Higginbotham Eve J, Feldman Robert, Stiles Michael, Dubiner Harvey
Department of Ophthalmology, University of Maryland School of Medicine, 419 W Redwood St, Suite 580, Baltimore, MD 21201, USA.
Arch Ophthalmol. 2002 Jul;120(7):915-22. doi: 10.1001/archopht.120.7.915.
To compare the efficacy and safety of a fixed combination of 0.005% latanoprost and 0.5% timolol maleate administered once daily vs monotherapy with either 0.005% latanoprost once daily or 0.5% timolol twice daily.
Patients with either primary or secondary open-angle glaucoma or ocular hypertension participated in a 6-month, randomized, double-masked, multicenter study with 3 parallel treatment groups. The double-masked period was preceded by a 2- to 4-week "run-in" treatment with timolol. Subjects could receive fixed combination therapy during a 6-month open-label extension.
The difference between groups in mean diurnal intraocular pressure reduction in study eye(s) from baseline through 6 months of treatment.
Overall, 418 patients were enrolled in the study; 332 completed the open-label phase. Diurnal intraocular pressure levels were similar at baseline, but at week 26, they were 19.9 +/- 3.4 mm Hg in the fixed combination therapy group, 20.8 +/- 4.6 mm Hg in latanoprost-treated patients, and 23.4 +/- 5.4 mm Hg in timolol-treated patients (data are given as mean +/- SD). The mean change from baseline was greater among patients receiving fixed combination therapy compared with each monotherapy group (P<.01). Fixed combination therapy effectively lowered intraocular pressure levels for up to 1 year. All treatments were well tolerated.
The combination of 0.005% latanoprost and 0.5% timolol administered once daily is effective and well tolerated for up to 12 months.
比较每日一次给予0.005%拉坦前列素与0.5%马来酸噻吗洛尔的固定复方制剂与每日一次给予0.005%拉坦前列素单药治疗或每日两次给予0.5%马来酸噻吗洛尔单药治疗的疗效和安全性。
原发性或继发性开角型青光眼或高眼压症患者参与了一项为期6个月的随机、双盲、多中心研究，该研究有3个平行治疗组。在双盲期之前，先进行为期2至4周的噻吗洛尔“导入”治疗。受试者可在为期6个月的开放标签延长期接受固定复方制剂治疗。
从基线到治疗6个月期间，各治疗组研究眼平均日眼压降低幅度的差异。
总体而言，418例患者纳入研究；332例完成开放标签阶段。基线时的日眼压水平相似，但在第26周时，固定复方制剂治疗组为19.9±3.4 mmHg，拉坦前列素治疗患者为20.8±4.6 mmHg，噻吗洛尔治疗患者为23.4±5.4 mmHg（数据以均值±标准差表示）。与各单药治疗组相比，接受固定复方制剂治疗的患者从基线开始的平均变化更大（P<0.01）。固定复方制剂治疗可有效降低眼压水平长达1年。所有治疗耐受性良好。
每日一次给予0.005%拉坦前列素与0.5%马来酸噻吗洛尔的复方制剂有效，且在长达12个月的时间内耐受性良好。
