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眼内治疗对分支和中央视网膜静脉阻塞引起的黄斑水肿的疗效和安全性:系统评价。

Efficacy and safety of intravitreal therapy in macular edema due to branch and central retinal vein occlusion: a systematic review.

机构信息

University Eye Hospital, Albert Ludwig University, Freiburg, Germany ; University Eye Hospital, Medical School of Hannover, Hannover, Germany.

出版信息

PLoS One. 2013 Oct 25;8(10):e78538. doi: 10.1371/journal.pone.0078538. eCollection 2013.

Abstract

BACKGROUND

Intravitreal agents have replaced observation in macular edema in central (CRVO) and grid laser photocoagulation in branch retinal vein occlusion (BRVO). We conducted a systematic review to evaluate efficacy and safety outcomes of intravitreal therapies for macular edema in CRVO and BRVO.

METHODS AND FINDINGS

MEDLINE, Embase, and the Cochrane Library were systematically searched for RCTs with no limitations of language and year of publication. 11 RCTs investigating anti-VEGF agents (ranibizumab, bevacizumab, aflibercept) and steroids (triamcinolone, dexamethasone implant) with a minimum follow-up of 1 year were evaluated.

EFFICACY CRVO

Greatest gain in visual acuity after 12 months was observed both under aflibercept 2 mg: +16.2 letters (8.5 injections), and under bevacizumab 1.25 mg: +16.1 letters (8 injections). Ranibizumab 0.5 mg improved vision by +13.9 letters (8.8 injections). Triamcinolone 1 mg and 4 mg stabilized visual acuity at a lower injection frequency (-1.2 letters, 2 injections).

BRVO

Ranibizumab 0.5 mg resulted in a visual acuity gain of +18.3 letters (8.4 injections). The effect of dexamethasone implant was transient after 1.9 implants in both indications.

SAFETY

Serious ocular adverse events were rare, e.g., endophthalmitis occurred in 0.0-0.9%. Major differences were found in an indirect comparison between steroids and anti-VEGF agents for cataract progression (19.8-35.0% vs. 0.9-7.0%) and in required treatment of increased intraocular pressure (7.0-41.0% vs. none). No major differences were identified in systemic adverse events.

CONCLUSIONS

Anti-VEGF agents result in a promising gain of visual acuity, but require a high injection frequency. Dexamethasone implant might be an alternative, but comparison is impaired as the effect is temporary and it has not yet been tested in PRN regimen. The ocular risk profile seems to be favorable for anti-VEGF agents in comparison to steroids. Because comparative data from head-to-head trials are missing currently, clinicians and patients should carefully weigh the benefit-harm ratio.

摘要

背景

玻璃体内药物已取代了中央(CRVO)视网膜静脉阻塞(BRVO)中的黄斑水肿的观察和格栅激光光凝。我们进行了一项系统评价,以评估玻璃体内治疗对 CRVO 和 BRVO 黄斑水肿的疗效和安全性。

方法和发现

系统地检索了 MEDLINE、Embase 和 Cochrane 图书馆的 RCTs,无语言和出版年份的限制。评估了 11 项研究抗血管内皮生长因子药物(雷珠单抗、贝伐单抗、阿柏西普)和皮质类固醇(曲安奈德、地塞米松植入物)的 RCTs,这些研究的随访时间均至少为 1 年。

CRVO 的疗效:在阿柏西普 2mg 下,12 个月后视力最佳提高了+16.2 个字母(8.5 次注射),在贝伐单抗 1.25mg 下,视力最佳提高了+16.1 个字母(8 次注射)。雷珠单抗 0.5mg 可使视力提高+13.9 个字母(8.8 次注射)。曲安奈德 1mg 和 4mg 以较低的注射频率稳定了视力(-1.2 个字母,2 次注射)。

BRVO 的疗效:雷珠单抗 0.5mg 可使视力提高+18.3 个字母(8.4 次注射)。在这两种适应证下,地塞米松植入物在 1.9 次植入后效果均是暂时的。

安全性

严重眼部不良事件罕见,例如眼内炎发生率为 0.0-0.9%。在皮质类固醇和抗血管内皮生长因子药物的间接比较中,发现白内障进展(19.8-35.0%比 0.9-7.0%)和需要治疗的眼压升高(7.0-41.0%比无)之间存在显著差异。未发现全身不良事件的显著差异。

结论

抗血管内皮生长因子药物可显著提高视力,但需要较高的注射频率。地塞米松植入物可能是一种替代方法,但由于其效果是暂时的,尚未在 PRN 方案中进行测试,因此比较受到限制。与皮质类固醇相比,抗血管内皮生长因子药物的眼部风险状况似乎更有利。由于目前缺乏头对头试验的比较数据,临床医生和患者应仔细权衡利弊。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99c9/3808377/3271add42043/pone.0078538.g001.jpg

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