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贝伐珠单抗生物类似药玻璃体腔内注射治疗儿童的初步经验:病例系列和文献复习。

Initial Experience With Biosimilar Bevacizumab-bvzr For Intravitreal Use in Children: A Case Series and Literature Review.

出版信息

Ophthalmic Surg Lasers Imaging Retina. 2023 Feb;54(2):84-88. doi: 10.3928/23258160-20230130-01. Epub 2023 Feb 1.

DOI:10.3928/23258160-20230130-01
PMID:36780635
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10874225/
Abstract

BACKGROUND AND OBJECTIVE

We report our initial experience with intravitreal bevacizumab-bvzr, a bevacizumab biosimilar approved by the US Food and Drug Administration in 2019 and recently introduced by our institution for off-label ophthalmologic use in children.

PATIENTS AND METHODS

This was an Institutional Review Board-approved single-institution retrospective case series of pediatric patients 21 years or younger who received at least one intravitreal injection of biosimilar bevacizumab-bvzr.

RESULTS

Twelve eyes of 9 patients were identified as having received intravitreal bevacizumab-bvzr, with a total of 13 injections performed. Indications for injection included retinopathy of prematurity (7/13), choroidal neovascularization (3/13), retinal vein occlusion (2/13), and Coats disease (1/13). Following injection of bevacizumab-bvzr, all patients experienced a positive clinical response. No occurrences of postinjection inflammation, intraocular pressure anomalies, or endophthalmitis were observed with a median follow-up of 18 weeks.

CONCLUSION

In the absence of controlled studies, this case series supports the use of intravitreal bevacizumab-bvzr as an anti-vascular endothelial growth factor therapy option, including in the pediatric population and resource-poor settings. .

摘要

背景与目的

我们报告了我们在玻璃体腔内使用贝伐单抗-bvzr(一种于 2019 年获得美国食品和药物管理局批准的贝伐单抗生物类似药,最近我们机构引入该药在儿童中进行标签外眼科使用)的初步经验。

患者与方法

这是一项机构审查委员会批准的单机构回顾性病例系列研究,纳入了 21 岁或以下接受至少一次玻璃体腔内生物类似贝伐单抗-bvzr 注射的儿科患者。

结果

共纳入 9 例患者的 12 只眼,共进行了 13 次注射。注射的适应证包括早产儿视网膜病变(7/13)、脉络膜新生血管(3/13)、视网膜静脉阻塞(2/13)和 Coats 病(1/13)。在注射贝伐单抗-bvzr 后,所有患者均出现了阳性的临床反应。在中位随访 18 周时,未观察到注射后炎症、眼内压异常或眼内炎的发生。

结论

在缺乏对照研究的情况下,本病例系列研究支持将玻璃体腔内使用贝伐单抗-bvzr 作为一种抗血管内皮生长因子治疗选择,包括在儿科人群和资源匮乏的环境中使用。