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玻璃体内注射雷珠单抗和阿柏西普治疗糖尿病性黄斑水肿患者的三年结局:一项比较研究。

Three year outcomes of intravitreal ranibizumab and aflibercept treatment of patients with diabetic macular edema: A comparative study.

作者信息

Akbas Yusuf Berk, Alagoz Cengiz, Cakmak Semih, Demir Gokhan, Alagoz Nese, Artunay Halil Ozgur

机构信息

University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Olimpiyat Bulvari Yolu, Basaksehir, Istanbul 34480, Turkey.

University of Health Sciences, Beyoğlu Eye Training and Research Hospital, Istanbul, Turkey.

出版信息

Ther Adv Ophthalmol. 2023 Aug 28;15:25158414231195174. doi: 10.1177/25158414231195174. eCollection 2023 Jan-Dec.

Abstract

BACKGROUND

Diabetic macular edema (DME) is the most common cause of visual deterioration in patients with diabetes mellitus. Various treatment options have been used for DME, including intravitreal injection of steroids and anti-vascular endothelial growth factors.

OBJECTIVES

To evaluate and compare the functional and anatomical outcomes of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) treatments in patients with DME.

DESIGN

Retrospective study.

METHODS

Four hundred three eyes of 235 naïve patients who underwent IVR or IVA treatment for DME followed up to 36 months included in the study. Best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline, year 1, 2 and 3. Primary endpoint of the study was the change in BCVA and CMT each year from baseline and requirement of additional treatment (laser/steroid injection).

RESULTS

There were 198 eyes in IVR group and 205 eyes in IVA group. The changes in mean BCVA were 0.09 ± 0.32 0.17 ± 0.41 Logarithm of the minimum angle of resolution (logMAR) ( = 0.042) at year 1, 0.09 ± 0.37 0.12 ± 0.45 logMAR ( = 0.512) at year 2 and 0.13 ± 0.36 0.15 ± 0.48 logMAR ( = 0.824) at year 3 in IVA and IVR groups, respectively. The baseline mean BCVA were lower ( = 0.004) in IVA group. The mean total number of injections was 7.93 ± 3.38 7.42 ± 3.05 ( = 0.112).

CONCLUSION

At year 1, change in mean BCVA was statistically significantly higher in IVA group; however this difference did not persist at years 2 and 3. Although the mean total number of injections was similar between groups, the requirement for adjuvant steroid treatment was significantly higher in ranibizumab group, which may affect the number of visits and treatment costs. Both ranibizumab and aflibercept treatments achieved a good long-term visual and anatomical response in DME patients.

摘要

背景

糖尿病性黄斑水肿(DME)是糖尿病患者视力下降的最常见原因。DME有多种治疗选择,包括玻璃体内注射类固醇和抗血管内皮生长因子。

目的

评估和比较玻璃体内注射雷珠单抗(IVR)和阿柏西普(IVA)治疗DME患者的功能和解剖学结果。

设计

回顾性研究。

方法

纳入235例初治患者的403只眼,这些患者接受了IVR或IVA治疗DME,并随访36个月。在基线、第1年、第2年和第3年测量最佳矫正视力(BCVA)和中心黄斑厚度(CMT)。研究的主要终点是每年BCVA和CMT相对于基线的变化以及额外治疗(激光/类固醇注射)的需求。

结果

IVR组有198只眼,IVA组有205只眼。在第1年,IVA组和IVR组平均BCVA的变化分别为0.09±0.32和0.17±0.41最小分辨角对数(logMAR)(P = 0.042);在第2年,分别为0.09±0.37和0.12±0.45 logMAR(P = 0.512);在第3年,分别为0.13±0.36和0.15±0.48 logMAR(P = 0.824)。IVA组的基线平均BCVA较低(P = 0.004)。平均注射总次数为7.93±3.38和7.42±3.05(P = 0.112)。

结论

在第1年,IVA组平均BCVA的变化在统计学上显著更高;然而,这种差异在第2年和第3年并未持续。尽管两组间平均注射总次数相似,但雷珠单抗组辅助类固醇治疗的需求显著更高,这可能会影响就诊次数和治疗费用。雷珠单抗和阿柏西普治疗在DME患者中均取得了良好的长期视觉和解剖学反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a7a3/10464826/fca77b0c00eb/10.1177_25158414231195174-fig1.jpg

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