Comparison of the Clinical Effects of Bromfenac Sodium and Fluorometholone after LASEK Surgery

Kun-Ju Yang
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Abstract

Objective: To compare the effectiveness of bromfenac sodium and fluorometholone eye drops on relieving corneal irritation and its safety in clinical applications after laser epithelial keratomileusis (LASEK) surgery. Methods: This was a prospective randomized, controlled study. A total of 60 patients (120 eyes) who underwent LASEK surgery from April 2017 to February 2018 in Tianjin Eye Hosptial were divided randomly into a bromfenac sodium group and a fluorometholone group according to the random number table, 30 patients (60 eyes) were included in each group. In the first week after the surgery, the bromfenac sodium group was given 0.1% bromfenac sodium eye drops twice a day, and then from the second week, this eye drops changed to 4 times per day for 1 month and 2 times per day in the following month. While the fluorometholone group was given 0.3% sodium hyaluronate eye drops twice a day in the first week after the surgery, then the eye drops changed to 0.1% fluorometholone by giving 4 times per day, which was gradually tapered in every month to the end. Corneal irritation and epithelial healing were evaluated at 1 d, 2 d, 3 d and 5 d after surgery. Examinations of uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, slit lamp, Schirmer Ⅰ test (SⅠT), tear film break-up time (BUT) and corneal epithelium integrity evaluation were performed 1 week, 1 month and 3 months after surgery. An intraocular pressure (IOP) examination was performed 1 week, 2 weeks, 1 month, 3 months and 4 months. The data were analyzed by repeated measures ANOVA, independent sample t-test and Mann-Whitney U test. Results: The scores for corneal irritation in the bromfenac sodium group were significantly lower than those in the fluorometholone group after surgery (Fgroups=7.8, P=0.018; Ftimes=121.7, P<0.001; Finteraction=273.4, P<0.001). At 1 month after surgery, the mean visual acuity of both groups recovered to 1.0 or better. There were no statistically significant differences in UCVA, BCVA or refraction between the two groups. At 1 month after surgery, there were 6 cases (10%) of corneal haze in the bromfenac sodium group while there were 2 cases (3%) in the fluorometholone group. The correction of IOP in the bromfenac sodium group after surgery were all below 21 mmHg, while there were 5 cases (9%) of high IOP at 2 weeks and 3 cases (5%) at 1 month in the fluorometholone group. After 3 months, both SⅠT and BUT in the two groups returned to normal levels, and the difference was not statistically significant. After 3 months, the corneal epithelium had totally recovered in most of the patients in the two groups. There was no statistically significant difference between the two groups. Conclusions: Bromfenac sodium eye drops can effectively alleviate corneal irritation after LASEK surgery. It is safe and effective for the recovery of vision and anti-inflammatory effects. Furthermore, bromfenac sodium can reduce the risk of postoperative high intraocular pressure caused by glucocorticoids. However, the incidence of corneal haze is slightly higher. Key words: bromfenac sodium; non-steroid anti-inflammatory drugs; glucocorticoids; laser epithelial keratomileusis; steroid-induced glaucoma
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溴芬酸钠与氟美洛酮LASEK术后临床疗效比较
目的:比较溴芬酸钠与氟美隆滴眼液对激光上皮性角膜磨砂术(LASEK)术后角膜刺激的缓解效果及临床应用的安全性。方法:前瞻性随机对照研究。选取2017年4月至2018年2月在天津市眼科医院行LASEK手术的患者60例(120只眼),按照随机数字表法随机分为溴芬酸钠组和氟美隆组,每组30例(60只眼)。溴芬酸钠组术后第1周给予0.1%溴芬酸钠滴眼液,每日2次,从第2周起改为每日4次,连续1个月,次月改为每日2次。氟美洛酮组术后第一周给予0.3%透明质酸钠滴眼液,每日2次,后改为0.1%氟美洛酮滴眼液,每日4次,逐月逐渐减量,直至结束。分别于术后1 d、2 d、3 d和5 d评估角膜刺激和上皮愈合情况。术后1周、1个月、3个月分别行未矫正视力(UCVA)、最佳矫正视力(BCVA)、屈光、裂隙灯、SchirmerⅠ试验(SⅠT)、泪膜破裂时间(BUT)、角膜上皮完整性评价。术后1周、2周、1个月、3个月、4个月分别进行眼内压(IOP)检查。数据分析采用重复测量方差分析、独立样本t检验和Mann-Whitney U检验。结果:术后溴芬酸钠组角膜刺激评分明显低于氟美洛酮组(f组=7.8,P=0.018;Ftimes = 121.7, P < 0.001;Finteraction = 273.4, P < 0.001)。术后1个月,两组平均视力恢复到1.0以上。两组患者的UCVA、BCVA及屈光无统计学差异。术后1个月,溴芬酸钠组有6例(10%)角膜混浊,氟美隆组有2例(3%)。溴芬酸钠组术后IOP矫正均低于21 mmHg,氟美隆组术后2周高IOP 5例(9%),1个月高IOP 3例(5%)。3个月后,两组SⅠT、BUT均恢复到正常水平,差异无统计学意义。3个月后,两组患者角膜上皮均完全恢复。两组间差异无统计学意义。结论:溴芬酸钠滴眼液能有效缓解LASEK术后角膜刺激。具有安全有效的恢复视力和抗炎作用。溴芬酸钠可降低术后糖皮质激素引起的高眼压风险。但角膜雾霾的发病率略高。关键词:溴芬酸钠;非甾体抗炎药;糖皮质激素;激光上皮性角膜磨镶术;类固醇青光眼
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