University of Tampere and Tampere University Hospital, Finland.
Acta Ophthalmol. 2010 May;88(3):329-36. doi: 10.1111/j.1755-3768.2010.01907.x.
The purpose of this study was to investigate the tolerability and intraocular pressure (IOP) reducing effect of the first preservative-free prostaglandin tafluprost (Taflotan) in patients exhibiting ocular surface side-effects during latanoprost (Xalatan) treatment.
A total of 158 patients were enrolled in this open-label multicentre study. Eligible patients had to have at least two ocular symptoms, or one sign and one symptom, during treatment with latanoprost. At baseline, the patients were directly switched from latanoprost to preservative-free tafluprost for 12 weeks. The patients were queried for ocular symptoms, and ocular signs were assessed by using tear break-up time, Schirmer's test, fluorescein staining and evaluation of conjunctival hyperaemia and blepharitis. In addition, HLA-DR and MUC5AC in conjunctival impression cytology specimens were analyzed, and a drop discomfort/quality of life (QoL) questionnaire was employed. IOP was measured at all visits.
Preservative-free tafluprost maintained IOP at the same level after 12- weeks treatment (16.4 +/- 2.7 mmHg) as latanoprost at baseline (16.8 +/- 2.5 mmHg). During treatment with preservative-free tafluprost, the number of patients having irritation/burning/stinging (56.3%), itching (46.8%), foreign body sensation (49.4%), tearing (55.1%) and dry eye sensation (64.6%) decreased to 28.4%, 26.5%, 27.1%, 27.1% and 39.4% correspondingly. The number of the patients with abnormal fluorescein staining of cornea (81.6%) and conjunctiva (84.2%), blepharitis (60.1%), conjunctival hyperaemia (84.2%) and abnormal Schirmer's test (71.5%) was also reduced significantly to 40.6%, 43.2%, 40.6%, 60.0% and 59.4% correspondingly. The tear break-up time improved significantly from 4.5 +/- 2.5 seconds to 7.8 +/- 4.9 seconds. A reduction in the number of patients with abnormal conjunctival cells based on HLA-DR and MUC5AC was also detected.
Preservative-free tafluprost maintained IOP at the same level as latanoprost, but was better tolerated in patients having signs or symptoms while on preserved latanoprost. Preservative-free tafluprost treatment resulted in improved QoL, increased patient satisfaction and drop comfort.
本研究旨在探讨在使用拉坦前列素（Xalatan）治疗时出现眼部表面副作用的患者中，首支不含防腐剂的前列腺素他氟前列素（Taflotan）的耐受性和降眼压（IOP）效果。
共有 158 名患者参与了这项开放标签的多中心研究。符合条件的患者在接受拉坦前列素治疗期间必须至少有两种眼部症状，或一种体征和一种症状。在基线时，患者直接从拉坦前列素转为不含防腐剂的他氟前列素治疗 12 周。患者被询问眼部症状，并通过泪膜破裂时间、泪液分泌试验、荧光素染色以及评估结膜充血和睑缘炎来评估眼部体征。此外，还分析了结膜印迹细胞学标本中的 HLA-DR 和 MUC5AC，并使用滴眼液不适/生活质量（QoL）问卷。所有就诊时均测量 IOP。
不含防腐剂的他氟前列素在治疗 12 周后（16.4 ± 2.7 mmHg）保持与基线时拉坦前列素相同的 IOP 水平（16.8 ± 2.5 mmHg）。在使用不含防腐剂的他氟前列素治疗期间，出现刺激/灼烧/刺痛感（56.3%）、瘙痒（46.8%）、异物感（49.4%）、流泪（55.1%）和干眼感（64.6%）的患者数量减少至 28.4%、26.5%、27.1%、27.1%和 39.4%。角膜（81.6%）和结膜（84.2%）、睑缘炎（60.1%）、结膜充血（84.2%）和异常泪液分泌试验（71.5%）的荧光素染色异常的患者数量也分别显著减少至 40.6%、43.2%、40.6%、60.0%和 59.4%。泪膜破裂时间从 4.5 ± 2.5 秒显著改善至 7.8 ± 4.9 秒。还检测到基于 HLA-DR 和 MUC5AC 的异常结膜细胞数量减少。
不含防腐剂的他氟前列素维持了与拉坦前列素相同的 IOP 水平，但在使用含防腐剂的拉坦前列素时有体征或症状的患者中耐受性更好。不含防腐剂的他氟前列素治疗可改善生活质量，提高患者满意度和滴眼液舒适度。
