地塞米松玻璃体内植入物治疗台湾地区难治性及初治糖尿病性黄斑水肿的疗效。

Effect of dexamethasone intravitreal implant for refractory and treatment-naive diabetic macular edema in Taiwanese patients.

机构信息

Department of Ophthalmology, Far Eastern Memorial Hospital, New Taipei City, Taiwan, ROC.

Department of Electrical Engineering, Yuan Ze University, Taoyuan, Taiwan, ROC.

出版信息

J Chin Med Assoc. 2021 Mar 1;84(3):326-330. doi: 10.1097/JCMA.0000000000000483.

DOI:10.1097/JCMA.0000000000000483

PMID:33433135

Abstract

BACKGROUND

Dexamethasone (DEX) implant has been shown to improve visual and anatomic function in patients with diabetic macular edema (DME). The purpose of this study was to investigate the efficacy and safety of DEX implant between refractory and naive eyes with DME.

METHODS

We retrospectively reviewed data from pseudophakic patients with center-involved DME who received DEX implant (1 + as needed retreatment) from May 2015 to May 2017. Baseline clinical characteristics, changes in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) were analyzed and compared between the two groups. Adverse events were recorded.

RESULTS

Thirty-four eyes of 31 patients refractory to anti-vascular endothelial growth factor agents and 41 eyes of 38 treatment-naive patients were reviewed. Baseline characteristics were comparable between the two groups (p > 0.05). In the refractory eyes, significant improvements in both BCVA and CFT were observed at 1 month post DEX implant and sustained throughout 6 months. Mean change from baseline in BCVA at 6 months was -0.17 ± 0.35 logMAR (7.29 ± 16.22 letters) and 155.44 ± 112.67 μm in CFT. Similar trends of improvement were seen in treatment-naive eyes; however, the visual improvement (-0.30 ± 0.29 logMAR [16.42 ± 14.38 letters]) was significantly better than the refractory group, with significantly less injections (1.54 ± 0.49 versus 1.82 ± 0.38, p = 0.007). Between-group changes in CFT were comparable. No serious ocular complications occurred, and about a quarter of the patients had elevated intraocular pressures that were manageable with topical medications.

CONCLUSION

To our knowledge, this was the first study comparing DEX implant between treatment-naive and refractory Asian patients with DME. Intravitreal DEX implant can effectively treat refractory and treatment-naive patients with DME. In addition, superior visual outcomes were observed in the naive group comparing to the refractory group following DEX implant treatment in Taiwanese pseudophakic eyes with DME.

摘要

背景

地塞米松（DEX）植入物已被证明可改善糖尿病性黄斑水肿（DME）患者的视力和解剖功能。本研究的目的是研究 DEX 植入物在 DME 难治性和初治性眼中的疗效和安全性。

方法

我们回顾性分析了 2015 年 5 月至 2017 年 5 月接受 DEX 植入物（1+按需追加治疗）的中心受累 DME 假晶状体患者的数据。分析并比较了两组患者的最佳矫正视力（BCVA）和中心视网膜厚度（CFT）的基线临床特征变化。记录不良事件。

结果

回顾了 31 名接受抗血管内皮生长因子药物治疗的难治性患者的 34 只眼和 38 名初治患者的 41 只眼。两组患者的基线特征无差异（p>0.05）。在难治性眼中，DEX 植入后 1 个月时 BCVA 和 CFT 均显著改善，并持续 6 个月。6 个月时 BCVA 的平均基线变化为-0.17±0.35logMAR（7.29±16.22 个字母），CFT 为 155.44±112.67μm。初治眼中也出现了类似的改善趋势；然而，视力改善（-0.30±0.29logMAR[16.42±14.38 个字母]）明显优于难治性组，注射次数明显减少（1.54±0.49 与 1.82±0.38，p=0.007）。两组间 CFT 的变化无差异。未发生严重眼部并发症，约四分之一的患者眼压升高，经局部药物治疗即可控制。