Suppr超能文献

治疗和延长玻璃体腔内布罗鲁单抗治疗新生血管性黄斑水肿和转换治疗患者的疗效和安全性:一年随访研究。

Efficacy and safety of treat-and-extend intravitreal brolucizumab in naive and switched patients with macular neovascularization: one-year follow-up study.

机构信息

Ophthalmology Unit, Surgical Department, A.O. Ordine Mauriziano, Turin, Italy.

Ophthalmology Unit, Surgical Department, ASL TO5, Chieri, Italy.

出版信息

BMC Ophthalmol. 2024 Oct 4;24(1):436. doi: 10.1186/s12886-024-03706-0.

Abstract

BACKGROUND

to analyze, at one year, the efficacy and safety of treat-and-extend (T&E) intravitreal (IV) Brolucizumab in patients affected by macular neovascularization (MNV). Both naïve and previously treated (i.e., switched) patients were included, and the data from the two groups were compared.

METHODS

anatomical (i.e., central subfoveal thickness, CST; presence of fluid), functional (i.e., best corrected visual acuity, BCVA) and treatment-related (i.e., number of IV injections within the study period; number of patients reaching a 12-weeks interval between treatments) data from 41 eyes of 41 subjects (20 naïve and 21 switched) were analyzed. Patients were treated with 3 monthly IV injections followed by a T&E regimen based on a disease activity assessment performed at each scheduled IV treatment.

RESULTS

significant CST reduction (from 412.1 ± 115.8 to 273.2 ± 61.6; p < 0.05) and BCVA (mean; p) improvement were observed in the naïve group, while in the switched cohort, both parameters were almost stable. In the naïve and switched groups, 55% and 33.5% of patients, respectively, reached a 12-week IV interval at one year, with a mean of 6.55 ± 1 and 7.43 ± 0.68 IV treatments, respectively. One patient with mild anterior uveitis without sequelae was recorded.

CONCLUSION

In patients with MNV, IV Brolucizumab injections following a T&E regimen demonstrated great efficacy and a good safety profile, with greater anatomical and functional results in naïve patients.

TRIAL REGISTRATION

This study was approved by the Local Ethics Committee (protocol number 155/2020, general registry number n°11486, InterHospital Ethics Committee, San Luigi Gonzaga Hospital, Orbassano, Italy).

摘要

背景

分析一年时,贝伐珠单抗单抗治疗及随访(T&E)玻璃体腔内注射治疗新生血管性黄斑水肿(MNV)的疗效和安全性。纳入初治和(即转换)患者,比较两组数据。

方法

分析 41 例 41 眼患者(20 例初治,21 例转换)的解剖学(即中央视网膜厚度,CST;是否存在积液)、功能(即最佳矫正视力,BCVA)和治疗相关(即研究期间内 IV 注射次数;达到每 12 周治疗间隔的患者数)数据。患者接受 3 次每月的 IV 注射,随后根据每次预定 IV 治疗时的疾病活动评估进行 T&E 治疗。

结果

初治组 CST 显著降低(从 412.1±115.8 降至 273.2±61.6;p<0.05)和 BCVA 改善(均值;p),而转换组两项参数基本稳定。在初治和转换组中,分别有 55%和 33.5%的患者在一年时达到 12 周 IV 间隔,平均 IV 治疗次数分别为 6.55±1 和 7.43±0.68。记录到 1 例无后遗症的轻度前葡萄膜炎患者。

结论

在 MNV 患者中,贝伐珠单抗单抗 T&E 方案的 IV 注射显示出良好的疗效和安全性,初治患者具有更好的解剖学和功能结果。

试验注册

本研究得到当地伦理委员会(方案编号 155/2020,总注册号 11486,InterHospital Ethics Committee,San Luigi Gonzaga Hospital,Orbassano,意大利)的批准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579d/11452950/e16ad6c5e788/12886_2024_3706_Fig1_HTML.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验