溴芬酸钠与糖皮质激素在 LASIK术后的疗效比较

陈实玉  姜洋  余晨颖  李莹

中国医学科学院   北京协和医院眼科  100730

通讯作者 李莹 [e-mail]

国家自然基金项目 ( 81170826)

【摘要】 目的  评价溴芬酸钠滴眼液用于近视lasik术后相对于糖皮质激素的安全性、有效性及耐受性。方法  采用前瞻性研究，观察行lasik治疗的119例（238只眼）患者，以等效球镜（se）-6.0d为界分为lasik 中低度组与lasik高度组，各组再随机根据用药方案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10天，对照组使用0.1%地塞米松10天，此外两组患者术前准备、手术方法及术后其它用药均相同。在术前及术后一天、十天、一月、三月、半年进行常规检查，包括裸眼视力（ucva）、最佳矫正视力（bcva）、眼压（iop）、角膜地形图和视觉症状与体征等，并对这些指标进行组间比较。结果  所有试验组和对照组术后在视力、角膜地形图数据测量上无显著性差异；但lasik中低度组及高度组术后iop值均显著低于对照组，而两组中试验组对患者眼压的影响均小于对照组。除lasik中低度试验组报告了1例术后十天角膜上皮愈合不佳，其余所有患者角膜上皮均愈合良好，未见角膜上皮下雾状混浊（haze）和弥漫性板层角膜炎（dlk）。此外，试验组均无停用溴芬酸钠的个例，而对照组总共有6例因眼压升高而使用降眼压药物；lasik中低度组术后屈光状态稳定。结论  溴芬酸钠滴眼液用于lasik术后（包括中低度和高度）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；但高度近视患者还需要大样本长期临床观察。北京协和医院眼科李莹

comparison of clinical effects of bromfenac sodium versus glucocorticoid for post-lasik usage

chen shi-yu, jiang yang, yu chen-ying, li ying. department of ophthalmology, peking union medical college hospital, peking union medical college, chinese academy of medical sciences, beijing 100730, china

[abstract] objective  to evaluate the safety, effectiveness, compliance of bromfenac sodium ophthalmic solution  following lasik in comparison with glucocorticoid. methods  in this prospective trial, 119 patients (238 eyes) undergoing lasik were divided into 2 groups according to their spherical equivalent (se < -6.0d or se ≥ -6.0d), and they were further randomized into a nsaids group and a control group within each group in accordance with their post-lasik medication. 96 patients were included in group one (se < -6.0d) with equal number of patients in nsaids and control group, while the other 23 patients were included in group two (se ≥ -6.0d), of which 11 patients were in nsaids group and 12 patients in control group. the only difference of treatment for patients in nsaids and control group was that they used 0.1% bromfenac sodium ophthalmic solution bid and 0.1% dexamethasone qid respectively after lasik for 10 days. results of the routine examinations done before and 1, 10, 30, 90 and 180 days after lasik were recorded including ucva, bcva, iop, corneal topography, ocular symptoms and signs, which were then used for comparison between nsaids and control group. results  there was no statistically significant postoperative difference in visual acuity and corneal topography (k1, k2, sai, sri and cy) between nsaids and control group. however, nsaids group showed significantly lower iop than control group on day 10 post-lasik in group one, and on day 10 and 30 post-lasik in group two. no haze or dlk could be observed in both groups, and the epithelial flaps were all well positioned with satisfying healing process except for one case in the nsaids group from group two. bromfenac sodium ophthalmic solution was well tolerated by all patients in nsaids group without any case of discontinuation, but there were 6 patients from control group in total who were prescribe antiglaucoma medications due to elevated iop. the refractive status remained stable for patients from group one. conclusions  bromfenac sodium ophthalmic solution is safe, effective and could be well tolerated by patients for post-lasik usage, and its performance in recovery of visual acuity, anti-inflammation and stablizing refractive status and intraocular pressure is satisfying. but further long-term observation with a large sample is needed to clarify its clinical effects on high-myopia patients.

[keywords] laser in-situ keratomileusis (lasik); bromfenac sodium ophthalmic solution; non-steroidal anti-inflammatory drugs (nsaids); glucocorticoid (gc)