant decrease in IOP over time. A proportion of patients, on average 2.6%, experienced a sustained clinically significant IOP rise with these drugs overall compared with 1.5% in the fellow untreated eyes. However, such an increase was not seen with aflibercept.

摘要

目的

确定玻璃体内注射抗血管内皮生长因子(VEGF)药物后眼内压(IOP)持续差异。

设计

数据库研究。

参与者

向参与数据库的眼科提供者就诊的患者。

方法

我们在眼科协会智能研究视野登记处共确定了 23776 名仅在右眼接受单一类型抗 VEGF 药物(贝伐单抗、阿柏西普或雷珠单抗)注射的患者。亚组包括仅患有年龄相关性黄斑变性的患者和在研究前至少 1 年未接受抗 VEGF 注射的患者。我们对至少接受过 12、18 和 25 次注射的这 3 种药物的患者进行了检查。对于所有组,我们使用未治疗的对侧眼进行比较。

主要观察指标

至少 1 年随访时从基线开始的 IOP 平均变化以及具有临床显著 IOP 升高的眼的比例(定义为持续升高至少 6mmHg 至 IOP 超过 21mmHg)。

结果

所有组的所有患者在接受所有药物治疗后 IOP 均较基线下降,治疗眼平均下降 0.9mmHg,而未治疗对侧眼平均下降 0.2mmHg,差异具有统计学意义。考虑到与贝伐单抗相关的混杂因素,广义线性模型显示,在大多数亚组中,贝伐单抗对 IOP 的降低作用略低于阿柏西普和雷珠单抗。与相关未治疗对侧眼相比,接受注射治疗的眼睛中有 2.6%出现临床显著的 IOP 升高,而未治疗的对侧眼为 1.5%。阿柏西普、雷珠单抗和贝伐单抗的临床显著 IOP 升高率分别为 1.9%、2.8%和 2.8%,与未治疗的对侧眼相比,贝伐单抗和雷珠单抗的升高率显著更高,但阿柏西普则不然。

结论

这些来自真实世界数据的分析表明,抗 VEGF 玻璃体内注射随时间推移与眼压的小但具有统计学意义的降低有关。与未治疗的对侧眼相比,这些药物的总体平均比例为 2.6%的患者出现持续的临床显著 IOP 升高,而未治疗的对侧眼为 1.5%。然而,阿柏西普并未出现这种情况。

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