Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2019 May 28;9(5):e022031. doi: 10.1136/bmjopen-2018-022031.
To evaluate the comparative effectiveness and safety of intravitreal bevacizumab, ranibizumab and aflibercept for patients with choroidal neovascular age-related macular degeneration (cn-AMD), diabetic macular oedema (DMO), macular oedema due to retinal vein occlusion (RVO-MO) and myopic choroidal neovascularisation (m-CNV).
Systematic review and random-effects meta-analysis.
Multiple databases were searched from inception to 17 August 2017. Eligible head-to-head randomised controlled trials (RCTs) comparing the (anti-VEGF) drugs in adult patients aged ≥18 years with the retinal conditions of interest. Two reviewers independently screened studies, extracted data and assessed risk of bias.
19 RCTs involving 7459 patients with cn-AMD (n=12), DMO (n=3), RVO-MO (n=2) and m-CNV (n=2) were included. Vision gain was not significantly different in patients with cn-AMD, DMO, RVO-MO and m-CNV treated with bevacizumab versus ranibizumab. Similarly, vision gain was not significantly different between cn-AMD patients treated with aflibercept versus ranibizumab. Patients with DMO treated with aflibercept experienced significantly higher vision gain at 12 months than patients receiving ranibizumab or bevacizumab; however, this difference was not significant at 24 months. Rates of systemic serious harms were similar across anti-VEGF agents. Posthoc analyses revealed that an as-needed treatment regimen (6-9 injections per year) was associated with a mortality increase of 1.8% (risk ratio: 2.0 [1.2 to 3.5], 2 RCTs, 1795 patients) compared with monthly treatment in cn-AMD patients.
Intravitreal bevacizumab was a reasonable alternative to ranibizumab and aflibercept in patients with cn-AMD, DMO, RVO-MO and m-CNV. The only exception was for patients with DME and low visual acuity (<69 early treatment diabetic retinopathy study [ETDRS] letters), where treatment with aflibercept was associated with significantly higher vision gain (≥15 ETDRS letters) than bevacizumab or ranibizumab at 12 months; but the significant effects were not maintained at 24 months. The choice of anti-VEGF drugs may depend on the specific retinal condition, baseline visual acuity and treatment regimen.
CRD42015022041.
评估玻璃体内注射贝伐单抗、雷珠单抗和阿柏西普治疗年龄相关性黄斑变性脉络膜新生血管（cn-AMD）、糖尿病黄斑水肿（DMO）、视网膜静脉阻塞黄斑水肿（RVO-MO）和近视性脉络膜新生血管（m-CNV）患者的疗效和安全性。
系统评价和随机效应荟萃分析。
从建库至 2017 年 8 月 17 日，检索多个数据库。纳入比较贝伐单抗、雷珠单抗和阿柏西普治疗年龄≥18 岁且患有上述视网膜疾病的成年患者的头对头随机对照试验（RCT）。两位评审员独立筛选研究、提取数据和评估偏倚风险。
纳入了 19 项 RCT 共 7459 例 cn-AMD（n=12）、DMO（n=3）、RVO-MO（n=2）和 m-CNV（n=2）患者。cn-AMD、DMO、RVO-MO 和 m-CNV 患者接受贝伐单抗或雷珠单抗治疗的视力增益无显著差异。同样，cn-AMD 患者接受阿柏西普治疗的视力增益也不低于雷珠单抗。DMO 患者接受阿柏西普治疗 12 个月时的视力增益显著高于接受雷珠单抗或贝伐单抗治疗的患者，但 24 个月时的差异不显著。各抗 VEGF 药物的全身性严重不良事件发生率相似。事后分析显示，与每月治疗相比，cn-AMD 患者按需治疗方案（每年 6-9 次注射）与死亡率增加 1.8%相关（风险比：2.0 [1.2 至 3.5]，2 项 RCT，1795 例患者）。
在 cn-AMD、DMO、RVO-MO 和 m-CNV 患者中，玻璃体内注射贝伐单抗是雷珠单抗和阿柏西普的合理替代药物。唯一的例外是视力低于（<69 个早期治疗糖尿病视网膜病变研究 [ETDRS] 字母）的 DME 患者，与贝伐单抗或雷珠单抗相比，阿柏西普治疗 12 个月时视力增益显著更高（≥15 ETDRS 字母），但 24 个月时无显著效果。抗 VEGF 药物的选择可能取决于特定的视网膜状况、基线视力和治疗方案。
CRD42015022041。
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