Jampel Henry D, Bacharach Jason, Sheu Wang-Pui, Wohl Lisa G, Solish Alfred M, Christie William
Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9205, USA.
Am J Ophthalmol. 2002 Dec;134(6):863-71. doi: 10.1016/s0002-9394(02)01820-2.
To compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost 0.005% once daily with that of unoprostone 0.15% twice daily for patients with primary open-angle glaucoma or ocular hypertension.
Randomized clinical trial.
In a prospective, 8-week, investigator-masked, parallel-group study conducted at numerous centers in the United States, 165 previously treated patients with IOP >or= 25 mm Hg in one or both eyes after washout were randomly assigned to receive either latanoprost 0.005% once daily in the evening or unoprostone 0.15% twice daily. Observations procedures were Goldmann applanation tonometry, best-corrected visual acuity, slit lamp biomicroscopy, and ophthalmoscopy. The main outcome measure was change in the mean of the IOPs measured at 8:00 AM, 12 noon, and 4:00 PM between baseline (before treatment) and after 8 weeks of treatment.
The change in the mean +/- SD of the IOPs measured at 8:00 AM, 12 noon, and 4:00 PM was -7.2 +/- 3.2 mm Hg (28%) for latanoprost (25.3 +/- 2.8 mm Hg at baseline to 18.2 +/- 2.8 mm Hg at 8 weeks) and -3.9 +/- 2.6 mm Hg (15%) for unoprostone (25.5 +/- 3.3 mm Hg at baseline to 21.6 +/- 4.0 mm Hg; P <or=.001. No serious adverse event related to either medication was reported.
Over an 8-week period, latanoprost 0.005% once daily lowered IOP more than unoprostone 0.15% twice daily in patients with elevated IOP. Both agents were safe and well tolerated.
比较0.005%拉坦前列素每日一次与0.15%乌诺前列酮每日两次对原发性开角型青光眼或高眼压症患者的降眼压效果及安全性。
随机临床试验。
在美国多个中心进行的一项前瞻性、为期8周、研究者设盲的平行组研究中，165例在洗脱期后一只或两只眼睛眼压≥25 mmHg的既往治疗患者被随机分配接受每晚一次的0.005%拉坦前列素或每日两次的0.15%乌诺前列酮治疗。观察程序包括Goldmann压平眼压测量、最佳矫正视力、裂隙灯生物显微镜检查和检眼镜检查。主要观察指标是治疗前（基线）和治疗8周后上午8:00、中午12:00和下午4:00测量的眼压平均值的变化。
拉坦前列素组上午8:00、中午12:00和下午4:00测量的眼压平均值变化为-7.2±3.2 mmHg（28%）（基线时为25.3±2.8 mmHg，8周时为18.2±2.8 mmHg），乌诺前列酮组为-3.9±2.6 mmHg（15%）（基线时为25.5±3.3 mmHg，8周时为21.6±4.0 mmHg；P≤0.001）。未报告与任何一种药物相关的严重不良事件。
在8周的时间里，对于眼压升高的患者，0.005%拉坦前列素每日一次降低眼压的效果优于0.15%乌诺前列酮每日两次。两种药物均安全且耐受性良好。
