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比较抗血管内皮生长因子治疗近视脉络膜新生血管的效果:一项随机对照试验的系统评价和荟萃分析。

Comparison of antivascular endothelial growth factor treatment for myopia choroidal neovascularisation: a systematic review and meta-analysis of randomised controlled trials.

机构信息

Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.

Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China

出版信息

BMJ Open. 2023 Jul 20;13(7):e067921. doi: 10.1136/bmjopen-2022-067921.

Abstract

OBJECTIVES

To evaluate the efficacy and safety of anti-vascular endothelial growth factor (anti-VEGF) therapy for myopia choroidal neovascularisation (CNV), and to compare the efficacy of two different anti-VEGF retreatment criteria.

DATA SOURCES

PubMed, EMBASE, the Cochrane Library and ClinicalTrials.gov were searched from inception to 31 July 2022.

STUDY SELECTION

Randomised controlled trials (RCTs) comparing anti-VEGF with sham, photodynamic therapy (PDT) or PDT combination therapy in patients with myopia CNV were reviewed and selected. RCTs comparing visual acuity (VA) stabilisation or disease activity as anti-VEGF retreatment criteria were also included in the study.

DATA EXTRACTION AND SYNTHESIS

Two reviewers independently conducted data extraction and quality assessment. We used a random-effects model for all analyses. Primary outcomes included best-corrected visual acuity (BCVA) and central foveal thickness. Secondary outcomes included number of patients who gained more than three lines in BCVA, number of anti-VEGF injections and ocular adverse event (AE).

RESULTS

Seven RCTs involving 1007 patients were included. Compared with sham and PDT therapy, anti-VEGF therapy achieved better BCVA gains of -0.28 logMAR (95% CI -0.36 to -0.20, p<0.00001) and -0.14 logMAR (95% CI -0.17 to -0.10, p<0.00001), respectively. Both ranibizumab and bevacizumab improved patients' vision better than PDT therapy and no definitive increased risk of ocular AE was observed. Analysis of two small RCTs showed that PDT combination therapy had similar visual improvement and needed fewer anti-VEGF injections compared with anti-VEGF monotherapy (weighted mean difference (WMD)=1.30; 95% CI 1.24 to 1.37, p<0.00001). Anti-VEGF retreatment guided by disease activity criteria resulted in comparable visual improvement and reduced anti-VEGF injections compared with retreatment guided by VA stabilisation (WMD=0.83; 95% CI 0.42 to 1.25, p<0.0001).

CONCLUSIONS

Anti-VEGF therapy is effective and well-tolerated for myopia CNV patients. Anti-VEGF retreatment guided by disease activity criteria can achieve comparable efficacy and potentially reduce anti-VEGF injections.

PROSPERO REGISTRATION NUMBER

CRD42021292806.

摘要

目的

评估抗血管内皮生长因子(anti-VEGF)治疗近视脉络膜新生血管(CNV)的疗效和安全性,并比较两种不同的抗 VEGF 再治疗标准的疗效。

资料来源

从建库至 2022 年 7 月 31 日,检索了 PubMed、EMBASE、Cochrane 图书馆和 ClinicalTrials.gov。

研究选择

对比较抗 VEGF 与假手术、光动力疗法(PDT)或 PDT 联合治疗近视 CNV 的随机对照试验(RCT)进行了回顾和选择。还纳入了比较视力稳定或疾病活动作为抗 VEGF 再治疗标准的 RCT。

数据提取和综合

两名审查员独立进行数据提取和质量评估。我们对所有分析均采用随机效应模型。主要结局包括最佳矫正视力(BCVA)和中心凹视网膜厚度。次要结局包括 BCVA 增加超过 3 行的患者数量、抗 VEGF 注射次数和眼部不良事件(AE)。

结果

纳入了 7 项涉及 1007 名患者的 RCT。与假手术和 PDT 治疗相比,抗 VEGF 治疗分别获得了更好的 BCVA 改善,即 -0.28 对数视力(95%CI-0.36 至 -0.20,p<0.00001)和 -0.14 对数视力(95%CI-0.17 至 -0.10,p<0.00001)。雷珠单抗和贝伐单抗均改善了患者的视力,优于 PDT 治疗,且未观察到眼部 AE 风险明显增加。两项小型 RCT 的分析表明,与抗 VEGF 单药治疗相比,PDT 联合治疗具有相似的视力改善效果,且需要的抗 VEGF 注射次数更少(加权均数差(WMD)=1.30;95%CI 1.24 至 1.37,p<0.00001)。基于疾病活动标准的抗 VEGF 再治疗与基于视力稳定的再治疗相比,可获得相当的视力改善并减少抗 VEGF 注射次数(WMD=0.83;95%CI 0.42 至 1.25,p<0.0001)。

结论

抗 VEGF 治疗对近视 CNV 患者有效且耐受良好。基于疾病活动标准的抗 VEGF 再治疗可以达到相当的疗效,并可能减少抗 VEGF 注射次数。

PROSPERO 注册号:CRD42021292806。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0090/10360440/6b54f061afb3/bmjopen-2022-067921f01.jpg

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