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抗血管内皮生长因子治疗糖尿病黄斑水肿的早期和长期反应:方案I数据分析

Gonzalez VH, Campbell J, Holekamp NM, et al.

期刊名称:American Journal of Ophthalmology

卷期:2016年第172卷

关键词:
黄斑 内皮 水肿

摘要

目的:旨在确定兰尼单抗治疗糖尿病性黄斑水肿的早期视力反应是否与长期结局相关。设计:随机对照试验数据的事后分析。方法:使用糖尿病性视网膜病变临床研究网络的方案I研究兰尼单抗加即时和延迟激光治疗组合并数据来探索早期(12周)和晚期(52-156周)视敏度反应之间的关系(相对于基线的最佳矫正视力(CFB BCVA)平均变化;分类改善[<55-9或≥10早期治疗糖尿病性视网膜病变研究(ETDRS)字母]。结果:在分析人群(340只眼)中,12周时,39.7%,23.2%和37.1%的眼分别发生<5-5-9-和≥10 -BCVA改善,156周时,分别为34.2%,16.5%和49.3%。每个早期BCVA反应分类中(12周时<55-9和≥10个改善),与12周时相比,52-156周平均CFB BCVA变化小于5个字母。 CFB BCVA12周内改善<5字母分别与CFB BCVA52周和156周时改善≥10字母呈明显正相关和负相关。类似的关联在基线BCVA <69字母眼中得到证实,并且在多变量调整潜在混杂因素后,关联仍然明显。结论:12周时兰尼单抗±激光治疗带来的BCVA改善欠佳(<5字母) 明显(≥10个字母)类似(~40%)。早期BCVA反应欠佳眼的长期视觉预后较早期BCVA反应明显眼差(156周时平均改善3.013.8个字母)。

PURPOSE:To determine whether early visual acuity response to ranibizumab in diabetic macular edema is associated with long-term outcome.DESIGN:Post hoc analysis of randomized controlled trial data.METHODS:Pooled data from the ranibizumab plus prompt and deferred laser treatment arms of the Diabetic Retinopathy Clinical Research Network's Protocol I study were used to explore the relationship between early (week 12) and late (weeks 52-156) visual acuity response (mean change from baseline in best-corrected visual acuity [CFB BCVA]; categorized improvement [<5, 5-9, or 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] in BCVA).RESULTS:In the analysis population (340 eyes), <5-, 5- to 9-, and 10-letter BCVA improvements occurred in 39.7%, 23.2%, and 37.1% of eyes, respectively, at 12weeks, and 34.2%, 16.5%, and 49.3% of eyes at 156weeks. Within each early BCVA response category (<5, 5-9, and 10 letters of improvement at 12weeks), mean CFB BCVA at 52-156weeks varied by <5 letters from that at 12weeks. CFB BCVA and <5-letter improvement at 12weeks showed significant positive and negative association, respectively, with CFB BCVA and 10-letter improvement at 52 and 156weeks. Similar relationships were demonstrated in eyes with baseline BCVA <69 letters, and associations remained significant after multivariate adjustment for potential confounders.CONCLUSIONS:Ranibizumab ± laser therapy resulted in similar rates (40%) of suboptimal (<5-letter) and pronounced (10-letter) BCVA improvement at 12weeks. Eyes with suboptimal early BCVA response showed poorer long-term visual outcomes than eyes with pronounced early response (mean improvement 3.0 vs 13.8 letters at 156weeks).


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