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持续糖尿病性黄斑水肿患者改用阿柏西普治疗的疗效:一项系统评价与荟萃分析

Efficacy of switching therapy to aflibercept for patients with persistent diabetic macular edema: a systematic review and meta-analysis.

作者信息

Liu Yilin, Cheng Jiahan, Gao Yunxia, Qin Ling, Min Xiaoxue, Zhang Ming

机构信息

Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu 610041, China.

Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.

出版信息

Ann Transl Med. 2020 Mar;8(6):382. doi: 10.21037/atm.2020.02.04.

DOI:10.21037/atm.2020.02.04
PMID:32355826
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7186737/
Abstract

BACKGROUND

To evaluate functional and anatomical consequences of switching anti-vascular endothelial growth factor (anti-VEGF) therapy from bevacizumab and/or ranibizumab to aflibercept intravitreal injection for the treatment of persistent diabetic macular edema (DME).

METHODS

Analysis of switching treatment in patients with persistent DME was performed using a literature search across multiple databases (PubMed, Medline, EMBASE, Cochrane Library and Web of Science) prior to May 2019. Therapeutic effect parameters, including mean change of best-corrected visual acuity (BCVA) and central macular thickness (CMT), were extracted from baseline to different follow-up times post initial injections. The quality of studies was assessed with the Downs and Black checklist. Data pertaining to ocular and systemic safety adverse events (SAEs) were collected as well as subgroup analysis stratified by pre-switch anti-VEGF reagents. All results were analyzed and pooled using random-effects models with 95% confidence intervals (CI).

RESULTS

Fourteen studies involving 489 eyes met the inclusion criteria. The mean differences in BCVA were significantly improved at 1, 2 and 3 months with -0.11 logMAR (P=0.016), -0.22 logMAR (P<0.001) and -0.24 logMAR (P<0.01), respectively. Vision gain was also assessed following the aflibercept injection with a mean change of -0.10 logMAR (P<0.001) at 6 months and -0.08 logMAR (P=0.01) at 12 months. CMT reduction was significant from baseline with a mean decrease of 80.52 µm (P<0.001) at 1 month, 89.6 µm (P<0.013) at 2 months, 113.88 µm (P<0.001) at 3 months and 125.12 µm (P<0.001) at 6 months. Mean CMT continued to decline by 75.70 µm (P<0.001) at 12 months as well.

CONCLUSIONS

This meta-analysis indicated the comparable efficacy and safety of a conversion treatment to aflibercept in cases of unsatisfactory responses to other anti-VEGF drugs. Switching treatment produces significant advantage for vision acuity recovery and macular edema improvement among persistent DME patients.

摘要

背景

评估将抗血管内皮生长因子(anti-VEGF)治疗从贝伐单抗和/或雷珠单抗转换为阿柏西普玻璃体腔内注射治疗持续性糖尿病黄斑水肿(DME)的功能和解剖学后果。

方法

在2019年5月之前,通过在多个数据库(PubMed、Medline、EMBASE、Cochrane图书馆和Web of Science)中进行文献检索,对持续性DME患者的转换治疗进行分析。从初始注射后的基线到不同随访时间提取治疗效果参数,包括最佳矫正视力(BCVA)和中心黄斑厚度(CMT)的平均变化。使用Downs和Black清单评估研究质量。收集与眼部和全身安全性不良事件(SAE)相关的数据,以及按转换前抗VEGF试剂分层的亚组分析。所有结果均使用95%置信区间(CI)的随机效应模型进行分析和汇总。

结果

14项涉及489只眼的研究符合纳入标准。BCVA的平均差异在1、2和3个月时显著改善,分别为-0.11 logMAR(P = 0.016)、-0.22 logMAR(P < 0.001)和-0.24 logMAR(P < 0.01)。在注射阿柏西普后也评估了视力改善情况,6个月时平均变化为-0.10 logMAR(P < 0.001),12个月时为-0.08 logMAR(P = 0.01)。CMT从基线开始显著降低,1个月时平均降低80.52 µm(P < 0.001),2个月时降低89.6 µm(P < 0.013),3个月时降低113.88 µm(P < 0.001),6个月时降低125.12 µm(P < 0.001)。12个月时平均CMT也继续下降75.7 µm(P < 0.001)。

结论

这项荟萃分析表明,在对其他抗VEGF药物反应不佳的情况下,转换为阿柏西普治疗具有相当的疗效和安全性。转换治疗对持续性DME患者的视力恢复和黄斑水肿改善具有显著优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/2902cac09708/atm-08-06-382-fS.2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/427fa6f515cb/atm-08-06-382-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/7468bd86d71d/atm-08-06-382-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/49b4cca7040f/atm-08-06-382-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/c1cb0fd02f22/atm-08-06-382-fS.1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/2902cac09708/atm-08-06-382-fS.2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/427fa6f515cb/atm-08-06-382-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/7468bd86d71d/atm-08-06-382-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/49b4cca7040f/atm-08-06-382-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/c1cb0fd02f22/atm-08-06-382-fS.1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da1f/7186737/2902cac09708/atm-08-06-382-fS.2.jpg

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