Objective: To study the safety, efficacy and tolerability of the usage of 0.1% bromfenac sodium eye drops in small incision lenticule extraction (SMILE). Methods: Prospective case control study. Three groups were observed, including 60 patients (60 eyes) undergoing SMILE for myopia. After surgery, 20 patients (20 eyes) were treated with 0.1% bromfenac sodium eye drops twice daily for 10 days, 20 patients (20 eyes) were treated with topical compound tobramycin eye drops 4 times daily for 10 days, and 20 patients (20 eyes) were treated with topical compound tobramycin eye drops 4 times daily for 3 days and 0.1% bromfenac sodium eye drops twice daily thereafter for 7 days. All of the patients were examined preoperatively and at 1 day, 10 days, 1 month and 3 months postoperatively, including visual acuity, intraocular pressure, topography and adverse reactions. The differences among the 3 groups were analyzed by the single factor analysis of variance. Results: There was no significant difference among the 3 groups in the uncorrected visual acuity at 10 days, 1 month and 3 months postoperatively (F=0.77, 0.30, 0.36. P=0.47, 0.75, 0.69) . The intraocular pressure in the dexamethasone group at 10 days, 1 month and 3 months postoperatively was higher than the other two groups with no significant difference (F=0.56, 0.98, 0.63. P=0.57, 0.38, 0.54) . The surface asymmetry index of patients was 0.33±0.10, 0.50±0.17 and 0.55±0.21 in the bromfenac sodium group, 0.33±0.08, 0.49±0.16 and 0.60±0.37 in the dexamethasone-bromfenac sodium group, and 0.31±0.12, 0.52±0.23 and 0.55±0.19 in the dexamethasone group; preoperatively and at 1 and 3 months, respectively. There was no significant difference among the 3 groups in the surface asymmetry index at 1 and 3 months postoperatively (F=0.09, 0.21. P=0.91, 0.81) . The surface regularity index of patients was 0.15±0.12, 0.34±0.18 and 0.40±0.18 in the bromfenac sodium group, 0.18±0.17, 0.33±0.26 and 0.33±0.26 in the dexamethasone-bromfenac sodium group, and 0.30±0.25, 0.41±0.28 and 0.34±0.29 in the dexamethasone group preoperatively and at 1 and 3 months, respectively. There was no significant difference among the 3 groups in the surface regularity index at 1 and 3 months postoperatively (F=0.74, 0.39. P= 0.48, 0.68) . In the bromfenac sodium group, one patient complained of binocular visual fatigue at 10 days, and one patient complained of dryness in one eye at 1 and 3 months. Conclusion: Bromfenac sodium eye drops can be used to replace corticosteroids after SMILE procedure with high safety and good tolerance. Satisfactory recovery of visual acuity, intraocular pressure and ocular surface could be achieved. (Chin J Ophthalmol, 2017, 53: 18-22).
目的： 探讨在飞秒激光小切口角膜基质透镜取出术（SMILE）后应用0.1%溴芬酸钠滴眼液替代糖皮质激素的安全性、有效性及耐受性。 方法： 前瞻性病例对照研究。将2015年4至8月在北京协和医院眼科接受SMILE手术的60例近视眼患者按随机数字表法随机分为3个组，均选取右眼进行用药后情况观察（共60只眼），每组20只眼。溴芬酸钠组患者SMILE术后应用0.1%溴芬酸钠滴眼液2次/d应用10 d；地塞米松-溴芬酸钠组患者SMILE术后3 d应用地塞米松-妥布霉素滴眼液4次/d，术后第4天开始改为应用0.1%溴芬酸钠滴眼液2次/d，至术后10 d；地塞米松组患者SMILE术后应用地塞米松/妥布霉素滴眼液4次/d应用10 d。所有患者在术前及术后1 d、10 d、1个月、3个月进行检查，包括裸眼视力、眼压、角膜地形图和主观症状与不良反应。3个组间观察指标比较采用单因素方差分析。 结果： 3个组患者在术后10 d、1及3个月裸眼视力差异无统计学意义（F=0.77，0.30，0.36；P>0.05）。地塞米松组患者在术后10 d、1及3个月各观察时间段眼压均值均高于溴芬酸钠组及地塞米松-溴芬酸钠组，但差异无统计学意义（F=0.56，0.98，0.63；P>0.05）。溴芬酸钠组患者术前、术后1及3个月角膜地形图角膜表面非对称指数（SAI）均值分别为：0.33±0.10、0.50±0.17、0.55±0.21；地塞米松-溴芬酸钠组及地塞米松组分别为：0.33±0.08、0.49±0.16、0.60±0.37；0.31±0.12、0.52±0.23、0.55±0.19；3个组患者术后1及3个月SAI指数差异无统计学意义（F=0.09，0.21；P>0.05）。溴芬酸钠组患者术前、术后1及3个月角膜地形图表面规则指数（SRI）均值分别为：0.15±0.12、0.34±0.18、0.40±0.18；地塞米松-溴芬酸钠组及地塞米松组分别为：0.18±0.17、0.33±0.26、0.33±0.26；0.30±0.25、0.41±0.28、0.34±0.29；3个组患者术后1及3个月SRI指数方面差异亦无统计学意义（F=0.74，0.39；P>0.05）。3个组患者中仅溴芬酸钠组术后10 d存在1例患者双眼视疲劳症状、术后1及3个月存在1例患者单眼干眼症状，余各组患者术后术后各时间段均无不适主观症状与不良反应发生。 结论： 0.1%溴芬酸钠滴眼液用于SMILE术后可以替代糖皮质激素应用，安全、有效、具有良好的耐受性，在术后视力、眼压、眼表恢复方面均可获得满意的效果。（中华眼科杂志，2017，53：18-22）.
Keywords: Adrenal cortex hormones; Benzophenones; Bromobenzenes; Corneal surgery, laser; Dexamethasone; Laser, femtosecond; Ophthalmic solutions; Tobramycin.