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0.2μg/天氟轻松丙酮化物与雷珠单抗联合延迟激光治疗糖尿病性黄斑水肿的视力结果(糖尿病性视网膜病变临床研究网络协议I)

Visual Acuity Outcomes in Diabetic Macular Edema With Fluocinolone Acetonide 0.2 μg/Day Versus Ranibizumab Plus Deferred Laser (DRCR Protocol I).

作者信息

Singer Michael A, Miller Dan M, Gross Jeffrey G, Greven Craig M, Kapik Barry, Bailey Clare, Ghanchi Faruque, Kuppermann Baruch D

出版信息

Ophthalmic Surg Lasers Imaging Retina. 2018 Sep 1;49(9):698-706. doi: 10.3928/23258160-20180831-08.

Abstract

BACKGROUND AND OBJECTIVE

Visual outcomes of the FAME study (0.2 μg/day fluocinolone acetonide [FAc]) and Protocol I (0.5 mg ranibizumab plus deferred laser) were compared using the area under the curve (AUC) analysis method.

PATIENTS AND METHODS

Best-corrected visual acuity (BCVA) data collected during a period of 3 years of follow-up for patients enrolled in FAME or Protocol I were used to calculate AUC of the change in BCVA over a time curve.

RESULTS

In the overall population, there was a greater treatment effect for ranibizumab plus deferred laser compared with FAc. However, for subgroups of pseudophakic eyes, eyes with chronic diabetic macular edema (DME), and pseudophakic eyes with chronic DME, ranibizumab plus deferred laser and FAc were not found to be significantly different. The ranibizumab group received a median of 14 injections during a 36-month period compared with a mean of 1.3 injections in the FAc group.

CONCLUSION

In pseudophakic and chronic DME subgroups, FAc was comparable to ranibizumab plus deferred laser with fewer injections. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:698-706.].

摘要

背景与目的

采用曲线下面积(AUC)分析方法比较FAME研究(0.2μg/天醋酸氟轻松[FAc])和方案I(0.5mg雷珠单抗加延迟激光治疗)的视力结果。

患者与方法

使用在FAME或方案I研究中入组患者3年随访期间收集的最佳矫正视力(BCVA)数据,计算BCVA随时间变化曲线的AUC。

结果

在总体人群中,与FAc相比,雷珠单抗加延迟激光治疗具有更大的治疗效果。然而,在人工晶状体眼亚组、慢性糖尿病性黄斑水肿(DME)眼亚组以及患有慢性DME的人工晶状体眼亚组中,未发现雷珠单抗加延迟激光治疗与FAc有显著差异。在36个月期间,雷珠单抗组的中位注射次数为14次,而FAc组的平均注射次数为1.3次。

结论

在人工晶状体眼和慢性DME亚组中,FAc与雷珠单抗加延迟激光治疗效果相当,但注射次数更少。[《眼科手术、激光与视网膜成像》。2018;49:698 - 706。]

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