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房水生物标志物与康柏西普治疗糖尿病性黄斑水肿的真实世界疗效:一项针对老年患者的前瞻性研究

Aqueous-humor biomarkers and real-world efficacy of conbercept for diabetic macular edema: a prospective study in elderly patients.

作者信息

Xie Min

机构信息

Department of Ophthalmology, Luzhou Maternal and Child Health-Care Hospital, Luzhou, Sichuan, China.

Department of Ophthalmology, Luzhou Second People's Hospital, Luzhou, Sichuan, China.

出版信息

Front Endocrinol (Lausanne). 2025 Jul 7;16:1632878. doi: 10.3389/fendo.2025.1632878. eCollection 2025.

Abstract

BACKGROUND

To evaluate real-world efficacy of conbercept and the predictive value of aqueous-humor biomarkers in elderly diabetic macular edema (DME).

METHODS

In this single-arm, prospective study, 150 patients ≥ 65 years received three monthly conbercept injections followed by pro-re-nata dosing over 6 months. Baseline vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) levels were quantified from aqueous humor; best-corrected visual acuity (BCVA) and central subfield thickness (CST) were monitored. Mixed-effects modelling and receiver-operating-characteristic (ROC) analysis explored associations between biomarkers and outcomes.

RESULTS

Mean BCVA improved by approximately nine ETDRS letters, and CST declined by about 85 µm at Month 6. Higher baseline VEGF and IL-6 were associated with greater CST reduction and moderately increased odds of a ≥ 15-letter gain; VEGF showed fair discriminative ability (AUC=0.74). Treatment was well-tolerated, with no unexpected ocular or systemic adverse events.

CONCLUSION

Conbercept produced meaningful anatomical and functional benefits in an elderly DME cohort. Baseline aqueous VEGF and IL-6, while not definitive stand-alone tests, may help identify eyes likely to achieve pronounced anatomical improvement and warrant further investigation as components of a multi-marker predictive panel.

摘要

背景

评估康柏西普在老年糖尿病性黄斑水肿(DME)中的实际疗效以及房水生物标志物的预测价值。

方法

在这项单臂前瞻性研究中,150例年龄≥65岁的患者接受了每月3次的康柏西普注射,随后在6个月内按需给药。从房水中定量检测基线血管内皮生长因子(VEGF)和白细胞介素-6(IL-6)水平;监测最佳矫正视力(BCVA)和中心子野厚度(CST)。采用混合效应模型和受试者工作特征(ROC)分析来探索生物标志物与结局之间的关联。

结果

在第6个月时,平均BCVA提高了约9个ETDRS字母,CST下降了约85µm。较高的基线VEGF和IL-6水平与CST更大程度的降低以及≥15字母增益的几率适度增加相关;VEGF具有较好的鉴别能力(AUC=0.74)。治疗耐受性良好,未出现意外的眼部或全身不良事件。

结论

康柏西普在老年DME队列中产生了有意义的解剖学和功能效益。基线房水VEGF和IL-6虽然不是确定性的独立检测指标,但可能有助于识别可能实现显著解剖学改善的眼睛,作为多标志物预测组的组成部分值得进一步研究。

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