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临床实践中糖尿病性黄斑水肿的管理:当前策略与治疗选择的系统评价和荟萃分析

Managing Diabetic Macular Edema in Clinical Practice: Systematic Review and Meta-Analysis of Current Strategies and Treatment Options.

作者信息

Veritti Daniele, Sarao Valentina, Soppelsa Valentina, Lanzetta Paolo

机构信息

Department of Medicine - Ophthalmology, University of Udine, Udine, Italy.

Istituto Europeo di Microchirurgia Oculare (IEMO), Udine, Italy.

出版信息

Clin Ophthalmol. 2021 Jan 29;15:375-385. doi: 10.2147/OPTH.S236423. eCollection 2021.

Abstract

PURPOSE

This meta-analysis aims to summarize 12-month best-corrected visual acuity (BCVA) outcomes in response to anti-vascular endothelial growth factor (VEGF) therapy and dexamethasone implant for the treatment of diabetic macular edema (DME) and to identify factors affecting treatment response using evidence generated from meta-regression.

METHODS

A systematic review of electronic databases was conducted to identify randomized controlled trials (RCTs) and real-life/observational studies that reported 12-month changes in BCVA in patients with DME on anti-VEGF or dexamethasone implant treatment in monotherapy. Study factors that were analyzed are baseline patient characteristics, study type, drug employed, number of injections and 12-month change in BCVA. Data were pooled in a random-effects meta-analysis with BCVA change as the main outcome. Meta-regression was conducted to assess the impact of multiple covariates.

RESULTS

One-hundred-five heterogeneous study populations (45,032 eyes) were identified and included in the analysis. The use of anti-VEGFs and dexamethasone implant induced an overall increase of +8.13 ETDRS letters in BCVA at 12 months of follow-up. Meta-regression provided evidence that mean BCVA change using anti-VEGFs was not statistically higher for RCTs (p=0.35) compared to observational studies. Dexamethasone implant showed a trend for better results in observational studies over RCTs. Populations following a fixed aflibercept regimen performed better than those following a reactive treatment regimen. Mean BCVA gain was higher in younger populations (p<0.001), with lower baseline BCVA (p<0.0001) and longer diabetes duration (p<0.0001), receiving a higher number of injections (p<0.0001).

CONCLUSION

Intravitreal therapy with anti-VEGFs or dexamethasone implant produces a significant improvement in BCVA at 12 months in patients with DME. Meta-regression identified the modifiable covariates that can be targeted in order to maximize functional results.

摘要

目的

本荟萃分析旨在总结抗血管内皮生长因子(VEGF)疗法和地塞米松植入物治疗糖尿病性黄斑水肿(DME)后的12个月最佳矫正视力(BCVA)结果,并利用荟萃回归得出的证据确定影响治疗反应的因素。

方法

对电子数据库进行系统综述,以识别随机对照试验(RCT)和真实生活/观察性研究,这些研究报告了接受抗VEGF或地塞米松植入物单药治疗的DME患者12个月时BCVA的变化。分析的研究因素包括基线患者特征、研究类型、所用药物、注射次数和12个月时BCVA的变化。以BCVA变化作为主要结果,将数据汇总到随机效应荟萃分析中。进行荟萃回归以评估多个协变量的影响。

结果

共识别出105个异质性研究人群(45,032只眼)并纳入分析。在随访12个月时,使用抗VEGF药物和地塞米松植入物使BCVA总体提高了8.13个ETDRS字母。荟萃回归提供的证据表明,与观察性研究相比,RCT中使用抗VEGF药物时的平均BCVA变化在统计学上并无更高(p = 0.35)。地塞米松植入物在观察性研究中的结果显示出比RCT更好的趋势。遵循固定阿柏西普治疗方案的人群比遵循反应性治疗方案的人群表现更好。在年龄较小(p < 0.001)、基线BCVA较低(p < 0.0001)、糖尿病病程较长(p < 0.0001)且接受注射次数较多(p < 0.0001)的人群中,平均BCVA增益更高。

结论

玻璃体腔内注射抗VEGF药物或地塞米松植入物可使DME患者在12个月时的BCVA显著改善。荟萃回归确定了可针对的可改变协变量,以实现功能结果的最大化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f876/7856351/356add8db39b/OPTH-15-375-g0001.jpg

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