Objectiye To observe the effects of recombinant bovine basic fibroblast growth factor (r-bFGF) on the LASIK-induced neurotrophic epitheliopathy (LINE) and the recovery of corneal sensation after LASIK. Methods Prospective clinical study. LINE was found in 60 patients out of 1154 cases of LASIK (5.2% ). The 60 cases were randomly divided into three groups, each group including 20 cases.Group A was treated with r-bFGF eye drops (fusion protein), four times a day. Group B was treated with r-bFGF eye-gel, four times a day. Group C was treated with 0.1% sodium hyaluronate eye drops as a control. The treatment started since LINE was diagnosed. The typical clinical finding of LINE was punctate corneal erosion, which could be evaluated by slit-lamp examination and fluorescein staining. Masked CochetBonnet esthesiometry was performed in the central cornea one week preoperatively and 1, 3, 6 and 12 months postoperatively. Results ( 1 ) The average times of corneal erosion occurrence were ( 28.57 ±37.48 ) d, ( 30.82 ± 35.08 ) d and ( 16.84 ± 23.70 ) d in group A, group B and group C respectively. No significant differences were observed among the three groups ( F = 1.456,P -0.238), and the average times of corneal erosion disappearance were (7.19 ± 8.23 ) d, (2.86 ± 1.73 ) d and ( 7.00 ± 6.40 ) d in group A, group B and group C, respectively. The punctate corneal erosion cured significantly faster in r-bFGF eyegel treated group (P1 =0.007,P2 =0.014). (2)The loss of corneal sensation was greatest at 1 week after LASIK in all the three groups and improved at all subsequent examination time points. The corneal sensation gradually recovered through 12 months observation, but the r-bFGF eye-gel treated group showed faster recovery in comparison with the other two groups, had no statistic different at 6 month comparied with preoperation values( F = 0.55, P = 0.064). Conclusion The r-bFGF eye-gel is effective for both punctate corneal erosion (especially for severe LINE) and recovery of corneal sensation following LASIK surgery.%目的 评价重组牛碱性成纤维细胞生长因子(r-bFGF)对准分子激光原位角膜磨镶术(LASIK)后神经营养性角膜上皮病变(LINE)和角膜知觉恢复的疗效.方法 前瞻性临床随机对照研究.对2007年5月至2008年7月在解放军总医院眼科行双眼LASIK手术患者,术前同意按要求随访的手术病例进行观察,共连续观察1154例,收集术后出现LINE患者,收集满60例结束.所有病例按不平衡指数最小的分配原则随机分为3组,每组20例,并开始治疗.A组采用r-bFGF滴眼液滴眼,4次/d;B组采用r-bFGF眼用凝胶滴眼,4次/d;C组用0.1%玻璃酸钠滴眼液滴眼,4次/d作为对照.观察用药后LINE消失时间以及术后角膜知觉恢复情况.手术前及术后各时间点比较以及各组之间比较采用方差分析方法.结果 (1)LINE发生率为5.2%,临床双眼角膜上皮点状糜烂较对称性出现,术后LINE出现时间:r-bFGF滴眼液组(28.57±37.48)d,r-bFGF眼用凝胶组(30.82±35.08)d,玻璃酸钠组(16.84±23.70)d,3组之间的比较采用方差分析,差异无统计学意义(F=1.456,P=0.238);LINE平均消失时间:r-bFGF滴眼液组(7.19±8.23)d,r-bFGF眼用凝胶组(2.86±1.73)d,玻璃酸钠组(7.00±6.40)d,3组比较,差异无统计学意义(F=4.521,P=0.130).(2)术前角膜知觉,r-bFGF滴眼液组(52.5±8.2)mm,r-bFGF眼用凝胶组(53.0±5.5)mm,玻璃酸钠滴眼液组(51.8±8.1)mm,3组比较,差异无统计学意义(F=0.036,P=0.849).术后3 d角膜知觉均有显著性的下降,分别为(18.8±9.5)mm,(17.4±9.9)mm和(13.4±4.6)mm,仅为术前水平的25.9%～35.8%,但各组间差异无统计学意义(F=0.542,P=0.463).随着给药时间延长各组角膜知觉均在逐渐恢复.在术后6个月时,r-bFGF滴眼液组角膜知觉为(48.4±10.0)mm,凝胶组为(49.8±9.9)mm,而玻璃酸钠组为(39.4±11.0)mm,3组角膜知觉分别为术前水平的92.1%,94.0%及76.1%,显示r-bFGF药物治疗的两组角膜知觉恢复比玻璃酸钠组恢复更快.统计学上r-bFGF眼用凝胶组与术前比较,差异无统计学意义(F=0.55,P=0.064).但在术后12个月时,玻璃酸钠组才接近术前正常水平.其他两组角膜知觉平均值均完全达到术前正常水平.结论 r-bFGF有助于LASIK术后角膜神经营养性上皮病变的修复,加速LASIK术后角膜知觉的恢复.
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