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瑞巴派特与人工泪液治疗干眼症的安全性和有效性比较:一项系统评价和荟萃分析。

Safety and efficacy of rebamipide compared to artificial tears for the treatment of dry eye: a systematic review and meta-analysis.

作者信息

Chiu Ching-Wen, Tam Ka-Wai, Lin I-Chan

机构信息

School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.

Department of Medical Education, Taipei Veterans General Hospital, Taipei, 112201, Taiwan.

出版信息

BMC Ophthalmol. 2025 May 27;25(1):317. doi: 10.1186/s12886-025-04146-0.

DOI:10.1186/s12886-025-04146-0
PMID:40426110
Abstract

BACKGROUND

Rebamipide (RBM) is a novel drug that increases mucin secretion on the ocular surface. Nevertheless, the therapeutic efficacy of topical RBM for dry eye disease (DED) treatment remains inconclusive. Accordingly, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effectiveness of RBM for DED treatment.

METHODS

We searched the PubMed, Embase, and Cochrane Library databases for eligible RCTs. The primary outcome was posttreatment changes in tear breakup time (TBUT). We also assessed changes in the values of Schirmer's test (Sch), corneal fluorescein staining scores, and DED-related symptom scores.

RESULTS

We retrieved 12 RCTs with 1368 eyes published during 2012-2023. The results demonstrated that compared with artificial tears, 2% RBM significantly increased the TBUT [standard mean difference (SMD) = 1.42, 95% confidence interval (CI) = 0.20 to 2.64]. Moreover, 2% RBM led to more significant improvements in overall DED-related symptom scores than did artificial tears (SMD = - 1.61, 95% CI = - 2.61 to - 0.61). The differences in the adverse events between the 2% RBM and artificial tears groups were nonsignificant (SMD = 1.23, 95% CI = 0.62 to 2.44).

CONCLUSION

Topical RBM ophthalmic suspension is a safe and effective treatment for DED patients. Compared to artificial tears, 2% RBM improved TBUT and subjective symptoms of DED. It may be considered as the first-line treatment option for short- TBUT dry eye patients.

摘要

背景

瑞巴派特(RBM)是一种可增加眼表黏液分泌的新型药物。然而,局部应用RBM治疗干眼症(DED)的疗效仍不明确。因此,我们对研究RBM治疗DED有效性的随机对照试验(RCT)进行了系统评价和荟萃分析。

方法

我们在PubMed、Embase和Cochrane图书馆数据库中检索符合条件的RCT。主要结局是治疗后泪膜破裂时间(TBUT)的变化。我们还评估了泪液分泌试验(Sch)值、角膜荧光素染色评分和DED相关症状评分的变化。

结果

我们检索到2012年至2023年期间发表的12项RCT,共涉及1368只眼。结果表明,与人工泪液相比,2%RBM显著增加了TBUT[标准均数差(SMD)=1.42,95%置信区间(CI)=0.20至2.64]。此外,2%RBM比人工泪液在总体DED相关症状评分方面带来了更显著的改善(SMD=-1.61,95%CI=-2.61至-0.61)。2%RBM组和人工泪液组之间不良事件的差异无统计学意义(SMD=1.23,95%CI=0.62至2.44)。

结论

局部应用RBM眼药水对DED患者是一种安全有效的治疗方法。与人工泪液相比,2%RBM改善了TBUT和DED的主观症状。对于TBUT短的干眼症患者,它可被视为一线治疗选择。

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Treatment of Dry Eye Disease (DED) in Asia: Strategies for Short Tear Film Breakup Time-Type DED.亚洲干眼症(DED)的治疗:短泪膜破裂时间型干眼症的治疗策略
Pharmaceutics. 2023 Nov 5;15(11):2591. doi: 10.3390/pharmaceutics15112591.
2
Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial.1%和 2%瑞巴派特澄清溶液治疗干眼症的疗效和安全性:一项多中心随机试验。
BMC Ophthalmol. 2023 Aug 3;23(1):343. doi: 10.1186/s12886-023-03004-1.
3
Efficacy and safety of topical 2% rebamipide ophthalmic suspension in dry eye disease at tertiary care centre.
在三级保健中心,局部使用 2%瑞巴派特滴眼悬浮液治疗干眼症的疗效和安全性。
Indian J Ophthalmol. 2023 Apr;71(4):1598-1602. doi: 10.4103/IJO.IJO_2586_22.
4
Impact of Perioperative Dry Eye Treatment with Rebamipide Versus Artificial Tears on Visual Outcomes After Cataract Surgery in Japanese Population.在日本人群中,瑞巴派特与人工泪液围手术期干眼治疗对白内障手术后视觉效果的影响。
Ophthalmol Ther. 2022 Aug;11(4):1479-1491. doi: 10.1007/s40123-022-00523-w. Epub 2022 May 19.
5
Decrease of tear break-up time at Japanese eye clinics during five consecutive years.日本眼科诊所连续五年泪膜破裂时间缩短。
Sci Rep. 2022 Apr 27;12(1):6848. doi: 10.1038/s41598-022-11035-9.
6
Effects of Rebamipide on Differences in Power and Axis of Corneal Astigmatism Between Two Intra-patient Keratometric Measurements in Dry Eyes.瑞巴派特对干眼患者两次角膜曲率测量之间角膜散光度数和轴向差异的影响。
Ophthalmol Ther. 2021 Dec;10(4):891-904. doi: 10.1007/s40123-021-00368-9. Epub 2021 Jul 22.
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Dry eye: why artificial tears are not always the answer.干眼症:为何人工泪液并非总是解决方案。
BMJ Open Ophthalmol. 2021 Apr 8;6(1):e000697. doi: 10.1136/bmjophth-2020-000697. eCollection 2021.
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Clin Ophthalmol. 2020 Jun 18;14:1665-1673. doi: 10.2147/OPTH.S256351. eCollection 2020.
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A New Perspective on Dry Eye Classification: Proposal by the Asia Dry Eye Society.干眼分类的新视角:亚洲干眼学会的建议。
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