Konstas Anastasios G P, Karabatsas Costas H, Lallos Nikolaos, Georgiadis Nikolaos, Kotsimpou Aikaterini, Stewart Jeanette A, Stewart William C
University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece.
Ophthalmology. 2005 Apr;112(4):603-8. doi: 10.1016/j.ophtha.2004.11.032.
To evaluate the 24-hour efficacy of brimonidine purite versus dorzolamide, each added to latanoprost.
Double-masked, 2-center, prospective, crossover comparison.
Primary open-angle glaucoma (POAG) subjects.
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.
Twenty-four-hour efficacy of intraocular pressures of brimonidine purite versus dorzolamide, each added to latanoprost.
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.
This study suggests that brimonidine purite and dorzolamide, added to latanoprost, have similar efficacy and safety in POAG or ocular hypertensive subjects.
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。
双盲、双中心、前瞻性、交叉对照研究。
原发性开角型青光眼(POAG)患者。
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。
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。
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)。
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。