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比较地塞米松植入物和抗 VEGF 治疗黄斑水肿的疗效:系统评价和荟萃分析。

Comparing the efficacy of dexamethasone implant and anti-VEGF for the treatment of macular edema: A systematic review and meta-analysis.

机构信息

Department of Ophthalmology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Pediatrics, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

PLoS One. 2024 Jul 10;19(7):e0305573. doi: 10.1371/journal.pone.0305573. eCollection 2024.

Abstract

OBJECTIVES

To evaluate the clinical efficacy of dexamethasone (DEX) implant, for the treatment of macular edema (ME) caused by retinal vein occlusion (RVO) and diabetic retinopathy (DR) through a systematic review and meta-analysis.

METHODS

The PubMed, Embase and Cochrane Library databases were comprehensively searched from inception to November 21, 2022, for studies evaluating the clinical efficacy of DEX implant for patients with retinal vein occlusion macular edema (RVO-ME) or diabetic macular edema (DME). Randomized controlled trials (RCTs) published in English were considered eligible. The Cochrane Collaboration tool was applied to assess the risk of bias in each study. Effect estimates with 95% confidence intervals (CIs) were pooled using the random effects model. We also conducted subgroup analyses to explore the sources of heterogeneity and the stability of the results.

RESULTS

This meta-analysis included 8 RCTs (RVO-ME [n = 2] and DME [n = 6]) assessing a total of 336 eyes. Compared with anti-VEGF therapy, DEX implant treatment achieved superior outcomes in terms of best corrected visual acuity (BCVA) (mean difference [MD] = -3.68 ([95% CI, -6.11 to -1.25], P = 0.003), and no heterogeneity was observed (P = 0.43, I2 = 0%). DEX implant treatment also significantly reduced central macular thickness (CMT) compared with anti-VEGF treatment (MD = -31.32 [95% CI, -57.92 to -4.72], P = 0.02), and there was a high level of heterogeneity between trials (P = 0.04, I2 = 54%). In terms of severe adverse events, DEX implant treatment had a higher risk of elevated intraocular pressure than anti-VEGF therapy (RR = 6.98; 95% CI: 2.16 to 22.50; P = 0.001), and there was no significant difference in cataract progression between the two groups (RR = 1.83; 95% CI: 0.63 to 5.27, P = 0.31).

CONCLUSIONS

Compared with anti-VEGF therapy, DEX implant treatment is more effective in improving BCVA and reducing ME. Additionally, DEX implant treatment has a higher risk of elevated intraocular pressure. Due to the small number of studies and the short follow-up period, the results should be interpreted with caution. The long-term effects of the two treatments need to be further determined.

TRIAL REGISTRATION

Prospero Registration Number CRD42021243185.

摘要

目的

通过系统评价和荟萃分析评估地塞米松(DEX)植入物治疗视网膜静脉阻塞(RVO)和糖尿病性视网膜病变(DR)引起的黄斑水肿(ME)的临床疗效。

方法

全面检索 PubMed、Embase 和 Cochrane Library 数据库,检索时间截至 2022 年 11 月 21 日,以评估 DEX 植入物治疗视网膜静脉阻塞性黄斑水肿(RVO-ME)或糖尿病性黄斑水肿(DME)患者的临床疗效的研究。纳入以英语发表的随机对照试验(RCT)。应用 Cochrane 协作工具评估每项研究的偏倚风险。使用随机效应模型汇总具有 95%置信区间(CI)的效应估计值。我们还进行了亚组分析,以探索异质性的来源和结果的稳定性。

结果

这项荟萃分析纳入了 8 项 RCT(RVO-ME [n=2]和 DME [n=6]),共评估了 336 只眼。与抗 VEGF 治疗相比,DEX 植入物治疗在最佳矫正视力(BCVA)方面具有更好的疗效(平均差异[MD]=-3.68[95%CI,-6.11 至-1.25],P=0.003),且无异质性(P=0.43,I2=0%)。与抗 VEGF 治疗相比,DEX 植入物治疗还显著降低了中央黄斑厚度(CMT)(MD=-31.32[95%CI,-57.92 至-4.72],P=0.02),且试验间存在高度异质性(P=0.04,I2=54%)。在严重不良事件方面,DEX 植入物治疗的眼压升高风险高于抗 VEGF 治疗(RR=6.98;95%CI:2.16 至 22.50;P=0.001),两组之间白内障进展无显著差异(RR=1.83;95%CI:0.63 至 5.27,P=0.31)。

结论

与抗 VEGF 治疗相比,DEX 植入物治疗在提高 BCVA 和减轻 ME 方面更有效。此外,DEX 植入物治疗的眼压升高风险更高。由于研究数量较少且随访时间较短,因此应谨慎解释结果。两种治疗方法的长期效果尚需进一步确定。

试验注册

PROSPERO 注册号 CRD42021243185。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2936/11236136/3f2a07c1c562/pone.0305573.g001.jpg

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