Michaud J E, Friren B
Alcon Research, Ltd, South Freeway, Fort Worth, Texas, USA.
Am J Ophthalmol. 2001 Aug;132(2):235-43. doi: 10.1016/s0002-9394(01)00974-6.
The aim was to compare topical brinzolamide 1% twice daily with dorzolamide 2% twice daily, each given with timolol 0.5% twice daily, for safety and effects on intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
This double-blind, randomized, active controlled, parallel group study was conducted multinationally at 31 sites, in 241 patients as above, with assessments at baseline and monthly during 3 months of treatment. The primary end point was a diurnal reduction of trough/peak intraocular pressure from a timolol 0.5% twice daily baseline.
Both treatment regimens reduced intraocular pressure significantly at all time points (P <.001): brinzolamide plus timolol by -3.6 to -5.3 mm Hg (-14.2 to -21.9%), dorzolamide plus timolol by -3.6 mm Hg to -5.1 mm Hg (-14.1 to -21.2%). Clinically relevant intraocular pressure reductions (decreases 5 mm Hg or greater or absolute intraocular pressure values 21 mm Hg or less) were manifested by 50.0% to 89.3% of patients under brinzolamide plus timolol and by 43.9% to 85.4% under dorzolamide plus timolol. The treatments were equivalent in mean intraocular pressure-lowering. In general, both regimens were well tolerated. However, more patients (P =.001) experienced at least one adverse event with dorzolamide plus timolol (32.8%) as compared with brinzolamide plus timolol (14.7%); also, more patients (P =.001) experienced ocular discomfort (stinging and burning) after dorzolamide plus timolol (13.1%) than after brinzolamide plus timolol (1.7%).
In terms of intraocular pressure reduction, brinzolamide 1% twice daily was equivalent to dorzolamide 2% twice daily, each added to timolol 0.5% twice daily, but brinzolamide produced significantly less ocular burning and stinging.
旨在比较每天两次使用1%布林佐胺与每天两次使用2%多佐胺,二者均联合每天两次使用0.5%噻吗洛尔,对原发性开角型青光眼或高眼压症患者眼压的安全性及影响。
这项双盲、随机、活性对照、平行组研究在31个地点跨国开展,纳入241例上述患者,在治疗的3个月期间进行基线评估及每月一次的评估。主要终点是与每天两次使用0.5%噻吗洛尔基线相比,眼压谷值/峰值的日间降低情况。
两种治疗方案在所有时间点均显著降低眼压(P <.001):布林佐胺加噻吗洛尔降低3.6至5.3毫米汞柱(-14.2至-21.9%),多佐胺加噻吗洛尔降低3.6毫米汞柱至5.1毫米汞柱(-14.1至-21.2%)。使用布林佐胺加噻吗洛尔的患者中50.0%至89.3%以及使用多佐胺加噻吗洛尔的患者中43.9%至85.4%出现了具有临床意义的眼压降低(降低5毫米汞柱或更多或绝对眼压值21毫米汞柱或更低)。两种治疗在降低眼压均值方面相当。总体而言,两种方案耐受性良好。然而,与布林佐胺加噻吗洛尔(14.7%)相比,更多患者(P =.001)使用多佐胺加噻吗洛尔(32.8%)时经历了至少一次不良事件;此外,使用多佐胺加噻吗洛尔(13.1%)后出现眼部不适(刺痛和烧灼感)的患者比使用布林佐胺加噻吗洛尔(1.7%)后更多(P =.001)。
在降低眼压方面,每天两次使用1%布林佐胺与每天两次使用2%多佐胺相当,二者均联合每天两次使用0.5%噻吗洛尔,但布林佐胺引起的眼部烧灼感和刺痛明显更少。