Lee Aaron Y, Lee Cecilia S, Egan Catherine A, Bailey Clare, Johnston Robert L, Natha Salim, Hamilton Robin, Khan Rehna, Al-Husainy Sahar, Brand Christopher, Akerele Toks, Mckibbin Martin, Downey Louise, Tufail Adnan
Department of Ophthalmology, University of Washington, Seattle, Washington, USA.
Moorfields Eye Hospital NHS Foundation Trust, London, UK.
Br J Ophthalmol. 2017 Dec;101(12):1683-1688. doi: 10.1136/bjophthalmol-2016-309818. Epub 2017 May 6.
To compare the effectiveness of continuous aflibercept versus pro re nata (PRN) ranibizumab therapy for neovascular age-related macular degeneration (nAMD).
Multicentre, national electronic medical record (EMR) study on treatment naive nAMD eyes undergoing PRN ranibizumab or continuous (fixed or treat and extend (F/TE)) aflibercept from 21 UK hospitals. Anonymised data were extracted, and eyes were matched on age, gender, starting visual acuity (VA) and year of starting treatment. Primary outcome was change in vision at 1 year.
1884 eyes (942 eyes in each group) were included. At year 1, patients on PRN ranibizumab gained 1.6 ETDRS (Early Treatment Diabetic Retinopathy Study) letters (95% CI 0.5 to 2.7, p=0.004), while patients on F/TE aflibercept gained 6.1 letters (95% CI 5.1 to 7.1, p=2.2e-16). Change in vision at 1 year of the F/TE aflibercept group was 4.1 letters higher (95% CI 2.5 to 5.8, p=1.3e-06) compared with the PRN ranibizumab group after adjusting for age, starting VA, gender and year of starting therapy. The F/TE aflibercept group had significantly more injections compared with the PRN ranibizumab group (7.0 vs 5.8, p<2.2e-16), but required less clinic visits than the PRN ranibizumab group (10.8 vs 9.0, p<2.2e-16). Cost-effectiveness analysis showed an incremental cost-effectiveness ratio of 58 047.14 GBP/quality-adjusted life year for continuous aflibercept over PRN ranibizumab.
Aflibercept achieved greater VA gains at 1 year than ranibizumab. The observed VA differences are small and likely to be related to more frequent treatment with aflibercept, suggesting that ranibizumab should also be delivered by F/TE posology.
比较持续使用阿柏西普与按需（PRN）使用雷珠单抗治疗新生血管性年龄相关性黄斑变性（nAMD）的有效性。
一项多中心、全国性电子病历（EMR）研究，针对来自英国21家医院的初治nAMD患眼，这些患眼接受PRN雷珠单抗或持续（固定剂量或治疗并延长（F/TE））阿柏西普治疗。提取匿名数据，并根据年龄、性别、起始视力（VA）和开始治疗年份对患眼进行匹配。主要结局是1年时的视力变化。
共纳入1884只患眼（每组942只）。在第1年，PRN雷珠单抗组患者视力提高了1.6个早期糖尿病视网膜病变研究（ETDRS）字母（95%CI 0.5至2.7，p = 0.004），而F/TE阿柏西普组患者视力提高了6.1个字母（95%CI 5.1至7.1，p = 2.2×10⁻¹⁶）。在调整年龄、起始VA、性别和开始治疗年份后，F/TE阿柏西普组在1年时的视力变化比PRN雷珠单抗组高4.1个字母（95%CI 2.5至5.8，p = 1.3×10⁻⁰⁶）。F/TE阿柏西普组的注射次数明显多于PRN雷珠单抗组（7.0次对5.8次，p < 2.2×10⁻¹⁶），但所需的门诊就诊次数少于PRN雷珠单抗组（10.8次对9.0次，p < 2.2×10⁻¹⁶）。成本效益分析显示，持续使用阿柏西普相对于PRN雷珠单抗的增量成本效益比为58047.14英镑/质量调整生命年。
阿柏西普在1年时比雷珠单抗使视力提高更多。观察到的视力差异较小，可能与阿柏西普治疗更频繁有关，这表明雷珠单抗也应采用F/TE给药方案。
