关键词: clinical pharmacology medical retina ophthalmology

Mesh : Humans Angiogenesis Inhibitors / therapeutic use Endothelial Growth Factors / therapeutic use Vascular Endothelial Growth Factor A / therapeutic use Ranibizumab / therapeutic use Bevacizumab / therapeutic use Choroidal Neovascularization / drug therapy Myopia / drug therapy complications Intravitreal Injections Randomized Controlled Trials as Topic

来  源:   DOI:10.1136/bmjopen-2022-067921   PDF(Pubmed)

Abstract:
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.
PubMed, EMBASE, the Cochrane Library and ClinicalTrials.gov were searched from inception to 31 July 2022.
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.
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).
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).
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.
CRD42021292806.
摘要:
目的:评价抗血管内皮生长因子(抗VEGF)治疗近视脉络膜新生血管(CNV)的疗效和安全性。并比较两种不同抗VEGF再治疗标准的疗效。
方法:PubMed,EMBASE,Cochrane图书馆和ClinicalTrials.gov从成立到2022年7月31日进行了搜索。
方法:比较抗VEGF与假手术,光动力疗法(PDT)或PDT联合疗法对近视CNV患者进行了回顾和选择。将视敏度(VA)稳定或疾病活动作为抗VEGF再治疗标准的RCT也包括在研究中。
方法:两名评审员独立进行数据提取和质量评估。我们对所有分析都使用了随机效应模型。主要结果包括最佳矫正视力(BCVA)和中央凹厚度。次要结局包括获得BCVA三行以上的患者人数,抗VEGF注射次数和眼部不良事件(AE)。
结果:纳入7个RCTs,涉及1007例患者。与假手术和PDT治疗相比,抗VEGF治疗获得了更好的BCVA增益-0.28logMAR(95%CI-0.36至-0.20,p<0.00001)和-0.14logMAR(95%CI-0.17至-0.10,p<0.00001),分别。雷珠单抗和贝伐单抗均比PDT治疗更好地改善患者的视力,并且未观察到明确的眼部AE风险增加。对两个小型随机对照试验的分析表明,与抗VEGF单药治疗相比,PDT联合治疗具有相似的视觉改善,并且需要更少的抗VEGF注射(加权平均差(WMD)=1.30;95%CI1.24至1.37,p<0.00001)。与VA稳定性指导的再治疗相比,疾病活动标准指导的抗VEGF再治疗可产生相当的视觉改善和减少的抗VEGF注射(WMD=0.83;95%CI0.42至1.25,p<0.0001)。
结论:抗VEGF治疗对近视CNV患者有效且耐受性良好。由疾病活动标准指导的抗VEGF再治疗可以实现相当的功效并潜在地减少抗VEGF注射。
CRD42021292806。
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