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随机试验宽视野引导 PRP 治疗Ranibizumab 治疗的糖尿病黄斑水肿。

Randomised trial of wide-field guided PRP for diabetic macular oedema treated with ranibizumab.

机构信息

Newcastle Eye Centre, Newcastle Upon Tyne NHS Hospitals Foundation Trust, Tyne and Wear, UK.

Frimley Park Hospitals NHS Foundation Trust, Camberley, GU16 7UJ, UK.

出版信息

Eye (Lond). 2019 Jun;33(6):930-937. doi: 10.1038/s41433-019-0342-1. Epub 2019 Feb 6.

DOI:10.1038/s41433-019-0342-1
PMID:30728488
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6707207/
Abstract

BACKGROUND

Diabetic macular oedema (DMO) is effectively treated with ranibizumab but multiple injections are required. Where there is also peripheral ischaemia, it has been promoted that targeted panretinal photocoagulation (PRP) may reduce the number of injections.

METHOD

Patients with optical coherence tomography confirmed DMO and Ultra-widefield Fundus Fluorescein Angiography confirmed peripheral retinal ischaemia were randomised to PRP plus ranibizumab or ranibizumab monotherapy. After three injections, repeat injections were given until the visual acuity was stable and the macula was dry. Re-treatment was given if there was a drop of visual acuity and/or a recurrence of intra-retinal fluid. The primary outcome was the number of repeat injections required after the first 6 months up until 1 year.

RESULTS

There were 49 patients, 25 in the ranibizumab only group and 24 in the ranibizumab + PRP group recruited at seven UK sites. The average number of injections in the ranibizumab-only arm was 6.84 over 1 year and 2.52 between months 6 and 12. The average number of injections in the combined arm was 6.67, with the number of injections in the second 6 months 1.92. For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p = 0.33).

CONCLUSION

The addition of targeted PRP to areas of non-perfusion in a patient with DMO does not reduce the number of injections required in the first year. It seems most likely that local VEGF at the macula is the main cause of DMO.

摘要

背景

糖尿病性黄斑水肿(DMO)可以通过雷珠单抗治疗得到有效控制,但需要多次注射。对于同时存在周边缺血的情况,有人提倡对视网膜全光凝(PRP)进行靶向治疗,以减少注射次数。

方法

对光学相干断层扫描(OCT)证实的 DMO 和超广角眼底荧光血管造影(FFA)证实的周边视网膜缺血的患者进行随机分组,分别接受 PRP 联合雷珠单抗或雷珠单抗单药治疗。在进行三次注射后,根据视力稳定和黄斑干燥情况重复注射,直到视力稳定和黄斑干燥。如果视力下降和/或视网膜内液体复发,则进行再治疗。主要终点是首次 6 个月至 1 年内重复注射所需的次数。

结果

在七个英国研究中心共招募了 49 名患者,其中雷珠单抗单药组 25 名,雷珠单抗+PRP 组 24 名。雷珠单抗单药组的平均注射次数为 6.84 次,6 至 12 个月为 2.52 次。联合治疗组的平均注射次数为 6.67 次,第二个 6 个月的注射次数为 1.92 次。对于主要终点,比较 6 至 12 个月的注射次数,结果无统计学意义(p=0.33)。

结论

在 DMO 患者非灌注区添加靶向 PRP 并不能减少第一年所需的注射次数。最有可能的是,黄斑局部的 VEGF 是 DMO 的主要原因。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a5a/6707207/3a91e9ad636e/41433_2019_342_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a5a/6707207/f534d951d3fc/41433_2019_342_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a5a/6707207/ed104d041163/41433_2019_342_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a5a/6707207/3a91e9ad636e/41433_2019_342_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a5a/6707207/f534d951d3fc/41433_2019_342_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a5a/6707207/ed104d041163/41433_2019_342_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a5a/6707207/3a91e9ad636e/41433_2019_342_Fig3_HTML.jpg

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