0.1%溴芬酸钠滴眼液在中低度近视准分子激光上皮下角膜磨镶术后部分替代激素的作用研究

Clinical observation of partial using of 0.1% bromfenac sodium after laser-assisted subepithelial keratomileusis in low and medium myopia

目的观察非甾体类抗炎药0.1%溴芬酸钠滴眼液在中低度近视准分子激光上皮下角膜磨镶术(LASEK)后部分替代激素应用的临床疗效观察及对角膜生物力学的影响。方法本研究为前瞻性、随机对照队列临床研究,所有患者完善LASEK术前评估后顺利完成手术,随访至术后6个月。试验组58例,对照组60例,2组术前屈光度、眼压、角膜厚度无差异,等效球镜度数均低于-6 DS。术后1个月内均使用氟米龙滴眼液,试验组术后1个月后改用溴芬酸钠滴眼液,对照组全程使用氟米龙滴眼液,逐渐减量至停药。在术后1、2、3、6个月观察角膜上皮下雾状混浊(haze)、视力、屈光度、眼压和角膜生物力学参数。结果角膜Haze试验组出现4例,发现后改用氟米龙,对照组出现1例,增加氟米龙用量,直至5例患者Haze逐渐消退,角膜均恢复透明。2组视力和屈光度在术后1、2、3、6个月差异无统计意义。2组术前,术后1、3个月及6个月非接触式眼压计测量的眼压差异均无统计学意义;而在术后2个月时试验组低于对照组约2 mm Hg(1 mm Hg=0.133 k Pa),且差异具有统计学意义(t=-2.486,P=0.016)。角膜补偿眼压(IOPcc)结果显示,2组术前,术后1、6个月IOPcc差异无统计学意义;而在术后2、3个月试验组低于对照组(分别为3 mm Hg和2 mm Hg),且差异具有统计学意义(t=-3.155,P=0.003;t=-2.409,P=0.02)。2组术后各时间点的角膜滞后量(CH)和角膜阻力因子(CRF)均低于术前,而2组间差异在各时间点均无统计学意义。此外,2组眼部充血及术后主观症状差异无统计学意义;且均无特殊不良反应。结论中低度近视眼LASEK术后与常规使用氟米龙相比,术后1个月后采用溴芬酸钠滴眼液替代氟米龙,主观感觉、视力、屈光度及角膜生物力学稳定性一致,眼压的波动更小,角膜Haze的发生率略高。

Objective To evaluate the effect of partial using of 0. 1% bromfenae sodium after laser-assisted subepithelial keratomileusis （LASEK） in low and medium myopia, including corneal biomechanies. Methods A randomized prospective cohort clinical study was performed. There were 58 cases in the experimental group and 60 cases in the control group with the equivalent spherical degrees less than -6 DS. All patients were taken preoperative evaluation and successful LASEK surgery. The follow-up time was six months. There was no differences in the preoperative refraction, intraocular pressure （IOP） and corneal thickness between the two groups. All patients used 0.1% fluorometholone eye drops within one month after the surgery; then 0.1% bronffenac sodium eyedrops was used in the experimental group from the second month, while the control group continued to take fluorometholone eye drops, gradually tapered to the end. The corneal haze （Haze）, visual acuity, refraction, IOP and corneal biomechanical parameters were checked 1 month, 2 months, 3 months and 6 months after LASEK. Results There were 4 cases of Haze happened in the experiment group, who switched to use fluorometholone eye drops; 1 case of haze happened in control group who was asked to increase the dose of fluorometholone eye drops. These 5 cases of Haze were all gradually subsided to recover corneal transparency. There was no statistically significant difference in visual acuity and refraction 1 month, 2 months, 3 months and 6 months after LASEK between the two groups. There was no statistically significant difference in I postoperative IOP（NCT） at 1 month, 3 months and 6 months, while at 2 months the average IOP in the experimental group was higher than that in the control group by about 2 mmHg （1 mmHg = 0. 133 kPa） （t = -2.486, P = 0.016 ）. There was no statistically significant difference in postoperative IOP（ORA） at 1 month and 6 months, while in 2 months and 3 months the average IOP in the experimental group was higher than that in the control group by about 3 mmHg and 2 mmHg respectively （ t = - 3. 155, P = 0. 003 ; t = - 2.409, P = 0. 02）. Both in the experimental group and the control group, the postoperative corneal lag （CH） and corneal resistance factor （CRF） were lower than the preoperative, and the difference between the two groups was not statistically significant at all the time points. In addition, there was no significant difference after the eye congestion and postoperative subjective symptoms between the two groups, and no special adverse reaction in all patients. Conclusions Compared with the conventional use of fluorometholone, partial using of O. 1% bromfenac sodium after LASEK in low and medium myopia will perform the same subjective sensation, visual acuity, refraction and corneal biomechanical stability, smaller fluctuations in IOP and slightly higher incidence of corneal Haze.