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地塞米松泪小管内植入物用于慢性季节性/常年性变应性结膜炎患者的疗效与安全性:一项系统评价和荟萃分析

The Efficacy and Safety of Dexamethasone Intracanalicular Insert Use in Patients with Chronic Seasonal/Perennial Allergic Conjunctivitis: A Systematic Review and Meta-Analysis.

作者信息

Alsudais Ali S, Alshehri Waleed Mohammed, Alrehaili Ahmed M, Albeladi Reyadh Khalid, Khoshhal Mohammed, Albelowi Ahmed, Alzahrani Raghad Saleh, Alnabihi Ahmed, Bashrahil Bader, Alabbasi Omar

机构信息

College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.

King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.

出版信息

Clin Ophthalmol. 2024 Sep 21;18:2657-2666. doi: 10.2147/OPTH.S470657. eCollection 2024.

Abstract

OBJECTIVE

This meta-analysis evaluated the efficacy and safety of DEXTENZA, an intracanalicular dexamethasone insert, for the treatment of seasonal/perennial allergic conjunctivitis.

METHODS

Multiple databases, including PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov, the Directory of Open Access Journals, and Scopus, were searched for randomized controlled trials (RCTs) comparing the efficacy of DEXTENZA with a placebo. The primary efficacy endpoint was the change in the conjunctival allergen challenge (CAC) model. The GRADE approach was used to assess the certainty of evidence, and the revised Cochrane risk of bias tool for randomized trials was employed to assess bias.

RESULTS

Four RCTs involving 323 participants met the eligibility criteria, and all had a low risk of bias. A meta-analysis revealed a statistically significant increase in the mean CAC change for conjunctival itching, with low heterogeneity among measurements at 3 minutes (P < 0.00001, I2 = 47%), 5 minutes (P < 0.00001, I2 = 46%), and 7 minutes (P < 0.00001, I2 = 41%). Additionally, the meta-analysis found a statistically significant increase in the mean CAC change for conjunctival redness with low heterogeneity (P < 0.00001, I2 = 15%). The pooled analysis showed no significant difference (P = 0.57, I2 = 0%) between the DEXTENZA and placebo groups in the frequency of adverse events.

CONCLUSION

DEXTENZA has emerged as a promising and viable treatment option for patients with seasonal/perennial allergic conjunctivitis and is an effective alternative to current therapeutic modalities.

摘要

目的

本荟萃分析评估了眼内插入式地塞米松制剂DEXTERZA治疗季节性/常年性变应性结膜炎的有效性和安全性。

方法

检索了多个数据库,包括PubMed、Cochrane对照试验中央注册库(CENTRAL)、ClinicalTrials.gov、开放获取期刊目录和Scopus,以查找比较DEXTERZA与安慰剂疗效的随机对照试验(RCT)。主要疗效终点是结膜变应原激发(CAC)模型的变化。采用GRADE方法评估证据的确定性,并使用修订的Cochrane随机试验偏倚风险工具评估偏倚。

结果

四项涉及323名参与者的RCT符合纳入标准,且所有研究的偏倚风险均较低。荟萃分析显示,结膜瘙痒的平均CAC变化有统计学显著增加,3分钟(P < 0.00001,I2 = 47%)、5分钟(P < 0.00001,I2 = 46%)和7分钟(P < 0.00001,I2 = 41%)时测量值的异质性较低。此外,荟萃分析发现结膜充血的平均CAC变化有统计学显著增加,异质性较低(P < 0.00001,I2 = 15%)。汇总分析显示,DEXTERZA组和安慰剂组不良事件发生率无显著差异(P = 0.57,I2 = 0%)。

结论

DEXTERZA已成为季节性/常年性变应性结膜炎患者一种有前景且可行的治疗选择,是当前治疗方式的有效替代方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/654d/11423825/7801b0fa51a6/OPTH-18-2657-g0001.jpg

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