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一项关于局部应用环孢素A治疗干眼病的随机试验的更新系统评价及荟萃分析

An Updated Systematic Review With Meta-Analysis Of Randomized Trials On Topical Cyclosporin A For Dry-Eye Disease.

作者信息

Tuan Hsin-I, Chi Sheng-Chu, Kang Yi-No

机构信息

Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.

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

出版信息

Drug Des Devel Ther. 2020 Jan 17;14:265-274. doi: 10.2147/DDDT.S207743. eCollection 2020.

Abstract

BACKGROUND/AIMS: To evaluate the effects of topical cyclosporin A (CsA) and artificial tears (ATs) for treating patients with dry-eye disease (DED).

METHODS

On January 25, 2019, five electronic databases and reference lists were searched for randomized clinical trials (RCTs) comparing CsA with ATs among patients with DED. The search strategy had no restriction on language or time. Two authors extracted surgery, mean age, anesthesia for Schirmer's test, tear-breakup time, Schirmer's test score, fluorescein-staining score, ocular surface-disease index, and adverse events. Mean differences (MDs) were calculated for continuous outcomes and Peto ORs for dichotomous data with zero cells. Results were analyzed with 95% CIs in a random-effect model.

RESULTS

Eleven RCTs recruiting 1,085 cases with DED were included. Pooled results showed that CsA had better tear-breakup time (MD 0.94, 95% CI 0.08-1.80), fluorescein-staining score (standardized MD -0.72, 95% CI -1.28 to -0.16), and ocular surface-disease index (MD -4.75, 95% CI -6.31 to -3.18) when compared to ATs. Although CsA had more adverse events than ATs (Peto OR 7.70, 95% CI 3.17-18.68), no serious adverse events were reported.

CONCLUSION

Overall, CsA is an effective option for treating patients with DED, yet our evidence indicated decreasing effects when CsA was combined with ATs. CsA may be worth suggesting to relatively older patients with DED. We anticipate further RCTs to explore the effects of treatment duration, optimal dosage, and efficacy of CsA in different DED etiology.

摘要

背景/目的:评估局部应用环孢素A(CsA)和人工泪液(ATs)治疗干眼症(DED)患者的效果。

方法

2019年1月25日,检索了五个电子数据库和参考文献列表,以查找比较CsA与ATs治疗DED患者的随机临床试验(RCT)。检索策略对语言或时间无限制。两位作者提取了手术、平均年龄、泪液分泌试验的麻醉方式、泪膜破裂时间、泪液分泌试验评分、荧光素染色评分、眼表疾病指数和不良事件。计算连续结果的平均差(MDs)和零单元格二分数据的Peto比值比。结果采用随机效应模型进行95%置信区间分析。

结果

纳入了11项招募1085例DED患者的RCT。汇总结果显示,与ATs相比,CsA具有更好的泪膜破裂时间(MD 0.94,95%CI 0.08 - 1.80)、荧光素染色评分(标准化MD -0.72,95%CI -1.28至-0.16)和眼表疾病指数(MD -4.75,95%CI -6.31至-3.18)。虽然CsA的不良事件比ATs多(Peto OR 7.70,95%CI 3.17 - 18.68),但未报告严重不良事件。

结论

总体而言,CsA是治疗DED患者的有效选择,但我们的证据表明,CsA与ATs联合使用时效果会降低。CsA可能值得推荐给年龄较大的DED患者。我们期待进一步的RCT来探索治疗持续时间、最佳剂量以及CsA在不同DED病因中的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f21/6974131/832998a9594f/DDDT-14-265-g0001.jpg

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