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SALT 试验:激光小梁成形术后使用类固醇:短期抗炎治疗对选择性激光小梁成形术疗效的影响。

SALT Trial: Steroids after Laser Trabeculoplasty: Impact of Short-Term Anti-inflammatory Treatment on Selective Laser Trabeculoplasty Efficacy.

机构信息

Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California.

Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

出版信息

Ophthalmology. 2019 Nov;126(11):1511-1516. doi: 10.1016/j.ophtha.2019.05.032. Epub 2019 Jun 6.

Abstract

PURPOSE

This study examined whether short-term use of topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy affected the efficacy of selective laser trabeculoplasty (SLT).

DESIGN

Double-masked, randomized, placebo-controlled, dual-center, multisurgeon trial.

PARTICIPANTS

Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy were randomized to 1 of 3 groups in a ratio of 1:1:1 as follows: ketorolac 0.5%, prednisolone 1%, or saline tears.

METHODS

After SLT, patients randomized into each group were instructed to use an unmarked drop 4 times daily starting the day of SLT and continuing for 4 additional days. The Kruskal-Wallis test and Wilcoxon rank-sum test were used for continuous variables when comparing 2 or 3 treatment groups, respectively. The Fisher exact test was used for categorical variables.

MAIN OUTCOME MEASURES

The primary outcome of this study was IOP at 12 weeks. Secondary outcome measures included IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation.

RESULTS

Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites. The NSAID, steroid, and placebo groups were similar in baseline demographics and baseline IOP (mean, 23.3±3.9 mmHg; P = 0.57). There was no statistically significant difference in IOP decrease among groups at week 6. Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1 mmHg, -5.2±2.7 mmHg, and -3±4.3 mmHg, respectively; P = 0.02 [analysis of variance] and P = 0.002 [t test] for NSAID vs. placebo groups; P = 0.02 for steroid vs. placebo groups).

CONCLUSIONS

Significantly better IOP reduction at 12 weeks was measured in eyes treated with steroid or NSAID drops after SLT. Short-term postoperative use of NSAID or steroid drops may improve IOP reduction after SLT. Longer-term follow-up studies are indicated.

摘要

目的

本研究旨在探讨短期局部使用非甾体类抗炎药(NSAID)或皮质类固醇治疗是否会影响选择性激光小梁成形术(SLT)的疗效。

设计

双盲、随机、安慰剂对照、双中心、多外科医生试验。

参与者

年龄大于 18 岁、眼压(IOP)超过 18mmHg 的患者,临床医生决定 SLT 是适当的治疗方法,这些患者被随机分为 3 组,比例为 1:1:1,如下所示:酮咯酸 0.5%、泼尼松龙 1%或生理盐水泪液。

方法

在 SLT 后,随机分为每组的患者被指示从 SLT 当天开始每天使用 4 次未标记的滴眼剂,持续 4 天。当比较 2 个或 3 个治疗组时,分别使用 Kruskal-Wallis 检验和 Wilcoxon 秩和检验进行连续变量比较。Fisher 确切检验用于分类变量。

主要观察指标

本研究的主要结局是 12 周时的 IOP。次要结局指标包括 1 周和 6 周时的 IOP、患者报告的疼痛和可检测到的前房炎症。

结果

96 只眼的 85 名患者符合纳入标准,并在两个地点入组。NSAID、皮质类固醇和安慰剂组在基线人口统计学和基线 IOP(平均值,23.3±3.9mmHg;P=0.57)方面相似。在第 6 周时,各组之间的 IOP 降低没有统计学上的显著差异。与安慰剂组相比,NSAID 和皮质类固醇组在第 12 周时 IOP 降低均有统计学显著差异(平均分别为-6.2±3.1mmHg、-5.2±2.7mmHg 和-3±4.3mmHg;P=0.02[方差分析]和 P=0.002[t 检验],NSAID 与安慰剂组;P=0.02,皮质类固醇与安慰剂组)。

结论

在 SLT 后使用皮质类固醇或 NSAID 滴眼剂治疗的眼睛,12 周时的 IOP 降低显著更好。SLT 后短期使用 NSAID 或皮质类固醇滴眼剂可能会改善 IOP 降低。需要进行更长时间的随访研究。

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