噻吗洛尔半水合物与噻吗洛尔马来酸盐治疗高眼压症和开角型青光眼的比较。

Timolol hemihydrate vs timolol maleate to treat ocular hypertension and open-angle glaucoma.

作者信息

DuBiner H B, Hill R, Kaufman H, Keates E U, Zimmerman T J, Mandell A I, Mundorf T K, Bahr R L, Schwartz L W, Towey A W, Hurvitz L M, Starita R J, Sassani J W, Ropo A, Gunn R, Stewart W C

机构信息

Clayton Eye Center, Morrow, Georgia, USA.

出版信息

Am J Ophthalmol. 1996 May;121(5):522-8. doi: 10.1016/s0002-9394(14)75426-1.

DOI:10.1016/s0002-9394(14)75426-1

PMID:8610795

Abstract

PURPOSE

We compared the therapeutic efficacy and safety of timolol hemihydrate to timolol maleate in patients with ocular hypertension and chronic open-angle glaucoma.

METHODS

We conducted this three-month study as a multicentered, masked, parallel group comparison. Both the 0.25% and 0.5% concentrations were evaluated against similar concentrations of timolol maleate. Dosing was twice daily. An open-label, nine-month study followed the masked portion of the protocol, in which all patients received either 0.25% or 0.5% timolol hemihydrate. A total of 371 patients were included in both the 0.25% and 0.5% studies.

RESULTS

We found statistically similar intraocular pressures with both the 0.25% (18.3 and 18.6 mm Hg for the hemihydrate and maleate groups, respectively) and 0.5% (19.9 and 19.5 mm Hg for the hemihydrate and maleate groups, respectively) concentrations of timolol hemihydrate and timolol maleate after three months of masked treatment. Likewise, peak intraocular effect at two hours after taking the medication was statistically similar between medicines at both concentrations. Likewise, both ocular and systemic safety were similar between the maleate and hemihydrate preparations at both concentrations. In the nine-month open-label protocol, therapeutic efficacy (19.9 and 19.1 mm Hg for the 0.25% and 0.5% concentrations, respectively) and safety of timolol hemihydrate were similar to effect and safety of the three-month protocol.

CONCLUSIONS

This study suggests that timolol hemihydrate had an ocular hypotensive efficacy and safety profile statistically equivalent to that of timolol maleate for up to three months of therapy. Timolol hemihydrate showed efficacy and safety similar to that observed within the first three months, for up to one year of therapy.

摘要

目的

我们比较了半水合噻吗洛尔与马来酸噻吗洛尔治疗高眼压症和慢性开角型青光眼患者的疗效及安全性。

方法

我们进行了这项为期三个月的多中心、双盲、平行组对照研究。评估了0.25%和0.5%浓度的半水合噻吗洛尔与相同浓度的马来酸噻吗洛尔的疗效。给药方式为每日两次。在该方案的双盲部分之后进行了一项为期九个月的开放标签研究，所有患者均接受0.25%或0.5%的半水合噻吗洛尔治疗。0.25%和0.5%浓度的研究共纳入371例患者。

结果

在为期三个月的双盲治疗后，我们发现0.25%（半水合噻吗洛尔组和马来酸噻吗洛尔组分别为18.3和18.6 mmHg）和0.5%（半水合噻吗洛尔组和马来酸噻吗洛尔组分别为19.9和19.5 mmHg）浓度的半水合噻吗洛尔和马来酸噻吗洛尔在眼压降低方面具有统计学相似性。同样，两种浓度的药物在服药后两小时的眼压峰值效应在统计学上也相似。同样，两种浓度的马来酸噻吗洛尔制剂和半水合噻吗洛尔制剂在眼部和全身安全性方面也相似。在为期九个月的开放标签方案中，半水合噻吗洛尔的治疗效果（0.25%和0.5%浓度分别为19.9和19.1 mmHg）和安全性与为期三个月方案的效果和安全性相似。