玻璃体内法尼单抗治疗新生血管性老年黄斑变性、糖尿病性黄斑水肿和视网膜静脉闭塞的有效性和安全性:一项 Meta 分析。

IF 2.1 4区 医学 Q2 OPHTHALMOLOGY Ophthalmologica Pub Date : 2024-10-03 DOI:10.1159/000541662
Prem A H Nichani, Marko M Popovic, Andrew Mihalache, Ananya Pathak, Rajeev H Muni, David T W Wong, Peter J Kertes
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引用次数: 0

摘要

导言:玻璃体内抗血管内皮生长因子(VEGF)疗法已成为许多视网膜疾病的主要治疗方法。新型双特异性抗血管内皮生长因子/血管生成素 2(Ang2)药物在治疗范例中与广泛使用的单特异性抗血管内皮生长因子药物的疗效和安全性比较仍不清楚:对MEDLINE、Embase和Cochrane图书馆进行了系统性文献检索,以确定2015年至2024年7月期间发表的比较观察性研究和随机对照试验。经三位独立审稿人评估后,纳入了评估法尼单抗与单特异性抗血管内皮生长因子药物治疗 FDA 规定的视网膜疾病的原始英文同行评议全文文章,这些文章至少包含一组各治疗组的疗效和/或安全性结果数据,且随访期至少 3 个月。采用 Cochrane RoB2 和 ROBINS-I 工具、PRISMA 和 GRADE 指南对数据进行评估。所有结果均在最后一次随访时收集。采用 95% 置信区间 (CI) 进行随机效应荟萃分析,计算加权平均差 (WMD) 和风险比 (RR)。最佳矫正视力(BCVA,ETDRS 字母)的变化、中央子场厚度(CSFT,μm)的变化和视网膜积液的存在是主要终点;眼部不良事件是次要终点:在13项研究中,针对新生血管性老年黄斑变性(nAMD)、糖尿病性黄斑水肿(DME)和视网膜静脉闭塞(RVO),2226只眼睛接受了抗血管内皮生长因子单药治疗,3022只眼睛接受了法替单抗治疗。各治疗组的最终BCVA值和变化情况相似。在 DME 和 RVO 患者中,法尼单抗能显著提高 CSFT 的降低率,而在 nAMD 患者中则不然。各组的眼部不良反应发生率相似:结论:在nAMD、DME和RVO患者中,法尼单抗和抗血管内皮生长因子单药治疗在BCVA方面没有差异。虽然法尼单抗在DME和RVO眼的最终随访中对中央亚视野厚度的改善效果更佳,但在nAMD眼中却未见这种效果。未来的研究需要确定法尼单抗治疗视网膜血管疾病的长期安全性和有效性。
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Efficacy and Safety of Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion: A Meta-Analysis.

Introduction: Intravitreal anti-vascular endothelial growth factor (VEGF) therapy has become the mainstay of treatment in many retinal diseases. The comparative efficacy and safety of newer bispecific anti-VEGF/angiopoietin 2 (Ang2) agents in the treatment paradigm versus widely used monospecific anti-VEGF agents remains unclear.

Methods: A systematic literature search of MEDLINE, Embase, and Cochrane Library was conducted to identify comparative observational studies and randomized controlled trials published from 2015 to Jul 2024. With assessment by three independent reviewers, original English peer-reviewed full-text articles evaluating faricimab versus monospecific anti-VEGF agent(s) in FDA-indicated retinal disease with data on at least one set of efficacy and/or safety outcomes for each treatment arm and a minimum 3-month follow-up period were included. Data were appraised using the Cochrane RoB2 and ROBINS-I tools, PRISMA, and GRADE guidelines. All outcomes were collected at last follow-up. Random effects meta-analyses with 95% confidence intervals (CI) were conducted to calculate weighted mean differences (WMD) and risk ratios (RR). Change in best-corrected visual acuity (BCVA, ETDRS letters), change in central subfield thickness (CSFT, μm), and presence of retinal fluid were primary endpoints; ocular adverse events were secondary endpoints.

Results: Across 13 studies, in the context of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO), 2226 eyes received anti-VEGF monotherapy and 3022 received faricimab. Final and change in BCVA were similar between treatment groups. Faricimab was associated with a significantly higher reduction in CSFT in DME and RVO eyes but not in nAMD eyes. The incidence of ocular adverse events were similar between groups.

Conclusion: There was no difference in BCVA between faricimab and anti-VEGF monotherapy in nAMD, DME, and RVO. While faricimab offered superior improvement in central subfield thickness at final follow-up for DME and RVO eyes, this effect was not seen in nAMD eyes. Future studies are needed to establish the long-term safety and efficacy of faricimab for retinal vascular disease.

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来源期刊
Ophthalmologica
Ophthalmologica 医学-眼科学
CiteScore
5.10
自引率
3.80%
发文量
39
审稿时长
3 months
期刊介绍: Published since 1899, ''Ophthalmologica'' has become a frequently cited guide to international work in clinical and experimental ophthalmology. It contains a selection of patient-oriented contributions covering the etiology of eye diseases, diagnostic techniques, and advances in medical and surgical treatment. Straightforward, factual reporting provides both interesting and useful reading. In addition to original papers, ''Ophthalmologica'' features regularly timely reviews in an effort to keep the reader well informed and updated. The large international circulation of this journal reflects its importance.
期刊最新文献
Efficacy and Safety of Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion: A Meta-Analysis. Baseline features in Polypoidal Choroidal Vasculopathy in Caucasian patients. Changes of Optical Coherence Tomography Biomarkers after Peeling of Epiretinal Membranes. New Approaches in the Management of Submacular Hemorrhages. Diagnostic work-up of retinal vasculitis: An algorithmic approach.
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