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季节性过敏性结膜炎患者使用瑞普沙林:一项系统评价和荟萃分析。

Reproxalap in patients with seasonal allergic conjunctivitis: a systematic review and meta-analysis.

作者信息

Elgadi Ammar, Abdalmotalib Malaz M, Noorallah Tibyan, Abdelazim Egbal, Mohammed Fatma Ali Merghani

机构信息

Faculty of Medicine, University of Khartoum, Khartoum, Sudan.

出版信息

J Ophthalmic Inflamm Infect. 2025 Apr 28;15(1):39. doi: 10.1186/s12348-025-00497-3.

DOI:10.1186/s12348-025-00497-3
PMID:40295385
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12037956/
Abstract

INTRODUCTION

Seasonal allergic conjunctivitis (SAC) is a hypersensitivity condition characterized by itching, tearing, and redness. It affects over 20% of the general population with limited therapeutic options. Reproxalap, a novel small-molecule aldehyde trap, has emerged as a potential treatment option for SAC by targeting reactive aldehydes involved in inflammation. In this systematic review and meta-analysis, we assessed the efficacy and safety of Reproxalap in treating SAC.

METHODS

Multiple databases were searched including PubMed, Cochrane Library, Scopus, and Google Scholar, to identify relevant studies. Clinical trials involving patients diagnosed with SAC and treated with Reproxalap (0.25% or 0.5%) were included. The primary outcomes were symptom relief (efficacy) and side effects (safety). Data extraction and risk of bias assessment were performed independently by two reviewers. Meta-analysis was conducted using RevMan 5.4 software.

RESULTS

Five RCTs involving 625 participants were included. Reproxalap significantly reduced ocular itching compared to control groups for both 0.25% (SMD: -0.31, 95% CI: -0.50 to -0.13, P = .001) and 0.5% concentrations (SMD: -0.31, 95% CI: -0.51 to -0.10, P = 0.004). No significant difference was observed between the two doses (SMD: -0.02, 95% CI: -0.23 to 0.19, P = 0.83). Side effects were more frequent in both Reproxalap groups compared to controls, with odds ratios of 35.31 (95% CI: 17.83 to 69.90, P < 0.00001) for 0.25% and 45.64 (95% CI: 18.49 to 112.66, P < 0.00001) for 0.5%. The 0.5% dose had significantly higher odds of side effects compared to the 0.25% dose (OR: 1.66, 95% CI: 1.10 to 2.51, P = 0.02). Heterogeneity was low for all outcomes (I = 0%).

CONCLUSION

Reproxalap reduces ocular itching associated with SAC. While both 0.25% and 0.5% concentrations are effective, safe and tolerable. Further research should focus on the long-term benefits and applicability of Reproxalap on diverse populations.

摘要

引言

季节性过敏性结膜炎(SAC)是一种以瘙痒、流泪和眼红为特征的超敏反应性疾病。它影响着超过20%的普通人群,且治疗选择有限。Reproxalap是一种新型小分子醛捕获剂,通过靶向参与炎症反应的活性醛,已成为SAC的一种潜在治疗选择。在本系统评价和荟萃分析中,我们评估了Reproxalap治疗SAC的疗效和安全性。

方法

检索了多个数据库,包括PubMed、Cochrane图书馆、Scopus和谷歌学术,以识别相关研究。纳入了涉及诊断为SAC并接受Reproxalap(0.25%或0.5%)治疗的患者的临床试验。主要结局为症状缓解(疗效)和副作用(安全性)。两名评价者独立进行数据提取和偏倚风险评估。使用RevMan 5.4软件进行荟萃分析。

结果

纳入了5项涉及625名参与者的随机对照试验。与对照组相比,0.25%(标准化均数差:-0.31,95%可信区间:-0.50至-0.13,P = 0.001)和0.5%浓度的Reproxalap均显著降低了眼部瘙痒(标准化均数差:-0.31,95%可信区间:-0.51至-0.10,P = 0.004)。两种剂量之间未观察到显著差异(标准化均数差:-0.02,95%可信区间:-0.23至0.19,P = 0.83)。与对照组相比,两个Reproxalap组的副作用更频繁,0.25%组的比值比为35.31(95%可信区间:17.83至69.90,P < 0.00001),0.5%组为45.64(95%可信区间:18.49至112.66,P < 0.00001)。0.5%剂量组的副作用发生率显著高于0.25%剂量组(比值比:1.66,95%可信区间:1.10至2.51,P = 0.02)。所有结局的异质性均较低(I² = 0%)。

结论

Reproxalap可减轻与SAC相关的眼部瘙痒。0.25%和0.5%浓度均有效、安全且可耐受。进一步的研究应关注Reproxalap对不同人群的长期益处和适用性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/d66659f20900/12348_2025_497_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/683013fc805a/12348_2025_497_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/a02832897a76/12348_2025_497_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/d66659f20900/12348_2025_497_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/683013fc805a/12348_2025_497_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/88ce13ce7ac0/12348_2025_497_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/a02832897a76/12348_2025_497_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d771/12037956/d66659f20900/12348_2025_497_Fig4_HTML.jpg

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Life (Basel). 2024 May 21;14(6):650. doi: 10.3390/life14060650.
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Cytokines in Allergic Conjunctivitis: Unraveling Their Pathophysiological Roles.过敏性结膜炎中的细胞因子:揭示其病理生理作用
Life (Basel). 2024 Mar 7;14(3):350. doi: 10.3390/life14030350.
3
The Phase 3 INVIGORATE Trial of Reproxalap in Patients with Seasonal Allergic Conjunctivitis.Reproxalap用于季节性过敏性结膜炎患者的3期INVIGORATE试验。
Clin Ophthalmol. 2023 Dec 13;17:3867-3875. doi: 10.2147/OPTH.S441009. eCollection 2023.
4
NLRP3 Inflammasome as a Potential Therapeutic Target in Dry Eye Disease.NLRP3 炎性小体在干燥性眼病中的潜在治疗靶点
Int J Mol Sci. 2023 Jun 29;24(13):10866. doi: 10.3390/ijms241310866.
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6
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