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从苯扎氯铵保存的拉坦前列素到聚季铵盐保存的曲伏前列素:一项关于眼表安全性和耐受性的6个月研究。

From benzalkonium chloride-preserved Latanoprost to Polyquad-preserved Travoprost: a 6-month study on ocular surface safety and tolerability.

作者信息

Rossi Gemma Caterina Maria, Scudeller Luigia, Rolle Teresa, Pasinetti Gian Maria, Bianchi Paolo Emilio

机构信息

University Eye Clinic of Pavia, IRCCS Policlinico San Matteo Foundation , Pavia , Italy +39 0382 503730 ; +39 0382 527006 ;

出版信息

Expert Opin Drug Saf. 2015 May;14(5):619-23. doi: 10.1517/14740338.2015.1017467. Epub 2015 Mar 10.

Abstract

BACKGROUND

To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

摘要

背景

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。

方法

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])。

结果

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)。

结论

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。

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