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降低眼压药物预防玻璃体内抗血管内皮生长因子注射后眼压峰值的随机临床试验

Randomized Clinical Trial of Intraocular Pressure-Lowering Medications on Preventing Spikes in Intraocular Pressure Following Intravitreal Anti-Vascular Endothelial Growth Factor Injections.

作者信息

Soomsawasdi Piriya, Rojananuangnit Kulawan, Arayangkoon Eakkachai, Chantiwas Ratchada, Pengrungreungwong Sureeporn, Preawsampran Nontakorn, Tinpowong Natnaree, Samakhararaksakul Rujira, Katkingkaew Kanokwan, Seekhum Natthapuch, Sathim Wanwisa

机构信息

Department of Ophthalmology, Mettapracharak (Wat Rai Khing) Hospital, 52 Moo 2 Rai Khing Sam Pran, Nakhon Pathom, 73210, Thailand.

出版信息

Ophthalmol Ther. 2025 Feb;14(2):351-362. doi: 10.1007/s40123-024-01081-z. Epub 2024 Dec 18.

Abstract

INTRODUCTION

Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents are a primary management option for retinal diseases. Acute elevation of intraocular pressure (IOP) is a complication associated with these injections that should be considered. This study investigated and compared the prophylactic effects of fixed combination anti-glaucoma medication on IOP spikes following intravitreal anti-VEGF injections.

METHODS

This randomized double-blind clinical trial included one eye of each participant indicated for treatment with intravitreal injection of anti-VEGF agents (bevacizumab, aflibercept, and ranibizumab) and randomly allocated to one of the three prophylactic anti-glaucoma medications, with each drug further divided into one- and two-drop regimens before intravitreal injection. Participants with allergies or contraindications to medications were excluded from the pretreatment groups and were invited to participate in the control group.

RESULTS

The study involved 308 participants: 89 in the dorzolamide/timolol group, 86 in the brimonidine/timolol group, 101 in the brinzolamide/brimonidine group, and 32 in the control group. Baseline characteristics and IOP were comparable across all groups. In the prophylactic premedication groups, mean IOP at 30 min were within 21 mmHg and returned to their baseline at 1 h. Mean IOP measurements between baseline and 30 min in the brimonidine/timolol two-drop regimen were not significantly different: 13.72 ± 4.63 vs 15.11 ± 4.39 mmHg, p = 0.096. In the control group, IOP significantly increased from baseline at 30 min and 1 h post-injection: 14.31 ± 4.10, 22.15 ± 8.64, and 18.36 ± 7.52 mmHg, respectively, p < 0.001.

CONCLUSION

Topical fixed combination anti-glaucoma medication used as a prophylactic treatment before intravitreal anti-VEGF injections significantly prevented IOP spikes post-injection, with a comparable effect among three medications. Prophylactic treatment of IOP spikes should be considered as standard care to prevent further damage in patients with compromised retinal vascular and optic nerve perfusion.

TRIAL REGISTRATION

TCTR20241005001, retrospectively registered.

摘要

引言

玻璃体内注射抗血管内皮生长因子(anti-VEGF)药物是视网膜疾病的主要治疗选择。眼内压(IOP)急性升高是这些注射相关的一种并发症,应予以考虑。本研究调查并比较了固定复方抗青光眼药物对玻璃体内注射抗VEGF药物后IOP峰值的预防作用。

方法

这项随机双盲临床试验纳入了每一位拟接受玻璃体内注射抗VEGF药物(贝伐单抗、阿柏西普和雷珠单抗)治疗的参与者的一只眼睛,并随机分配至三种预防性抗青光眼药物之一,每种药物在玻璃体内注射前再分为一滴和两滴给药方案。对药物过敏或有用药禁忌的参与者被排除在预处理组之外,并受邀参加对照组。

结果

该研究纳入了308名参与者:多佐胺/噻吗洛尔组89名,溴莫尼定/噻吗洛尔组86名,布林佐胺/溴莫尼定组101名,对照组32名。所有组的基线特征和IOP具有可比性。在预防性预处理组中,30分钟时的平均IOP在21 mmHg以内,并在1小时时恢复到基线水平。溴莫尼定/噻吗洛尔两滴给药方案在基线和30分钟之间的平均IOP测量值无显著差异:分别为13.72±4.63 mmHg和15.11±4.39 mmHg,p = 0.096。在对照组中,注射后30分钟和1小时时IOP较基线显著升高:分别为14.31±4.10、22.15±8.64和18.36±7.52 mmHg,p < 0.001。

结论

玻璃体内注射抗VEGF药物前使用局部固定复方抗青光眼药物进行预防性治疗可显著预防注射后IOP峰值,三种药物的效果相当。IOP峰值的预防性治疗应被视为标准治疗,以防止视网膜血管和视神经灌注受损患者受到进一步损害。

试验注册

TCTR20241005001,回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35a6/11754773/6ef7a2064da7/40123_2024_1081_Fig1_HTML.jpg

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