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2%多佐胺与0.2%溴莫尼定治疗青光眼或高眼压症患者的安全性及有效性比较。

Comparison of the safety and efficacy of dorzolamide 2% and brimonidine 0.2% in patients with glaucoma or ocular hypertension.

作者信息

Whitson Jess T, Henry Charles, Hughes Bret, Lee David A, Terry Stuart, Fechtner Robert D

机构信息

Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas 75390, USA.

出版信息

J Glaucoma. 2004 Apr;13(2):168-73. doi: 10.1097/00061198-200404000-00015.

Abstract

PURPOSE

To compare the intraocular pressure (IOP) reduction between dorzolamide 2% and brimonidine 0.2% in primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

METHODS

This study was a prospective, double-masked, randomized, crossover comparison of dorzolamide 2% (Trusopt) and brimonidine 0.2% (Alphagan), three times daily during two six-week study periods. The primary endpoint was mean change from baseline in trough IOP and secondary endpoints were mean change from baseline in IOP one and three hours after dosing. T-tests and a repeated-measures ANOVA were used to statistically evaluate the data.

RESULTS

Of 43 patients enrolled, 41 completed the first treatment and 38 completed both treatments. Baseline IOP for dorzolamide was 24.3 mm Hg and brimonidine, 24.6 mm Hg (P = 0.9). Mean IOP reduction at trough was similar for both agents, 3.0 mm Hg (P = 0.96). Reductions at one and three hours were comparable (P = ns). Both agents were well tolerated with adverse events consistent with the package inserts. Dorzolamide was associated with more frequent stinging (P = 0.017) and burning (P < 0.001), while brimonidine was associated with more frequent dry eye (P = 0.04).

CONCLUSIONS

Dorzolamide and brimonidine, as monotherapy, produced equivalent IOP-lowering efficacy at trough and at one and three hours after instillation, and both were well tolerated.

摘要

目的

比较2%多佐胺与0.2%溴莫尼定在原发性开角型青光眼(POAG)或高眼压症(OHT)患者中降低眼压(IOP)的效果。

方法

本研究为前瞻性、双盲、随机、交叉对照试验,比较2%多佐胺(Trusopt)与0.2%溴莫尼定(Alphagan),在两个为期六周的研究阶段中,每日滴眼三次。主要终点为给药后最低眼压相对于基线的平均变化,次要终点为给药后1小时和3小时眼压相对于基线的平均变化。采用t检验和重复测量方差分析对数据进行统计学评估。

结果

43例入组患者中,41例完成了第一个治疗阶段,38例完成了两个治疗阶段。多佐胺组的基线眼压为24.3 mmHg,溴莫尼定组为24.6 mmHg(P = 0.9)。两种药物在最低眼压时的平均眼压降低幅度相似,均为3.0 mmHg(P = 0.96)。给药后1小时和3小时的眼压降低幅度相当(P = 无显著差异)。两种药物耐受性均良好,不良事件与药品说明书一致。多佐胺组刺痛(P = 0.017)和烧灼感(P < 0.001)更常见,而溴莫尼定组干眼(P = 0.04)更常见。

结论

多佐胺和溴莫尼定作为单一疗法,在滴眼后最低眼压时、1小时和3小时降低眼压的效果相当,且耐受性良好。

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