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晨晚间应用拉坦前列素/噻吗洛尔固定合剂治疗开角型青光眼和高眼压症的疗效:一项随机临床试验。

Efficacy of Morning Versus Evening Latanoprost/Timolol Fixed Combination for Open-Angle Glaucoma and Ocular Hypertension: A Randomized Clinical Trial.

机构信息

Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology & Visual Science Key Lab, Capital Medical University, Beijing, China.

Department of Glaucoma, Hebei Eye Hospital, Xingtai, Hebei, China.

出版信息

Transl Vis Sci Technol. 2024 Jan 2;13(1):21. doi: 10.1167/tvst.13.1.21.

Abstract

PURPOSE

To compare the efficacy of morning and evening latanoprost/timolol fixed-combination (LTFC) dosing in patients with primary open-angle glaucoma (POAG) and ocular hypertension.

METHODS

In this double-blind, randomized clinical trial, 63 untreated Chinese patients with POAG and ocular hypertension were enrolled. All patients received LTFC and were randomized (1:1) to group 1, morning (8 AM) dosing, or group 2, evening (8 PM) dosing. Vehicle drops were used in the morning or evening, accordingly, to preserve masking. Patients were treated for 4 weeks. Outcomes included mean reduction of the 24-hour intraocular pressure (IOP) and IOP fluctuation from baseline after a 4-week treatment.

RESULTS

Fifty-six patients were included in the final analysis. In both groups, the posttreatment IOP values were significantly lower than those at baseline at each 24-hour measuring time point. A significant difference between the groups in IOP reduction from baseline was observed at the 9:30 AM time point (4.01 ± 2.62 vs. 2.42 ± 3.23 mm Hg, evening dosing versus morning dosing group; P = 0.048). Both groups showed decreased IOP fluctuation after treatment. However, the morning dosing group had a significantly greater decrease in diurnal IOP fluctuation than that of the evening dosing group (2.04 ± 2.32 mm Hg vs. 0.50 ± 1.70 mm Hg, respectively; P = 0.012).

CONCLUSIONS

Both morning and evening LTFC dosing can effectively reduce 24-hour IOP and IOP fluctuation. Morning dosing is more likely to effectively control diurnal IOP fluctuations.

TRANSLATIONAL RELEVANCE

This multicenter, double-blind, randomized clinical trial generates robust evidence on the optimal LTFC dosing regimen to help clinical decision-making in the treatment of raised IOP.

摘要

目的

比较早晨和傍晚给予拉坦前列素/噻吗洛尔固定合剂(LTFC)治疗原发性开角型青光眼(POAG)和高眼压症患者的疗效。

方法

本双盲、随机临床试验纳入了 63 例未经治疗的中国 POAG 和高眼压症患者。所有患者均接受 LTFC 治疗,并随机(1:1)分为第 1 组(早晨 8 点给药)或第 2 组(晚上 8 点给药)。相应地,早晨或晚上给予载体滴液以保持盲法。患者接受治疗 4 周。结局包括治疗 4 周后 24 小时眼压(IOP)的平均降低和从基线开始的 IOP 波动。

结果

共有 56 例患者纳入最终分析。两组患者在每个 24 小时测量时间点的治疗后 IOP 值均明显低于基线值。两组间从基线开始的 IOP 降低在上午 9:30 时存在显著差异(4.01 ± 2.62 对 2.42 ± 3.23mmHg,晚上给药组与早晨给药组;P = 0.048)。两组治疗后 IOP 波动均降低。然而,早晨给药组的日间 IOP 波动降低幅度显著大于晚上给药组(2.04 ± 2.32 对 0.50 ± 1.70mmHg,分别;P = 0.012)。

结论

早晨和傍晚给予 LTFC 均可有效降低 24 小时 IOP 和 IOP 波动。早晨给药更有可能有效控制日间 IOP 波动。

翻译

张宇鹏

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f989/10829799/ab8019b38cdf/tvst-13-1-21-f001.jpg

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