选择性激光小梁成形术后抗炎治疗:一项随机、双盲、安慰剂对照的临床试验。

Anti-inflammatory therapy after selective laser trabeculoplasty: a randomized, double-masked, placebo-controlled clinical trial.

机构信息

Department of Ophthalmology, Queen's University and Hotel Dieu Hospital, Kingston, Ontario, Canada.

Department of Ophthalmology, Queen's University and Hotel Dieu Hospital, Kingston, Ontario, Canada; Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, Ontario, Canada.

出版信息

Ophthalmology. 2014 Dec;121(12):2356-61. doi: 10.1016/j.ophtha.2014.07.017. Epub 2014 Sep 16.

Abstract

PURPOSE

To investigate the effect of anti-inflammatory therapy on selective laser trabeculoplasty (SLT) outcomes.

DESIGN

Randomized, double-masked, placebo-controlled trial.

PARTICIPANTS

Patients with primary open-angle or pseudo-exfoliation glaucoma.

METHODS

Patients undergoing SLT were randomized to receive placebo (artificial tears), prednisolone acetate 1%, or ketorolac tromethamine 0.5% eye drops 4 times per day for 5 days commencing immediately after SLT.

MAIN OUTCOME MEASURES

Change in intraocular pressure (IOP) from baseline to the 1-month post-SLT visit.

RESULTS

Mean change in IOP at the 1-month primary outcome time point, as well as all other time points, was not significantly different among groups (P = 0.99). Likewise, a repeated-measures, mixed-effects model did not find significant differences in IOP outcome at the 1-month time point (P = 0.95). The IOP was reduced in all groups at the 1-month post-SLT time point and all other time points, and no significant differences were found between groups using separate unadjusted cross-sectional analyses of variance (P > 0.15 for analyses at all time points). Treatment failure rates were not different among groups (P = 0.75), and at 1 year after SLT, the percentage of patients maintaining a 20% IOP reduction ranged from 18% to 22% in the 3 study groups.

CONCLUSIONS

Anti-inflammatory therapy after SLT does not seem to substantially influence the IOP-lowering effect of SLT. In this study of patients with low baseline IOP, SLT showed limited efficacy in achieving a sustained reduction in IOP.

摘要

目的

研究抗炎治疗对选择性激光小梁成形术(SLT)结果的影响。

设计

随机、双盲、安慰剂对照试验。

参与者

原发性开角型或假性剥脱性青光眼患者。

方法

接受 SLT 的患者被随机分配接受安慰剂(人工泪液)、醋酸泼尼松龙 1%或酮咯酸氨丁三醇 0.5%滴眼液,每天 4 次,在 SLT 后立即开始,持续 5 天。

主要观察指标

从基线到 SLT 后 1 个月就诊时的眼压(IOP)变化。

结果

主要结局时间点(1 个月)和所有其他时间点的 IOP 平均变化在各组之间无显著差异(P = 0.99)。同样,重复测量混合效应模型也未发现 1 个月时 IOP 结果存在显著差异(P = 0.95)。所有组在 SLT 后 1 个月时的 IOP 均降低,且在所有其他时间点均降低,使用单独的未调整的横截面方差分析,各组之间无显著差异(所有时间点的分析 P > 0.15)。各组之间的治疗失败率无差异(P = 0.75),在 SLT 后 1 年,3 个研究组中维持 20%IOP 降低的患者比例范围为 18%至 22%。

结论

SLT 后进行抗炎治疗似乎不会显著影响 SLT 的降眼压效果。在这项研究中,在基线 IOP 较低的患者中,SLT 在实现持续降低 IOP 方面效果有限。

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