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玻璃体内注射阿柏西普改善糖尿病视网膜病变视网膜无灌注的疗效(AFFINITY研究)

Efficacy of intravitreal AFlibercept injection For Improvement of retinal Nonperfusion In diabeTic retinopathY (AFFINITY study).

作者信息

Kim Yoon Jeon, Yeo Joon Hyung, Son Gisung, Kang Hyojoo, Sung Yu Sub, Lee Joo Yong, Kim June-Gone, Yoon Young Hee

机构信息

Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Department of Ophthalmology, College of Medicine, Chung-Ang University, Seoul, Korea.

出版信息

BMJ Open Diabetes Res Care. 2020 Oct;8(1). doi: 10.1136/bmjdrc-2020-001616.

DOI:10.1136/bmjdrc-2020-001616
PMID:33077475
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7574886/
Abstract

INTRODUCTION

To evaluate the effects of intravitreal aflibercept injection on retinal nonperfusion in patients with diabetic retinopathy (DR) using ultrawide field (UWF) fluorescein angiography (FA).

RESEARCH DESIGN AND METHODS

Thirty-eight eyes of 38 consecutive patients with DR and substantial retinal nonperfusion (nonperfusion index (NPI): nonperfused/total gradable area >0.2) without macular edema were included in this prospective case series. Monthly injections of 2 mg aflibercept were given for 6 months. UWF-fundus photography and UWF-FA images were acquired at baseline, 6 months, and 12 months and evaluated by 2 masked, independent graders for the extent of retinal nonperfusion and vascular leakage. Twenty untreated fellow eyes were analyzed as controls.

RESULTS

Inter-grader agreement was strong (r=0.875) for NPI measurements. NPI was 0.46±0.10 at baseline; NPI was decreased to 0.43±0.08 (p=0.015) after 6 monthly injections of aflibercept and then slightly increased to 0.44±0.09 (p=0.123) after 6 months of observation. Vascular leakage also significantly decreased by 21.0% at 6 months (p=0.010). Untreated fellow eyes did not show significant changes in NPI and vascular leakage during follow-up. Reduction in retinal nonperfusion was associated with severe nonproliferative diabetic retinopathy (NPDR) (vs PDR, OR 19.119, p=0.025) and higher leakage index (per 0.1, OR 15.152, p=0.020).

CONCLUSIONS

Intensive aflibercept treatment was effective in reducing retinal capillary nonperfusion in patients with DR without macular edema. Severe NPDR and profound vascular leakage were significantly associated with retinal reperfusion after aflibercept treatment.

TRIAL REGISTRATION NUMBER

NCT03006081.

摘要

简介

使用超广角(UWF)荧光素血管造影(FA)评估玻璃体内注射阿柏西普对糖尿病视网膜病变(DR)患者视网膜无灌注的影响。

研究设计与方法

本前瞻性病例系列纳入了38例连续的DR患者的38只眼,这些患者有大量视网膜无灌注(无灌注指数(NPI):无灌注/可分级总面积>0.2)且无黄斑水肿。每月注射2mg阿柏西普,共6个月。在基线、6个月和12个月时获取UWF眼底照片和UWF-FA图像,并由2名独立的盲态分级者评估视网膜无灌注和血管渗漏的程度。将20只未经治疗的对侧眼作为对照进行分析。

结果

分级者间对NPI测量的一致性很强(r = 0.875)。基线时NPI为0.46±0.10;每月注射阿柏西普6次后,NPI降至0.43±0.08(p = 0.015),然后在观察6个月后略有增加至0.44±0.09(p = 0.123)。血管渗漏在6个月时也显著降低了21.0%(p = 0.010)。未经治疗的对侧眼在随访期间NPI和血管渗漏未显示出显著变化。视网膜无灌注的减少与严重非增殖性糖尿病视网膜病变(NPDR)相关(与增殖性糖尿病视网膜病变(PDR)相比,OR 19.119,p = 0.025)以及更高的渗漏指数(每0.1,OR 15.152,p = 0.020)。

结论

强化阿柏西普治疗对减少无黄斑水肿的DR患者的视网膜毛细血管无灌注有效。严重NPDR和严重血管渗漏与阿柏西普治疗后的视网膜再灌注显著相关。

试验注册号

NCT03006081。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161e/7574886/acdce0ef90a9/bmjdrc-2020-001616f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161e/7574886/b49cb2bfde5c/bmjdrc-2020-001616f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161e/7574886/e80b50f4e064/bmjdrc-2020-001616f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161e/7574886/acdce0ef90a9/bmjdrc-2020-001616f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161e/7574886/b49cb2bfde5c/bmjdrc-2020-001616f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161e/7574886/e80b50f4e064/bmjdrc-2020-001616f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161e/7574886/acdce0ef90a9/bmjdrc-2020-001616f03.jpg

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