Gross Ronald L, Sullivan E Kenneth, Wells David T, Mallick Sushanta, Landry Theresa A, Bergamini Michael V W
Department of Ophthalmology, Cullen Eye Institute, Baylor College of Medicine, Houston, TX, USA.
Clin Ophthalmol. 2007 Sep;1(3):317-22.
To compare the IOP-lowering efficacy of the fixed combination of travoprost 0.004%/timolol 0.5% dosed once daily in the morning with the concomitant administration of travoprost 0.004% dosed once daily in the evening and timolol 0.5% dosed once daily in the morning.
This was an analysis of pooled data from two similarly designed prospective, randomized, controlled clinical trials comparing the fixed combination and concomitant therapy.
Mean IOP ranged from 15.7 to 16.8 mmHg for the fixed combination group, and from 15.1 to 16.4 mmHg for the concomitant group. Mean IOP reductions were up to 9.0 mmHg in the fixed combination group, and up to 8.8 mmHg in the concomitant group. The differences in mean IOP change between treatment groups ranged from -0.2 to +0.9 mmHg across visits and time points. The safety profile was generally similar between groups. An exception was the incidence of ocular hyperemia, which was 13.7% with the fixed combination and 20.8% with concomitant therapy (p = 0.02).
The fixed combination of travoprost 0.004% and timolol 0.5% provides IOP-lowering efficacy that is similar to concomitant administration of travoprost 0.004% dosed once daily in the evening and timolol 0.5% dosed once daily in the morning.
比较早晨每日一次给药的0.004%曲伏前列素/0.5%噻吗洛尔固定复方制剂与晚上每日一次给药的0.004%曲伏前列素和早晨每日一次给药的0.5%噻吗洛尔联合使用时降低眼压的疗效。
这是一项对两项设计相似的前瞻性、随机、对照临床试验的汇总数据进行的分析，比较了固定复方制剂和联合治疗。
固定复方制剂组的平均眼压范围为15.7至16.8 mmHg，联合治疗组为15.1至16.4 mmHg。固定复方制剂组的平均眼压降低幅度高达9.0 mmHg，联合治疗组高达8.8 mmHg。各访视和时间点治疗组间平均眼压变化的差异在-0.2至+0.9 mmHg之间。两组的安全性概况总体相似。一个例外是眼部充血的发生率，固定复方制剂组为13.7%，联合治疗组为20.8%（p = 0.02）。
0.004%曲伏前列素和0.5%噻吗洛尔固定复方制剂降低眼压的疗效与晚上每日一次给药的0.004%曲伏前列素和早晨每日一次给药的0.5%噻吗洛尔联合使用时相似。
