玻璃体内注射Brolucizumab治疗新生血管性年龄相关性黄斑变性的短期安全性和有效性:一项多中心回顾性真实世界研究

IF 2.1 4区 医学 Q2 OPHTHALMOLOGY Ophthalmologica Pub Date : 2023-01-01 Epub Date: 2023-01-31 DOI:10.1159/000529410
Dong Ju Kim, Ki Won Jin, Jeong Mo Han, Seung Hyun Lee, Yong Seok Park, Joo Yong Lee, Eun Kyoung Lee, Jun Sung Lee, Seong Taeck Kim, Min Ho Shin, Christopher Seungkyu Lee, Hyun Ho Jung, Jae Yong Jang, Min Kim, Yung Hui Kim, Jae Hui Kim, Kyu Hyung Park, Sang Jun Park, Kwangsic Joo, Yong Sok Ji, Min Sagong, Se Joon Woo
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引用次数: 1

摘要

该研究的目的是确定韩国新生血管性年龄相关性黄斑变性(nAMD)患者玻璃体内注射brolucizumab的短期安全性和有效性。方法:本多中心回顾性研究涉及韩国13家医院或视网膜中心290例患者的294只眼(治疗naïve 20只眼[6.8%],未治疗naïve 274只眼[93.2%])。纳入在2021年4月1日至11月30日期间接受brolucizumab注射的nAMD患者,随访≥1个月。主要结局是安全性、眼内炎症(IOI)发生率和潜在危险因素。次要结果是疗效,即最佳矫正视力(BCVA)和光学相干断层扫描测量的黄斑厚度和视网膜液的变化。结果:平均年龄71.63±8.66岁。随访时间为2.38±0.79个月。随访期间平均注射单抗次数为1.52±0.58次。IOI的总发生率为13.9% (n = 41眼)。以前葡萄膜炎为主(8.8%,26眼),其次为视网膜血管炎(2.4%,7眼)和视网膜闭塞性血管炎(0.3%,1眼)。在随访中,大多数眼在接受或不接受皮质类固醇治疗时出现IOI消退(n = 40, 97.5%)和BCVA恢复(n = 39, 95.1%)。年龄、性别、IOI史或其他抗血管内皮生长因子注射史与IOI的发生无关。然而,只有较薄的中央凹下脉络膜厚度(SFCT)与IOI的发生相关(优势比= 0.995,p = 0.020)。1个月时BCVA较基线改善(基线0.518±0.356 vs. 1个月0.503±0.383,p = 0.023),但改善未维持。3个月后解剖改善明显。结论:在韩国的nAMD患者中,brolucizumab注射后的IOI发生率为13.9%。无论是否使用类固醇治疗,IOI都得到了很好的控制。术后绝大多数(95.1%)眼视力恢复到术前水平。IOI的发生和闭塞性血管炎很少见。在短期内,注射brolucizumab可有效改善1个月的视力,干燥视网膜液3个月。
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Short-Term Safety and Efficacy of Intravitreal Brolucizumab Injections for Neovascular Age-Related Macular Degeneration: A Multicenter Retrospective Real-World Study.

Introduction: The aim of the study was to determine the short-term real-world safety and efficacy of intravitreal brolucizumab injections in Korean patients with neovascular age-related macular degeneration (nAMD).

Methods: This multicenter retrospective study involved 294 eyes (treatment naïve 20 eye [6.8%] and nontreatment naïve 274 eyes [93.2%]) of 290 patients from 13 hospitals or retinal centers in South Korea. Patients with nAMD who received brolucizumab injection(s) between April 1 and November 30, 2021, with a follow-up ≥1 month, were included. Primary outcomes were safety, incidence of intraocular inflammation (IOI), and potential risk factors. The secondary outcome was efficacy, i.e., change in best-corrected visual acuity (BCVA) and optical coherence tomography-measured macular thickness and retinal fluid.

Results: The mean age was 71.63 ± 8.66. The follow-up period was 2.38 ± 0.79 months. The mean number of brolucizumab injections during the follow-up was 1.52 ± 0.58. The overall incidence of IOI was 13.9% (n = 41 eyes). Most IOI cases were of anterior uveitis (8.8%, 26 eyes), followed by retinal vasculitis (2.4%, seven eyes) and occlusive retinal vasculitis (0.3%, one eye). Most eyes showed IOI resolution (n = 40, 97.5%) and BCVA restoration (n = 39, 95.1%) with or without corticosteroid treatment during the follow-up. Age, sex, IOI history, or other anti-vascular endothelial growth factor injection histories were not associated with the occurrence of IOI. However, only thin subfoveal choroidal thickness (SFCT) was associated with the occurrence of IOI (odds ratio = 0.995, p = 0.020). BCVA at 1 month improved from baseline (baseline 0.518 ± 0.356 vs. 1 month 0.503 ± 0.383, p = 0.023), but the improvement was not maintained. Anatomical improvement was significant after 3 months.

Conclusion: In Korean patients with nAMD, the incidence of IOI following brolucizumab injections was 13.9%. IOI was well-controlled with or without steroid treatment. Most IOI eyes (95.1%) were restored to the level of vision before. IOI occurrence and occlusive vasculitis was rare. In the short term, brolucizumab injection effectively improved vision at 1 month and dried retinal fluid for 3 months.

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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.
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