Pillunat L E, Larsson L-I
Department of Ophthalmology, Augenklinik der Techn, Universität Dresden, Germany.
Br J Ophthalmol. 2003 Dec;87(12):1492-6. doi: 10.1136/bjo.87.12.1492.
To evaluate the efficacy and safety of replacing current dual ocular hypotensive therapy with latanoprost 0.005% monotherapy in patients with open angle glaucoma.
This randomised, open label, parallel group, multinational study included 466 patients with open angle glaucoma currently on dual ocular hypotensive therapy, including a beta adrenergic receptor antagonist. Patients were assigned (1:3) to ongoing dual therapy or a switch to monotherapy with latanoprost 0.005% once daily for 6 months. Intraocular pressure (IOP) was measured at 10 am and 5 pm at baseline, month 3, and month 6. Groups were compared for differences in diurnal IOP change, IOP success rates (IOP < or =22 mm Hg with < or =15% increase from baseline), and clinical success rates (not requiring change in therapy).
Baseline mean diurnal IOP was 17.8 (SD 2.0) mm Hg in the latanoprost group and 17.6 (2.1) mm Hg in the dual therapy group. After 6 months, mean diurnal IOP was reduced by 0.26 (0.18) (SEM 1.4%) mm Hg (p=0.153) in the group switched to latanoprost and by 0.37 (0.25) (2.1%) mm Hg (p=0.138) in those continuing dual therapy (difference: 0.11 mm Hg; p=0.641). Success rates defined by IOP criteria were 83% for latanoprost and 89% for continued dual therapy (difference: 6%; p=0.122). Clinical success rates were 97% for latanoprost and 99% for dual therapy (difference: 2%; p=0.161). Ocular adverse events were reported by 23% of patients in both treatment groups.
Latanoprost monotherapy is a safe and effective alternative for many patients with open angle glaucoma requiring dual topical ocular hypotensive therapy for IOP control.
评估用0.005%拉坦前列素单药治疗替代当前双药降眼压治疗对开角型青光眼患者的疗效和安全性。
这项随机、开放标签、平行组、多国研究纳入了466例目前正在接受双药降眼压治疗(包括一种β肾上腺素能受体拮抗剂)的开角型青光眼患者。患者按1:3分配至继续双药治疗组或换用0.005%拉坦前列素每日一次单药治疗组,为期6个月。在基线、第3个月和第6个月的上午10点和下午5点测量眼压(IOP)。比较两组间日间眼压变化、眼压成功率(眼压≤22 mmHg且较基线升高≤15%)和临床成功率(无需改变治疗方案)的差异。
拉坦前列素组基线平均日间眼压为17.8(标准差2.0)mmHg,双药治疗组为17.6(2.1)mmHg。6个月后,换用拉坦前列素组的平均日间眼压降低了0.26(0.18)(标准误1.4%)mmHg(p = 0.153),继续双药治疗组降低了0.37(0.25)(2.1%)mmHg(p = 0.138)(差异:0.11 mmHg;p = 0.641)。根据眼压标准定义的成功率,拉坦前列素组为83%,继续双药治疗组为89%(差异:6%;p = 0.122)。临床成功率,拉坦前列素组为97%,双药治疗组为99%(差异:2%;p = 0.161)。两个治疗组均有23%的患者报告了眼部不良事件。
对于许多需要双药局部降眼压治疗来控制眼压的开角型青光眼患者,拉坦前列素单药治疗是一种安全有效的替代方案。