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目的:评估重组人表皮生长因子(rh-EGF)滴眼液对圆锥角膜患者接受强化的跨上皮角膜交联术后早期上皮修复及泪膜稳定性的影响。方法:采用随机对照临床试验，连续收集2016年10月至2017年1月于厦门大学附属厦门眼科中心住院治疗的原发性进展期圆锥角膜并拟进行强化的离子电渗法跨上皮角膜交联术的患者66例66眼，其中男37例，女29例，平均年龄(21.27±3.80)岁。采用随机数字表法将患者随机分为对照组和试验组，每组33例33眼，分别使用羧甲基纤维素钠滴眼液和rh-EGF滴眼液点眼。在术前和术后第1、3、5、7、14、28天时对2个组患者分别行眼表疾病指数(OSDI)问卷评估、裂隙灯生物显微镜检查、角膜荧光素钠染色评分、非接触式眼压测量、裸眼视力(UCVA)和最佳矫正视力(BCVA)检查、球结膜充血程度评估、泪液分泌试验、非接触式泪膜破裂时间(NIBUT)测定、泪河高度测定并进行比较。结果:术后第7天，2个组患眼OSDI值均较术前显著增加，试验组患眼OSDI值较对照组低，差异均有统计学意义(均n P<0.05)。2个组角膜胶原交联手术前后不同时间点患眼角膜上皮染色评分值的总体比较差异均有统计学意义(n F组别＝16.701，n P<0.01；n F时间＝454.418，n P<0.01)，其中术后第3天和第5天，试验组患眼角膜上皮染色评分分别为1.79±0.65和0.91±0.46，明显低于对照组的2.70±0.68和1.55±0.51，差异均有统计学意义(均n P<0.01)。术后第3天和第5天，试验组患眼球结膜充血程度分值明显低于对照组，差异均有统计学意义(均n P<0.05)。2个组手术前后不同时间点患眼NIBUT值比较差异均有统计学意义(n F组别＝13.084，n P<0.01；n F时间＝34.383，n P<0.01)。2个组术后第7、14和28天时NIBUT值均较术前有所下降，差异均有统计学意义(均n P<0.01)，但随着术后时间的延长而逐渐回升；术后第7天和第14天，试验组患眼的NIBUT值分别为(8.18±2.26)s和(9.49±1.95)s，明显高于对照组的(5.93±2.33)s和(7.52±2.27)s，差异均有统计学意义(均n P0.05)。n 结论:rh-EGF对圆锥角膜患者接受强化的跨上皮角膜交联术后上皮修复具有明显促进作用，可在一定程度上改善患眼角膜交联术后早期不适，促进泪膜稳定性的恢复。“,”Objective:To investigate the impact of recombinant human epidermal growth factor (rh-EGF) on the epithelial recovery and the tear film stability after trans-epithelial corneal collagen crosslinking in patients with progressive keratoconus.Methods:A randomized controlled clinical trail was designed.Consecutive 66 patients (37 males and 29 females) with an average age of (21.27±3.80) years old diagnosed with primary progressive keratoconus and hospitalized in Xiamen Eye Center Affiliated to Xiamen University from October, 2016 to January, 2017 were enrolled and treated with unilateral enhanced transepithelial corneal crosslinking surgery by iontophoresis, and the patients were randomly divided into control group and experimental group according to random number table method, with 33 patients 33 eyes in each group.The eyes in the control group were treated with carboxy-methylcellulose sodium lubricant eye drops and the eyes in the experimental group were treated with rh-EGF eye drops.The ocular surface disease index (OSDI) questionare, slit lamp examination, Schirmer Ⅰ test, corneal fluorescein sodium staining scoring, non-contact tonometry, uncorrected visual acuity, best corrected visual acuity, bulbar conjunctival congestion scoring, lacrimal sevretion test, non-invasive break-up time of tear film (NIBUT), as well as tear meniscus height analysis were performed before surgery, and on day 1, day 3, day 5, day 7, day 14 and day 28 after surgery.This study followed the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Xiamen Eye Center Affiliated to Xiamen University (No.2016-ME-003).Results:On day 7 after surgery, the OSDI values were increased in both groups than the preoperative value, while the value in the experimental group was significantly lower than that in the control group (n P<0.05). There were statistically significant differences in the overall corneal epithelial staining score values between the two groups at different time points (n Fgroup=16.701, n P<0.01;n Ftime=454.418, n P<0.01). The corneal epithelial staining score in the experimental group on day 3 and day 5 after surgery were significantly lower than those in the control group (1.79±0.65n vs. 2.70±0.68; 0.91±0.46 n vs. 1.55±0.51) (both at n P<0.01). The conjunctival congestion score in the experimental group was significantly lower than that of the control group on day 3 and day 5 after surgery (both atn P<0.05). There were statistically significant differences in the overall NIBUT values between the two groups at different time points (n Fgroup=13.084, n P<0.01;n Ftime=34.383, n P<0.01). The NIBUT values were significantly decreased rapidly on day 7, day 14 and day 28 after surgery in both groups (all atn P<0.01), but gradually recovered.The NIBUT of the experimental group on day 7 and day 14 after surgery were significantly higher than those of the control group ([8.18±2.26]secondsn vs. [5.93±2.33]seconds; [9.49±1.95]secondsn vs. [7.52±2.27]seconds) (both at n P0.05).n Conclusions:Recombinant human epidermal growth factor has positive effects in the patients received enhanced transepithelial corneal crosslinking surgery, presenting with promotion of epithelial healing, relief of post-operative discomfort, and the recovery of tear film stability.