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玻璃体内注射康柏西普治疗中度至重度非增殖性糖尿病视网膜病变的疗效和安全性。

Efficacy and safety of intravitreal injection of conbercept for moderate to severe nonproliferative diabetic retinopathy.

作者信息

Shen Lu, Zheng Yuxiang, Gao Zelan, Li Qirui, Dai Min, Yang Wenchang, Zhang Qiying, Li Dongli, Hu Yijun, Yuan Ling

机构信息

Department of Ophthalmology, The First Affiliated Hospital of Kunming Medical University, Kunming, China.

Department of Ophthalmology, Yan'an Hospital of Kunming City, Kunming, China.

出版信息

Front Med (Lausanne). 2024 May 23;11:1394358. doi: 10.3389/fmed.2024.1394358. eCollection 2024.

Abstract

PURPOSE

This study aimed to assess the effectiveness and safety of intravitreal injection of conbercept (IVC) in treating moderate to severe nonproliferative diabetic retinopathy (NPDR), with or without accompanying diabetic macular edema.

METHODS

In this longitudinal retrospective study, 35 patients (50 eyes) with moderate to severe NPDR and Diabetic Retinopathy Severity Scale (DRSS) scores between 43 and 53 were treated at the Department of Ophthalmology, First Affiliated Hospital of Kunming Medical University, from October 2018 to January 2023. Treatment protocol included three monthly IVC injections followed by a (PRN) regimen over a two-year follow-up period. Outcome measures were best-corrected visual acuity (BCVA), intraocular pressure, central macular thickness (CMT), extent of hard exudate (HE), and changes in DRSS scores. DRSS scores before and after treatment were analyzed using the Wilcoxon rank-sum test. Both systemic and ocular adverse events were meticulously documented to ascertain safety.

RESULTS

From baseline to the final follow-up, the mean BCVA improved from 0.41 ± 0.39 to 0.23 ± 0.20 logMAR (<0.05). The mean CMT decreased from 306.22 ± 77.40 to 297.97 ± 88.15 μm ( = 0.385). At 24 months, DRSS scores improved by ≥1 stage in 40 eyes (80%), ≥ 2 stages in 28 eyes (56%), ≥3 stages in 10 eyes (20%), and remained stable in 6 eyes (12%). The DRSS scores at each follow-up interval demonstrated statistically significant improvement from baseline (<0.05). In 15 of 27 eyes (55.56%) with diabetic macular edema (DME), there was a significant reduction in the mean area of HE from baseline (<0.05). No serious systemic adverse events were observed.

CONCLUSION

IVC is an effective and safe treatment for moderate to severe NPDR, demonstrating significant improvements in DRSS scores.

摘要

目的

本研究旨在评估玻璃体内注射康柏西普(IVC)治疗中度至重度非增殖性糖尿病视网膜病变(NPDR)(无论是否伴有糖尿病性黄斑水肿)的有效性和安全性。

方法

在这项纵向回顾性研究中,2018年10月至2023年1月期间,昆明医科大学第一附属医院眼科对35例(50只眼)中度至重度NPDR且糖尿病视网膜病变严重程度量表(DRSS)评分在43至53之间的患者进行了治疗。治疗方案包括每月进行3次IVC注射,随后在两年的随访期内采用按需(PRN)治疗方案。观察指标包括最佳矫正视力(BCVA)、眼压、中心黄斑厚度(CMT)、硬性渗出(HE)范围以及DRSS评分的变化。使用Wilcoxon秩和检验分析治疗前后的DRSS评分。详细记录全身和眼部不良事件以确定安全性。

结果

从基线到最终随访,平均BCVA从0.41±0.39提高到0.23±0.20 logMAR(P<0.05)。平均CMT从306.22±77.40降至297.97±88.15μm(P = 0.385)。在24个月时,40只眼(80%)的DRSS评分改善≥1级,28只眼(56%)改善≥2级,10只眼(20%)改善≥3级,6只眼(12%)保持稳定。每个随访间隔的DRSS评分与基线相比均有统计学显著改善(P<0.05)。在27只患有糖尿病性黄斑水肿(DME)的眼中,有15只眼(55.56%)的平均HE面积与基线相比有显著减少(P<0.05)。未观察到严重的全身不良事件。

结论

IVC是治疗中度至重度NPDR的一种有效且安全的方法,可使DRSS评分有显著改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b620/11153662/a8ffcbc2c11e/fmed-11-1394358-g001.jpg

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