不含防腐剂的玻璃酸钠联合氟米龙滴眼液治疗白内障伴干眼的随机单盲对照研究

背景 干眼是白内障术后的常见并发症,推测不含防腐剂的人工泪液可以安全、有效地控制术后炎症,防止术后眼部感染以及减少干眼症状,但关于其临床疗效的研究尚少见报道. 目的 探讨伴有干眼的白内障患者术后应用不含防腐剂的玻璃酸钠联合氟米龙滴眼液的治疗效果.方法 本研究为前瞻性、随机、单盲对照研究,选择2015年1-12月于烟台毓璜顶医院确诊的60例60眼拟行白内障手术且术前伴有干眼的患者,采用随机数字表法分为2个组,每组30例,均取右眼为受检眼.试验组患者在白内障术后采用不含防腐剂的质量分数0.1％玻璃酸钠滴眼液和质量分数0.1％氟米龙滴眼液治疗,对照组患者则采用含防腐剂的0.1％玻璃酸钠滴眼液和0.1％氟米龙滴眼液治疗.分别在术后第1个月和第2个月末测量2个组受检眼的眼表疾病指数(OSDI)、泪膜破裂时间(BUT)、基础泪液分泌试验(SⅠt)值、角膜荧光素染色评分、印迹细胞学分级、杯状细胞密度和泪液中白细胞介素(IL)-1β、肿瘤坏死因子(TNF)-α、过氧化氢酶(CAT)和超氧化物歧化酶2(SOD2)的质量浓度,并进行比较. 结果 术前2个组患者年龄、性别、OSDI、BUT、SⅠt值、角膜荧光素染色评分、杯状细胞密度、印迹细胞学分级的比较差异均无统计学意义(均P＞0.05).术后1个月和2个月试验组受检眼OSDI、角膜荧光素染色评分、印迹细胞学分级较基线的下降幅度,BUT、SⅠt值、杯状细胞密度较基线的增加幅度均高于对照组,差异均有统计学意义(F=13.058、8.027、3.755、21.652、70.962、92.354,均P＜0.05).术后1个月和2个月试验组受检眼泪液中IL-1β和TNF-d质量浓度均低于对照组,CAT和SOD2质量浓度均高于对照组,差异均有统计学意义(F=18.731、9.070、15.357、351.359;均P＜0.05). 结论 手术后应用不含防腐剂的0.1％玻璃酸钠和0.1％氟米龙滴眼液可以明显改善白内障伴干眼患者的干眼症状,并提示其具有抗炎、抗氧化作用.

A randomized controlled clinical study on the combination of preservative-free sodium hyaluronate and fluorometholone eyedrops for cataract with dry-eye

Background Cataract with preexisted dry eye is a common eye disease.It is speculated that preservative-free artificial tears can inhibit inflammatory procedure,prevent postoperative eye infections and reduce dry eye symptoms.However,relevant literature is rare up to now.Objective This study was to evaluate and compare the therapeutic effects between preservative-free or preservative sodium hyaluronate combined with fluorometholone eyedrops for cataract with dry-eye.Methods A randomized controlled single-blind clinical study was performed.Sixty patients with dry-eye syndrome who was going to receive surgery for cataract removal were enrolled in Yuhuangding Hospital from January to December 2015 under the informed consent.The patients were randomly divided into the test group and control group.Preservative-free or preservative 0.1％ sodium hyaluronate combined with 0.1％ fluorometholone eye drops were topically administered in the eyes of the test group and control group,respectively.Ocular Surface Disease Index (OSDI) score,breakup time of tearfilm (BUT),Schirmer Ⅰ test (S I t),corneal fluorescein staining,impression cytology,goblet cell density and the concentrations of interleukin (IL)-1β,tumor necrosis factor (TNF)-α,catalase (CAT),superoxide dismutase 2 (SOD2) in tears were evaluated and compared.Results There were significant differences in gender,ages,OSDI scores,BUT,S I t value,corneal fluorescein staining scores,impression cytology findings,and goblet cell density between the two groups (all at P＞0.05).OSDI,corneal fluorescein staining scores and imprint cellular level were evidently reduced,and BUT,S I t values and goblet cell density were significantly increased 1 month and 2 months after operation in comparison with the baseline values in the test group (F =13.058,8.027,3.755,21.652,70.962,92.354,all at P ＜ 0.05).The concentrations of IL-1β and TNF-α in tears of the test group were significantly lower,and CAT and SOD2 in the tears of the test group were significantly higher than those in the control group 1 month and 2 months after operation (F=18.731,9.070,15.357,351.359,all at P＞0.05).Conclusions 0.1％ preservative-free sodium hyaluronate combined with 0.1％ fluorometholone eyedrops can relieve the symptoms and signs of dry-eyes following cataract surgery by playing antiinflammatory and antioxidant effects.