Kałuzny Jakub J, Szaflik Jerzy, Czechowicz-Janicka Krystyna, Kałuzny Józef, Orzałkiewicz Alicja, Zaleska-Zmijewska Anna, Krajewska Małgorzata, Stewart Jeanette A, Leech Jessica N, Stewart Wiliam C
Kliniki Okulistyki Akademii Medycznej im. Ludwika Rydygiera w Bydgoszczy.
Klin Oczna. 2004;106(1-2 Suppl):241-2.
To establish the efficacy and safety of timolol 0.5%/dorzolamide 2% fixed combination versus timolol 0.5%/pilocarpine 2% fixed combination, each given twice daily, in primary open-angle glaucoma and ocular hypertensive patients.
In this prospective, multicenter, double-masked trial, 37 patients were treated twice daily with timolol for 4 weeks. Then, they were randomized to one of the treatment medications for 6 weeks, after which they were treated with timolol again for 2 weeks before placed on the opposite treatment medication for 6 weeks.
A total of 36 patients completed the trial. The mean baseline intraocular pressure (IOP) was 22.3 +/- 3.7 mmHg. Following 6 weeks of treatment, the mean decrease of IOP was 18.0 +/- 2.2 mmHg for timolol/dorzolamide combination and 17.4 +/- 2.0 for timolol/pilocarpine combination. The mean diurnal curve IOP was 18.1 +/- 2.2 mmHg for timolol/dorzolamide group and 16.7 +/- 1.9 mmHg for timolol/pilocarpine group. These differences were statistically significant. Statistically more patients reported ocular pain and diminished vision during use of the timolol/pilocarpine combination.
This study suggest that timolol 0.5%/pilocarpine 2% fixed combination can provide at least similar efficacious reduction in IOP as timolol 0.5 %/dorzolamide 2% fixed combination in patients with primary open-angle glaucoma and ocular hypertension.
比较0.5%噻吗洛尔/2%多佐胺固定复方制剂与0.5%噻吗洛尔/2%毛果芸香碱固定复方制剂,每日两次给药,在原发性开角型青光眼和高眼压症患者中的疗效和安全性。
在这项前瞻性、多中心、双盲试验中,37例患者每日两次使用噻吗洛尔治疗4周。然后,将他们随机分为一种治疗药物组,治疗6周,之后再次使用噻吗洛尔治疗2周,然后换用另一种治疗药物治疗6周。
共有36例患者完成试验。平均基线眼压(IOP)为22.3±3.7 mmHg。治疗6周后,噻吗洛尔/多佐胺联合用药组眼压平均降低18.0±2.2 mmHg,噻吗洛尔/毛果芸香碱联合用药组眼压平均降低17.4±2.0 mmHg。噻吗洛尔/多佐胺组平均昼夜眼压曲线为18.1±2.2 mmHg,噻吗洛尔/毛果芸香碱组为16.7±1.9 mmHg。这些差异具有统计学意义。在使用噻吗洛尔/毛果芸香碱联合用药期间,报告眼部疼痛和视力下降的患者在统计学上更多。
本研究表明,在原发性开角型青光眼和高眼压症患者中,0.5%噻吗洛尔/2%毛果芸香碱固定复方制剂降低眼压的疗效至少与0.5%噻吗洛尔/2%多佐胺固定复方制剂相似。