LASIK术后局部应用溴芬酸钠与糖皮质激素药物的疗效比较

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（12.36±1.30） mmHg和（17.32±4.74） mmHg,术后1个月分别为（12.10±2.12） mmHg和（14.81±2.26）mmHg,组间和各时间点间的差异均有统计学意义（F分组=2.188,P=0.121；F时间=14.025,P=0.000；F交互作用=15.805,P=0.000）.除中低度SE试验组有1例患者术后10d角膜上皮愈合不佳外,其余所有患者角膜上皮均愈合良好,未出现角膜上皮下雾状混浊（haze）和弥漫性板层角膜炎（DLK）.试验组均无患者停用溴芬酸钠,而对照组有6例8眼因眼压升高而使用降眼压药物；中低度SE组术后屈光状态稳定.结论 0.1％溴芬酸钠滴眼液用于近视眼LASIK术后安全、有效,患者具有良好的耐受性,在术后视力、眼压、抗炎、抑制屈光回退等方面可获得满意的效果；但高度近视患者还需要大样本长期临床观察.

Comparison of clinical effects between bromfenac sodium versus glucocorticoid following LASIK

Background 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） mmHg and （13.33 ±2.10） mmHg in 3 months,（11.67 ±2.48） mmHg and （13.64± 1.37）mmHg in 6 months after operation,respectively,showing significant differences among the groups and various timepoints （Fgroup =4.067,P =0.045 ; Ftime =10.689,P =0.000 ; Finteraction =2.897,P =0.023）.In the high SE subjects of the NSAIDs and glucocorticoid group,the IOP values were （12.36± 1.30） mmHg and （17.32±4.74） mmHg in postoperative 10 days,（12.10t2.12）mmHg and （14.81 ±2.26）mmHg in postoperative I month,with a significant difference among the groups and timepoints （Fgroup =2.188,P =0.121 ;Ftime =14.025,P =0.000 ;Fi tion =15.805,P=0.000）.No haze or diffuse lamellar keratitis （DLK） appeared in both groups,and the epithelial flaps were wellpositioned with satisfying healing process except for one eye in the moderate and low SE eyes of the NSAIDs group.Bromfenac sodium ophthalmic solution 0.1％ was well tolerated by all patients in the NSAIDs group,but discontinuation sensation occurred in 8 eyes of 6 patients and the antiglaucoma drugs were administered due to elevated IOP in the glucocorticoid group.The refractive status remained stable for patients of the moderate and low SE group.Conclusions Bromfenac sodium ophthalmic solution 0.1％ is safe,effective and well tolerated after topically administered following LASIK,and its outcomes in recovery of visual acuity,anti-inflammation and stabilizing refractive status and IOP are satisfying.But long-term attention should be payed to the high-myopic eyes.