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无防腐剂的0.0015%他氟前列素在青光眼患者中的疗效和耐受性：一项前瞻性交叉研究。

Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study.

作者信息

Lee Wonseok, Lee Sunghoon, Bae HyoungWon, Kim Chan Yun, Seong Gong Je

机构信息

Department of Ophthalmology, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, Republic of Korea.

Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, #211Eonjuro, Gangnam-gu, Seoul, 06273, Republic of Korea.

出版信息

BMC Ophthalmol. 2017 Apr 28;17(1):61. doi: 10.1186/s12886-017-0453-z.

DOI:10.1186/s12886-017-0453-z
PMID:28454526
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5410066/
Abstract

BACKGROUND

The aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost using a prospective crossover study.

METHODS

Primary open angle glaucoma (POAG) and normotensive glaucoma (NTG) patients were randomized enrolled. Group 1 ("NPT to PT") patients used preservative-free 0.0015% tafluprost (NPT) for 6 months and then changed to preservative containing 0.0015% tafluprost(PT) for 6 months. Group 2 ("PT to NPT") patients used preservative containing 0.0015% tafluprost for 6 months and changed to preservative-free 0.0015% tafluprost for 6 months. At 1, 3, 6, 7, 9, and 12 months, we measured intraocular pressure for efficacy and graded corneal erosion, tear break-up time (TBUT), and subjective discomfort.

RESULTS

A total of 20 patients and 20 eyes were enrolled. In Group 1 and 2, intraocular pressure was well controlled to approximately 14 mmHg (9.38-18.46% decrease). Generally, subjective satisfaction was improved after changing from PT to NPT (p = 0.03) and TBUT using PT was numerically inferior to that using NPT (p = 0.06) but not when changing from NPT to PT.

CONCLUSION

Both preservative containing and preservative-free 0.0015% tafluprost reduced intraocular pressure significantly. In addition, changing medication from PT to NPT might improve subjective satisfaction and tear break up time.

TRIAL REGISTRATION

The trial registration number is NCT 03104621 (Apr/1/2017). Retrospectively registered.

摘要

背景

本研究旨在通过前瞻性交叉研究评估含0.0015%他氟前列素防腐剂和不含防腐剂的0.0015%他氟前列素的疗效和耐受性。

方法

原发性开角型青光眼（POAG）和正常眼压性青光眼（NTG）患者被随机纳入研究。第1组（“从无防腐剂到含防腐剂组”）患者使用不含防腐剂的0.0015%他氟前列素（NPT）6个月，然后改用含0.0015%他氟前列素防腐剂的药物（PT）6个月。第2组（“从含防腐剂到无防腐剂组”）患者使用含0.0015%他氟前列素防腐剂的药物6个月，然后改用不含防腐剂的0.0015%他氟前列素6个月。在第1、3、6、7、9和12个月时，我们测量眼压以评估疗效，并对角膜糜烂、泪膜破裂时间（TBUT）和主观不适进行分级。

结果

共纳入20例患者20只眼。在第1组和第2组中，眼压得到良好控制，降至约14 mmHg（降低9.38 - 18.46%）。总体而言，从PT改为NPT后主观满意度有所提高（p = 0.03），使用PT时的TBUT在数值上低于使用NPT时（p = 0.06），但从NPT改为PT时并非如此。

结论

含0.0015%他氟前列素防腐剂和不含防腐剂的药物均能显著降低眼压。此外，从PT改为NPT可能会提高主观满意度和泪膜破裂时间。

试验注册

试验注册号为NCT 03104621（2017年4月1日）。回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/5a22ea61be5e/12886_2017_453_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/bd8e64d7ca82/12886_2017_453_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/79f2a4de45a6/12886_2017_453_Fig2_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/5d8665f47e04/12886_2017_453_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/d7852fdb47b6/12886_2017_453_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/5a22ea61be5e/12886_2017_453_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/bd8e64d7ca82/12886_2017_453_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/79f2a4de45a6/12886_2017_453_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/f3d8ab207995/12886_2017_453_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/5d8665f47e04/12886_2017_453_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/d7852fdb47b6/12886_2017_453_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/997f/5410066/5a22ea61be5e/12886_2017_453_Fig6_HTML.jpg

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