Martinez Antonio, Sanchez Manuel
Instituto Gallego de Oftalmología, Santiago de Compostela, La Coruña, Spain.
Curr Med Res Opin. 2007 May;23(5):1025-32. doi: 10.1185/030079907x182149.
To compare the efficacy and tolerability of a once daily evening dose of the latanoprost/timolol fixed combination (LTFC) with that of a once-daily evening dose of the bimatoprost/timolol fixed combination (BTFC) in patients with open-angle glaucoma with elevated intraocular pressure (IOP) insufficiently responsive to monotherapy with prostaglandin analogues/prostamides.
Prospective, randomized, evaluator masked, single-center study.
36 patients with a diagnosis of open-angle glaucoma, with or without pseudoexfoliation, and inadequate control of IOP, insufficiently responsive to monotherapy with prostaglandin analogues/prostamides.
The primary end-points were the change in IOP at 9:00 am from baseline to week 4, and the difference between treatment groups in the mean diurnal IOP reduction from baseline to week 4.
BTFC provided significantly greater mean diurnal IOP reduction [mean (standard deviation)] 2.8 (0.9) mmHg, compared with LTFC 2.1 (0.6) mmHg, p = 0.0214. Both treatments significantly reduced the IOP from baseline at each IOP time-point measured, p < 0.0001, and for the mean diurnal IOP; p = 0.0049 for the LTFC, and p < 0.0001 for the BTFC. There were no significant differences in average hyperemia scores among groups, 1.25 (0.5) vs. 1.62 (0.69), p = 0.3835, for the LTFC and the BTFC, respectively.
The results of this study showed a significantly higher IOP-lowering effect of a once-daily evening dose of the BTFC compared to that of a once-daily evening administration of the LTFC.
比较每晚一次剂量的拉坦前列素/噻吗洛尔固定复方制剂(LTFC)与每晚一次剂量的比马前列素/噻吗洛尔固定复方制剂(BTFC),在对前列腺素类似物/前列腺酰胺单药治疗反应不足、眼压升高的开角型青光眼患者中的疗效和耐受性。
前瞻性、随机、评估者盲法、单中心研究。
36例诊断为开角型青光眼的患者,有或无假性剥脱,眼压控制不佳,对前列腺素类似物/前列腺酰胺单药治疗反应不足。
主要终点为上午9点时眼压从基线到第4周的变化,以及治疗组之间从基线到第4周的平均日眼压降低差值。
与LTFC组的2.1(0.6)mmHg相比,BTFC组的平均日眼压降低幅度显著更大[均值(标准差)]为2.8(0.9)mmHg,p = 0.0214。在每个测量的眼压时间点,两种治疗均使眼压从基线显著降低,p < 0.0001,对于平均日眼压也是如此;LTFC组p = 0.0049,BTFC组p < 0.0001。两组间平均充血评分无显著差异,LTFC组和BTFC组分别为1.25(0.5)和1.62(0.69),p = 0.3835。
本研究结果表明,每晚一次剂量的BTFC降低眼压的效果显著高于每晚一次剂量的LTFC。