0.1％溴芬酸钠水合物滴眼液与糖皮质激素在LASEK术后的疗效比较

Comparison of clinical effects of bromfenac sodium ophthalmic solution 0.1% versus glucocorticoids for post-LASEK usage

目的 探讨准分子激光角膜上皮瓣下磨镶术（LASEK）后0.1％溴芬酸钠水合物滴眼液部分替代糖皮质激素的安全性、有效性及耐受性.方法 前瞻性研究.将接受LASEK的60例（120只眼）近视眼患者随机分为两组,各60只眼.所有患者LASEK术后先使用0.1％地塞米松1周,之后试验组患者术后2 ～12周给予0.1％溴芬酸钠水合物滴眼液2次/d,对照组则给予0.1％氟米龙并逐渐减量.在术前及术后3d、10 d、1个月、3个月、6个月进行常规检查,包括裸眼视力、最佳矫正视力、眼压、角膜地形图和主观症状与体征等,并对所有患者右眼记录指标进行统计分析先行描述统计探索,验证数据的独立性、正态性和方差齐性.三者都满足的行独立样本t检验,其一不满足的行Mann-Whitney非参数检验.双眼观察,统计右眼.结果 试验组和对照组术后角膜地形图检查结果无明显差异.试验组和对照组术后10 d、1个月、3个月和6个月眼压分别为（16.33±6.21）、（15.67±2.82）、（15.35±2.22）、（13.10±3.41）和（16.87±3.68）、（14.05±2.23）、（14.39±2.22）、（13.18 ±2.49） mmHg（1 mmHg =0.133 kPa,差异均无统计学意义（=0.81,1.95,1.84,0.85,P＞0.05）.试验组术后1个月的视力优于对照组,分别为5.16±0.08和5.02±0.09（t=2.32,P＜0.05）,余观察点差异无统计学意义.试验组在术后6个月有4只眼出现视疲劳,4只眼出现眼干.试验组术后1个月有2只眼出现0.5级角膜上皮下雾状混浊（haze）,术后2个月又有2只眼新出现0.5级haze,对照组术后1个月有2只眼出现0.5级haze,但均未影响视力,且加强局部用药频率1个月后上述haze均消失.对照组总共有4例因眼压升高而使用降眼压药物.结论 0.1％溴芬酸钠水合物滴眼液用于LASEK术后可以减少糖皮质激素用量或者部分替代糖皮质激素,安全、有效、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;LASEK术后早期均有0.5级haze个例发生,加强局部用药频率1个月后消失.

Objective To evaluate the safety,effectiveness and compliance of Bronuck （bromfenac sodium ophthalmic solution 0.1 %） following LASEK in comparison with glucocorticoids.Methods In this prospective trial,60 patients （120 eyes） undergoing LASEK were randomized into the bromfenac sodium group （60 eyes） and control group （60 eyes）.Patients in both groups initially received dexamethasone 0.1% four times a day after LASEK for 7 days,and then the patients in the bromfenac sodium group were given Bronuck twice a day for the next 11 weeks,while the patients from the control group were given fluorometholone 0.1% with gradually decreased doses during the same period.Results of the routine examinations done before and 3,10,30,90 and 180 days after LASEK were recorded,including uncorrected visual acuity,best corrected visual acuity,intraocular pressure （IOP）,corneal topography,ocular symptoms and signs,which were used for comparison between the two groups.All data of right eyes were analyzed for their independence,normality and homogeneity of variance.Independent samples t-test or non-parametric Mann-Whitney test was performed accordingly.Results There was no statistically significant difference in IOP and corneal topography （K1,K2,SAI,SRI and CY） between the two groups postoperatively.The IOP was （16.33 ± 6.21） mmHg（1 mmHg =0.133 kPa）,（15.67 ± 2.82） mmHg,（15.35 ± 2.22） mmHg and （13.10 ± 3.41） mmHg in the bromfenac sodium group,and （16.87 ± 3.68）mmHg,（14.05 ± 2.23） mmHg,（14.39 ± 2.22） mmHg and （13.18 ± 2.49） mmHg in the control group at 10,30,90 and 180 days,respectively.The bromfenac sodium group showed significantly better uncorrected visual acuity （5.16 ± 0.08） than the control group （5.02 ± 0.09） on day 30 （t =2.32,P 〈0.05）.In the bromfenac sodium group,four eyes had visual fatigue,and four eyes had dry eye symptoms on day 180.Epithelial flaps were all well positioned with satisfying healing process.Each group had one case （two eyes） of haze on day 30,and the bromfenac sodium group had another case （2 eyes） of new-onset haze on day 60.But all the cases of haze were graded 0.5 according to the Fantes Standard,too mild to compromise their visual acuities,and were resolved after frequent topical medication for 1 month.Four patients from the control group were prescribed antiglaucoma medications due to elevated IOP.The refractive status remained stable for patients from both groups.Conclusions Administration of Bronuck can reduce the amount of or partially substitute for corticosteroids.Mild haze early after LASEK may disappear after intensive treatment.