LASIK术后应用重组人表皮生长因子衍生物的近期疗效及安全性

The short term effect and safety of recombinant human epidermal growth factor used in corneal post-LASIK

目的:通过前瞻性观察重组人表皮生长因子衍生物(re-combinant human epidermal growth factor,rhEGF)早期应用于准分子激光原位角膜磨镶术(LASIK)后患者的角膜反应,评价外源性表皮生长因子对术后角膜上皮修复作用及安全性。方法:采用随机、单盲、非平行对照的方法,抽取LASIK后患者,设EGF组和对照组。比较、分析两组病例术后1,3wk;1,3mo的裸眼视力、屈光度、疼痛、畏光、异物感、眼干、角膜上皮点状染色、混合性充血、泪膜破裂时间(BUT)、Schirmer’s Test、角膜上皮下雾状混浊(Haze)等情况的变化及药物毒性。结果:术前、术后两组间性别、年龄、屈光度无统计学差异。术后3mo时EGF组综合指数优于对照组(P<0.05)。两组术前、术后均无疼痛、畏光感者;术后1wk两组均出现个别患者觉异物感(P>0.05),随后症状消失;术后1wk和3mo时部分患者觉眼干感,EGF组明显较对照组轻(P<0.05)。两组均未发生Haze病例;术后1wk和3mo时EGF组Schirmer’s Test值明显优于对照组(P<0.05)。观察全程中未出现药物毒副作用。结论:重组人表皮生长因子衍生物能减轻LASIK后眼表刺激症状,促进角膜上皮机械性损伤的修复,稳定泪膜,安全、无毒副作用。

AIM：To evaluate the effects and safety of ectogenous EGF on corneal epithelium recovery after Laser assisted in situ keratomileusis （LASIK） by observing corneal response prospectively in early period of post-LASIK. METHODS： Post-LASIK patients were enrolled and divided into EGF group and controlled group through a randomized, single blind, non-parallel controlled trial, In this trial, we contrasted and analyzed drug toxicity and the changes of items of each group at postoperative 1st week, 3rd week, 1st month and 3rd month. The items include naked visual acuity, diopter, pain feeling, photophobia, foreign body sensation, drying eye feeling, corneal epithelial opacity, mixing hyperaemia, tear breakup time（ BUT）, Schirmer＇s Test and Haze. RESULTS： There were no statistical differences between two groups on sexing, aging, diopter preoperatively and postoperatively. The general effect of EGF group was significantly better than controlled group at 3rd month postoperatively（P〈 0.05）. Nobody complained pain and photophobia preoperatively and postoperatively in each group at any time. Only several patients felt foreign body sensation in each group at 1st week, and disappeared very soon （ P〉 0.05）. Drying eye feeling of some cases in EGF group was slighter statistically than in controlled group at 1st week and 3rd month （P〈0.05）. We had never observed haze preoperatively and postoperatively in each group at any time. Just Schirmer ＇s Test value recovering in EGF group was better statistically than in controlled group at 1st week and 3rd month （P〈 0.05）. There were no differences in other signs between the two groups（P〉0.05）. There was no drug toxicity during the trial. CONCLUSION ： rhEGF can relieve ocular surface irritation of post-LASIK and toxicity comes from steroid eye drops, benefit to epithelium recovery from mechanical injury, and stabilize lacrimal film safely and without creating toxic and side effects.