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DME 患者中联合导航激光光凝 (Navilas) 和玻璃体内雷珠单抗与雷珠单抗单药治疗的 3 年数据比较。

3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients.

机构信息

Department of Ophthalmology, University Hospital, LMU, Munich, Germany.

Forstenrieder Allee 59, Munich, Germany.

出版信息

PLoS One. 2018 Aug 23;13(8):e0202483. doi: 10.1371/journal.pone.0202483. eCollection 2018.

Abstract

PURPOSE

The prospective, comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema has shown advantage of a combination therapy compared to ranibizumab monotherapy at year 1 with significantly reduced injections. The purpose of this retrospective study was to determine the long-term visual gains and need of injections in a 3 year-follow-up period.

METHODS

Retrospective analysis of patients of the original study in the long-term follow-up from month 12 to 36. BCVA measurements following the original 1 year study were taken using logMAR charts. Injections were provided with standard of care using PRN, based on change in BCVA and CRT using SD-OCT scans. Main outcome measures were change in BCVA and mean number of injections from 12 to 36 months.

RESULTS

BCVA was stable in both groups from 12 through 36 months, showing a change of 0.16 ± 0.1 log MAR. Following the initial reduction in required injections at month 12, combination therapy patients continued to require 1.3 times fewer injections over the next 24 months (2.91 ± 2.3 vs 3.85±3.7 injections for monotherapy).

CONCLUSIONS

Combination of navigated laser and ranibizumab achieved BCVA gains equivalent to anti-VEGF monotherapy. These results could be maintained through month 36. Required injections were 2.0 injections lower in year 1 and further 1.3 times fewer in year 2 and 3 in the combination group compared to monotherapy. Adding navigated laser photocoagulation to intravitreal anti-VEGF therapy may still represent a superior therapeutic approach to DME patients.

摘要

目的

前瞻性、对比评估联合导航激光光凝和玻璃体内雷珠单抗治疗糖尿病黄斑水肿,与雷珠单抗单药治疗相比,联合治疗在第 1 年具有优势,注射次数明显减少。本回顾性研究的目的是在 3 年随访期间确定长期视力提高和注射需求。

方法

对原始研究中患者的长期随访(从第 12 个月到第 36 个月)进行回顾性分析。使用 logMAR 图表进行原始 1 年研究后 BCVA 的测量。根据 BCVA 和 SD-OCT 扫描 CRT 的变化,采用 PRN 标准,按需提供注射。主要观察指标为 12 至 36 个月的 BCVA 变化和平均注射次数。

结果

两组患者从 12 个月到 36 个月 BCVA 均保持稳定,logMAR 变化为 0.16±0.1。在第 12 个月注射次数减少后,联合治疗组在接下来的 24 个月内继续需要少 1.3 倍的注射次数(联合治疗组为 2.91±2.3 次,单药治疗组为 3.85±3.7 次)。

结论

导航激光与雷珠单抗联合治疗可获得与抗 VEGF 单药治疗相当的 BCVA 改善。这些结果可维持到第 36 个月。与单药治疗相比,联合治疗组第 1 年注射次数减少 2.0 次,第 2 年和第 3 年减少 1.3 倍。将导航激光光凝联合玻璃体内抗 VEGF 治疗可能仍然是糖尿病黄斑水肿患者的一种优越治疗方法。

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