Rossi Gemma Caterina Maria, Scudeller Luigia, Rolle Teresa, Pasinetti Gian Maria, Bianchi Paolo Emilio
University Eye Clinic of Pavia, IRCCS Policlinico San Matteo Foundation , Pavia , Italy +39 0382 503730 ; +39 0382 527006 ;
Expert Opin Drug Saf. 2015 May;14(5):619-23. doi: 10.1517/14740338.2015.1017467. Epub 2015 Mar 10.
To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost.
Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pressure (IOP) measurement and ocular surface status (tear film break-up time [TF-BUT], corneal staining and ocular surface disease index [OSDI]) were evaluated at baseline and 6 months later.
A total of 44 patients were enrolled. Median (interquartile range [IQR]) baseline IOP was 18 (15.5 - 21) and 16 (14 - 17) mmHg (p < 0.0001) after 6 months. At baseline, 18 (40.9%) patients presented an IOP of < 18 mmHg, 11 (25%) < 16 mmHg, 2 (4.3%) < 14 mmHg and 1 (2.3%) < 12 mmHg; 6 months later the proportions were 36 (81.8%) (p < 0.0001), 21 (47.7%) (p = 0.00075), 8 (18.2%) (p = 0.0143) and 6 (13.6%) (p = 0.0253). Concerning safety, TF-BUT improved from 8 [IQR 6 - 10] to 10 [IQR 8 - 12] s (p < 0.0001). No eye developed corneal staining; punctate keratitis was absent in 13 (29.5%) patients at baseline and in 31 (70.4%) after 6 months (p < 0.001). OSDI changed from 16 (10 - 30) to 9 (2 - 20).
No patient treated with PQ-Travoprost developed ocular surface disease after 6 months of monotherapy, whereas many patients reached a good IOP control with lower IOP values. Ocular surface status statistically improved when examined by TF-BUT and corneal staining.
评估聚季铵盐保存的曲伏前列素（PQ - 曲伏前列素）在先前使用苯扎氯铵（BAK）保存的拉坦前列素治疗的患者中的安全性和耐受性。
对开角型青光眼或高眼压症患者进行为期6个月的队列研究。在基线和6个月后评估完整的眼科检查、眼压（IOP）测量和眼表状况（泪膜破裂时间[TF - BUT]、角膜染色和眼表疾病指数[OSDI]）。
共纳入44例患者。基线时眼压中位数（四分位间距[IQR]）为18（15.5 - 21）mmHg，6个月后为16（14 - 17）mmHg（p < 0.0001）。基线时，18例（40.9%）患者眼压< 18 mmHg，11例（25%）< 16 mmHg，2例（4.3%）< 14 mmHg，1例（2.3%）< 12 mmHg；6个月后这些比例分别为36例（81.8%）（p < 0.0001）、21例（47.7%）（p = 0.00075）、8例（18.2%）（p = 0.0143）和6例（13.6%）（p = 0.0253）。关于安全性，TF - BUT从8 [IQR 6 - 10]秒改善至10 [IQR 8 - 12]秒（p < 0.0001）。无眼出现角膜染色；基线时13例（29.5%）患者无点状角膜炎，6个月后31例（70.4%）患者无点状角膜炎（p < 0.001）。OSDI从16（10 - 30）变为9（2 - 20）。
接受PQ - 曲伏前列素单药治疗6个月后，无患者发生眼表疾病，而许多患者眼压得到良好控制，眼压值降低。通过TF - BUT和角膜染色检查，眼表状况在统计学上有所改善。
