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一项为期1年的双盲、随机研究,比较多佐胺、噻吗洛尔和倍他洛尔对角膜的影响。多佐胺角膜效应研究组。

A double-masked, randomized, 1-year study comparing the corneal effects of dorzolamide, timolol, and betaxolol. Dorzolamide Corneal Effects Study Group.

作者信息

Lass J H, Khosrof S A, Laurence J K, Horwitz B, Ghosh K, Adamsons I

机构信息

Department of Ophthalmology, Case Western Reserve University, Cleveland, Ohio, USA.

出版信息

Arch Ophthalmol. 1998 Aug;116(8):1003-10. doi: 10.1001/archopht.116.8.1003.

Abstract

OBJECTIVE

To compare the long-term effects of dorzolamide hydrochloride (Trusopt, Merck and Co Inc, White-house Station, NJ), timolol maleate, and betaxolol hydrochloride on corneal endothelial cell density and corneal thickness.

METHODS

This 1-year multicenter study was conducted in 298 patients with ocular hypertension or open-angle glaucoma who had a baseline central corneal endothelial cell density greater than 1500 cells/mm2 and central corneal thickness less than 0.68 mm in each eye. Patients were randomized to 0.5% betaxolol twice daily, 0.5% timolol twice daily, or 2.0% dorzolamide 3 times daily. Specular microscopy and ultrasonic pachymetry of the central cornea was performed at baseline and 6 and 12 months following institution of therapy. Endothelial cell densities were determined by a single masked observer.

RESULTS

The mean percent changes from baseline for both outcome measures were similar in all 3 treatment groups at both 6 and 12 months. After 1 year of treatment, the mean percent loss in endothelial cell density from baseline was 3.6%, 4.5%, and 4.2% for the dorzolamide, timolol, and betaxolol groups, respectively. The mean percent change from baseline for corneal thickness was 0.47%, -0.25%, and 0.39% for the dorzolamide, timolol, and betaxolol groups, respectively.

CONCLUSIONS

Dorzolamide is equivalent to timolol and betaxolol in terms of the change in central endothelial cell density and thickness after 1 year of therapy. All 3 treatments exhibit good long-term corneal tolerability in patients with normal corneas at baseline.

摘要

目的

比较盐酸多佐胺(Trusopt,默克公司,新泽西州白宫站)、马来酸噻吗洛尔和盐酸倍他洛尔对角膜内皮细胞密度和角膜厚度的长期影响。

方法

这项为期1年的多中心研究纳入了298例高眼压症或开角型青光眼患者,这些患者每只眼睛的中央角膜内皮细胞密度基线值大于1500个细胞/mm²,中央角膜厚度小于0.68mm。患者被随机分为每日两次使用0.5%倍他洛尔、每日两次使用0.5%噻吗洛尔或每日三次使用2.0%多佐胺。在基线以及治疗开始后6个月和12个月时,对中央角膜进行镜面显微镜检查和超声测厚。内皮细胞密度由一名单盲观察者测定。

结果

在6个月和12个月时,所有3个治疗组中两种结局指标相对于基线的平均变化百分比相似。治疗1年后,多佐胺组、噻吗洛尔组和倍他洛尔组内皮细胞密度相对于基线的平均损失百分比分别为3.6%、4.5%和4.2%。多佐胺组、噻吗洛尔组和倍他洛尔组角膜厚度相对于基线的平均变化百分比分别为0.47%、-0.25%和0.39%。

结论

在治疗1年后,就中央内皮细胞密度和厚度的变化而言,多佐胺与噻吗洛尔和倍他洛尔相当。所有3种治疗方法在基线角膜正常的患者中均表现出良好的长期角膜耐受性。

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