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地塞米松植入剂(Ozurdex)治疗糖尿病性黄斑水肿的早期疗效:真实世界研究

[Early efficacy of dexamethasone implant (OZURDEX) in diabetic macular edema: Real life study].

作者信息

Sarda V, Fajnkuchen F, Nghiem-Buffet S, Grenet T, Chaine G, Giocanti-Auregan A

机构信息

Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France.

Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France; Centre ophtalmologique d'imagerie et de laser, 75015 Paris, France.

出版信息

J Fr Ophtalmol. 2017 May;40(5):408-413. doi: 10.1016/j.jfo.2016.10.017. Epub 2017 Mar 21.

Abstract

PURPOSE

To assess early efficacy of dexamethasone intravitreal implant 0.7mg (OZURDEX) at the time of peak efficacy (2 months after injection) in patients with decreased visual acuity secondary to diabetic macular edema (DME).

MATERIALS AND METHODS

Retrospective monocentric study. Inclusion criteria were best-corrected visual acuity (BCVA)≤70 letters (20/40) due to DME and central retinal thickness (CRT)≥300 microns (Cirrus 2, Carl Zeiss Meditec, Inc, Dublin). Enrolled patients could be treatment naive or not (after failure of laser photocoagulation and/or anti-VEGF therapy). Follow-up was at least 6 months. Our primary endpoint was BCVA gain at M2 after injection. Secondary endpoints were best-corrected visual acuity at 2 and 4 months, central retinal thickness at 2 and 4 months, mean interval between 2 injections, and adverse events.

RESULT

Nineteen eyes of 19 patients were included in this study. The mean age was 67.45 years, sex ratio was 2.17 men/women, and the patients were all type 2 diabetics. Three of 19 patients were treatment naive for anti-VEGF intravitreal injection, and 52.3% were pseudophakic (10/19 patients). The mean gain of BCVA at M2 was +7.7 letters. The mean BCVA was 51.1 ETDRS letters at baseline and 58.8 at M2. Mean CRT was 568.9μm at baseline and 291.2μm at M2. Treatment with dexamethasone implant was mainly a second-line treatment after failure of other treatments (macular laser photocoagulation and/or intravitreal injection of anti-VEGF). Three patients were naive of anti-VEGF treatment. Intraocular pressure≥25mmHg was found in 2 patients, and controlled medically. No glaucoma surgery was performed.

CONCLUSION

The dexamethasone implant (OZURDEX) allows an anatomical and functional improvement in patients suffering from vision loss due to DME. In this series, the implant was well tolerated.

摘要

目的

评估玻璃体内注射0.7mg地塞米松植入剂(Ozurdex)在治疗因糖尿病性黄斑水肿(DME)导致视力下降患者达到疗效峰值时(注射后2个月)的早期疗效。

材料与方法

回顾性单中心研究。纳入标准为因DME导致最佳矫正视力(BCVA)≤70字母(20/40)且中心视网膜厚度(CRT)≥300微米(Cirrus 2,卡尔蔡司医疗技术公司,都柏林)。入选患者可以是初治患者或非初治患者(激光光凝和/或抗VEGF治疗失败后)。随访至少6个月。我们的主要终点是注射后M2时的BCVA提高。次要终点包括2个月和4个月时的最佳矫正视力、2个月和4个月时的中心视网膜厚度、两次注射之间的平均间隔时间以及不良事件。

结果

本研究纳入了19例患者的19只眼。平均年龄为67.45岁,性别比为男性/女性 = 2.17,所有患者均为2型糖尿病患者。19例患者中有3例为抗VEGF玻璃体内注射初治患者,52.3%为人工晶状体眼(10/19例患者)。M2时BCVA的平均提高为 +7.7字母。基线时平均BCVA为51.1 ETDRS字母,M2时为58.8字母。基线时平均CRT为568.9μm,M2时为291.2μm。地塞米松植入剂治疗主要是在其他治疗(黄斑激光光凝和/或玻璃体内注射抗VEGF)失败后的二线治疗。3例患者未接受过抗VEGF治疗。2例患者眼压≥25mmHg,通过药物控制。未进行青光眼手术。

结论

地塞米松植入剂(Ozurdex)可使因DME导致视力丧失的患者在解剖结构和功能上得到改善。在本系列研究中,该植入剂耐受性良好。

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