LASIK术后局部应用溴芬酸钠与糖皮质激素药物的疗效比较  

Comparison of clinical effects between bromfenac sodium versus glucocorticoid following LASIK

作　　者：陈实玉[1] 姜洋[1] 余晨颖[1] 李莹[1] 

机构地区：[1]中国医学科学院北京协和医院眼科,100730

出　　处：《中华实验眼科杂志》2014年第3期251-256,共6页Chinese Journal Of Experimental Ophthalmology

基　　金：国家自然基金项目（81170826）

摘　　要：背景 随着准分子激光角膜原位磨镶术（LASIK）的普及,术后糖皮质激素滴眼液点眼引起的并发症有增高趋势.质量分数0.1％溴芬酸钠水合物滴眼液是非甾体类抗炎药,可用于LASIK术后的抗炎治疗,但其与糖皮质激素疗效、安全性和耐受性的比较研究较少. 目的 比较0.1％溴芬酸钠水合物滴眼液和糖皮质激素滴眼液作为近视眼LASIK术后抗炎药物的安全性、有效性及耐受性. 方法 采用前瞻性随机对照研究方法.纳入2011年1月至2012年5月在北京协和医院眼科行LASIK的近视患者119例238眼,先以等效球镜（SE）-6.0 D为界分为中低度SE组与高度SE组,各组再采用分层随机法根据用药方案亚分为试验组和对照组.其中试验组LASIK术后使用0.1％溴芬酸钠滴眼液点眼,每日4次,共10 d；对照组使用质量分数0.1％地塞米松滴眼液以相同方式点眼.此外两组患者术前准备、手术方法及术后其他用药均相同.在术前及术后1d、10d、1个月、3个月和6个月进行常规检查,包括裸眼视力（UCVA）、最佳矫正视力（BCVA）、眼压、角膜地形图、视觉症状与体征评分,并对这些指标进行组间比较. 结果 所有试验组和对照组手术前后视力、角膜地形图K1、K2、SAI、SRI及CY值的差异均无统计学意义（P＞0.05）；中低度SE组及高度SE组LASIK术后眼压值均显著低于术前,而2个组中试验组的眼压均低于对照组,其中中低度SE组试验组和对照组术后10d的眼压分别为（13.31±2.44）mmHg（1 mmHg=0.133 kPa）和（16.62±4.74）mmHg,术后1个月分别为（12.93±2.25） mmHg和（12.82±1.72） mmHg,术后3个月分别为（13.83±3.08）mmHg和（13.33±2.10） mmHg,术后6个月分别为（11.67 ±2.48）mmHg和（13.64±1.37） mmHg,组间和各时间点间的差异均有统计学意义（F分组=4.067,P=0.045;F时间=10.689,P=0.000;F相互作用=2.897,P=0.023）；高度SE组试验组和对照组术后10d眼压值分别为（12Background Laser in-situ keratomileusis （LASIK） has been widely used to correct myopia,and the glucocorticoid-induced complication is increased.Bromfenac sodium 0.1％ is a non-steroidal anti-inflammatory drug used post-LASIK,but if it is better in clinical effects,safety and tolerance than glucocorticoid is unclear.Objective This study was to evaluate the safety,effectiveness,compliance of bromfenac sodium ophthalmic solution compared with glucocortieoid following LASIK.Methods A prospective randomized controlled trail were performed.Two hundred thirty-eight myopic eyes of 119 patients for LASIK were included in Peking Union Medical College Hospital from January 2011 to May 2012.The myopic eyes were firstly assigned to moderate and low spherical equivalent （SE） group （≤-6.0 D） or high SE group（＞-6.0 D） and then were further randomized into a NSAIDs subgroup and a glucocorticoid subgroup.Bromfenac sodium ophthalmic solution 0.1％ was topically administered 4 times per day for 10 days in the NSAIDs subgroup,and 0.1％ dexamethasone eye drops was used in the same way in the glucocorticoid subgroup after the LASIK.Uncorrected visual acuity （UCVA）,best corrected visual acuity （BCVA）,intraocular pressure （IOP）,corneal topography,clinical symptom were examined and compared between the groups 1 day,10 days,1 month,3 months and 6 months after LASIK.Results There was no statistically significant postoperative difference in visual acuity and corneal topography （K1,K2,surface asymmetry index [SAI],surface regular index [SRI] and cylinder） between the NSAIDs and control group （P＞0.05）.Postoperative IOP was significantly lower than that in preoperation,and lower IOP was found in the NSAIDs group than that of the glucocorticoid group.The IOP values in the moderate and low SE subjects of the NSAIDs group and glucocorticoid group were （13.31±2.44） mmHg and （16.62±4.74） mmHg on postoperative 10 days,（12.93±2.25） mmHg and （12.82± 1.72） mmHg in 1 month,（13.83±3.08）

关 键 词：准分子激光角膜原位磨镶术 溴芬酸钠 非甾体类抗炎药 糖皮质激素 

分 类 号：R779.63[医药卫生—眼科]