Real-World Outcomes of Ranibizumab Treatment for Diabetic Macular Edema in a United Kingdom National Health Service Setting
Real-World Outcomes of Ranibizumab Treatment for Diabetic Macular Edema in a United Kingdom National Health Service Setting
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DOI：
10.1016/j.ajo.2016.09.002
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发表时间：
2016-12-01
影响因子：
4.2
通讯作者：
Rajendram, Ranjan
中科院分区：
文献类型：
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作者：
Patrao, Namritha V.;Antao, Sheelah;Rajendram, Ranjan
目的：在英国国家卫生服务中心的一项临床研究中，确定玻璃体内注射雷尼比单抗治疗糖尿病黄斑水肿(DME)的视力(VA)和光谱域光学相干断层扫描(OCT)结果。设计：回顾性干预病例系列。研究对象：2013年8月至2014年3月在伦敦穆尔菲尔德眼科医院的4个部位连续接受雷尼比单抗治疗的DME患者。方法：2000年10月Topcon3D10月，连续164例(200只眼)受累于DME，VA=350MU，开始玻璃体内注射3次，并至少随访6个月。随后的再次治疗在VA和OCT的指导下进行，以达到治疗稳定的目的。结果：基线时平均视力5 4.4(+/-15.2 6)个字母，平均CST为490.16(+/-116.54)mm，平均MV为10.46(+/-2.2 8)mm(3例)。12个月时平均视力变化为+6.6(+/-13.35)个字母(P=.0003)。共获得10个字母者77例，占40.3%；获得15个字母者48例，占25.1%；丢失10个字母者17例，占8.9%；丢失15个字母者12例，占6.3%。术后12个月CST和MV的平均变化分别为-133.9(+/-160.12)mm(P=0.0001)和-1.5(+/-1.96)mm(3)(P=0.0001)。平均12个月注射7.2次(+/-2.3)。结论：每月3次负荷量注射0.5 mg雷尼比单抗，然后在临床环境下进行再次治疗，其结果与临床试验的结果相似。((C)2016 Elsevier Inc.保留所有权利。)
PURPOSE: To determine visual acuity (VA) and spectral-domain optical coherence tomography (OCT) outcomes with intravitreal ranibizumab for diabetic macular edema (DME) in a United Kingdom National Health Service clinical setting.DESIGN: Retrospective interventional case series.PARTICIPANTS: Consecutive patients with DME, treated with the first ranibizumab injection between August 2013 and March 2014 across 4 sites of Moorfields Eye Hospital, London..METHODS: Two hundred eyes of 164 consecutive patients with center-involving DME and VA = 350 mu m on Topcon 3D OCT 2000, initiated on a loading phase of 3 intravitreal ranibizumab injections and who had at least 6 months follow-up were reviewed. Subsequent retreatment was guided by VA and OCT with the aim of treating to stability. VA, OCT CST, and macular volume (MV) were recorded at baseline and monthly to 12 months.RESULTS: The mean VA, mean CST, and mean MV at baseline were 54.4 (+/- 15.26) letters, 490.16 (+/- 116.54) mu m, and 10.46 (+/- 2.28) mm(3). The mean VA change at 12 months was + 6.6 (+/- 13.35) letters (P = .0003). A total of 40.3% of patients (n = 77) gained >= 10 letters and 25.1% (n = 48) gained >= 15 letters; 8.9% (n = 17) lost >= 10 letters and 6.3% (n = 12) lost >= 15 letters. At 12 months, the mean change in CST and MV were -133.9 (+/- 160.12) mu m (P = .0001) and -1.5 (+/- 1.96) mm(3) (P = .0001), respectively. An average of 7.2 (+/- 2.3) injections were given over 12 months.CONCLUSIONS: Outcomes with 3 loading injections of 0.5 mg ranibizumab given monthly followed by pro re nata retreatment in a clinical setting are comparable with outcomes from clinical trials. ((C) 2016 Elsevier Inc. All rights reserved.)