Holz F G, Tadayoni R, Beatty S, Berger A R, Cereda M G, Hykin P, Staurenghi G, Wittrup-Jensen K, Nilsson J, Kim K, Sivaprasad S
Department of Ophthalmology, University of Bonn, Bonn, Germany.
Department of Ophthalmology, Hôpital Lariboisière, Paris, France.
Eye (Lond). 2016 Aug;30(8):1063-71. doi: 10.1038/eye.2016.90. Epub 2016 May 20.
PurposeTo identify the strongest variable(s) linked with the number of ranibizumab injections and outcomes in AURA, and to identify ways to improve outcomes using this association.MethodsAURA was a large observational study that monitored visual acuity over a 2-year period in patients with neovascular age-related macular degeneration (AMD) who received ranibizumab injections. Baseline characteristics, resource use, and outcomes were analyzed using an instrumental variable approach and regression analysis.ResultsData were analyzed from 2227 patients enrolled in AURA. Optical coherence tomography (OCT) and ophthalmoscopy were the most common diagnostic tests used, and this combination was the strongest instrumental variable. Use of OCT and ophthalmoscopy affected the number of injections given and resulted in an increase in visual acuity gains from baseline of 17.6 letters in year 1 and 2.5 letters in year 2. Regression models using the instrumental variable (OCT and ophthalmoscopy combined) showed that ≥5.1 (95% CI: 3.3-11.4) ranibizumab injections were needed to maintain visual acuity from baseline to year 1 and ≥8.3 (95% CI: 5.3-18.8) injections were needed to maintain visual acuity from year 1 to year 2. To gain ≥15 letters, ≥7.9 (95% CI: 5.1-17.5) ranibizumab injections would be needed in year 1 and ≥16.1 (95% CI: 10.3-36.4) injections would be needed over 2 years.ConclusionsThese findings highlight the role that regular monitoring plays in guiding neovascular AMD therapy and they showed that the number of ranibizumab injections needed to maintain visual acuity is higher than that administered in AURA.
目的
确定与阿瓦斯汀（ranibizumab）注射次数及阿瓦斯汀治疗视网膜新生血管年龄相关性黄斑变性（AURA）研究结果相关的最强变量，并利用这种关联确定改善治疗结果的方法。
方法
AURA是一项大型观察性研究，对接受阿瓦斯汀注射的新生血管性年龄相关性黄斑变性（AMD）患者进行了为期2年的视力监测。使用工具变量法和回归分析对基线特征、资源使用情况和治疗结果进行分析。
结果
对AURA研究中纳入的2227例患者的数据进行了分析。光学相干断层扫描（OCT）和检眼镜检查是最常用的诊断检查，这种组合是最强的工具变量。OCT和检眼镜检查的使用影响了注射次数，并使第1年的视力较基线提高了17.6个字母，第2年提高了2.5个字母。使用工具变量（OCT和检眼镜检查联合）的回归模型显示，从基线到第1年维持视力需要≥5.1次（95%CI：3.3 - 11.4）阿瓦斯汀注射，从第1年到第2年维持视力需要≥8.3次（95%CI：5.3 - 18.8）注射。要提高≥15个字母，第1年需要≥7.9次（95%CI：5.1 - 17.5）阿瓦斯汀注射，2年内需要≥16.1次（95%CI：10.3 - 36.4）注射。
结论
这些发现突出了定期监测在指导新生血管性AMD治疗中所起的作用，并且表明维持视力所需的阿瓦斯汀注射次数高于AURA研究中的给药次数。
