Larsson L I
Department of Ophthalmology, Uppsala University Hospital, Sweden.
J Glaucoma. 2001 Apr;10(2):109-14. doi: 10.1097/00061198-200104000-00007.
To measure the effect on intraocular pressure (IOP) for 24 hours after repeated administration of the fixed combination of latanoprost 0.005% and timolol 0.5%.
A randomized, double-masked placebo-controlled crossover study including 20 patients with ocular hypertension was carried out. Patients were randomized to treatment with the fixed combination of latanoprost and timolol or with placebo. The eyedrop was taken at 8 AM. After 2 weeks of treatment, the patients were hospitalized, and the IOP was measured at 8 AM, and thereafter every other hour until midnight, and also at 3 AM, 6 AM, and 8 A.M. After a washout period of 4 weeks, they switched to the other eyedrop, and after 2 weeks of treatment were hospitalized and the IOP measurements were repeated at the same intervals.
The mean 24-hour IOP was 14.7 +/- 0.3 mm Hg (mean +/- standard error of the mean) for latanoprost and timolol and 19.4 +/- 0.3 mm Hg for placebo. This corresponds to a significant IOP difference of 4.7 +/- 0.4 mm Hg (95% confidence interval 3.8-5.8; P < 0.001) between the two treatments in favor of the combination. At all measured time points, except at 3 AM, the mean IOP was lower with latanoprost and timolol than with placebo. During daytime measurements the mean IOP was 13.9 +/- 0.7 mm Hg for the fixed combination and 19.5 +/- 0.7 mm Hg for the placebo. Corresponding figures at nighttime were 16.1 +/- 0.7 mm Hg and 19.2 +/- 0.7 mmHg, respectively.
The fixed combination of latanoprost and timolol significantly reduced IOP after administration once daily for 2 weeks in patients with ocular hypertension. A reduction of IOP during a 24-hour period was seen, with a greater IOP reduction during daytime compared with nighttime. The fixed combination applied once daily could be a convenient alternative to concomitant therapy with its individual components.
测量重复给予0.005%拉坦前列素与0.5%噻吗洛尔的固定复方制剂后24小时内对眼压(IOP)的影响。
开展了一项随机、双盲、安慰剂对照的交叉研究,纳入20例高眼压症患者。患者被随机分为接受拉坦前列素与噻吗洛尔的固定复方制剂治疗或接受安慰剂治疗。滴眼液于上午8点使用。治疗2周后,患者住院,于上午8点测量眼压,此后每隔一小时测量一次直至午夜,并且在凌晨3点、6点和上午8点也进行测量。经过4周的洗脱期后,他们换用另一种滴眼液,治疗2周后再次住院并按相同间隔重复测量眼压。
拉坦前列素与噻吗洛尔组的24小时平均眼压为14.7±0.3 mmHg(平均值±平均标准误差),安慰剂组为19.4±0.3 mmHg。这相当于两种治疗之间眼压存在显著差异,差值为4.7±0.4 mmHg(95%置信区间3.8 - 5.8;P < 0.001),支持复方制剂。在所有测量时间点,除了凌晨3点,拉坦前列素与噻吗洛尔组的平均眼压低于安慰剂组。白天测量时,固定复方制剂的平均眼压为13.9±0.7 mmHg,安慰剂为19.5±0.7 mmHg。夜间相应数字分别为16.1±0.7 mmHg和19.2±0.7 mmHg。
对于高眼压症患者,拉坦前列素与噻吗洛尔的固定复方制剂每日给药一次,连续2周后可显著降低眼压。观察到24小时内眼压降低,与夜间相比,白天眼压降低幅度更大。每日应用一次的固定复方制剂可能是其各成分联合治疗的一种方便替代方案。