Aung T, Chew P T, Yip C C, Chan Y H, See J L, Khng C G, Hoh S T, Ng L H, Lee H M
Singapore National Eye Centre, Singapore.
Am J Ophthalmol. 2001 May;131(5):636-42. doi: 10.1016/s0002-9394(00)00943-0.
To compare the intraocular pressure)-lowering effect and side effects of latanoprost 0.005% once daily with unoprostone 0.12% twice daily.
Sixty patients with primary open-angle glaucoma or ocular hypertension were randomized to receive either latanoprost once daily in the evening and placebo once daily in the morning, or unoprostone twice daily in the morning and evening. The study was double masked and followed a crossover design with two treatment periods of 1 month separated by a 3-week washout period. The intraocular pressure was measured at 9 AM and 5 PM on the baseline and day 28 visits, and at 9 AM on day 2 and day 14 visits of each treatment period. The 9 AM measurement was taken 2 hours and 13 hours after the last drop of unoprostone and latanoprost, and the 5 PM measurement was at 10 and 21 hours, respectively. The mean of the measurements was calculated. Safety parameters were also recorded.
Fifty-six patients completed both treatment periods and had intraocular pressure data available for evaluation. After 1 month of treatment, latanoprost significantly reduced intraocular pressure (mean +/- SEM) by 6.1 +/- 0.5 mm Hg (P <.001) and unoprostone by 4.2 +/- 0.4 mm Hg (P <.001) adjusted from an overall baseline of 22.3 +/- 0.5 mm Hg and 23.2 +/- 0.4 mm Hg, respectively. The difference of 1.9 mm Hg between treatments was statistically significant in favor of latanoprost [P =.003, analysis of covariance (ANCOVA)]. Unadjusted analysis of responders using the percentage decrease in intraocular pressure showed that the proportion of responders in the latanoprost-treated group was greater than in the unoprostone-treated group. Adverse ocular symptoms and findings were mild in both treatment groups. Eye redness and ocular irritation were the most frequently reported events.
Latanoprost once daily was significantly more effective in reducing intraocular pressure compared with unoprostone twice daily after 1 month of treatment in patients with primary open-angle glaucoma and ocular hypertension. Both drugs were well tolerated with few ocular adverse events.
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降低眼压的效果及副作用。
60例原发性开角型青光眼或高眼压症患者被随机分为两组，一组晚上每日一次使用拉坦前列素，早上每日一次使用安慰剂；另一组早晚每日两次使用乌诺前列酮。该研究采用双盲交叉设计，两个治疗期各为1个月，中间有3周的洗脱期。在基线期和第28天访视时的上午9点和下午5点测量眼压，在每个治疗期的第2天和第14天访视时上午9点测量眼压。上午9点的测量在最后一滴乌诺前列酮和拉坦前列素后2小时和13小时进行，下午5点的测量分别在10小时和21小时进行。计算测量值的平均值。还记录了安全参数。
56例患者完成了两个治疗期并拥有可供评估的眼压数据。治疗1个月后，从总体基线分别为22.3±0.5 mmHg和23.2±0.4 mmHg调整后，拉坦前列素显著降低眼压（均值±标准误）6.1±0.5 mmHg（P<.001），乌诺前列酮降低4.2±0.4 mmHg（P<.001）。两种治疗之间1.9 mmHg的差异具有统计学意义，拉坦前列素更具优势[P=.003，协方差分析（ANCOVA）]。使用眼压降低百分比对有反应者进行的未调整分析表明，拉坦前列素治疗组的有反应者比例高于乌诺前列酮治疗组。两个治疗组的眼部不良症状和体征均较轻。眼红和眼部刺激是最常报告的事件。
在原发性开角型青光眼和高眼压症患者中，治疗1个月后，每日一次的拉坦前列素与每日两次的乌诺前列酮相比，在降低眼压方面显著更有效。两种药物耐受性良好，眼部不良事件较少。
