Santhakumaran Sangeetha, Salimi Ali, Brunetti Vanessa C, Galic John
Faculty of Medicine, McGill University, Montreal, Canada.
Department of Ophthalmology, Faculty of Medicine, McGill University, Montreal, Canada.
J Curr Ophthalmol. 2022 Jul 26;34(2):133-147. doi: 10.4103/joco.joco_308_21. eCollection 2022 Apr-Jun.
To assess the real-world efficacy and safety of aflibercept for the treatment of diabetic macular edema (DME).
A systematic search was conducted across multiple databases. Articles were included if participants had DME and received aflibercept treatment for a minimum of 52 ± 4 weeks. Primary outcomes included changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). A risk of bias assessment of studies was completed, pooled estimates were obtained, and a meta-regression was performed. Information on adverse events was collected.
The search yielded 2112 articles, of which 30 were included. Aflibercept was more effective than laser photocoagulation functionally (12-month BCVA-weighted mean difference [WMD] = 10.77 letters, < 0.001; 24 months = 8.12 letters, < 0.001) and anatomically (12-month CMT WMD = -114.12 μm, < 0.001; 24 months = -90.4 μm, = 0.004). Compared to bevacizumab, aflibercept was noninferior at improving BCVA at 12 months (WMD = 1.71 letters, = 0.34) and 24 months (WMD = 1.58 letters, = 0.083). One study found that aflibercept was more effective than bevacizumab anatomically at 1 and 2 years ( < 0.001 at 12 and 24 months). Compared to ranibizumab, aflibercept rendered a greater improvement in BCVA at 1 year (WMD = 1.76 letters, = 0.001), but not 2 years (WMD = 1.66 letters, = 0.072). CMT was not significantly different between both therapies at 12 months (WMD = -14.30 μm, = 0.282) and 24 months ( = 0.08). One study reported greater functional improvement with aflibercept compared with dexamethasone ( = 0.004), but inferiority in reducing CMT ( < 0.001). Meta-regression analysis demonstrated that dosing schedule was found to impact outcomes at 12 and 24 months, while study design and sample size did not impact outcomes at 12 months. There were minimal safety concerns using aflibercept therapy.
Aflibercept is a safe and effective therapy option for DME in the clinical setting, performing superiorly to laser photocoagulation. Evidence regarding comparisons with bevacizumab, ranibizumab, and dexamethasone is mixed and limited.
评估阿柏西普治疗糖尿病性黄斑水肿（DME）的真实疗效和安全性。
对多个数据库进行系统检索。纳入的文章要求参与者患有DME且接受阿柏西普治疗至少52±4周。主要结局包括最佳矫正视力（BCVA）和中心黄斑厚度（CMT）的变化。完成对研究的偏倚风险评估，获得合并估计值，并进行Meta回归分析。收集不良事件信息。
检索得到2112篇文章，其中30篇被纳入。在功能方面（12个月时BCVA加权平均差[WMD]=10.77字母，P<0.001；24个月时=8.12字母，P<0.001）和解剖学方面（12个月时CMT WMD=-114.12μm，P<0.001；24个月时=-90.4μm，P=0.004），阿柏西普比激光光凝更有效。与贝伐单抗相比，阿柏西普在12个月（WMD=1.71字母，P=0.34）和24个月（WMD=1.58字母，P=0.083）时改善BCVA方面不劣于贝伐单抗。一项研究发现，在1年和2年时，阿柏西普在解剖学上比贝伐单抗更有效（12个月和24个月时P<0.001）。与雷珠单抗相比，阿柏西普在1年时BCVA改善更大（WMD=1.76字母，P=0.001），但在2年时并非如此（WMD=1.66字母，P=0.072）。两种治疗在12个月（WMD=-14.30μm，P=0.282）和24个月（P=0.08）时CMT无显著差异。一项研究报告称，与地塞米松相比，阿柏西普在功能改善方面更显著（P=0.004），但在降低CMT方面较差（P<0.001）。Meta回归分析表明，给药方案对12个月和24个月时的结局有影响，而研究设计和样本量对12个月时的结局无影响。使用阿柏西普治疗的安全性担忧极小。
在临床环境中，阿柏西普是治疗DME的一种安全有效的治疗选择，其效果优于激光光凝。与贝伐单抗、雷珠单抗和地塞米松比较的证据参差不齐且有限。
