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法米替尼与其他抗 VEGF 疗法治疗年龄相关性黄斑变性和糖尿病性黄斑水肿的疗效和安全性比较:一项随机临床试验的系统评价和荟萃分析。

Comparative efficacy and safety of Faricimab and other anti-VEGF therapy for age-related macular degeneration and diabetic macular edema: A systematic review and meta-analysis of randomized clinical trials.

机构信息

Department of Pharmacy, Seventh Affiliated Hospital of Southern Medical University, Foshan, Guangdong, China.

出版信息

Medicine (Baltimore). 2023 Dec 15;102(50):e36370. doi: 10.1097/MD.0000000000036370.

Abstract

INTRODUCTION

A systematic review and meta-analysis were conducted to evaluate the efficacy and the overall safety of Faricimab compared with other anti-vascular endothelial growth factors (VEGF) therapy for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME).

MATERIALS AND METHODS

A systematic literature search of a comprehensive electronic database was performed to identify randomized clinical trials published from January 2013 to January 2023 for Faricimab in AMD and DME. Weighted mean differences and risk ratios were used to integrate the different studies.

RESULTS

A total of 4 randomized controlled trials (RCTs) with 1678 AMD patients and 3 RCTs with 20 DME patients were included in the meta-analysis.In patients with AMD, a significant difference was found in the number of injections between Faricimab and other anti-VEGF therapy (MD = -2.42, 95% CI [-3.93 to -0.90], P = .002).No significant difference was found for the change in best corrected visual acuity (BVCA), central subfoveal thickness (CST), and gaining 15 or more letters. Similarly, no significant difference was found for adverse events.In patients with DME, a significant difference was observed for CST (MD = -22.41, 95% CI [-29.95 to -14.86], P < .00001) and the number of injections(MD = -0.93, 95% CI [-1.33 to -0.54], P < .00001). No significant difference was found for BVCA and gaining 15 or more letters, and no significant difference was found for adverse events.

CONCLUSIONS

Comprehensive evidence confirms that Faricimab achieves non-inferior or even better CST improvement than other anti-VEGF therapies with extended dosing intervals, but more long-term follow-up studies are needed to support our conclusions.

摘要

简介

本文进行了系统评价和荟萃分析,以评估 Faricimab 相较于其他抗血管内皮生长因子(VEGF)疗法在治疗新生血管性年龄相关性黄斑变性(AMD)和糖尿病黄斑水肿(DME)方面的疗效和整体安全性。

材料与方法

对 2013 年 1 月至 2023 年 1 月期间发表的 Faricimab 治疗 AMD 和 DME 的所有随机临床试验进行了全面的电子数据库系统检索。使用加权均数差和风险比来整合不同的研究。

结果

共有 4 项 AMD 患者的随机对照试验(RCT)和 3 项 DME 患者的 RCT 纳入荟萃分析。在 AMD 患者中,Faricimab 与其他抗 VEGF 治疗之间的注射次数存在显著差异(MD = -2.42,95%CI [-3.93 至 -0.90],P =.002)。最佳矫正视力(BCVA)、中心凹下脉络膜厚度(CST)和增加 15 个或更多字母的变化没有显著差异。同样,不良反应也没有显著差异。在 DME 患者中,CST(MD = -22.41,95%CI [-29.95 至 -14.86],P <.00001)和注射次数(MD = -0.93,95%CI [-1.33 至 -0.54],P <.00001)有显著差异。BCVA 和增加 15 个或更多字母没有显著差异,不良反应也没有显著差异。

结论

全面的证据证实,Faricimab 在延长给药间隔的情况下,与其他抗 VEGF 疗法相比,在 CST 改善方面具有非劣效性甚至更好的疗效,但需要更多的长期随访研究来支持我们的结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b49e/10727610/b7ff64827b54/medi-102-e36370-g001.jpg

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