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在英国国民医疗服务体系背景下,雷珠单抗治疗糖尿病性黄斑水肿的真实世界疗效

Real-World Outcomes of Ranibizumab Treatment for Diabetic Macular Edema in a United Kingdom National Health Service Setting.

作者信息

Patrao Namritha V, Antao Sheelah, Egan Catherine, Omar Amer, Hamilton Robin, Hykin Philip G, Sivaprasad Sobha, Rajendram Ranjan

机构信息

National Institute of Health Research Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.

National Institute of Health Research Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom; University College of London Institute of Ophthalmology, London, United Kingdom.

出版信息

Am J Ophthalmol. 2016 Dec;172:51-57. doi: 10.1016/j.ajo.2016.09.002. Epub 2016 Sep 13.

Abstract

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 ≤79 ETDRS letters, central subfield macular thickness (CST) ≥350 μm 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) μm, and 10.46 (± 2.28) mm. 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) μm (P = .0001) and -1.5 (± 1.96) mm (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.

摘要

目的

在英国国家医疗服务体系的临床环境中,确定玻璃体内注射雷珠单抗治疗糖尿病性黄斑水肿(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。

参与者

2013年8月至2014年3月期间在伦敦摩尔菲尔德眼科医院4个地点接受首次雷珠单抗注射治疗的连续性DME患者。

方法

对164例连续性中心凹受累且VA≤79 ETDRS字母、在Topcon 3D OCT 2000上中心子野黄斑厚度(CST)≥350μm、开始接受3次玻璃体内雷珠单抗注射负荷期治疗且至少随访6个月的患者的200只眼进行回顾。后续再治疗以VA和OCT为指导,目标是治疗至病情稳定。在基线时以及每月直至12个月时记录VA、OCT CST和黄斑体积(MV)。

结果

基线时平均VA、平均CST和平均MV分别为54.4(±15.26)字母、490.16(±116.54)μm和10.46(±2.28)mm。12个月时平均VA变化为+6.6(±13.35)字母(P = .0003)。共有40.3%的患者(n = 77)视力提高≥10字母,25.1%(n = 48)的患者视力提高≥15字母;8.9%(n = 17)的患者视力下降≥10字母,6.3%(n = 12)的患者视力下降≥15字母。12个月时,CST和MV的平均变化分别为-133.9(±160.12)μm(P = .0001)和-1.5(±1.96)mm(P = .0001)。12个月内平均注射7.2(±2.3)次。

结论

在临床环境中每月给予3次0.5mg雷珠单抗负荷注射,随后根据需要进行再治疗的结果与临床试验结果相当。

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