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前列腺素类似物的疗效与耐受性:一项随机对照临床试验的荟萃分析

Efficacy and tolerability of prostaglandin analogs: a meta-analysis of randomized controlled clinical trials.

作者信息

Aptel Florent, Cucherat Michel, Denis Philippe

机构信息

Department of Ophthalmology, Edouard Herriot Hospital, Lyon, France.

出版信息

J Glaucoma. 2008 Dec;17(8):667-73. doi: 10.1097/IJG.0b013e3181666557.

DOI:10.1097/IJG.0b013e3181666557
PMID:19092464
Abstract

AIM

This systematic meta-analysis was performed to evaluate the intraocular pressure (IOP) lowering effects and tolerability of latanoprost, bimatoprost, and travoprost.

METHODS

Clinical trials published up to July 2006 were thoroughly searched using all available databases and resources. The inclusion criteria were prospective randomized controlled clinical trials; patients with primary open-angle glaucoma or ocular hypertension; and prostaglandin monotherapy, without systemic/ocular medications or laser/surgery that could affect IOP within the past 3 months. Study quality was assessed with the Jadad scoring system, and potential bias was eliminated by robust statistical and independent reviews of publications. The main outcome measures were efficacy assessed by IOP (taken at 8 AM, noon, 4 PM, and 8 PM) change at 3 months from baseline and tolerability assessed by the incidence of conjunctival hyperemia.

RESULTS

Eight trials were identified (n=1610 patients). IOP change from baseline was statistically significantly greatest with bimatoprost, compared with latanoprost at all time points [weighted mean (WM) 8 AM: WM=0.50 mm Hg; P=0.05; 95% confidence intervals (CIs) 0.01-0.99; noon: WM=1.17 mm Hg; P<0.001; 95% CI 0.68-1.66; 4 PM: WM=0.78 mm Hg; P=0.003; 95% CI 0.26-1.29; 8 PM: WM=0.67 mm Hg; P=0.04; 95% CI 0.02-1.32], and with travoprost during the daytime (8 AM: WM=1.02 mm Hg; P=0.004; 95% CI 0.32-1.72; noon: WM=0.86 mm Hg; P=0.02; 95% CI 0.12-1.59). Latanoprost and travoprost were comparable in their ability to reduce IOP at all time points (P<or=0.82). The incidence of hyperemia was less with latanoprost and travoprost [latanoprost vs. bimatoprost: relative risk=0.59; P<0.001; 95% CI 0.50-0.69; travoprost vs. bimatoprost: relative risk=0.84; P=0.05; 95% CI 0.70-1.00].

CONCLUSIONS

The findings suggest a greater efficacy of bimatoprost compared with latanoprost and travoprost, although the incidence of hyperemia was lower with the latter 2 agents.

摘要

目的

进行该系统荟萃分析以评估拉坦前列素、比马前列素和曲伏前列素降低眼压(IOP)的效果及耐受性。

方法

利用所有可用数据库和资源全面检索截至2006年7月发表的临床试验。纳入标准为前瞻性随机对照临床试验;原发性开角型青光眼或高眼压症患者;前列腺素单药治疗,且在过去3个月内未使用可能影响眼压的全身/眼部药物或激光/手术。采用Jadad评分系统评估研究质量,并通过可靠的统计分析和对出版物的独立评审消除潜在偏倚。主要结局指标为3个月时眼压(上午8点、中午、下午4点和晚上8点测量)相对于基线的变化评估疗效,以及通过结膜充血发生率评估耐受性。

结果

共确定8项试验(n = 1610例患者)。与拉坦前列素相比,比马前列素在所有时间点使眼压从基线的变化在统计学上显著更大[加权均值(WM)上午8点:WM = 0.50 mmHg;P = 0.05;95%置信区间(CI)0.01 - 0.99;中午:WM = 1.17 mmHg;P < 0.001;95% CI 0.68 - 1.66;下午4点:WM = 0.78 mmHg;P = 0.003;95% CI 0.26 - 1.29;晚上8点:WM = 0.67 mmHg;P = 0.04;95% CI 0.02 - 1.32],与曲伏前列素相比,白天(上午8点:WM = 1.02 mmHg;P = 0.004;95% CI 0.32 - 1.72;中午:WM = 0.86 mmHg;P = 0.02;95% CI 0.12 - 1.59)眼压变化也更大。拉坦前列素和曲伏前列素在所有时间点降低眼压的能力相当(P≤0.82)。拉坦前列素和曲伏前列素的充血发生率较低[拉坦前列素对比马前列素:相对危险度 = 0.59;P < 0.001;95% CI 0.50 - 0.69;曲伏前列素对比马前列素:相对危险度 = 0.84;P = 0.05;95% CI 0.70 - 1.00]。

结论

研究结果表明,比马前列素比拉坦前列素和曲伏前列素疗效更佳,尽管后两种药物的充血发生率较低。

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