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洛度沙胺眼用凝胶与氟米龙滴眼液治疗角膜屈光手术后患者的疗效和安全性:Meta 分析。

Efficacy and safety of loteprednol etabonate versus fluorometholone in the treatment of patients after corneal refractive surgery: a meta-analysis.

机构信息

Department of Pharmacy, Eye & ENT Hospital, Fudan University, No. 83 Fenyang Road, Shanghai, 200031, China.

出版信息

Int Ophthalmol. 2023 Jul;43(7):2477-2486. doi: 10.1007/s10792-023-02646-w. Epub 2023 Mar 4.

Abstract

PURPOSE

To perform a systematic evaluation of the efficacy and safety of loteprednol etabonate (LE) 0.5% versus fluorometholone (FML) 0.1% for treating patients after corneal refractive surgery with the aim of providing an evidence-based rationale for clinical drug selection.

METHODS

Electronic databases (PubMed, EMBASE, Cochrane Library, Web of Science, WanFang, and CNKI) were searched (from inception to December 2021) for comparative clinical studies that evaluated LE versus FML treatment for post-corneal refractive surgery patients. Meta-analysis was performed using the RevMan 5.3 software. The pooled risk ratio (RR) and weighted mean difference (WMD) with corresponding 95% confidence interval (CI) were calculated.

RESULTS

Nine studies with a total sample size of 2677 eyes were included in this analysis. FML 0.1% and LE 0.5% produced a similar incidence of corneal haze within 6 months after surgery (P = 0.13 at 1 month, P = 0.66 at 3 months, and P = 0.12 at 6 months). There was no statistically significant difference between the two groups in terms of the mean logMAR postoperative uncorrected distance visual acuity (WMD: - 0.00; 95% CI: - 0.01 to 0.00; P = 0.29) and spherical equivalent (WMD: 0.01; 95% CI: - 0.01 to 0.03; P = 0.35). LE 0.5% appears to have a higher tendency to reduce the incidence of ocular hypertension compared FML 0.1%, but there was no statistical significance (RR: 0.63; 95% CI: 0.27 to 1.50; P = 0.30).

CONCLUSION

This meta-analysis demonstrated that LE 0.5% and FML 0.1% had comparable efficacy in preventing corneal haze and corticosteroid-induced ocular hypertension, with no difference in visual acuity in patients after corneal refractive surgery.

摘要

目的

系统评价 0.5% loteprednol etabonate(LE)与 0.1% fluorometholone(FML)治疗角膜屈光手术后患者的疗效和安全性,为临床药物选择提供循证依据。

方法

检索 PubMed、EMBASE、Cochrane 图书馆、Web of Science、万方和中国知网(从建库至 2021 年 12 月)等电子数据库,收集比较 LE 与 FML 治疗角膜屈光手术后患者的临床研究。采用 RevMan 5.3 软件进行荟萃分析。计算合并风险比(RR)和加权均数差(WMD)及其 95%置信区间(CI)。

结果

纳入 9 项研究,共 2677 只眼。术后 6 个月内,FML 0.1%和 LE 0.5%所致角膜混浊发生率相似(1 个月时 P=0.13,3 个月时 P=0.66,6 个月时 P=0.12)。两组术后未矫正距离视力的平均 logMAR 差异无统计学意义(WMD:-0.00;95%CI:-0.01 至 0.00;P=0.29)和球镜等效(WMD:0.01;95%CI:-0.01 至 0.03;P=0.35)。LE 0.5%似乎较 FML 0.1%更能降低眼压升高的发生率,但差异无统计学意义(RR:0.63;95%CI:0.27 至 1.50;P=0.30)。

结论

本荟萃分析表明,LE 0.5%与 FML 0.1%在预防角膜混浊和皮质类固醇引起的眼压升高方面疗效相当,对角膜屈光手术后患者的视力无影响。

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