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原发性开角型青光眼患者中,在拉坦前列素基础上加用溴莫尼定纯品与多佐胺后的24小时眼压情况。

24-hour intraocular pressures with brimonidine purite versus dorzolamide added to latanoprost in primary open-angle glaucoma subjects.

作者信息

Konstas Anastasios G P, Karabatsas Costas H, Lallos Nikolaos, Georgiadis Nikolaos, Kotsimpou Aikaterini, Stewart Jeanette A, Stewart William C

机构信息

University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece.

出版信息

Ophthalmology. 2005 Apr;112(4):603-8. doi: 10.1016/j.ophtha.2004.11.032.

Abstract

OBJECTIVE

To evaluate the 24-hour efficacy of brimonidine purite versus dorzolamide, each added to latanoprost.

DESIGN

Double-masked, 2-center, prospective, crossover comparison.

PARTICIPANTS

Primary open-angle glaucoma (POAG) subjects.

METHODS

Subjects were randomized to brimonidine purite or dorzolamide, each given twice daily, for the first 6-week treatment period after a 6-week latanoprost run-in. Subjects began the opposite treatment for the second 6-week period after a 6-week latanoprost-only treatment between periods. Intraocular pressure (IOP) was measured at 8 am, 12 pm, 4 pm, 8 pm, 12 am, 4 am, and 8 am at each baseline and at the end of each treatment period. This study provided an 80% power that a 1.5-mmHg difference could be excluded between groups if 27 subjects completed the study. A standard deviation (SD) of 2.8 mmHg was assumed.

MAIN OUTCOME MEASURES

Twenty-four-hour efficacy of intraocular pressures of brimonidine purite versus dorzolamide, each added to latanoprost.

RESULTS

In 31 completed subjects, the baseline mean diurnal 24-hour IOP (+/- SD) was 19.0+/-1.7 mmHg for brimonidine purite and 19.0+/-1.6 mmHg for dorzolamide (P = 0.52). The 8 am IOP after 6 weeks of therapy was 18.4+/-2.1 mmHg for brimonidine purite and 18.9+/-1.9 mmHg for dorzolamide (P = 0.40). The mean diurnal IOP was 16.9+/-1.5 mmHg for brimonidine purite and 16.8+/-1.5 mmHg for dorzolamide (P = 0.66). Dorzolamide caused a more bitter taste (P = 0.01) than brimonidine purite.

CONCLUSIONS

This study suggests that brimonidine purite and dorzolamide, added to latanoprost, have similar efficacy and safety in POAG or ocular hypertensive subjects.

摘要

目的

评估在拉坦前列素基础上加用布林佐胺与多佐胺的24小时疗效。

设计

双盲、双中心、前瞻性、交叉对照研究。

受试者

原发性开角型青光眼(POAG)患者。

方法

在6周的拉坦前列素导入期后,受试者被随机分为接受布林佐胺或多佐胺治疗,均每日给药2次,为期6周的首个治疗期。在两个治疗期之间进行6周的仅用拉坦前列素治疗后,受试者开始为期6周的相反治疗。在每个基线以及每个治疗期结束时,于上午8点、中午12点、下午4点、晚上8点、午夜12点、凌晨4点和上午8点测量眼压(IOP)。如果27名受试者完成研究,本研究有80%的把握度可排除两组之间1.5 mmHg的差异。假定标准差(SD)为2.8 mmHg。

主要观察指标

在拉坦前列素基础上加用布林佐胺与多佐胺后的24小时眼压疗效。

结果

在31名完成研究的受试者中,布林佐胺组基线平均昼夜24小时眼压(±标准差)为19.0±1.7 mmHg,多佐胺组为19.0±1.6 mmHg(P = 0.52)。治疗6周后上午8点的眼压,布林佐胺组为18.4±2.1 mmHg,多佐胺组为18.9±1.9 mmHg(P = 0.40)。平均昼夜眼压,布林佐胺组为16.9±1.5 mmHg,多佐胺组为16.8±1.5 mmHg(P = 0.66)。多佐胺比布林佐胺引起的口苦感更明显(P = 0.01)。

结论

本研究提示,在POAG或高眼压受试者中,拉坦前列素基础上加用布林佐胺和多佐胺具有相似的疗效和安全性。

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