Faculty of Medicine, University of Calgary , Calgary, Canada.
J Ocul Pharmacol Ther. 2010 Oct;26(5):503-11. doi: 10.1089/jop.2010.0032.
The aim of this study was to assess the effectiveness of dorzolamide-timolol (DT) in the management of open-angle glaucoma (OAG) and ocular hypertension.
An open-label, 12-week, multicenter, Canadian study was conducted. Patients with untreated OAG or ocular hypertension received DT for 12 weeks to reduce intraocular pressure (IOP). If target IOP was not reached after the first 6-week treatment period, a prostaglandin (PG) (latanoprost) was added for the remaining 6 weeks. Primary outcome measures were changes in IOP from baseline to 6 and 12 weeks of treatment, and secondary outcome measures included the proportion of patients achieving target IOP and the proportion of patients achieving therapeutic response defined as a reduction of 5.0 mmHg or 20% in IOP from baseline. IOP values were the mean of 2 measures taken before and at least 2 h after patients administered the study medication.
A total of 164 patients were enrolled. Mean [standard deviation (SD)] population age was 63.0 (12.3) years and 53.0% of the patients were men. At week 6, the mean (SD) absolute and percent change in IOP for the total population was (-11.1) (4.9) and (-36.4)% (13.9%), respectively, and 92.1% of the patients achieved a reduction in IOP of at least 5 mmHg. Therapeutic target was achieved by 136 (82.9%) patients (DT subgroup) at 6 weeks, whereas 28 (17.1%) patients were changed to a combination therapy of DT and latanoprost [DT plus PG (DT & PG) subgroup]. Between weeks 6 and 12, DT was effective in sustaining the IOP within therapeutic target, whereas addition of latanoprost reduced the IOP of the DT & PG subgroup by an additional 6.3 mmHg or 22.1% (20.1%). At week 12, patients in the DT subgroup experienced a clinically and statistically significant mean (SD) decrease in IOP from a baseline of 12.2 mmHg or 40.4% (11.9%) (P < 0.001), whereas these values corresponded to 13.4 mmHg and 39.7% (15.7%) (P < 0.001), respectively, in the DT & PG subgroup. The proportion of patients who achieved therapeutic response during the entire 12-week study period was over 82%. Treatment-related adverse events (AEs) were reported by 19 (14.0%) patients in the DT subgroup and by 6 (21.4%) patients in the combination subgroup. Eye disorders and nervous system disorders were among the most common treatment-related AEs in both subgroups. No serious AEs were reported during the study period.
DT alone and DT in combination with a PG are effective in significantly reducing IOP in patients with untreated OAG or ocular hypertension. The treatment was safe and well tolerated with a low incidence of AEs.
本研究旨在评估多佐胺-噻吗洛尔（DT）在开角型青光眼（OAG）和高眼压症的治疗中的效果。
这是一项开放标签、12 周、多中心、加拿大的研究。未经治疗的 OAG 或高眼压症患者接受 DT 治疗 12 周以降低眼内压（IOP）。如果在前 6 周治疗后未达到目标 IOP，则在剩余的 6 周内添加前列腺素（PG）（拉坦前列素）。主要疗效指标为治疗 6 周和 12 周时 IOP 与基线相比的变化，次要疗效指标包括达到目标 IOP 的患者比例和达到治疗反应的患者比例，定义为 IOP 从基线降低 5.0mmHg 或 20%。IOP 值是患者在接受研究药物治疗前和至少 2 小时后测量的 2 次测量值的平均值。
共有 164 名患者入组。人群平均（标准偏差[SD]）年龄为 63.0（12.3）岁，53.0%的患者为男性。在第 6 周时，总体人群的 IOP 绝对值（SD）和百分比变化分别为（-11.1）（4.9）和（-36.4）%（13.9），92.1%的患者 IOP 降低至少 5mmHg。在第 6 周时，136 名（82.9%）患者（DT 亚组）达到治疗目标，而 28 名（17.1%）患者改为 DT 和拉坦前列素联合治疗[DT 加 PG（DT&PG）亚组]。在第 6 周至第 12 周期间，DT 有效维持 IOP 在治疗目标范围内，而添加拉坦前列素使 DT&PG 亚组的 IOP 进一步降低 6.3mmHg 或 22.1%（20.1%）。在第 12 周时，DT 亚组的患者经历了 IOP 的临床和统计学显著降低，从基线的 12.2mmHg 或 40.4%（11.9%）（P<0.001），而 DT&PG 亚组的相应值分别为 13.4mmHg 和 39.7%（15.7%）（P<0.001）。在整个 12 周研究期间，达到治疗反应的患者比例超过 82%。DT 亚组有 19 名（14.0%）患者和联合亚组有 6 名（21.4%）患者报告了与治疗相关的不良事件（AE）。在两个亚组中，眼部疾病和神经系统疾病是最常见的与治疗相关的 AE。在研究期间未报告严重的 AE。
单独使用 DT 和 DT 联合 PG 均可有效显著降低未经治疗的 OAG 或高眼压症患者的 IOP。治疗安全且耐受良好，AE 发生率低。
Zotero 插件