Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada,
Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
Ophthalmologica. 2024;247(1):19-29. doi: 10.1159/000533443. Epub 2023 Aug 14.
The comparative safety and efficacy of different doses of intravitreal triamcinolone acetonide (IVTA) for diabetic macular edema (DME) and macular edema (ME) secondary to retinal vein occlusion (RVO) is unclear.
This meta-analysis aimed to compare the safety and efficacy of different doses of IVTA in this setting.
A systematic literature search for randomized clinical trials (RCTs) was conducted on Cochrane Library, Ovid MEDLINE, and EMBASE from January 2005 to May 2022. Studies that reported on patients with DME or ME secondary to RVO that received treatment with different doses of IVTA were included. A random-effects meta-analysis was performed. Cochrane's Risk of Bias Tool 2 was used to assess the risk of bias, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines were used to assess certainty of evidence.
Five RCTs reporting on 1,041 eyes at baseline were included in this meta-analysis. In eyes with ME secondary to RVO, high-dose (4 mg) IVTA achieved a significantly better change in best-corrected visual acuity (WMD = -4.75 ETDRS letters, 95% CI = [-7.73, -1.78], p = 0.002) and reduction in retinal thickness (WMD = -93.02 μm, 95% CI = [-153.23, -32.82], p = 0.002) at months 4-6 compared to low-dose (1-2 mg) IVTA. However, high-dose IVTA had a higher risk of intraocular pressure-related adverse events (RR = 2.99, 95% CI = [1.05, 8.50], p = 0.04) and cataract surgery (RR = 5.67, 95% CI = [3.09, 10.41], p < 0.00001) than low-dose IVTA in eyes with ME secondary to RVO. These efficacy and safety differences in high-dose and low-dose IVTA were not observed in DME eyes.
The RCT evidence in this setting is limited. High-dose IVTA achieved greater improvements in visual acuity and reductions in retinal thickness than low-dose IVTA at months 4-6. However, high-dose IVTA had a less favorable safety profile than low-dose IVTA. The significance of these outcomes was based on patients with ME secondary to RVO, but not DME.
不同剂量玻璃体内曲安奈德(IVTA)治疗糖尿病性黄斑水肿(DME)和视网膜静脉阻塞(RVO)继发黄斑水肿(ME)的安全性和疗效尚不清楚。
本荟萃分析旨在比较该情况下不同剂量 IVTA 的安全性和疗效。
对 Cochrane 图书馆、Ovid MEDLINE 和 EMBASE 自 2005 年 1 月至 2022 年 5 月进行了随机临床试验(RCT)的系统文献检索。纳入了接受不同剂量 IVTA 治疗的 DME 或 RVO 继发 ME 患者的 RCT 研究。进行了随机效应荟萃分析。使用 Cochrane 偏倚风险工具 2 评估偏倚风险,并使用推荐评估、制定与评价(GRADE)指南评估证据确定性。
本荟萃分析纳入了 5 项 RCT 研究,共纳入了 1041 只基线眼。在 RVO 继发 ME 眼中,高剂量(4 mg)IVTA 在 4-6 个月时视力矫正最佳视力(BCVA)改善(WMD = -4.75 ETDRS 字母,95%CI = [-7.73,-1.78],p = 0.002)和视网膜厚度降低(WMD = -93.02 μm,95%CI = [-153.23,-32.82],p = 0.002)方面明显优于低剂量(1-2 mg)IVTA。然而,高剂量 IVTA 发生与眼压相关的不良反应(RR = 2.99,95%CI = [1.05,8.50],p = 0.04)和白内障手术(RR = 5.67,95%CI = [3.09,10.41],p < 0.00001)的风险高于低剂量 IVTA。在 RVO 继发 DME 眼中,高剂量和低剂量 IVTA 之间并未观察到这些疗效和安全性差异。
本研究中 RCT 证据有限。高剂量 IVTA 在 4-6 个月时在视力改善和视网膜厚度降低方面优于低剂量 IVTA。然而,高剂量 IVTA 的安全性不如低剂量 IVTA。这些结果的意义基于 RVO 继发 ME 患者,但不适用于 DME 患者。