小牛血去蛋白提取物眼用凝胶治疗弥漫性角膜上皮点状脱落的疗效观察

摘要

目的 探讨小牛血去蛋白提取物眼用凝胶治疗弥漫性角膜上皮点状脱落的临床疗效.方法 收集36例(36只眼)弥漫性角膜上皮点状脱落患者,随机分为2组,其中小牛血去蛋白提取物组(试验组)19例,重组牛碱性成纤维细胞生长因子眼用凝胶组(对照组)17例.两组均每天4次,每次1滴,疗程14 d.用药前和用药后14 d分别进行角膜染色评分、泪膜破裂时间(BUT)、Schirmer泪液分泌试验(SⅠt)和视力的评估.根据数据的正态分布和方差齐性选择合适的统计方法.计量资料采用t检验,不符合正态性及方差不齐时,采用Wilcoxon非参数法,同组前后比较采用配对t检验.计数资料采用卡方、校正卡方、Fisher精确检验等.结果 用药后14d,试验组与对照组角膜染色评分较基线期分别下降(3.895±2.307)和(2.235±2.047),差异有统计学意义(t=5.7083,4.5019；P＜0.01).且两组间下降幅度差异有统计学意义(t=2.2712,P =0.0296).两组治疗14 d后的BUT均较基线期明显增加(Z =2.226,2.527；P＜0.05),但组间差异无统计学意义(Z=1.336,P=0.1815).治疗14 d后,试验组与对照组的SⅠt结果较基线期变化无统计学意义(t=0.4207,1.1255；P＞0.05),组间差异无统计学意义(t=0.9830,P=0.3325).两组视力变化较基线期无统计学意义(Z=1.897,1.786;P＞0.05).结论 小牛血去蛋白提取物眼用凝胶治疗弥漫性角膜上皮脱落疗效确切,且优于重组牛碱性成纤维细胞生长因子眼用凝胶.%Objective To evaluate the clinical efficacy of protein-free calf blood extract ophthalmic gel for diffuse punctate corneal epithelial defects.Methods 36 patients (36 eyes) with diffuse punctate corneal epithelial defects were enrolled between Oct.2008 and Apr.2009 in outpatient clinic from Eye Ear Nose and Throat Hospital of Fudan University.Patients were randomized divided into protein-free calf blood extract ophthalmic gel group (the test group,19 eyes)and recombinant bovine basic fibroblast growth factor ophthalmic gel group (the control group,17 eyes).The drugs were delivered in both groups 4 times per day,one drop each time in the 14 days duration.Corneal staining,the tear break-up time,the Schirmer value and visual acuity were evaluated on the pre-delivery day and the post-delivery day 14.Results On day 14,both the test group and control group had a significant decrease from baseline in corneal staining (the test group t =5.7083,P =0.0000 and the control group t=4.5019,P=0.0004,respectively).And improvements of corneal staining in the test group was more significant than that in the control group (t=2.2712,P =0.0296).Improvements were seen in BUT values in both group on day 14,as compared to baseline (the test group Z =2.226,P =0.0260 and the control group Z =2.527,P =0.0115,respectively).However,there was no significant difference between groups (Z =1.336,P =0.1815).As to the Schirmer value,there were neither difference within groups from baseline (the test group t =0.4207,P =0.6790 and the control group t =1.1255,P =0.2770,respectively).Nor between groups (t=0.9830,P=0.3325).And no obvious changes from baseline in visual acuity were observed in both groups (the test group Z =1.897,P=0.0578 and the control group Z =1.786,P =0.0741,respectively).Conclusion The efficacy of protein-free calf blood extract ophthalmic gel is prior to recombinant bovine basic fibroblast growth factor ophthalmic gel in patients with diffuse punctate corneal epithelial defects.