重组人表皮生长因子衍生物滴眼剂治疗角膜病的随机双盲平行对照临床研究

Clinical evaluation of recombinant human epidermal growth factor derivative eye drops in the treatment of keratopathies

目的 :评价重组人表皮生长因子衍生物 (rhEGF)滴眼剂对轻度干眼症伴点状角膜病变、单纯疱疹性地图状角膜溃疡及中轻度化学烧伤治疗的疗效和安全性。方法 :用随机、双盲、平行对照的方法 ,研究rhEGF滴眼剂与bFGF滴眼剂对 40例轻度干眼症斑点状角膜病变、40例单纯疱疹性地图状角膜溃疡及 40例角膜中轻度化学烧伤患者的临床疗效和安全性。结果 :对于轻度干眼症伴有点状角膜病变、单纯疱疹性地图状角膜溃疡、角膜中轻度化学烧伤组 ,rhEGF滴眼剂的有效率分别为 80 % ( 16/2 0 ) ,10 0 % ( 2 0 /2 0 )和 90 % ( 18/2 0 ) ;对照组有效率分别为 80 % ( 16/2 0 ) ,10 0 %和 95 % ( 19/2 0 )。两组的临床疗效经检验无统计学意义 (P >0 .0 5 )。rhEGF滴眼剂的耐受性良好未出现眼局部或全身不良反应。结论 :重组人表皮生长因子衍生物滴眼剂是治疗轻度干眼症伴点状角膜病变、单纯疱疹性地图状角膜溃疡及角膜中轻度化学烧伤的有效和安全的药物。

Objective To evaluate the efficacy and safety of recombinant human epidermal growth factor derivative(rhEGF) eye drops for mild dry eye syndrome with punctate corneal lesion (PCL),herpes simplex corneal ulcer(HSCU) and mild or moderate corneal chemical burn(CD).Methods A randomized,double-blind and parallel study was carried out.The treating period was at most 4 weeks.One hundred twenty subjects with PCL,HSCU and CD were recruited.Results For the PCL,HSCU and CD patients,the clinical effective rates were 80%(16/20),100%(20/20) and 90%(18/20) respectively in the trial groups,and 80%(16/20),100%(20/20) and 95%(19/20) respectively in control groups with no significant difference between trial and control groups.The good tolerance to rhEGF was showed in all subjects,and no adverse reaction was found during the observing period.Conclusion rhEGF eye drop is an effective and safe drug for PCL,HSCU and CD.