LASIK术后质量分数0．5％氯替泼诺滴眼液应用的随机对照研究

A randomized-controlled clinical trial on the application of 0. 5% loteprednol etabonate eye drops aftermyopic laser-assisted in situ keratomileusis surgery

背景近视性准分子激光角膜原位磨镶术（LASIK）后需局部使用糖皮质激素滴眼液已成为共识，具有良好抗炎效果且不良反应小的糖皮质激素滴眼液有利于术后角膜上皮的快速修复。目的评估质量分数0．5％氯替泼诺滴眼液在LASIK术后的『临床应用效果。方法采用前瞻性随机对照研究设计。本研究经中山大学中山眼科中心伦理委员会批准，所有患者纳入前均充分了解本研究的内容并签署知情同意书。112例224眼纳入研究，其中共97例194眼完成随访。双眼接受近视性LASIK的患者以随机数字表法分为0．5％氯替泼诺滴眼液点眼组（试验组）54例108眼和对照组43例86眼，两组患者年龄及术前等效球镜度差异均无统计学意义（P〉0．05）。两组的基础治疗方法一致。试验组从术后第1天开始局部点用0．5％氯替泼诺滴眼液，每日4次，共1周，对照组以同样的方法点用妥布霉素地塞米松滴眼液。分别于术后1d、1周、1个月对2个组患者的主观症状进行评分，并行裸眼视力、最佳矫正视力（BCVA）、眼压、中央角膜厚度、角膜荧光素染色检查，同时观查术眼的术中和术后并发症情况，以评价0．5％氯替泼诺滴眼液点眼的安全性。结果在随访过程中，未观察到与药物相关的全身和眼部严重并发症。术后1d、1周和1个月，试验组和对照组主观症状评分（包括眼痛、异物感、视物模糊评分）比较，差异均无统计学意义（P〉0．05）。术后1周，试验组和对照组校正后的实际眼压分别为（16．27±3．31）mmHg和（17．49±4．48）mmHg，差异有统计学意义（t=-2．113，P=0．036）；术后1个月，试验组和对照组校正后的实际眼压分别为（15．01±3．22）mmHg和（15．304-4．17）mmHg，差异无统计学意义（t=-0．532，P=0．595）。术后1d，试验组发生轻度弥漫性层间角膜炎（DLK）者7眼，对照组为5眼，差异无统计学意义（X^2=0．153，P=0．926），术后1周和1个月两组中均未发现DLK。术后1d、1周和1个月两组间的角膜荧光素染色评分差异均无统计学意义（Z=-0．566，P：0．571；Z=-0．689，P=0．491：z=-1．628，P=0．103）。结论0．5％氯替泼诺滴眼液用于LASIK术后可以有效控制术后炎症反应和DLK，并且减少了传统糖皮质激素升高眼压的风险。

Background It has become a consensus about the necessity of topical administration of corticosteroid eye solutions after myopic laser-assisted in situ keratomileusis （ LASIK）. The glucocorticoid eye drops with good anti-inflammatory effect and less adverse effects is helpful for the repair of corneal epithelium following LASIK. Objective This study was to evaluate the clinical effects of 0.5% loteprednol etabonate eye drops after LASIK. Methods A prospective randomized-controlled study was designed. One hundred and twelve myopia patients （224 eyes）who had received LASIK were included in this study and randomly divided into two groups, and 97 patients finished the follow-up, including 108 eyes of 54 patients in the 0.5% loteprednol etabonate eye drops treatment group and 86 eyes of 43 patients in the control group. 0.5% loteprednol etabonate eye drops or dexamethasone/tobramycin eye drops were administered topically to the treatment group and control group,respectively 4 times daily from postoperative day 1 through day 7 following LASIK in addition to regular basic treatment. The follow-up was performed 1 day, 1 week and 1 month after LASIK. Subjective symptoms including eye pain,foreign body sensation and blurring were scored, and uncorrected visual acuity （UCVA）, best corrected visual acuity（BCVA） ,intraocular pressure（IOP） , central corneal thickness, corneal fluorescein staining and diffuse laminar keratitis（DLK） were evaluated and compared between the two groups 1 day, 1 week, and 1 month after LASIK. This clinical trial was approved by the Ethic Commission of Zhongshan Ophthalmic Center, and written informed consent was obtained from each patient before the trial. Results No drug-related ocular and systemic adverse events were found in the treatment group throughout the follow-up duration. There was no significant difference in the subjective symptom score after 1 day, 1 week and 1 month （P〉0. 05 ）. At 1 week post-LASIK, the corrected actual IOP was （16.27±3.31） mmHg in the treatment group and（17.49±4.48） mmHg in the control group,with a statistically significant difference between them （ t = -2.113, P = 0. 036 ）. However, there was no statistically significant difference in IOP between the treatment group（ 15.01 ±3.22） mmHg and the control group（ 15.30±4. 17） mmHg at 1 month post-LASIK （t =-0. 532,P= 0. 595）. Mild diffuse lamellar keratitis developed in 7 eyes in the treatment group and 5 eyes in the control group without a significant difference on the first day after LASIK （X^2 = 0. 153, P = 0. 926）. The scores of corneal fluorescein staining were not statistically different between the two groups at 1 day, 1 week and 1 month postoperative（ Z= -0. 566 ,P=0. 571 ;Z= -0. 689 ,P=0.491 ;Z=-1. 628 ,P=O. 103 ）. Conclusions 0.5% loteprednol etabonate eye drops could effectively inhibit postoperative inflammation and low the incidence of DLK. It can lessen the risk of IOP elevation in comparison with traditional steroid eye drops.