摘要目的 以碱性成纤维细胞生长因子滴眼液为阳性对照药物,通过随机、双盲的多中心平行对照临床试验,评价小牛血去蛋白提取物眼凝胶治疗角膜上皮缺损的疗效和安全性.方法 对外伤或手术所致角膜上皮缺损的240只眼进行随机双盲分组,试验组和对照组各120只眼.试验组用小牛血去蛋白提取物眼凝胶,对照组用碱性成纤维细胞生长因子滴眼液,每日4次,每次1滴,连续用药2周.用药后对患者的症状(疼痛、畏光和流泪)、体征(睫状或结膜充血、角膜缺损面积和角膜新生血管)和用药依从性等进行记录,每周检查至少两次,连续观察2周,并进行统计学分析.结果 此研究实际入选239只眼,试验组120只眼,对照组119只眼.其中角膜移植术后角膜上皮缺损61只眼,翼状胬肉术后角膜上皮缺损106只眼,玻璃体切割术后角膜上皮缺损24只眼,化学机械性角膜上皮损伤36只眼,其他病因导致的角膜上皮缺损12只眼.在试验过程中试验组脱落3例、对照组脱落2例.有10/239只眼滴用药物后出现一过性眼局部轻微的烧灼感或少许刺痛感,没有严重不良事件出现.从症状积分、体征积分和总积分的比较看,试验组和对照组治疗后的各项主客观指标均较前有明显改善,但各阶段两组间各指标改善程度比较其差异全部没有统计学意义.试验组的角膜上皮缺损修复的平均时间为(5.03±3.58)d,对照组为(4.84±2.87)d,试验组和对照组之间差异没有统计学意义(t=0.446,P=0.656).从疗效四级评分和综合有效率两个疗效综合评价指标进行PP和ITT分析,试验组和对照组间差异全部无统计学意义.结论 小牛血去蛋白提取物眼凝胶(每天4次点眼)治疗角膜上皮缺损的疗效和安全性与碱性成纤维细胞生长因子滴眼液相似,能迅速有效地帮助修复缺损的角膜上皮,疗效肯定,耐受性好,安全性高.

abstractsObjective To evaluate the safety and effectiveness of protein-free calf blood extract eye gel for repairing corneal epithelial defect by multiple centers,double mask and randomized clinical study with parrel contrast of bFGF eye gel as positive control.Methods Two hundred forty eyes with corneal epithelial defect due to bums or surgery were randomized into experimental and control groups, then protein-free calf blood extract eye gel and basic fibroblast growth factor(bFGF)eye gel were double maskly used for 2 weeks(q.i.d).Every patient was checked at least twice a week until the end of observation.The symptom and signs after drug administration has been recorded and analyzed statistically.Results 239 eyes (120 eyes in experimental group and 119 eyes in control group)were actually enrolled into the investigation.Among them,61 eyes with corneal epithelial defect suffered from corneal transplantation, 106 eyes from pterygium excision, 24 eyes from corneal epithelial scraping during vitrectomy, 36 eyes from mechanical abrasion, and 12 eyes from other dis-eases.During observation, 10 of 239 eyes have temporary mild burning and little pain alter drug installation.There were no significant differences statistically in the symptoms, signs and effectiveness between experimental and control groups, though all the cases showed improved signs.The average time for fully corned epithelial repair in experimental group was(5.034+ 3.58)days, but(4.84±2.87)days in control group(t=0.446, P=0.656).Conclusion Protein-free calf blood extract eye gel(q.i.d)is safe and effective for repairing de-fective corneal epithelium as bFGF eye gel do.