Susanna R, Giampani J, Borges A S, Vessani R M, Jordao M L
Glaucoma Service, Department of Ophthalmology and Otolaringology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
Ophthalmology. 2001 Feb;108(2):259-63. doi: 10.1016/s0161-6420(00)00495-4.
To compare the intraocular pressure (IOP) reducing effect and safety of latanoprost 0.005% once daily with unoprostone 0.12% twice daily in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).
An 8-week, double-masked, randomized, parallel-group, single-center clinical trial.
A total of 108 patients with POAG or OH were enrolled.
After completing a wash-out of ocular hypotensive medications, patients were randomized to receive either latanoprost once daily in the evening plus placebo once daily in the morning, or unoprostone twice daily (morning and evening).
IOP was measured at 10:00 AM and at 5:00 PM at baseline and at week 8, and before 12:00 noon at week 2. Ocular and systemic safety assessments were performed.
From an overall baseline of 24.1 mmHg, latanoprost reduced IOP by 6.7 mmHg (28%) and unoprostone reduced IOP by 3.3 mmHg (14%). The difference between the groups of 3.4 mmHg was significant (P: < 0.001, analysis of covariance; 95% confidence interval [CI]: -4.7 to -2.1) in favor of latanoprost. A >/=30% reduction in mean IOP from baseline was achieved by 44% of latanoprost-treated patients compared with 8% of unoprostone-treated patients. The incidence of adverse events was low and comparable between the groups.
Latanoprost administered once daily was significantly more effective in reducing IOP compared with unoprostone administered twice daily in patients with POAG and OH.
比较0.005%拉坦前列素每日一次与0.12%乌诺前列酮每日两次对原发性开角型青光眼（POAG）或高眼压症（OH）患者的降眼压效果及安全性。
一项为期8周的双盲、随机、平行组、单中心临床试验。
共纳入108例POAG或OH患者。
在停用降眼压药物洗脱期结束后，患者被随机分为两组，一组每晚一次接受拉坦前列素治疗，同时每天早晨一次接受安慰剂治疗；另一组每天早晨和晚上各接受一次乌诺前列酮治疗。
在基线、第8周时上午10:00和下午5:00以及第2周中午12:00之前测量眼压。进行眼部和全身安全性评估。
从总体基线眼压24.1 mmHg开始，拉坦前列素使眼压降低6.7 mmHg（28%），乌诺前列酮使眼压降低3.3 mmHg（14%）。两组之间3.4 mmHg的差异具有显著性（P：<0.001，协方差分析；95%置信区间[CI]：-4.7至-2.1），拉坦前列素组更具优势。44%接受拉坦前列素治疗的患者眼压较基线平均降低≥30%，而接受乌诺前列酮治疗的患者这一比例为8%。不良事件发生率较低，且两组之间相当。
对于POAG和OH患者，每日一次使用拉坦前列素在降低眼压方面明显比每日两次使用乌诺前列酮更有效。
