Unità Dipartimentale Semplice di Glaucoma, University of Tor Vergata, Rome, Italy; Istituto di Ricovero e Cura a Carattere Scientifico Fondazione G.B. Bietti, Rome, Italy.
Am J Ophthalmol. 2010 Oct;150(4):575-80. doi: 10.1016/j.ajo.2010.05.003. Epub 2010 Aug 4.
To compare the ocular hypotensive effect of bimatoprost plus timolol and travoprost plus timolol fixed combinations in glaucoma patients whose disease was controlled but had not reached their target intraocular pressure (IOP) with the fixed combination of latanoprost plus timolol.
A 2 × 3-month, multicenter, prospective, randomized, double-masked, cross-over clinical trial.
Eighty-nine open-angle glaucoma (OAG) patients were included. After a 6-week run-in period with latanoprost plus timolol, patients were randomized to either travoprost plus timolol or bimatoprost plus timolol for 3 months. Patients then switched to the opposite therapy for 3 additional months. The primary end point was the comparison of mean daily IOP after 3 months of each treatment.
At baseline, mean IOP was 16.5 mm Hg (95% confidence interval, 16.0 to 17.0 mm Hg) with treatment with latanoprost plus timolol. Both bimatoprost plus timolol and travoprost plus timolol statistically significantly reduced the mean IOP from baseline (P < .0001). Mean IOP at month 3 was statistically significantly lower in the bimatoprost plus timolol group compared with the travoprost plus timolol group (14.7 mm Hg [95% confidence interval, 14.3 to 15.3 mm Hg] vs 15.4 mm Hg [95% confidence interval, 15.0 to 15.9 mm Hg]; P = .0041). IOP was lower during bimatoprost plus timolol treatment at all time points and statistical significance was reached at 8 am, 11 am, and 5 pm, but not at 2 pm and 8 pm. Both treatments showed similar tolerability profile.
Bimatoprost plus timolol and travoprost plus timolol can provide additional IOP-lowering effect in patients not fully controlled with latanoprost plus timolol. The observed additional IOP reduction was greater with bimatoprost plus timolol with a similar tolerability profile.
比较贝美前列素加噻吗洛尔与曲伏前列素加噻吗洛尔固定组合在眼压控制但未达到目标眼压的青光眼患者中的降眼压效果与拉坦前列素加噻吗洛尔固定组合的比较。
2×3 个月、多中心、前瞻性、随机、双盲、交叉临床试验。
纳入 89 例开角型青光眼(OAG)患者。经过拉坦前列素加噻吗洛尔 6 周的导入期后,患者被随机分为曲伏前列素加噻吗洛尔或贝美前列素加噻吗洛尔治疗 3 个月。然后患者再切换到相反的治疗方案 3 个月。主要终点是比较每种治疗方案 3 个月后的平均每日眼压。
在基线时,拉坦前列素加噻吗洛尔治疗的平均眼压为 16.5mmHg(95%置信区间,16.0 至 17.0mmHg)。贝美前列素加噻吗洛尔和曲伏前列素加噻吗洛尔均显著降低了从基线的平均眼压(P<.0001)。贝美前列素加噻吗洛尔组的平均眼压在 3 个月时明显低于曲伏前列素加噻吗洛尔组(14.7mmHg[95%置信区间,14.3 至 15.3mmHg]与 15.4mmHg[95%置信区间,15.0 至 15.9mmHg];P=0.0041)。在所有时间点,贝美前列素加噻吗洛尔治疗时眼压均较低,在 8 点、11 点和 5 点达到统计学意义,但在 2 点和 8 点未达到统计学意义。两种治疗方法的耐受性相似。
贝美前列素加噻吗洛尔和曲伏前列素加噻吗洛尔可在拉坦前列素加噻吗洛尔未完全控制的患者中提供额外的眼压降低作用。贝美前列素加噻吗洛尔观察到的额外眼压降低幅度更大,且耐受性相似。