0.005%拉坦前列素每日一次与2%毛果芸香碱每日三次联合应用于开角型青光眼或高眼压症患者时降低眼压的附加作用。一项为期6个月的随机、多中心研究。德国拉坦前列素研究组

The additive intraocular pressure-lowering effect of latanoprost 0.005% daily once and pilocarpine 2% t.i.d. in patients with open-angle glaucoma or ocular hypertension. a 6-month, randomized, multicenter study. German Latanoprost Study Group.

作者信息

Diestelhorst M

机构信息

Department of Ophthalmology, University of Cologne, Germany.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2000 May;238(5):433-9. doi: 10.1007/s004170050375.

DOI:10.1007/s004170050375

PMID:10901475

Abstract

PURPOSE

To compare the additional intraocular pressure-lowering effect of latanoprost 0.005% administered once daily with that of pilocarpine 2% administered three times daily in patients with primary open-angle glaucoma or ocular hypertension currently on monotherapy with timolol 0.5% twice daily.

METHODS

In a 6-month, multicenter, randomized, open-label study 242 patients with POAG or OH whose IOP was not controlled with timolol 0.5% b.i.d. were enrolled. Eyes had not been treated with pilocarpine and latanoprost for at least 2 years. An analysis of covariance with diurnal IOP change from baseline to month 6 for study eyes was performed.

RESULTS

Four patients on latanoprost 0.005% and 35 on pilocarpine 2% did not complete the study (P<0.001). Two hundred and forty patients were included in the intent-to-treat analysis. For both treatments the diurnal IOP reduction after 6 months was statistically significant (P<0.001). IOP (mean+/-SD) was reduced from 23.3+/-2.8 to 17.8+/-2.8 (-5.6) mmHg in the latanoprost 0.005% group and from 23.0+/-3.2 to 18.5+/-2.4 (-4.8) mmHg in pilocarpine 2% t.i.d.-treated eyes. The mean difference of -0.8 mmHg (per protocol, PP) and -1.6 mmHg (intend-to-treat, ITT) was statistically significant (P<0.04, PP; P<0.001, ITT) in favor of latanoprost 0.005%. Two eyes treated with latanoprost showed an iris color change. Thirty-six patients in the latanoprost group and 106 in the pilocarpine 2% group reported ocular adverse events (P<0.001).

CONCLUSION

From the data we conclude that the additivity of latanoprost 0.005% is at least as effective as pilocarpine 2% t.i.d. in reducing IOP when added to eyes currently on monotherapy with timolol 0.5% b.i.d. Latanoprost was better tolerated than pilocarpine 2% eye drops in this study. The increase in iris pigmentation requires further investigation.

摘要

目的

比较0.005%拉坦前列素每日一次给药与2%毛果芸香碱每日三次给药对目前正在接受0.5%噻吗洛尔每日两次单药治疗的原发性开角型青光眼或高眼压症患者的额外降眼压效果。

方法

在一项为期6个月的多中心、随机、开放标签研究中，纳入了242例眼压未被0.5%噻吗洛尔每日两次控制的原发性开角型青光眼或高眼压症患者。研究眼至少2年未接受过毛果芸香碱和拉坦前列素治疗。对研究眼从基线到第6个月的日间眼压变化进行协方差分析。

结果

4例使用0.005%拉坦前列素和35例使用2%毛果芸香碱的患者未完成研究（P<0.001）。240例患者纳入意向性分析。两种治疗在6个月后的日间眼压降低均具有统计学意义（P<0.001）。0.005%拉坦前列素组眼压（平均值±标准差）从23.3±2.8降至17.8±2.8（-5.6）mmHg，2%毛果芸香碱每日三次治疗组眼压从23.0±3.2降至18.5±2.4（-4.8）mmHg。-0.8 mmHg的平均差值（符合方案分析，PP）和-1.6 mmHg（意向性分析，ITT）具有统计学意义（P<0.04，PP；P<0.001，ITT），支持0.005%拉坦前列素。2例接受拉坦前列素治疗的患者出现虹膜颜色改变。拉坦前列素组36例患者和2%毛果芸香碱组106例患者报告了眼部不良事件（P<0.001）。