Stewart W C, Day D G, Stewart J A, Holmes K T, Jenkins J N
Pharmaceutical Research Network, LLC, Charleston, SC 29412-2464, USA.
Eye (Lond). 2004 Sep;18(9):905-10. doi: 10.1038/sj.eye.6701353.
To compare ocular tolerability of dorzolamide 2%, brinzolamide 1%, and placebo given three times daily.
A prospective, double-masked, three-centre, crossover comparison in which 25 ocular hypertensive or primary-open angle glaucoma subjects were randomized to receive dorzolamide, brinzolamide, or placebo three times daily for 3 days. Intraocular pressure, visual acuity, a visual analogue scale, and ocular and systemic symptom queries were completed at the end of each period.
After chronic dosing, there was a significant difference in ocular pain on the visual analogue scale among the groups at the 10-s postinstillation time point with dorzolamide having the highest level (22.5+/-28.9) compared to brinzolamide (5.0+/-8.7) or placebo (3.2+/-10.4) (P=0.0006). No differences between groups were observed preinstillation nor following dosing at 3 or 10-min postinstillation. On the initial instillation, the 10-s postinstillation pain was rated as 43.3+/-77.1, which was significantly higher than after chronic dosing (P=0.017). On the ocular symptom query, dorzolamide had the highest incidence of burning/stinging and redness compared to the other groups, but was generally characterized as mild. There were no significant differences in the visual acuity at any time point.
This study suggests that subjects treated with dorzolamide suffer more ocular pain upon instillation compared to brinzolamide or placebo. However, pain symptoms are fewer following chronic dosing and are generally characterized as mild.
比较每日三次给予2%多佐胺、1%布林佐胺和安慰剂的眼耐受性。
一项前瞻性、双盲、三中心、交叉比较研究,25名高眼压或原发性开角型青光眼患者被随机分组,接受每日三次多佐胺、布林佐胺或安慰剂治疗,为期3天。在每个阶段结束时完成眼压、视力、视觉模拟评分以及眼部和全身症状询问。
长期给药后,在滴药后10秒时,各组间视觉模拟评分的眼部疼痛存在显著差异,多佐胺组(22.5±28.9)疼痛水平最高,高于布林佐胺组(5.0±8.7)或安慰剂组(3.2±10.4)(P = 0.0006)。滴药前以及滴药后3分钟或10分钟时,未观察到组间差异。首次滴药时,滴药后10秒的疼痛评分为43.3±77.1,显著高于长期给药后(P = 0.017)。在眼部症状询问中,与其他组相比,多佐胺组灼痛/刺痛和眼红的发生率最高,但一般为轻度。在任何时间点,视力均无显著差异。
本研究表明,与布林佐胺或安慰剂相比,接受多佐胺治疗的患者在滴药时眼部疼痛更明显。然而,长期给药后疼痛症状较少,且一般为轻度。