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溴莫尼定/拉坦前列素与噻吗洛尔/多佐胺的比较:两项随机、双盲、平行临床试验

Comparison of brimonidine/latanoprost and timolol/dorzolamide: two randomized, double-masked, parallel clinical trials.

作者信息

Zabriskie Norman, Netland Peter A

机构信息

John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA.

出版信息

Adv Ther. 2003 Mar-Apr;20(2):92-100. doi: 10.1007/BF02850256.

Abstract

Two double-masked, randomized, parallel, multicenter trials of similar design were conducted to compare the IOP-lowering efficacy of dual therapy with brimonidine 0.2% and latanoprost 0.005% with the fixed combination of timolol 0.5%/dorzolamide 2% in patients with glaucoma or ocular hypertension. The combination of brimonidine and latanoprost produced significantly greater mean IOP reductions at each visit in both trials. In study 1, the mean reduction at peak drug effect after 6 weeks was 9.2 mm Hg (34.7%) with brimonidine and latanoprost and 6.7 mm Hg (26.1%) with timolol/dorzolamide (P=.024); respective reductions at week 12 were 9.0 mm Hg (33.9%) and 6.5 mm Hg (25.3%) (P=.044). At the month 1 visit in study 2, the mean peak IOP reduction was 10.6 mm Hg (39.0%) with dual therapy and 6.3 mm Hg (25.1%) with the fixed combination (P=.001). After 3 months, reductions were 9.1 mm Hg (33.4%) and 6.6 mm Hg (26.3%) (P=.047). In these studies, the combination of brimonidine and latanoprost provided IOP control superior to that of the fixed combination of timolol/dorzolamide.

摘要

开展了两项设计相似的双盲、随机、平行、多中心试验,以比较0.2%溴莫尼定与0.005%拉坦前列素联合治疗与0.5%噻吗洛尔/2%多佐胺固定复方制剂降低青光眼或高眼压症患者眼压的疗效。在两项试验中,每次随访时,溴莫尼定和拉坦前列素联合用药降低眼压的幅度均显著更大。在研究1中,6周时药物效应达峰值时,溴莫尼定和拉坦前列素联合用药使眼压平均降低9.2 mmHg(34.7%),噻吗洛尔/多佐胺联合用药使眼压平均降低6.7 mmHg(26.1%)(P = 0.024);12周时各自降低幅度分别为9.0 mmHg(33.9%)和6.5 mmHg(25.3%)(P = 0.044)。在研究2中,第1个月随访时,联合治疗使眼压峰值平均降低10.6 mmHg(39.0%),固定复方制剂使眼压峰值平均降低6.3 mmHg(25.1%)(P = 0.001)。3个月后,降低幅度分别为9.1 mmHg(33.4%)和6.6 mmHg(26.3%)(P = 0.047)。在这些研究中,溴莫尼定和拉坦前列素联合用药在控制眼压方面优于噻吗洛尔/多佐胺固定复方制剂。

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