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比马前列素/噻吗洛尔固定复方制剂与拉坦前列素/噻吗洛尔固定复方制剂治疗开角型青光眼患者的安全性及降眼压效果比较

A comparison of the safety and intraocular pressure lowering of bimatoprost/timolol fixed combination versus latanoprost/timolol fixed combination in patients with open-angle glaucoma.

作者信息

Martinez Antonio, Sanchez Manuel

机构信息

Instituto Gallego de Oftalmología, Santiago de Compostela, La Coruña, Spain.

出版信息

Curr Med Res Opin. 2007 May;23(5):1025-32. doi: 10.1185/030079907x182149.

Abstract

PURPOSE

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.

DESIGN

Prospective, randomized, evaluator masked, single-center study.

PARTICIPANTS

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.

MAIN OUTCOME MEASURE

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

设计

前瞻性、随机、评估者盲法、单中心研究。

参与者

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。

主要观察指标

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。

结果

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。

结论

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。

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