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以色列贝伐单抗治疗失败后使用雷珠单抗治疗糖尿病性黄斑水肿(DERBI研究)

Diabetic macular edema treated with ranibizumab following bevacizumab failure in Israel (DERBI study).

作者信息

Ehrlich Rita, Pokroy Russell, Segal Ori, Goldstein Michaella, Pollack Ayala, Hanhart Joel, Barak Yoreh, Kehat Rinat, Shulman Shiri, Vidne Orit, Abu Ahmad Wiessam, Chowers Itay

机构信息

1 Department of Ophthalmology, Rabin Medical Center, Petah Tikva, Israel.

2 Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Eur J Ophthalmol. 2019 Mar;29(2):229-233. doi: 10.1177/1120672118782102. Epub 2018 Jun 19.

Abstract

PURPOSE

: To evaluate the outcome of second-line intravitreal ranibizumab treatment in eyes with diabetic macular edema having persistent edema following initial therapy with intravitreal bevacizumab.

METHODS

: Diabetic macular edema treated with ranibizumab following bevacizumab failure in Israel was a retrospective, multi-center study. Consecutive eyes with persistent diabetic macular edema following at least three previous intravitreal bevacizumab injections prior to intravitreal ranibizumab, at least three-monthly intravitreal ranibizumab injections and at least 12 months of follow-up were included. Data collected included demographics, ocular findings, diabetes control, details of intravitreal bevacizumab and ranibizumab injections, and visual and anatomical measurements before and after intravitreal ranibizumab treatment.

RESULTS

: In total, 202 eyes of 162 patients treated at 11 medical centers across Israel were included. Patients received a mean (±standard deviation) of 8.8 ± 4.9 intravitreal bevacizumab injections prior to the switch to intravitreal ranibizumab. A mean of 7.0 ± 2.7 intravitreal ranibizumab injections were given during the 12 months following the switch to intravitreal ranibizumab. The median central subfield retinal thickness (±interquartile range) by spectral-domain optical coherence tomography decreased from 436 ± 162 µm at baseline to 319 ± 113 µm at month 12 (p < 0.001). Median logMAR visual acuity (±interquartile range) improved from 0.40 ± 0.48 at baseline to 0.38 ± 0.40 at month 12 (p = 0.001). Linear regression suggested that higher number of intravitreal ranibizumab injections and higher pre-switch central subfield retinal thickness were associated with favorable visual outcome. Higher number of intravitreal bevacizumab injections and the presence of intraretinal fluid before the switch lessened the odds of favorable outcome.

CONCLUSION

: Switching from bevacizumab to ranibizumab in persistent diabetic macular edema was associated with anatomical improvement in the majority of eyes and ⩾2 lines of vision improvement in 22% of eyes.

摘要

目的

评估玻璃体内注射雷珠单抗作为二线治疗对初始接受玻璃体内注射贝伐单抗治疗后仍存在持续性水肿的糖尿病性黄斑水肿患者的疗效。

方法

在以色列进行的一项回顾性多中心研究中,对贝伐单抗治疗失败后接受雷珠单抗治疗的糖尿病性黄斑水肿患者进行研究。纳入标准为:在接受玻璃体内注射雷珠单抗之前,至少接受过3次玻璃体内注射贝伐单抗治疗且仍存在持续性糖尿病性黄斑水肿,接受至少3个月的每月1次玻璃体内注射雷珠单抗治疗,并且至少随访12个月。收集的数据包括人口统计学资料、眼部检查结果、糖尿病控制情况、玻璃体内注射贝伐单抗和雷珠单抗的详细情况,以及玻璃体内注射雷珠单抗治疗前后的视力和解剖学测量数据。

结果

以色列11个医疗中心共纳入了162例患者的202只眼。患者在改用玻璃体内注射雷珠单抗之前平均(±标准差)接受了8.8±4.9次玻璃体内注射贝伐单抗。在改用玻璃体内注射雷珠单抗后的12个月内,平均接受了7.0±2.7次玻璃体内注射雷珠单抗。通过光谱域光学相干断层扫描测量的中央子野视网膜厚度中位数(±四分位间距)从基线时的436±162μm降至第12个月时的319±113μm(p<0.001)。对数最小分辨角视力中位数(±四分位间距)从基线时的0.40±0.48提高到第12个月时的0.38±0.40(p=0.001)。线性回归分析表明,玻璃体内注射雷珠单抗的次数越多以及改用前中央子野视网膜厚度越高,与良好的视力预后相关。玻璃体内注射贝伐单抗的次数越多以及改用前存在视网膜内液体会降低良好预后的几率。

结论

对于持续性糖尿病性黄斑水肿患者,从贝伐单抗改用雷珠单抗治疗与大多数患者的解剖学改善相关,并且22%的患者视力提高了至少2行。

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