Konstas A G P, Mikropoulos D, Dimopoulos A T, Moumtzis G, Nelson L A, Stewart W C
Department Ophthalmology, Glaucoma Unit, 1st University, Thessaloniki, Greece.
Br J Ophthalmol. 2008 Nov;92(11):1498-502. doi: 10.1136/bjo.2008.145219. Epub 2008 Aug 14.
To evaluate open-angle glaucoma patients, who were insufficiently controlled on latanoprost monotherapy, to determine the 24 h intraocular pressure (IOP) efficacy and safety when changing them to dorzolamide/timolol (DTFC) or latanoprost/timolol fixed combination (LTFC) or adding DTFC.
A prospective, observer-masked, placebo-controlled, crossover, comparison. Consecutive adults with primary open-angle or exfoliative glaucoma who exhibit a mean baseline IOP >21 mm Hg on latanoprost monotherapy were randomised for 3 months to: DTFC, LTFC or DTFC and latanoprost. Patients were then crossed over to the next treatment for periods 2 and 3. At the end of the latanoprost run-in and after each 3-month treatment period, patients underwent 24 h IOP monitoring.
31 patients completed this study. All three adjunctive therapies significantly reduced the IOP at each time point and for the mean 24 h curve, except at 18:00 and 02:00 with DTFC and 02:00 with LTFC. When the three treatments were compared directly, the DTFC and latanoprost therapy demonstrated lower IOPs versus the other treatment groups, including: the mean 24 h pressure, maximum as well as minimum levels and individual time points following a modified Bonferroni correction (p<0.0032).
This study showed DTFC, LTFC and the addition of DTFC to latanoprost significantly decrease the IOP compared with latanoprost alone, but the latter therapy regime yields the greatest IOP reduction.
评估使用拉坦前列素单药治疗控制不佳的开角型青光眼患者,在换用多佐胺/噻吗洛尔(DTFC)或拉坦前列素/噻吗洛尔固定复方制剂(LTFC)或加用DTFC时的24小时眼压(IOP)疗效及安全性。
一项前瞻性、观察者设盲、安慰剂对照、交叉比较研究。将在拉坦前列素单药治疗时平均基线眼压>21 mmHg的原发性开角型或剥脱性青光眼连续成年患者随机分组,接受为期3个月的治疗:DTFC、LTFC或DTFC与拉坦前列素联合治疗。然后患者在第2和第3阶段交叉接受下一种治疗。在拉坦前列素导入期结束时以及每个3个月治疗期结束后,患者接受24小时眼压监测。
31例患者完成本研究。除DTFC在18:00和02:00以及LTFC在02:00时外,所有三种辅助治疗在每个时间点及平均24小时眼压曲线均显著降低眼压。当直接比较三种治疗时,DTFC与拉坦前列素联合治疗与其他治疗组相比眼压更低,包括:平均24小时眼压、最高及最低水平以及经改良Bonferroni校正后的各个时间点(p<0.0032)。
本研究表明,与单独使用拉坦前列素相比,DTFC、LTFC以及在拉坦前列素基础上加用DTFC均能显著降低眼压,但后一种治疗方案眼压降低幅度最大。