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抗血管内皮生长因子药物与地塞米松植入剂(Ozurdex)治疗累及黄斑中心凹的糖尿病性黄斑水肿(CiDME)的随机研究

Anti-VEGF versus dexamethasone implant (Ozurdex) for the management of Centre involved Diabetic Macular Edema (CiDME): a randomized study.

作者信息

Sharma Ashish, Bellala Keerthi, Dongre Pankaj, Reddy Prahalad

机构信息

Department of Vitreoretina, Lotus Eye Hospital, and Institute, Avinashi Road, Coimbatore, TN, 641014, India.

Department of Retina and Vitreous Surgery, L V Prasad Eye Institute, GMRV Campus, Visakhapatnam, Andhra Pradesh, India.

出版信息

Int Ophthalmol. 2020 Jan;40(1):67-72. doi: 10.1007/s10792-019-01151-3. Epub 2019 Aug 3.

Abstract

PURPOSE

To compare the efficacy and safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection versus dexamethasone implant (Ozurdex) for the treatment of center-involved DME (CiDME).

METHOD

This prospective randomized comparative study included 40 eyes (38 patients) of CiDME. They were randomized into two groups. Patients in group A received the intravitreal anti-VEGF injection (bevacizumab 1.25 mg or ranibizumab 0.5 mg) and those in group B received dexamethasone implant (0.7 mg) pro-re-nata after 4 weeks and 3 months, respectively. The primary outcome was measured at 3 months from the baseline that included improvement in BCVA, reduction in CFT, and adverse effects during the follow-up period.

RESULTS

Mean best-corrected visual acuity (BCVA) improved from 0.51 ± 0.275 LogMAR units (20/63) to 0.20 ± 0.185 LogMAR units (20/32) in group A and from 0.56 ± 0.213 LogMAR units (20/80) to 0.141 ± 0.177 LogMAR units (20/32) in group B at 3 months. There was no significant difference in mean BCVA between both the groups (p = .27). The mean central foveal thickness (CFT) improved from 443.55 ± 131.536 µ to 277.66 ± 76.184 µ and from 460.95 ± 125.462 µ to 233.25 ± 37.552 µ at 3 months in group B (p = .02).

CONCLUSION

Both the groups had the similar visual outcome. However, the superior anatomical result was observed in dexamethasone implant group during this short follow-up.

摘要

目的

比较玻璃体内注射抗血管内皮生长因子(抗VEGF)与地塞米松植入物(Ozurdex)治疗累及黄斑中心凹糖尿病性黄斑水肿(CiDME)的疗效和安全性。

方法

这项前瞻性随机对照研究纳入了40只CiDME患眼(38例患者)。将他们随机分为两组。A组患者接受玻璃体内抗VEGF注射(贝伐单抗1.25mg或雷珠单抗0.5mg),B组患者分别在4周和3个月后按需接受地塞米松植入物(0.7mg)。主要结局指标在基线后3个月进行测量,包括最佳矫正视力(BCVA)的改善、中心凹视网膜厚度(CFT)的降低以及随访期间的不良反应。

结果

3个月时,A组平均最佳矫正视力(BCVA)从0.51±0.275 LogMAR单位(20/63)提高到0.20±0.185 LogMAR单位(20/32),B组从0.56±0.213 LogMAR单位(20/80)提高到0.141±0.177 LogMAR单位(20/32)。两组间平均BCVA无显著差异(p = 0.27)。3个月时,B组平均中心凹视网膜厚度(CFT)从443.55±131.536µm改善至277.66±76.184µm,从460.95±125.462µm改善至233.25±37.552µm(p = (此处原文似乎有误,推测应为p = 0.02))。

结论

两组视力结局相似。然而,在此次短期随访中,地塞米松植入物组观察到更优的解剖学结果。

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