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

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）、SchirmerI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）、SchirmerI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、SchirmerI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，SchirmerI试验：P=0．053，FL：P=0．005；ⅡB组BUT：P=0．006，SchirmerI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，SchirmerI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。

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, for- eign 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 Test I, corneal fluorescein staining （FL）, symptoms changes of self-evaluatiorr Results Ocular symptoms and signs improved significantly after treat- ment 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 Test I （P=0.573）, and bFGF was better to reduce corneal fluorescein staining （P=0.375）, but the different was not significant. Significant change of symp- toms 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 Test I decreased in 10 days after LASIK, but increased in 30 days, than that of 10 days after operation （groupⅡA BUT： P=0.142, Schirmer Test I ： P=0.053; grouplIB BUT： P=0.006, Schirmer Test I ： P=0.010）. Corneal flnorescein staining aggravated in 10 day after LASIK, and improved in 30 days, with significant differences （gronpⅡA P=0.005, groupⅡB P=0.079）. There was no significant difference between grouplIA and grouplIB 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.