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比较治疗视网膜中央静脉阻塞所致黄斑水肿的药物疗法的疗效和安全性。

Comparison of the efficacy and safety of drug therapies for macular edema secondary to central retinal vein occlusion.

机构信息

Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai, China.

School of Information Science and Engineering, East China University of Science and Technology, Shanghai, China.

出版信息

BMJ Open. 2018 Dec 28;8(12):e022700. doi: 10.1136/bmjopen-2018-022700.

DOI:10.1136/bmjopen-2018-022700
PMID:30593547
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6318534/
Abstract

OBJECTIVES

To evaluate the efficacy and safety of anti-vascular endothelial growth factor (VEGF) agents and corticosteroids for the treatment of macular oedema (ME) secondary to central retinal vein occlusion (CRVO).

DESIGN

Systematic review and network meta-analysis.

PARTICIPANTS

Patients from previously reported randomised controlled trials (RCTs) comparing anti-VEGF and corticosteroids for the treatment of ME secondary to CRVO.

METHODS

Literature searches were conducted using PubMed, Medline, Embase, Cochrane Library and clinicaltrials.gov until March 2017. Therapeutic effects were estimated using the proportions of patients gaining/losing ≥15 letters, best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Treatment safety was estimated using the proportions of adverse events, namely increased intraocular pressure (IOP), cataracts, vitreous haemorrhage (VH) and retinal tear. The software ADDIS (V.1.16.8) was used for analysis. Treatment effect and safety of different drugs could be ranked based on simulation.

RESULTS

Eleven RCTs comprising 2060 patients were identified. Regarding patients gaining ≥15 letters, aflibercept and ranibizumab were significantly more effective than sham/placebo at 6 months. Regarding patients losing ≥15 letters at 6 months, ranibizumab showed significant improvement compared with dexamethasone. Aflibercept, bevacizumab or ranibizumab showed greater improvements in BCVA than sham/placebo at 6 months. Intravitreal ranibizumab injection demonstrated greater CRT reduction than both sham and dexamethasone did. Dexamethasone had a higher risk of increased IOP than aflibercept and ranibizumab. Ranibizumab demonstrated a greater risk of cataracts than dexamethasone. Aflibercept and ranibizumab demonstrated low incidence of VH and retinal tear, respectively. Aflibercept had a slight advantage over ranibizumab as assessed by benefit-risk analysis.

CONCLUSIONS

Anti-VEGF agents have advantages in the treatment of ME secondary to CRVO. Aflibercept and ranibizumab showed marked BCVA improvement and CRT reduction. Aflibercept may have a slight advantage over ranibizumab. The results of this study can serve as a reference for clinicians to provide patient-tailored treatment.

PROSPERO REGISTRATION NUMBER

CRD42017064076.

摘要

目的

评估抗血管内皮生长因子(VEGF)药物和皮质类固醇治疗视网膜中央静脉阻塞(CRVO)继发黄斑水肿(ME)的疗效和安全性。

设计

系统评价和网络荟萃分析。

参与者

来自先前报道的比较抗 VEGF 和皮质类固醇治疗 CRVO 继发 ME 的随机对照试验(RCT)的患者。

方法

使用 PubMed、Medline、Embase、Cochrane 图书馆和 clinicaltrials.gov 进行文献检索,检索时间截至 2017 年 3 月。使用患者获得/丧失≥15 个字母、最佳矫正视力(BCVA)和中心视网膜厚度(CRT)的比例来估计治疗效果。使用不良反应(即眼压升高、白内障、玻璃体积血和视网膜裂孔)的比例来估计治疗安全性。使用 ADDIS(V.1.16.8)软件进行分析。可以根据模拟对不同药物的治疗效果和安全性进行排名。

结果

共纳入 11 项 RCT,涉及 2060 例患者。在获得≥15 个字母的患者中,阿柏西普和雷珠单抗在 6 个月时的疗效明显优于假手术/安慰剂。在 6 个月时丧失≥15 个字母的患者中,雷珠单抗与地塞米松相比显示出显著改善。阿柏西普、贝伐单抗或雷珠单抗在 6 个月时的 BCVA 改善优于假手术/安慰剂。玻璃体内注射雷珠单抗比假手术和地塞米松都能更有效地降低 CRT。地塞米松导致眼压升高的风险高于阿柏西普和雷珠单抗。雷珠单抗导致白内障的风险高于地塞米松。阿柏西普和雷珠单抗导致玻璃体积血和视网膜裂孔的发生率较低。利风险分析评估,阿柏西普优于雷珠单抗。

结论

抗 VEGF 药物在治疗 CRVO 继发 ME 方面具有优势。阿柏西普和雷珠单抗显示出明显的 BCVA 改善和 CRT 降低。阿柏西普可能比雷珠单抗略有优势。本研究结果可为临床医生为患者提供个体化治疗提供参考。

PROSPERO 注册号:CRD42017064076。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6683/6318534/c847478a41be/bmjopen-2018-022700f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6683/6318534/c847478a41be/bmjopen-2018-022700f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6683/6318534/c847478a41be/bmjopen-2018-022700f02.jpg

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