糖尿病黄斑水肿患者中的布卢单抗与阿非利百普:随机对照试验的 Meta 分析。

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2024-12-10 eCollection Date: 2024-01-01 DOI:10.2147/OPTH.S487055
Leonardo B Justino, Gustavo B Justino, Fabrissio P Graffunder, William W Binotti, Ali Khodor, Jonathan T Caranfa
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引用次数: 0

摘要

目的:评估糖尿病黄斑水肿(DME)患者使用brolucizumab与aflibercept的疗效和安全性:我们通过试验序列分析(TSA)进行了系统回顾和荟萃分析。我们检索了 Embase、Cochrane Central Register of Controlled Trials 和 PubMed 数据库中从开始到 2024 年 2 月 16 日的随机对照试验 (RCT),这些试验对 DME 患者的视觉、解剖和安全性结果进行了报告。我们对安全性结果进行了TSA,以评估统计错误的风险:结果:纳入了来自3项RCT的1253名患者(1253只眼睛),其中57%接受了brolucizumab治疗,43%接受了aflibercept治疗。平均随访时间从52周到100周不等。在比较最佳矫正视力与基线相比的平均变化时,布卢单抗的疗效不劣于阿夫利拜特(最小二乘法平均差 [LSMD] 0.29;95% 置信区间 [CI] -1.37 至 1.95;P = 0.73)。与阿夫利百普相比,brolucizumab组的中央子场厚度变化明显更大(LSMD -24.5 μm;95% CI -48.2 to -0.7 μm;p < 0.05)。特别关注的不良事件(AESIs)发生率(风险比[RR] 1.7;p = 0.08)和≥1次眼部不良事件(AEs)发生率(RR 0.95;p = 0.45)在组间无显著差异:结论:布鲁珠单抗在功能结果方面不劣于阿夫利拜因,而在解剖参数方面优于阿夫利拜因。眼部AEs和AESIs数量较少,且无统计学意义。我们的研究结果表明,为了建议将布卢单抗作为治疗二极体视网膜病变的替代药物,必须开展新的研究试验,以评估安全性结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Brolucizumab versus Aflibercept in Patients with Diabetic Macular Edema: A Meta-Analysis of Randomized Controlled Trials.

Purpose: To assess efficacy and safety of brolucizumab versus aflibercept in patients with diabetic macular edema (DME).

Patients and methods: We performed a systematic review and meta-analysis with trial sequential analysis (TSA). We searched Embase, Cochrane Central Register of Controlled Trials and PubMed databases from inception to February 16, 2024 for randomized controlled trials (RCTs) comparing brolucizumab with aflibercept in patients with DME and reporting any of the visual, anatomical and safety outcomes of interest. We conducted a TSA of safety outcomes to assess the risk of statistical errors.

Results: 1253 patients (1253 eyes) from 3 RCTs were included, of whom 57% received brolucizumab and 43% received aflibercept. Mean follow-up ranged from 52 to 100 weeks. Brolucizumab was non-inferior to aflibercept when comparing the mean change of best-corrected visual acuity from baseline (least squares mean difference [LSMD] 0.29; 95% confidence interval [CI] -1.37 to 1.95; p = 0.73). Change in central subfield thickness was significantly greater in the brolucizumab group compared with aflibercept (LSMD -24.5 μm; 95% CI -48.2 to -0.7 μm; p < 0.05). Incidence of adverse events of special interest (AESIs) (risk ratio [RR] 1.7; p = 0.08) and incidence of ≥1 ocular adverse events (AEs) (RR 0.95; p = 0.45) were not significantly different between groups.

Conclusion: Brolucizumab was non-inferior in functional outcomes and was superior to aflibercept in anatomical parameters. Ocular AEs and AESIs were numerically low and not statistically significant. Our findings underscore the importance of new RCTs powered to assess safety outcomes in order to suggest brolucizumab as an alternative to the treatment of DME.

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