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拉坦前列素、比马前列素和曲伏前列素治疗眼压升高患者的比较:一项为期12周的随机、盲法评估者多中心研究。

A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study.

作者信息

Parrish Richard K, Palmberg Paul, Sheu Wang-Pui

机构信息

Bascom Palmer Eye Institute, Miami, Florida 33136, USA.

出版信息

Am J Ophthalmol. 2003 May;135(5):688-703. doi: 10.1016/s0002-9394(03)00098-9.

Abstract

PURPOSE

To Internet Advance publication at ajo.com Feb 13, 2003. compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost, bimatoprost, and travoprost in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).

DESIGN

Interventional study.

METHODS

This 12-week, randomized, parallel-group study was conducted at 45 US sites. Previously treated patients with OAG or OH and an IOP > or =23 mm Hg in one or both eyes after washout received either latanoprost 0.005%, bimatoprost 0.03%, or travoprost 0.004% once daily in the evening. At baseline and after 6 and 12 weeks of therapy, masked evaluators measured IOP in triplicate at 8:00 AM, 12 noon, 4:00 PM, and 8:00 PM, and masked investigators graded conjunctival hyperemia before the 8:00 AM IOP measurement. The primary efficacy outcome measure was change between baseline and Week 12 in the 8:00 AM IOP (time of peak drug effect).

RESULTS

In all, 410 of 411 randomized patients were included in intent-to-treat analyses (latanoprost, 136; bimatoprost, 136; travoprost, 138). Baseline mean 8:00 AM IOP levels were similar (P =.772); by week 12, reductions were observed in all 3 groups (P <.001 for each). Adjusted (ANCOVA) reductions in mean IOP at 8:00 AM were similar (P =.128) as were those at 12 noon, 4:00 PM, and 8:00 PM. Fewer latanoprost-treated patients reported ocular adverse events (P <.001, latanoprost vs bimatoprost), fewer reported hyperemia (P =.001, latanoprost vs bimatoprost), and average hyperemia scores were lower at week 12 (P =.001, latanoprost vs bimatoprost).

CONCLUSIONS

Latanoprost, bimatoprost, and travoprost were comparable in their ability to reduce IOP in OAG and OH patients. Latanoprost exhibited greater ocular tolerability.

摘要

目的

于2003年2月13日在ajo.com上进行网络预发表。比较拉坦前列素、比马前列素和曲伏前列素在开角型青光眼(OAG)或高眼压症(OH)患者中的降眼压效果和安全性。

设计

干预性研究。

方法

这项为期12周的随机平行组研究在美国45个地点进行。之前接受过治疗的OAG或OH患者,洗脱期后一只或两只眼睛的眼压≥23 mmHg,每晚接受一次0.005%拉坦前列素、0.03%比马前列素或0.004%曲伏前列素治疗。在基线以及治疗6周和12周后,由盲态评估者在上午8:00、中午12:00、下午4:00和晚上8:00测量眼压,测量三次,由盲态研究者在上午8:00眼压测量前对结膜充血进行分级。主要疗效指标是基线至第12周上午8:00(药物作用高峰时间)眼压的变化。

结果

411名随机分组患者中,410名纳入意向性分析(拉坦前列素组136名;比马前列素组136名;曲伏前列素组138名)。基线时上午8:00眼压平均水平相似(P = 0.772);到第12周时,三组均观察到眼压降低(每组P < 0.001)。上午8:00平均眼压的调整后(协方差分析)降低幅度相似(P = 0.128),中午12:00、下午4:00和晚上8:00时也是如此。拉坦前列素治疗组报告眼部不良事件的患者较少(P < 0.001,拉坦前列素对比马前列素),报告充血的患者较少(P = 0.001,拉坦前列素对比马前列素),第12周时平均充血评分较低(P = 0.001,拉坦前列素对比马前列素)。

结论

拉坦前列素、比马前列素和曲伏前列素在降低OAG和OH患者眼压的能力方面相当。拉坦前列素表现出更高的眼部耐受性。

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