Rulo A H, Greve E L, Geijssen H C, Hoyng P F
Department of Ophthalmology, University of Amsterdam, The Netherlands.
Ophthalmology. 1996 Aug;103(8):1276-82. doi: 10.1016/s0161-6420(96)30510-1.
Currently available ocular hypotensive agents often fail to lower intraocular pressure (IOP) in patients with normal-pressure glaucoma (NPG). The authors evaluated the IOP-reducing potential and side effects of latanoprost, a newly developed ocular hypotensive agent, in this patient group.
A randomized, double-masked, placebo-controlled cross-over study was performed in 30 patients with NPG, 29 of whom completed the study. During three periods of 3 weeks each, patients received, in a random order, 50 micrograms/ml latanoprost once daily, 15 micrograms/ml latanoprost twice daily, and placebo. Per dose, one drop of the study medication was applied topically in both eyes. At the end of each treatment period, diurnal IOP measurements were obtained. General and ocular symptoms were recorded, and a detailed ocular examination was performed on each visit to monitor side effects.
Average IOP reduction after 50 micrograms/ml latanoprost once daily, 15 micrograms/ml latanoprost twice daily, and placebo was 3.6 +/- 1.9 mmHg (21.3%, P < 0.001), 2.4 +/- 1.5 mmHg (14.2%, P < 0.001), and 0.4 +/- 1.8 mmHg (2.4%, not significant), respectively. The difference between the two latanoprost dose regimens was significant (P = 0.001). Efficacy of latanoprost correlated with initial IOP (r2 = 0.76, P < 0.001). A mild, but statistically significant, increase in conjunctival hyperemia was observed in both latanoprost treatment groups.
Both latanoprost regimens significantly reduce IOP in patients with NPG, but 50 micrograms/ml latanoprost once daily is more effective in reducing IOP than 15 micrograms/ml latanoprost twice daily. Lowering the concentration did not result in an improved side effects profile. Latanoprost is more effective at higher IOP levels.
目前可用的降眼压药物常常无法降低正常眼压性青光眼（NPG）患者的眼压（IOP）。作者评估了一种新开发的降眼压药物拉坦前列素在该患者群体中的降眼压潜力和副作用。
对30例NPG患者进行了一项随机、双盲、安慰剂对照的交叉研究，其中29例完成了研究。在三个为期3周的时间段内，患者随机接受每日一次50微克/毫升拉坦前列素、每日两次15微克/毫升拉坦前列素和安慰剂治疗。每次给药时，将一滴研究药物局部滴入双眼。在每个治疗期结束时，测量昼夜眼压。记录全身和眼部症状，并在每次就诊时进行详细的眼部检查以监测副作用。
每日一次50微克/毫升拉坦前列素、每日两次15微克/毫升拉坦前列素和安慰剂治疗后的平均眼压降低分别为3.6±1.9 mmHg（21.3%，P<0.001）、2.4±1.5 mmHg（14.2%，P<0.001）和0.4±1.8 mmHg（2.4%，无显著性差异）。两种拉坦前列素给药方案之间的差异具有显著性（P=0.001）。拉坦前列素的疗效与初始眼压相关（r2=0.76，P<0.001）。在两个拉坦前列素治疗组中均观察到结膜充血有轻度但具有统计学显著性的增加。
两种拉坦前列素方案均能显著降低NPG患者的眼压，但每日一次50微克/毫升拉坦前列素在降低眼压方面比每日两次15微克/毫升拉坦前列素更有效。降低浓度并未改善副作用情况。拉坦前列素在较高眼压水平时更有效。
