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市售0.005%拉坦前列素与噻吗洛尔和多佐胺固定复方制剂的24小时昼夜曲线比较。

Twenty-four-hour diurnal curve comparison of commercially available latanoprost 0.005% versus the timolol and dorzolamide fixed combination.

作者信息

Konstas Anastasios G P, Papapanos Panayiotis, Tersis Ioannis, Houliara Dimitra, Stewart William C

机构信息

University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece.

出版信息

Ophthalmology. 2003 Jul;110(7):1357-60. doi: 10.1016/S0161-6420(03)00404-4.

Abstract

PURPOSE

To evaluate the efficacy and safety of commercially available latanoprost 0.005% given every evening versus timolol 0.5% and dorzolamide 2% fixed combination (TDFC) given twice daily to white Greeks with primary open-angle glaucoma and ocular hypertensive patients.

DESIGN

A single-masked, two-center, crossover comparison with two 6-week treatment periods occurring after at least a 3-week medicine-free period. Diurnal curve intraocular pressures were taken at 2:00 AM, 6:00 AM, 10:00 AM, 2:00 PM, 6:00 PM, and 10:00 PM.

PARTICIPANTS

Thirty-four subjects with primary open-angle glaucoma or ocular hypertension were enrolled.

INTERVENTIONS

Latanoprost 0.005% given every evening and TDFC twice daily.

MAIN OUTCOME MEASURES

The primary efficacy variable was diurnal intraocular pressure.

RESULTS

Thirty-three patients completed the study. On the last day of treatment, the mean diurnal intraocular pressure for latanoprost was 15.9 +/- 2.3 mmHg and for TDFC was 15.3 +/- 2.0 mmHg (P = 0.05). Individual time points for intraocular pressure were not statistically different between groups except at the 10:00 PM time point, when the mean for TDFC was 14.6 +/- 2.7 mmHg and for latanoprost was 16.6 +/- 3.1 mmHg (P < 0.006). Eighteen patients overall preferred latanoprost versus 2 patients for the fixed combination, generally because of the greater convenience of once daily dosing. Adverse events were not significantly different between groups except that a bitter taste was found more frequently with TDFC (n = 9) than with latanoprost (n = 0; P = 0.009). Despite screening to exclude intolerance to beta-blockers, a single patient had to discontinue the TDFC because of new-onset asthma.

CONCLUSIONS

This study indicates that the 24-hour diurnal intraocular pressure is lowered more, by a small but statistically significant amount, with TDFC compared with latanoprost in primary open-angle glaucoma and ocular hypertensive patients.

摘要

目的

评估每晚使用的市售0.005%拉坦前列素与每日两次使用的0.5%噻吗洛尔和2%多佐胺固定复方制剂(TDFC)对患有原发性开角型青光眼的希腊白种人和高眼压症患者的疗效和安全性。

设计

一项单盲、双中心、交叉对照研究,在至少3周的停药期后进行两个为期6周的治疗阶段。于凌晨2:00、上午6:00、上午10:00、下午2:00、下午6:00和晚上10:00测量昼夜眼压曲线。

参与者

招募了34名患有原发性开角型青光眼或高眼压症的受试者。

干预措施

每晚使用0.005%拉坦前列素,每日两次使用TDFC。

主要观察指标

主要疗效变量为昼夜眼压。

结果

33名患者完成了研究。在治疗的最后一天,拉坦前列素组的平均昼夜眼压为15.9±2.3 mmHg,TDFC组为15.3±2.0 mmHg(P = 0.05)。除晚上10:00时间点外,两组眼压的各个时间点无统计学差异,晚上10:00时,TDFC组平均眼压为14.6±2.7 mmHg,拉坦前列素组为16.6±3.1 mmHg(P < 0.006)。总体上,18名患者更喜欢拉坦前列素,而只有2名患者更喜欢固定复方制剂,这通常是因为每日一次给药更方便。除了TDFC组(n = 9)比拉坦前列素组(n = 0;P = 0.009)更频繁地出现苦味外,两组不良事件无显著差异。尽管进行了筛查以排除对β受体阻滞剂不耐受的情况,但仍有一名患者因新发哮喘而不得不停用TDFC。

结论

本研究表明,在原发性开角型青光眼和高眼压症患者中,与拉坦前列素相比,TDFC降低24小时昼夜眼压的幅度更大,虽幅度较小但具有统计学意义。

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