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日本博鲁力单抗治疗后眼内炎症的发生率和危险因素:一项多中心年龄相关性黄斑变性研究。

INCIDENCE AND RISK FACTORS OF INTRAOCULAR INFLAMMATION AFTER BROLUCIZUMAB TREATMENT IN JAPAN: A Multicenter Age-Related Macular Degeneration Study.

机构信息

Department of Ophthalmology, Jichi Medical University, Shimotsuke-shi, Tochigi, Japan.

Department of Ophthalmology and Micro-technology, Yokohama City University Medical Center, Yokohama, Japan.

出版信息

Retina. 2024 Apr 1;44(4):714-722. doi: 10.1097/IAE.0000000000004009.

Abstract

PURPOSE

To investigate the incidence of intraocular inflammation (IOI) and its risk factors following intravitreal injections of brolucizumab for neovascular age-related macular degeneration in Japan.

METHODS

A total of 1,351 Japanese consecutive patients with neovascular age-related macular degeneration who were treated with brolucizumab from May 2020 to May 2022 at 14 institutions were examined. The variables analyzed were the number of brolucizumab injections, time to onset of IOI, and risk factors.

RESULTS

Intraocular inflammation developed in 152 eyes (11.3%). Retinal vasculitis and/or retinal occlusion occurred in 53 eyes (3.9%). Ninety-four patients received bilaterally, bilateral IOI occurred in five patients (5.3%). Sixteen eyes (1.2%) had irreversible visual acuity loss and nine eyes (0.67%) had visual loss of three lines or more due to retinal vasculitis and/or retinal occlusion. The cumulative IOI incidence was 4.5%, 10.3%, and 12.2% at 30, 180, and 365 days (1-year), respectively. History of IOI (including retinal vasculitis) and/or retinal occlusion (odds ratio [OR], 5.41; P = 0.0075) and female sex (OR, 1.99; P = 0.0004) were significantly associated with IOI onset.

CONCLUSION

The 1-year cumulative incidence of IOI in Japanese neovascular age-related macular degeneration patients treated with brolucizumab was 12.2%. History of IOI (including retinal vasculitis) and/or retinal occlusion and female sex were significant risk factors.

摘要

目的

研究玻璃体内注射布罗利珠单抗治疗日本新生血管性年龄相关性黄斑变性后眼内炎症(IOI)的发生率及其危险因素。

方法

对 2020 年 5 月至 2022 年 5 月在 14 家机构接受布罗利珠单抗治疗的 1351 例日本连续新生血管性年龄相关性黄斑变性患者进行检查。分析的变量包括布罗利珠单抗注射次数、IOI 发病时间和危险因素。

结果

152 只眼(11.3%)发生眼内炎症。视网膜血管炎和/或视网膜阻塞发生于 53 只眼(3.9%)。94 例患者接受双侧注射,5 例患者(5.3%)出现双侧 IOI。16 只眼(1.2%)出现不可逆视力丧失,9 只眼(0.67%)因视网膜血管炎和/或视网膜阻塞导致视力丧失 3 行或更多。30、180 和 365 天(1 年)时 IOI 的累积发生率分别为 4.5%、10.3%和 12.2%。IOI 病史(包括视网膜血管炎)和/或视网膜阻塞史(比值比[OR],5.41;P=0.0075)和女性(OR,1.99;P=0.0004)与 IOI 发病显著相关。

结论

日本接受布罗利珠单抗治疗的新生血管性年龄相关性黄斑变性患者 1 年 IOI 的累积发生率为 12.2%。IOI 病史(包括视网膜血管炎)和/或视网膜阻塞史和女性是显著的危险因素。

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