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对于先前对贝伐单抗或雷珠单抗难治的糖尿病性黄斑水肿,转换为阿柏西普的疗效:高质量非随机研究的荟萃分析。

Efficacy of Conversion to Aflibercept for Diabetic Macular Edema Previously Refractory to Bevacizumab or Ranibizumab: A Meta-analysis of High-Quality Nonrandomized Studies.

机构信息

First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.

出版信息

Ann Pharmacother. 2020 Aug;54(8):750-756. doi: 10.1177/1060028020904358. Epub 2020 Jan 31.

Abstract

Aflibercept has been widely used in treating diabetic macular edema (DME). However, the effect of aflibercept in treating DME refractory to bevacizumab or ranibizumab has not been well established. To assess the therapeutic effect of switching from bevacizumab or ranibizumab to aflibercept in the treatment of refractory DME. Relevant studies were searched from 3 databases: the Cochrane Library, PubMed, and Web of Science. Data on changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and adverse events within the follow-up period were collected and pooled using weighted mean differences (WMDs) with corresponding 95% CIs in a random effects model. The between-study heterogeneity was tested using the χ test and the 2 statistic, and funnel plots were used to evaluate the publication bias. A total of 11 nonrandomized trials met the inclusion criteria and were included in the meta-analysis. Our studies showed significant improvements in the BCVA (WMD = 100.55; 95% CI = 68.46 to 132.63; < 0.01) and reduction in CMT (WMD = 0.09; 95% CI = 0.03 to 0.14; < 0.01) after switching to aflibercept. Although a large amount of heterogeneity was detected in the CMT results among these studies, the sensitivity analyses showed the reliability and stability of our results. There were significant improvements in both visual and anatomical outcomes after switching from bevacizumab or ranibizumab to aflibercept, without risk of adverse events. Thus, switching therapy may be a safe and effective treatment for patients with refractory DME.

摘要

阿柏西普已广泛用于治疗糖尿病性黄斑水肿(DME)。然而,阿柏西普治疗贝伐单抗或雷珠单抗治疗抵抗的 DME 的效果尚未得到很好的证实。本研究旨在评估在治疗抵抗性 DME 中从贝伐单抗或雷珠单抗转换为阿柏西普的治疗效果。从 Cochrane Library、PubMed 和 Web of Science 这 3 个数据库中搜索相关研究。使用随机效应模型,收集并汇总随访期间最佳矫正视力(BCVA)、中心黄斑厚度(CMT)和不良事件变化的数据,并采用加权均数差(WMD)及其相应的 95%置信区间(CI)表示。使用 χ 检验和卡方检验来检验组间异质性,并采用漏斗图来评估发表偏倚。共有 11 项非随机试验符合纳入标准并纳入荟萃分析。我们的研究表明,转换为阿柏西普后 BCVA 显著改善(WMD = 100.55;95%CI = 68.46 至 132.63; < 0.01),CMT 降低(WMD = 0.09;95%CI = 0.03 至 0.14; < 0.01)。尽管这些研究中 CMT 结果存在大量异质性,但敏感性分析显示了我们结果的可靠性和稳定性。从贝伐单抗或雷珠单抗转换为阿柏西普后,视力和解剖学结果均有显著改善,且无不良事件风险。因此,转换治疗可能是治疗抵抗性 DME 患者的一种安全有效的治疗方法。

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