Riva Ivano, Katsanos Andreas, Floriani Irene, Biagioli Elena, Konstas Anastasios G P, Centofanti Marco, Quaranta Luciano
*Centre for the Study of Glaucoma, University of Brescia, Brescia ‡Laboratory of Clinical Research, IRCCS, Istituto di Ricerche Farmacologiche Mario Negri, Milano ∥DSCMT, University of Tor Vergata, Rome, Italy †Ophthalmology Department, University of Ioannina, Ioannina §Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece.
J Glaucoma. 2014 Oct-Nov;23(8):535-40. doi: 10.1097/IJG.0000000000000073.
The aim of the study was to evaluate the long-term 24-hour intraocular pressure (IOP) efficacy of travoprost monotherapy in primary open-angle glaucoma patients.
A total of 36 previously untreated primary open-angle glaucoma patients were enrolled in this 5-year study. Patients underwent an untreated 24-hour IOP evaluation. Subsequently all patients were assigned to topical therapy with travoprost 0.004% eye-drops preserved with benzalkonium chloride (Travatan, Alcon Laboratories Inc., Fort Worth, TX) administered once in the evening (8:00 PM) in both eyes. All patients were then scheduled for a 24-hour IOP assessment approximately 12 months after the baseline visit. This schedule of follow-up was maintained for the whole duration of the trial. The predetermined range of target IOP reduction selected in this cohort of patients ranged between 20% and 30%.
A total of 34 patients completed all phases of the investigation. The mean survival time was 57.3±2.0 months and the cumulative survival rate was 0.82±0.6 at 60 months. Travoprost reduced the mean 24-hour IOP from 23.4±1.7 mm Hg at baseline to 16.8±2.4 mm Hg (28.4%), 16.8±2.5 mm Hg (28.1%), 16.8±2.4 mm Hg (28.5%), 16.7±2.5 mm Hg (28.6%), and 16.9±2.4 mm Hg (27.8%), respectively at the end of the first, second, third, fourth, and fifth year follow-up. No drug-related serious adverse events were registered during the study.
The present study demonstrated the long-term 24-hour efficacy of travoprost for the treatment of primary open-angle glaucoma.
本研究旨在评估曲伏前列素单药治疗对原发性开角型青光眼患者的长期24小时眼压(IOP)疗效。
共有36例未经治疗的原发性开角型青光眼患者参与了这项为期5年的研究。患者接受了一次未经治疗的24小时眼压评估。随后,所有患者均被分配接受每晚(晚上8点)双眼使用含苯扎氯铵防腐剂的0.004%曲伏前列素滴眼液(适利达,爱尔康实验室公司,沃思堡,德克萨斯州)进行局部治疗。然后,所有患者在基线访视后约12个月安排进行一次24小时眼压评估。在整个试验期间均维持该随访计划。在该组患者中选定的目标眼压降低的预定范围为20%至30%。
共有34例患者完成了研究的所有阶段。平均生存时间为57.3±2.0个月,60个月时的累积生存率为0.82±0.6。曲伏前列素使平均24小时眼压从基线时的23.4±1.7毫米汞柱分别降至随访第一年、第二年、第三年、第四年和第五年末的16.8±2.4毫米汞柱(降低28.4%)、16.8±2.5毫米汞柱(降低28.1%)、16.8±2.4毫米汞柱(降低28.5%)、16.7±2.5毫米汞柱(降低28.6%)和16.9±2.4毫米汞柱(降低27.8%)。在研究期间未记录到与药物相关的严重不良事件。
本研究证明了曲伏前列素治疗原发性开角型青光眼的长期24小时疗效。