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从拉坦前列素转换为不含防腐剂的他氟前列素滴眼液的益处:两项IIIb期临床试验的荟萃分析

Benefits of switching from latanoprost to preservative-free tafluprost eye drops: a meta-analysis of two Phase IIIb clinical trials.

作者信息

Uusitalo Hannu, Egorov Evgeniy, Kaarniranta Kai, Astakhov Yuri, Ropo Auli

机构信息

Department of Ophthalmology, SILK, University of Tampere, Tampere University Hospital, Tampere, Finland.

Department of Ophthalmology, The Russian National Research Medical University, Moscow, Russia.

出版信息

Clin Ophthalmol. 2016 Mar 15;10:445-54. doi: 10.2147/OPTH.S91402. eCollection 2016.

Abstract

INTRODUCTION

Glaucoma patients frequently exhibit ocular surface side effects during treatment with prostaglandin eye drops. The present work investigated whether glaucoma patients suffering from signs and symptoms of ocular surface disease while using preserved latanoprost eye drops benefited from switching to preservative-free tafluprost eye drops.

PATIENTS AND METHODS

The analysis was based on 339 glaucoma patients enrolled in two Phase IIIb trials. The patients were required to have two symptoms, or one sign and one symptom of ocular surface disease at baseline, and at least 6 months preceding treatment with latanoprost eye drops preserved with benzalkonium chloride. All eligible patients were switched from latanoprost to preservative-free tafluprost for a total of 12 weeks. Ocular symptoms and ocular signs were evaluated at baseline and at 2 weeks, 6 weeks, and 12 weeks after commencing treatment with tafluprost. Intraocular pressure (IOP), drop discomfort, and treatment preference were evaluated to investigate the clinical efficacy and patient-related outcomes.

RESULTS

After 12 weeks of treatment with preservative-free tafluprost, the incidences of irritation/burning/stinging, foreign body sensation, tearing, itching, and dry eye sensation had diminished to one-third of those reported for preserved latanoprost at baseline. The incidences of blepharitis and corneal/conjunctival fluorescein staining had in turn decreased to one-half of those reported for preserved latanoprost. Severity of conjunctival hyperemia was halved during treatment with preservative-free tafluprost, and there was significant improvement in tear break-up time and tear production. A further reduction in IOP (~1 mmHg) was seen with preservative-free tafluprost compared with preserved latanoprost. Drop discomfort was alleviated during preservative-free tafluprost treatment, and an outstanding majority of patients (72%) preferred preservative-free tafluprost over preserved latanoprost.

CONCLUSION

This meta-analysis confirmed that IOP remained at the same level after replacing benzalkonium chloride-preserved latanoprost eye drops with preservative-free tafluprost eye drops. Preservative-free tafluprost significantly decreased the symptoms and signs of ocular surface disease and outrated latanoprost in drop comfort and treatment preference.

摘要

引言

青光眼患者在使用前列腺素滴眼液治疗期间经常出现眼表副作用。本研究调查了在使用含防腐剂的拉坦前列素滴眼液时出现眼表疾病体征和症状的青光眼患者改用不含防腐剂的他氟前列素滴眼液是否有益。

患者与方法

分析基于两项IIIb期试验中纳入的339例青光眼患者。患者在基线时需要有两种症状,或一种眼表疾病体征和一种症状,并且在使用苯扎氯铵保存的拉坦前列素滴眼液治疗前至少6个月有上述情况。所有符合条件的患者从拉坦前列素改用不含防腐剂的他氟前列素,共12周。在开始使用他氟前列素治疗的基线、2周、6周和12周时评估眼部症状和体征。评估眼压(IOP)、滴眼液不适感和治疗偏好,以研究临床疗效和患者相关结局。

结果

使用不含防腐剂的他氟前列素治疗12周后,刺激/灼烧/刺痛、异物感、流泪、瘙痒和干眼感的发生率降至基线时含防腐剂拉坦前列素报告发生率的三分之一。睑缘炎和角膜/结膜荧光素染色的发生率依次降至含防腐剂拉坦前列素报告发生率的一半。在使用不含防腐剂的他氟前列素治疗期间,结膜充血的严重程度减半,泪膜破裂时间和泪液分泌有显著改善。与含防腐剂的拉坦前列素相比,不含防腐剂的他氟前列素使眼压进一步降低(约1 mmHg)。在不含防腐剂的他氟前列素治疗期间,滴眼液不适感得到缓解,绝大多数患者(72%)更喜欢不含防腐剂的他氟前列素而不是含防腐剂的拉坦前列素。

结论

这项荟萃分析证实,用不含防腐剂的他氟前列素滴眼液替代含苯扎氯铵的拉坦前列素滴眼液后,眼压保持在相同水平。不含防腐剂的他氟前列素显著减轻了眼表疾病的症状和体征,在滴眼液舒适度和治疗偏好方面优于拉坦前列素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3854/4801127/e2d1e0fa8fbe/opth-10-445Fig1.jpg

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