0.01%比马前列素滴眼液与0.5%噻吗洛尔滴眼液对青光眼或高眼压症患者昼夜眼压、血压及灌注压的影响：一项随机、双盲、安慰剂对照临床试验
Effects of Topical Bimatoprost 0.01% and Timolol 0.5% on Circadian IOP, Blood Pressure and Perfusion Pressure in Patients with Glaucoma or Ocular Hypertension: A Randomized, Double Masked, Placebo-Controlled Clinical Trial.
作者信息
Oddone Francesco, Rossetti Luca, Tanga Lucia, Berardo Francesca, Ferrazza Manuela, Michelessi Manuele, Roberti Gloria, Manni Gianluca, Centofanti Marco
机构信息
Clinical and Research Institute of Ophthalmology IRCCS Fondazione G. B. Bietti, Via Livenza 3, 00198, Rome, Italy.
Clinica Oculistica, Dipartimento di Scienze della Salute, University of Milan, San Paolo Hospital, Via Antonio di Rudinì, 8 20142, Milan, Italy.
出版信息
PLoS One. 2015 Oct 20;10(10):e0140601. doi: 10.1371/journal.pone.0140601. eCollection 2015.
PURPOSE
To compare the 24-hour (24h) effects on intraocular pressure (IOP) and cardiovascular parameters of timolol 0.5% and bimatoprost 0.01% in open angle glaucoma and ocular hypertensive subjects.
METHODS
In this prospective, randomized, double masked, crossover, clinical trial, after washout from previous medications enrolled subjects underwent 24h IOP, blood pressure (BP) and heart rate (HR) measurements and were randomized to either topical bimatoprost 0.01% at night plus placebo in the morning or to timolol 0.5% bid. After 8 weeks of treatment a second 24h assessment of IOP, BP and HR was performed and then subjects switched to the opposite treatment for additional 8 weeks when a third 24h assessment was performed. The primary endpoint was the comparison of the mean 24h IOP after each treatment. Secondary endpoints included the comparisons of IOP at each timepoint of the 24h curve and the comparison of BP, HR, ocular perfusion pressure and tolerability.
RESULTS
Mean untreated 24h IOP was 20.3 mmHg (95%CI 19.0 to 21.6). Mean 24h IOP was significantly lower after 8 weeks of treatment with bimatoprost 0.01% than after 8 weeks of treatment with timolol 0.5% bid (15.7 vs 16.8 mmHg, p = 0.0003). Mean IOP during the day hours was significantly reduced from baseline by both drugs while mean IOP during the night hours was reduced by -2.3 mmHg (p = 0.0002) by bimatoprost 0.01% plus placebo and by -1.1 mmHg by timolol 0.5% bid (p = 0.06). Timolol 0.5% significantly reduced the mean 24h systolic BP from baseline, the diastolic BP during the day hours, the HR during the night hours, and the mean 24h systolic ocular perfusion pressure.
CONCLUSION
Both Bimatoprost 0.01% and Timolol 0.5% are effective in reducing the mean 24h IOP from an untreated baseline but Bimatoprost 0.01% is more effective than timolol 0.5% throughout the 24h. Timolol 0.5% effect on IOP is reduced during the night hours and is associated with reduced BP, HR and ocular perfusion pressure.
TRIAL REGISTRATION
EU Clinical Trial Register and EudraCT# 2010-024272-26.
目的
比较0.5%噻吗洛尔和0.01%比马前列素对开角型青光眼和高眼压症患者眼压（IOP）及心血管参数的24小时影响。
方法
在这项前瞻性、随机、双盲、交叉临床试验中，入组患者在停用先前药物洗脱期后，进行24小时眼压、血压（BP）和心率（HR）测量，并随机分为夜间局部使用0.01%比马前列素加早晨使用安慰剂组或0.5%噻吗洛尔每日两次组。治疗8周后，再次进行24小时眼压、血压和心率评估，然后患者换用相反治疗方案再进行8周，之后进行第三次24小时评估。主要终点是每种治疗后24小时平均眼压的比较。次要终点包括24小时眼压曲线各时间点眼压的比较以及血压、心率、眼灌注压和耐受性的比较。
结果
未治疗时的24小时平均眼压为20.3 mmHg（95%CI 19.0至21.6）。0.01%比马前列素治疗8周后的24小时平均眼压显著低于0.5%噻吗洛尔每日两次治疗8周后的眼压（15.7 vs 16.8 mmHg，p = 0.0003）。两种药物均使白天平均眼压较基线显著降低，而0.01%比马前列素加安慰剂使夜间平均眼压降低-2.3 mmHg（p = 0.0002），0.5%噻吗洛尔每日两次使夜间平均眼压降低-1.1 mmHg（p = 0.06）。0.5%噻吗洛尔使24小时平均收缩压较基线显著降低，白天舒张压、夜间心率以及24小时平均收缩眼灌注压降低。
结论
0.01%比马前列素和0.5%噻吗洛尔均能有效降低未治疗基线时的24小时平均眼压，但0.01%比马前列素在24小时内比0.5%噻吗洛尔更有效。0.5%噻吗洛尔在夜间对眼压的作用减弱，且与血压、心率和眼灌注压降低有关。
试验注册
欧盟临床试验注册，EudraCT# 2010-024272-26 。
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