Department of Ophthalmology, School of Medicine, University of Sao Paulo, Brazil.
J Glaucoma. 2010 Jun-Jul;19(5):331-5. doi: 10.1097/IJG.0b013e3181b4cab4.
To evaluate the additive effect of dorzolamide/timolol fixed combination in patients under monotherapy with latanoprost.
In this prospective, 4-week, randomized, open-label controlled clinical trial, patients with open-angle glaucoma or ocular hypertension, which presented at least 15% intraocular pressure (IOP) reduction after a minimum period of 15 days of monotherapy with latanoprost and whose IOP level was considered above the established target-IOP level were randomized to receive fixed combination of timolol/dorzolamide twice daily in one of eyes. The fellow eye was kept under monotherapy and was included in the control group. A modified diurnal tension curve (mDTC) followed by the water drinking test were performed in the baseline and week 4 visits to evaluate IOP profile between groups.
Forty-nine per-protocol patients were analyzed. After latanoprost monotherapy run-in period, IOP levels were significantly reduced (P<0.001) in both control and study groups to 15.34+/-2.96 mm Hg and 15.24+/-2.84 mm Hg (30.8% and 32.2% IOP reduction, respectively; P=0.552). At week 4, mean baseline diurnal IOP levels were 15.60+/-3.09 and 14.44+/-3.03 (7.4% difference; P=0.01). Mean baseline IOP modified diurnal tension curve peak after latanoprost run-in period were 17.47+/-3.68 mm Hg and 17.02+/-3.35 mm Hg (control and study eyes, respectively; P=0.530). At week 4 visit, mean water-drinking test peaks were significantly reduced in the study eye group in comparison with the control group: 19.02+/-3.81 mm Hg and 20.39+/-4.19 mm Hg, respectively (6.7% reduction; P=0.039).
In our sample, dorzolamide 2%/timolol 0.5% fixed combination as add-on therapy in patients with open-angle glaucoma or ocular hypertension under monotherapy with latanoprost with IOP already in mid-teens levels may further enhance pressure reduction.
评估与拉坦前列素单药治疗相比，多佐胺/噻吗洛尔固定联合治疗对眼压的额外降低作用。
这是一项前瞻性、4 周、随机、开放标签对照临床试验，纳入了至少接受 15 天拉坦前列素单药治疗后，眼压降低至少 15%的开角型青光眼或高眼压症患者，且其眼压水平被认为高于既定目标眼压水平。这些患者被随机分为两组，一组双眼接受每日两次多佐胺/噻吗洛尔固定联合治疗，另一组单眼继续接受拉坦前列素治疗作为对照组。在基线和第 4 周随访时，通过改良动态眼压曲线（mDTC）和饮水试验评估两组的眼压变化。
共 49 例符合方案的患者纳入分析。拉坦前列素单药治疗导入期后，两组的眼压均显著下降（P<0.001），分别降至 15.34+/-2.96mmHg 和 15.24+/-2.84mmHg（分别下降 30.8%和 32.2%；P=0.552）。第 4 周时，两组的平均基础日间眼压分别为 15.60+/-3.09mmHg 和 14.44+/-3.03mmHg（差值为 7.4%；P=0.01）。拉坦前列素单药治疗导入期后，两组的基础动态眼压曲线峰值分别为 17.47+/-3.68mmHg 和 17.02+/-3.35mmHg（分别为对照组和研究组的眼）（P=0.530）。第 4 周随访时，与对照组相比，研究组的饮水试验峰值显著降低：分别为 19.02+/-3.81mmHg 和 20.39+/-4.19mmHg（降低 6.7%；P=0.039）。
在本研究样本中，与拉坦前列素单药治疗眼压已处于青少年水平的开角型青光眼或高眼压症患者相比，多佐胺 2%/噻吗洛尔 0.5%固定联合治疗作为附加治疗可能进一步降低眼压。
