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评估青光眼药物疗效的24小时眼压研究的荟萃分析。

Meta-analysis of 24-hour intraocular pressure studies evaluating the efficacy of glaucoma medicines.

作者信息

Stewart William C, Konstas Anastasios G P, Nelson Lindsay A, Kruft Bonnie

机构信息

PRN Pharmaceutical Research Network, LLC, Dallas, Texas, USA.

出版信息

Ophthalmology. 2008 Jul;115(7):1117-1122.e1. doi: 10.1016/j.ophtha.2007.10.004. Epub 2008 Feb 20.

Abstract

PURPOSE

To evaluate efficacy and safety data of currently available ocular hypotensive medicines derived from 24-hour studies, of similar design, in patients with primary open-angle glaucoma (POAG), exfoliative glaucoma, or ocular hypertension (OH).

DESIGN

Meta-analysis of published articles evaluating patients with POAG, exfoliative glaucoma, or OH.

METHODS

We included articles that were randomized, prospective, single- or double-masked, comparative studies of ocular hypotensive therapies over 24 hours. Each article selected contained an untreated baseline, >or=4-week treatment period, >/=20 patients per treatment arm, and >or=6 time points not spaced >5 hours apart and used Goldmann applanation or Tonopen tonometry (supine measurements) to measure intraocular pressure (IOP).

MAIN OUTCOME MEASURE

Twenty-four-hour IOP efficacy.

RESULTS

This analysis included 864 separate 24-hour treatment curves from 386 patients in 28 treatment arms from 11 studies. A statistical difference in the mean diurnal pressure decrease existed between monotherapy treatments for POAG/OH patients, with bimatoprost (29%) and travoprost (27%) showing the greatest 24-hour reduction (P = 0.026). Timolol 0.5% was less effective than latanoprost (24% vs. 19% reduction) but decreased the pressure at each night time point (P = 0.0003). Dorzolamide showed a 19% 24-hour pressure reduction and brimonidine 0.2% a 14% one. In exfoliative glaucoma patients, latanoprost and travoprost showed higher baseline and treatment pressures, although the pressure reductions (29% and 31%, respectively) were greater generally than observed with POAG/OH. An evening-dosed latanoprost/timolol fixed combination reduced the pressure 33%, and the dorzolamide/timolol fixed combination (DTFC), 26%. However, the power to detect a difference for this specific comparison was probably low, due to the limited number of patients (n = 20) in the DTFC group. A statistical difference between evening-dosed (24%) and morning-dosed (18%) latanoprost (P<0.0001) was noted, but not between evening (27%) and morning (26%) travoprost (P = 0.074). The mean reduction of night time points was statistically lower than day time points for latanoprost (P = 0.031), timolol (P = 0.032), and brimonidine (P = 0.050), but not for dorzolamide. Dorzolamide (P = 0.60), travoprost (P = 0.064), and bimatoprost (P = 0.057) did not demonstrate nighttime pressures lower than daytime ones. The mean reduction of night time points was statistically lower than that of day time points for latanoprost (P = 0.031), timolol (P = 0.032), and brimonidine (P = 0.050), but not for dorzolamide (P = 0.60), bimatoprost (P = 0.057), travoprost (P = 0.064).

CONCLUSIONS

Similar relative efficacies generally exist in various classes of ocular hypotensive agents during night and day hours.

摘要

目的

评估目前可得的、来源于设计相似的24小时研究的降眼压药物,在原发性开角型青光眼(POAG)、剥脱性青光眼或高眼压症(OH)患者中的疗效和安全性数据。

设计

对评估POAG、剥脱性青光眼或OH患者的已发表文章进行荟萃分析。

方法

我们纳入了随机、前瞻性、单盲或双盲的24小时降眼压治疗对比研究的文章。每篇入选文章均包含一个未经治疗的基线、≥4周的治疗期、每个治疗组≥20例患者,以及≥6个时间点,时间点间隔不超过5小时,且使用Goldmann压平眼压计或Tonopen眼压计(仰卧位测量)测量眼压(IOP)。

主要观察指标

24小时眼压疗效。

结果

该分析纳入了来自11项研究中28个治疗组386例患者的864条独立的24小时治疗曲线。POAG/OH患者单药治疗的平均日间眼压降幅存在统计学差异,比马前列素(29%)和曲伏前列素(27%)的24小时降幅最大(P =  0.026)。0.5%噻吗洛尔的疗效低于拉坦前列素(降幅分别为24%和19%),但在每个夜间时间点可降低眼压(P = 0.0003)。多佐胺24小时眼压降幅为19%,0.2%溴莫尼定降幅为14%。在剥脱性青光眼患者中,拉坦前列素和曲伏前列素的基线眼压和治疗眼压较高,尽管其降幅(分别为29%和31%)总体上大于POAG/OH患者。每晚给药的拉坦前列素/噻吗洛尔固定复方降低眼压33%,多佐胺/噻吗洛尔固定复方(DTFC)降低26%。然而,由于DTFC组患者数量有限(n = 20),检测这一特定对比差异的效能可能较低。每晚给药的拉坦前列素(24%)和早晨给药的拉坦前列素(18%)之间存在统计学差异(P<0.0001),但每晚给药的曲伏前列素(27%)和早晨给药的曲伏前列素(26%)之间无统计学差异(P = 0.074)。拉坦前列素(P = 0.031)、噻吗洛尔(P = 0.032)和溴莫尼定(P = 0.050)夜间时间点的平均降幅在统计学上低于日间时间点,但多佐胺并非如此。多佐胺(P = 0.60)、曲伏前列素(P = 0.064)和比马前列素(P = 0.057)的夜间眼压未显示低于日间眼压。拉坦前列素(P = 0.031)、噻吗洛尔(P = 0.032)和溴莫尼定(P = 0.050)夜间时间点的平均降幅在统计学上低于日间时间点,但多佐胺(P = 0.60)、比马前列素(P = 0.057)、曲伏前列素(P = 0.06)并非如此。

结论

各类降眼压药物在白天和夜间的相对疗效通常相似。

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