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。