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玻璃体内注射布罗珠单抗治疗糖尿病性黄斑水肿后的真实世界转归,包括眼内炎症。

Real-world outcomes, including intraocular inflammation, after intravitreal brolucizumab for diabetic macular edema.

作者信息

Hirano Takao, Chiku Yoshiaki, Hoshiyama Ken, Takahashi Yoshiaki, Ito Shun, Murata Toshinori

机构信息

Department of Ophthalmology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.

Department of Ophthalmology, Omachi Municipal General Hospital, Nagano, Japan.

出版信息

Jpn J Ophthalmol. 2025 Jun 12. doi: 10.1007/s10384-025-01226-y.

DOI:10.1007/s10384-025-01226-y
PMID:40500587
Abstract

PURPOSE

This study aimed to assess the real-world outcomes, including intraocular inflammation (IOI), following administration of intravitreal brolucizumab (Beovu 6.0 mg/0.05 mL; Novartis) injections (IVBr) for diabetic macular edema (DME).

STUDY DESIGN

Retrospective study.

METHODS

A total of 56 eyes of 47 patients with DME were treated with IVBr for a minimum follow-up of at least 6 months between May 2022 and November 2023. A "non-strict pro re nata" dosing protocol for IVBr was used. The best corrected visual acuity (BCVA), central macular thickness (CMT), at baseline, 6 months, 1 year, and the latest visit date and IVBr frequency were assessed to evaluate the treatment efficacy. IOI incidence, baseline characteristics of patients with IOI, and treatment course were investigated.

RESULTS

BCVA significantly improved at 6 months and at the latest visit compared to baseline (P = 0.008 and 0.006, respectively). CMT was significantly thinner at 6 months, 1 year, and the latest visit compared to baseline (all, P < 0.001). In 46 eyes followed for more than 1 year, the number of IVBr from baseline to 1 year was 3.8 ± 1.9. Four eyes (7.1%) of four patients (8.5%) developed IOI during the observation period. All patients were women, with an average age of 70.8 ± 9.0 years (59-81 years). Upon IOI diagnosis, all patients received posterior sub-Tenon's triamcinolone acetonide and topical betamethasone sodium phosphate, resulting in rapid resolution.

CONCLUSION

IOI developed in four of 56 (7.1%) eyes and responded well to prompt steroid therapy after 1.5 years of IVBr use for DME. BCVA and CMT improved at all evaluation time points. With an average of 3.8 IVBr injections per year, IVBr showed long-term efficacy for DME in the real-world setting, although the occurrence of IOI should be monitored.

摘要

目的

本研究旨在评估玻璃体内注射布罗珠单抗(Beovu 6.0 mg/0.05 mL;诺华公司)治疗糖尿病性黄斑水肿(DME)后的实际疗效,包括眼内炎症(IOI)情况。

研究设计

回顾性研究。

方法

2022年5月至2023年11月期间,共对47例DME患者的56只眼进行了玻璃体内注射布罗珠单抗治疗,随访时间至少6个月。采用“非严格按需”给药方案。评估基线、6个月、1年及最近一次就诊时的最佳矫正视力(BCVA)、中心黄斑厚度(CMT)以及玻璃体内注射布罗珠单抗的频率,以评估治疗效果。调查IOI的发生率、发生IOI患者的基线特征及治疗过程。

结果

与基线相比,6个月及最近一次就诊时BCVA显著改善(P值分别为0.008和0.006)。与基线相比,6个月、1年及最近一次就诊时CMT显著变薄(均P<0.001)。在随访超过1年的46只眼中,从基线到1年的玻璃体内注射布罗珠单抗次数为3.8±1.9次。4例患者(8.5%)的4只眼(7.1%)在观察期内发生了IOI。所有患者均为女性,平均年龄70.8±9.0岁(59 - 81岁)。IOI确诊后,所有患者均接受了后Tenon囊下曲安奈德注射及局部应用倍他米松磷酸钠,炎症迅速消退。

结论

在使用玻璃体内注射布罗珠单抗治疗DME 1.5年后,56只眼中有4只(7.1%)发生了IOI,且对及时的类固醇治疗反应良好。在所有评估时间点,BCVA和CMT均有所改善。尽管应监测IOI的发生,但在实际应用中,玻璃体内注射布罗珠单抗平均每年注射3.8次,对DME显示出长期疗效。

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