PDF(Pubmed)
Abstract：
BACKGROUND: This systematic review and meta-analysis aimed to provide an updated evidence base for clinical decision-making by comparing the efficacy and safety of aflibercept 2 mg and ranibizumab in treating retinal vein occlusion (RVO).
METHODS: A systematic search was conducted using eight databases up to December 2021. Randomized controlled trials (RCTs) and real-world studies (RWSs) comparing aflibercept and ranibizumab in patients with RVO were evaluated. The primary outcomes assessed were efficacy, number of injections administered, and adverse events.
RESULTS: Three RCTs (424 patients) and 11 RWSs (1415 patients) were included. For central RVO (CRVO), RCTs demonstrated a comparable efficacy, whereas RWSs showed that mean changes from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were significantly greater with aflibercept compared to ranibizumab; the number of injections of aflibercept was fewer than that of ranibizumab in RCTs, but similar in RWSs. For branch RVO (BRVO), no statistically significant difference in efficacy between the two drugs in RCTs/RWSs was observed, with fewer injections of aflibercept at 12 months in RWSs. The safety profiles of both drugs were similar for both CRVO and BRVO.
CONCLUSIONS: For CRVO, aflibercept had similar efficacy and safety profile but with fewer injections versus ranibizumab in RCTs; RWSs showed greater BCVA improvement and CRT reduction with aflibercept than ranibizumab. For BRVO, RCTs showed similar in efficacy, safety, and injection numbers for both drugs, while RWSs demonstrated that aflibercept required fewer injections at 12 months of follow-up. Overall, this study provides updated evidence for clinical decision-making in the treatment of RVO.
METHODS: A systematic search was conducted using eight databases up to December 2021. Randomized controlled trials (RCTs) and real-world studies (RWSs) comparing aflibercept and ranibizumab in patients with RVO were evaluated. The primary outcomes assessed were efficacy, number of injections administered, and adverse events.
RESULTS: Three RCTs (424 patients) and 11 RWSs (1415 patients) were included. For central RVO (CRVO), RCTs demonstrated a comparable efficacy, whereas RWSs showed that mean changes from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were significantly greater with aflibercept compared to ranibizumab; the number of injections of aflibercept was fewer than that of ranibizumab in RCTs, but similar in RWSs. For branch RVO (BRVO), no statistically significant difference in efficacy between the two drugs in RCTs/RWSs was observed, with fewer injections of aflibercept at 12 months in RWSs. The safety profiles of both drugs were similar for both CRVO and BRVO.
CONCLUSIONS: For CRVO, aflibercept had similar efficacy and safety profile but with fewer injections versus ranibizumab in RCTs; RWSs showed greater BCVA improvement and CRT reduction with aflibercept than ranibizumab. For BRVO, RCTs showed similar in efficacy, safety, and injection numbers for both drugs, while RWSs demonstrated that aflibercept required fewer injections at 12 months of follow-up. Overall, this study provides updated evidence for clinical decision-making in the treatment of RVO.
摘要：
背景：本系统综述和荟萃分析旨在通过比较阿柏西普2mg和雷珠单抗治疗视网膜静脉阻塞（RVO）的疗效和安全性，为临床决策提供最新的证据基础。
方法：截至2021年12月，使用8个数据库进行了系统搜索。评估了在RVO患者中比较阿柏西普和雷珠单抗的随机对照试验（RCTs）和真实世界研究（RWSs）。评估的主要结果是疗效，注射次数，和不良事件。
结果：纳入了3个RCT（424例患者）和11个RWSs（1415例患者）。对于中央RVO(CRVO)，RCT表现出相当的疗效，而RWSs显示，与雷珠单抗相比，阿柏西普的最佳矫正视力（BCVA）和中央视网膜厚度（CRT）相对于基线的平均变化明显更大；在RCT中，阿柏西普的注射次数少于雷珠单抗，但在RWS中相似。对于分支RVO(BRVO)，两种药物在RCTs/RWSs中的疗效无统计学差异，在RWSs中12个月时注射阿柏西普较少。CRVO和BRVO两种药物的安全性相似。
结论：对于CRVO，在随机对照试验中,阿柏西普的疗效和安全性相似,但与雷珠单抗相比,其注射次数较少;与雷珠单抗相比,阿柏西普的RWSs显示出更大的BCVA改善和CRT减少.对于BRVO,随机对照试验显示出相似的疗效，安全,两种药物的注射次数，而RWS证明，在12个月的随访中，阿柏西普需要更少的注射。总的来说,本研究为RVO治疗的临床决策提供了最新证据.
方法：截至2021年12月，使用8个数据库进行了系统搜索。评估了在RVO患者中比较阿柏西普和雷珠单抗的随机对照试验（RCTs）和真实世界研究（RWSs）。评估的主要结果是疗效，注射次数，和不良事件。
结果：纳入了3个RCT（424例患者）和11个RWSs（1415例患者）。对于中央RVO(CRVO)，RCT表现出相当的疗效，而RWSs显示，与雷珠单抗相比，阿柏西普的最佳矫正视力（BCVA）和中央视网膜厚度（CRT）相对于基线的平均变化明显更大；在RCT中，阿柏西普的注射次数少于雷珠单抗，但在RWS中相似。对于分支RVO(BRVO)，两种药物在RCTs/RWSs中的疗效无统计学差异，在RWSs中12个月时注射阿柏西普较少。CRVO和BRVO两种药物的安全性相似。
结论：对于CRVO，在随机对照试验中,阿柏西普的疗效和安全性相似,但与雷珠单抗相比,其注射次数较少;与雷珠单抗相比,阿柏西普的RWSs显示出更大的BCVA改善和CRT减少.对于BRVO,随机对照试验显示出相似的疗效，安全,两种药物的注射次数，而RWS证明，在12个月的随访中，阿柏西普需要更少的注射。总的来说,本研究为RVO治疗的临床决策提供了最新证据.
