地塞米松与贝伐单抗对糖尿病性黄斑病变硬性渗出消退的疗效：来自BEVORDEX随机临床试验的数据。
Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomised clinical trial.
作者信息
Mehta Hemal, Fraser-Bell Samantha, Yeung Aaron, Campain Anna, Lim Lyndell L, Quin Godfrey J, McAllister Ian L, Keane Pearse A, Gillies Mark C
机构信息
The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, Australia.
National Institute for Health Research Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
出版信息
Br J Ophthalmol. 2016 Jul;100(7):1000-1004. doi: 10.1136/bjophthalmol-2015-307797. Epub 2015 Nov 4.
OBJECTIVE
To report the effect of bevacizumab versus dexamethasone on hard exudates (HEX) in diabetic macular oedema (DME).
DESIGN
Post hoc analysis of 24-month data from the Randomised clinical trial of BEVacizumab OR DEXamethasone for diabetic macular oedema (BEVORDEX) phase 2 multicentre randomised clinical trial. Eyes with centre-involving DME resistant to or unlikely to benefit from macular laser therapy were included. Eyes were randomly assigned to bevacizumab every 4 weeks or Ozurdex dexamethasone implant (DEX) every 16 weeks, both as required. The 68 eyes from 48 patients that completed 24-month follow-up were analysed. Two masked graders assessed extent and location of HEX on baseline, 12-month and 24-month foveal-centred colour fundus photographs using validated grading software.
RESULTS
Macular HEX was present in 60% of study eyes. Of these, 21 eyes were treated with DEX and 20 eyes with bevacizumab. Both treatments led to reduction in area of macular HEX at 12 months and 24 months. There was greater regression of HEX from the foveal centre in DEX-treated eyes (median change +890 µm, IQR=1040 µm) than bevacizumab-treated eyes (median change +7.0 µm, IQR=590 µm) at 12 months (p=0.04) but the difference was no longer statistically significant (p=0.10) by 24 months (DEX +1400 µm, IQR=1590 µm; bevacizumab +20 µm, IQR=2680 µm). Reassuringly, no study eye developed HEX at the foveal centre, a visually devastating consequence of diabetic maculopathy.
CONCLUSIONS
Bevacizumab and DEX were effective in reducing area of HEX in eyes with DME. DEX provided more rapid regression of HEX from the foveal centre although bevacizumab-treated eyes started to catch up by 24 months. Distance from the foveal centre as well as total area of macular HEX should be assessed when evaluating treatments for foveal-threatening HEX.
TRIAL REGISTRATION NUMBER
NCT01298076; Post-results.
目的
报告贝伐单抗与地塞米松治疗糖尿病性黄斑水肿（DME）中硬性渗出（HEX）的效果。
设计
对贝伐单抗或地塞米松治疗糖尿病性黄斑水肿（BEVORDEX）2期多中心随机临床试验的24个月数据进行事后分析。纳入对黄斑激光治疗耐药或不太可能从中获益的累及中心凹的DME患眼。根据需要，患眼被随机分配接受每4周一次的贝伐单抗治疗或每16周一次的Ozurdex地塞米松植入物（DEX）治疗。对48例患者完成24个月随访的68只眼进行分析。两名盲法分级者使用经过验证的分级软件，在基线、12个月和24个月以中心凹为中心的彩色眼底照片上评估HEX的范围和位置。
结果
60%的研究眼存在黄斑HEX。其中，21只眼接受DEX治疗，20只眼接受贝伐单抗治疗。两种治疗均使12个月和24个月时黄斑HEX面积减少。在12个月时，DEX治疗组患眼中HEX从中心凹中心的消退程度更大（中位数变化+890µm，四分位间距=1040µm），高于贝伐单抗治疗组（中位数变化+7.0µm，四分位间距=590µm）（p=0.04），但到24个月时差异不再具有统计学意义（p=0.10）（DEX+1400µm，四分位间距=1590µm；贝伐单抗+20µm，四分位间距=2680µm）。令人安心的是，没有研究眼在中心凹中心出现HEX，这是糖尿病性黄斑病变的一个视力毁灭性后果。
结论
贝伐单抗和DEX在减少DME患眼中HEX面积方面有效。DEX使HEX从中心凹中心的消退更快，尽管贝伐单抗治疗组的患眼在24个月时开始追赶。在评估针对威胁中心凹的HEX的治疗时，应评估距中心凹中心的距离以及黄斑HEX的总面积。
试验注册号
NCT01298076；结果公布后。
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