玻璃酸钠及碱性成纤维细胞生长因子滴眼液用于单纯干眼和LASIK术后患者的临床疗效

doi:10.13281/j.cnki.issn.1004-4469.2014.04.015

眼科 ›› 2104, Vol. 23 ›› Issue (4): 274-279.doi: 10.13281/j.cnki.issn.1004-4469.2014.04.015

玻璃酸钠及碱性成纤维细胞生长因子滴眼液用于单纯干眼和LASIK术后患者的临床疗效

张潇王忠海李莹姜洋罗岩陈秉钧丁欣

100730 中国医学科学院北京协和医学院北京协和医院眼科

收稿日期:2013-11-29 出版日期:2014-07-25 发布日期:2014-07-22
通讯作者: 李莹, Email：liyingpumch@sohu.com
基金资助:
国家自然科学基金（81170826）

Clinical efficacy of sodium hyaluronate and bFGF eye drops in dry eye and eyes after LASIK

ZHANG Xiao, WANG Zhong-hai, LI Ying, JIANG Yang, LUO Yan, CHEN Bing-jun, DING Xin.

Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China

Received:2013-11-29 Online:2014-07-25 Published:2014-07-22
Contact: LI Ying, Email：liyingpumch@sohu.com

摘要/Abstract

摘要： 目的观察0.1%玻璃酸钠滴眼液（SH）、碱性成纤维细胞生长因子（bFGF）滴眼液在单纯干眼和准分子激光原位角膜磨镶术（LASIK）后应用的有效性和安全性。设计随机对照研究。研究对象 2012年1月至2012年8月于北京协和医院就诊的单纯干眼患者70例（组Ⅰ）和接受LASIK手术后的患者40例（组II）。方法采用随机、平行对照试验方法，组Ⅰ和组II各分为两个亚组，采用随机数字法分别使用0.1% SH滴眼液（A组）和bFGF滴眼液（B组），每日4次，组Ⅰ局部连续使用14天，组II连续使用30天。在不同时间点（组I用药前、用药7天和14天，组II手术前、手术后1天、3天、10天和30天）观察患者症状和体征。问卷调查患者用药前后不同时间段的干眼症状，包括易疲劳、异物感、干涩感、烧灼感、眼胀感、眼痛、畏光和眼红，根据患者症状严重程度评为0～9分。主要指标 干眼症状评分，泪膜破裂时间（BUT）、Schirmer Ⅰ试验和角膜结膜荧光素染色（FL），症状评分。结果单纯干眼组（组I）治疗后干眼症状均明显改善，治疗后14天易疲劳（P=0.006）和眼痛（P=0.040）的改善ⅠA组优于ⅠB组，差异有统计学意义。症状明显改善的患者在ⅠA、ⅠB中分别为94.3%、78.6%。BUT（P=0.055）、Schirmer Ⅰ试验（P=0.573）改善ⅠA高于ⅠB， FL（P=0.375）减少ⅠB优于ⅠA，差异无统计学意义。LASIK术后组（组II），患者术后1、3天较术前出现不适症状，术后30天所有症状有明显改善，其中异物感（P=0.004）、烧灼感（P<0.001）、眼胀（P=0.005）、眼红（P=0.007）改善分数IIA组优于IIB组。术后10天，BUT、Schirmer Ⅰ试验均较术前减少，FL较术前增加，术后30天各项体征较术后10天改善（IIA组BUT： P=0.142，Schirmer Ⅰ试验：P=0.053，FL：P=0.005；IIB组BUT： P=0.006，Schirmer Ⅰ试验：P=0.010，FL：P=0.079），IIA组与IIB组各项体征改善比较无统计学意义（BUT：P=0.251，Schirmer Ⅰ试验：P=0.369，FL：P=0.060）。所有患者用药后未见副作用。结论 SH和bFGF滴眼液均能促进单纯干眼和LASIK术后角膜上皮修复，维持泪膜稳定性，减轻症状。SH滴眼液在改善某些（如易疲劳、异物感、烧灼感、眼胀、眼红、眼痛等）症状方面优于bFGF滴眼液。（眼科，2014， 23： 274-279）

关键词: , 玻璃酸钠；碱性成纤维细胞生长因子；干眼；准分子激光原位角膜磨镶术

Abstract: Objective To observe the efficiency and safety of 0.1% sodium hyaluronate (SH） eye drops and basic fibroblast growth factor (bFGF) eye drops in simplex dry eye and dry eye after LASIK. Design Randomized controlled study. Participants 70 cases with simplex dry eye (group Ⅰ) and 40 post-LASIK cases (group II) from January 2012 to August 2012. Method There were two subgroups in group I and group II respectively. 0.1% SH (A) and bFGF (B) eye drops were used randomly, four times a day for 14 days in group I and 30 days in group II. Changes of symptoms and signs were observed at different times. Dry eye symptoms including asthenopia, foreign body sensation, eye dry, burning sensation, swelling sensation, ophthalmodynia, conjunctiva congestion and photophobia were scored using questionnaire survey. Main Outcome Measures Score of dry eye symptoms, tear break-up time (BUT), Schirmer TestⅠ, corneal fluorescein staining (FL), symptoms changes of self-evaluation. Results Ocular symptoms and signs improved significantly after treatment in both subgroups of group Ⅰ (P<0.05). 0.1% SH eye drops was better than bFGF eye drops in improving asthenopia (P=0.006) and ophthalmodynia (P=0.040) at 14 days after treatment (P<0.05). SH was better to improve BUT (P=0.055) and Schirmer TestⅠ (P=0.573), and bFGF was better to reduce corneal fluorescein staining (P=0.375), but the different was not significant. Significant change of symptoms in patients using SH eye drops and bFGF eye drops were 94.3% and 78.6%, respectively. In group II, there were symptoms in 1 and 3 days after LASIK, and improved in 10 and 30 days post-operation. SH eye drops was better than bFGF eye drops in improving foreign body sensation (P=0.004), burning sensation (P<0.001), swelling sensation (P=0.005) and conjunctiva congestion (P=0.007). BUT and Schirmer TestⅠdecreased in 10 days after LASIK, but increased in 30 days, than that of 10 days after operation (groupIIA BUT: P=0.142, Schirmer TestⅠ: P=0.053; groupIIB BUT: P=0.006, Schirmer TestⅠ: P=0.010). Corneal fluorescein staining aggravated in 10 day after LASIK, and improved in 30 days, with significant differences (groupIIA P=0.005, groupIIB P=0.079). There was no significant difference between groupIIA and groupIIB in changes of dry eye signs. No side-effect was found during observation. Conclusion SH and bFGF eye drops can facilitate corneal epithelial repair, improve tear film stability, and alleviate various symptoms in simplex dry eye and post-LASIK patients. SH eye drops is better than bFGF eye drops in improving certain symptoms including asthenopia, foreign body sensation, burning sensation, swelling sensation, conjunctiva congestion and ophthalmodynia. (Ophthalmol CHN, 2014, 23: 274-279)

Key words: sodium hyaluronate, basic fibroblast growth factor, dry eye, LASIK

张潇王忠海李莹姜洋罗岩陈秉钧丁欣. 玻璃酸钠及碱性成纤维细胞生长因子滴眼液用于单纯干眼和LASIK术后患者的临床疗效[J]. 眼科, 2104, 23(4): 274-279.

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玻璃酸钠及碱性成纤维细胞生长因子滴眼液用于单纯干眼和LASIK术后患者的临床疗效

Clinical efficacy of sodium hyaluronate and bFGF eye drops in dry eye and eyes after LASIK

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