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高危增殖性糖尿病性视网膜病变患者行全视网膜光凝联合玻璃体腔内注射贝伐单抗治疗后黄斑区结构和功能评估: 一项对比、随机、对照临床试验。

Structural and functional assessment of macula in patients with high-risk proliferative diabetic retinopathy submitted to panretinal photocoagulation and associated intravitreal bevacizumab injections: a comparative, randomised, controlled trial.

机构信息

Division of Ophthalmology, University of São Paulo Medical School, São Paulo, Brazil.

出版信息

Ophthalmologica. 2013;230(1):1-8. doi: 10.1159/000348605. Epub 2013 May 14.

Abstract

PURPOSE

To compare the efficacy of therapy with panretinal photocoagulation (PRP) and intravitreal bevacizumab (IVB) injections versus PRP alone in patients with high-risk proliferative diabetic retinopathy (HR-PDR) with a 6-month follow-up.

METHODS

Forty-two patients with HR-PDR were prospectively studied in a randomised, masked, controlled trial. Both eyes of each patient were randomised either to the study group (SG) receiving PRP plus IVB injections or the control group (CG) receiving PRP alone. Mean change in visual acuity (VA), optical coherence tomography-measured foveal thickness (FT) and macular volume (MV) were compared.

RESULTS

Intergroup comparisons showed no significant difference in VA while FT exhibited a significant (p < 0.05) difference at 1 month of follow-up and MV was significantly reduced at the 1- and 3-month follow-up. Compared to baseline, VA was significantly worse at all follow-ups in the CG and was stable in the SG. FT increased significantly in the CG from baseline to the 1- and 6-month follow-ups and in the SG, no significant difference was observed. MV was significantly increased in the CG during all follow-up periods.

CONCLUSION

In HR-PDR, using IVB injections as adjuvant treatment to PRP reduces the VA deterioration and results in decreased FT and MV measurements compared to PRP alone.

摘要

目的

比较全视网膜光凝(PRP)联合玻璃体腔内注射贝伐单抗(IVB)与单纯 PRP 治疗高危增殖性糖尿病视网膜病变(HR-PDR)患者的疗效,随访时间为 6 个月。

方法

前瞻性随机对照研究 42 例 HR-PDR 患者,将每位患者的双眼随机分为研究组(SG),接受 PRP 联合 IVB 注射治疗;对照组(CG),接受单纯 PRP 治疗。比较两组视力(VA)、光学相干断层扫描测量的中心凹厚度(FT)和黄斑体积(MV)的平均变化。

结果

组间比较显示,VA 无显著差异,而 FT 在随访 1 个月时差异显著(p < 0.05),MV 在 1 个月和 3 个月随访时显著降低。与基线相比,CG 组在所有随访时间的 VA 均显著恶化,SG 组则保持稳定。CG 组 FT 从基线到 1 个月和 6 个月随访时均显著增加,而 SG 组无显著差异。CG 组 MV 在所有随访期间均显著增加。

结论

在 HR-PDR 中,IVB 注射作为 PRP 的辅助治疗可减少 VA 恶化,并降低 FT 和 MV 的测量值,优于单纯 PRP 治疗。

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