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目的探讨重组人表皮生长因子衍生物(rhEGF)滴眼液治疗干眼所引起的角膜上皮损伤——表层点状角膜病变(SPK)的临床效果及安全性。方法应用前瞻性评估研究方法,对干眼合并SPK674眼(337例),按随机双盲原则分为两组:rhEGF滴眼液试验组336眼(168例),其中轻、中、重症亚组依次为146、122、68眼;硫酸软骨素滴眼液(人工泪)对照组338眼(169例),其中轻、中、重症亚组依次为154、114、70眼,分别对疗效和不良反应情况进行观察评估。结果缓解干眼症状(眼疼、畏光、流泪、异物感):试验组和对照组两组之间轻、中、重亚组间两两对比,差异均无统计学意义(P=0.118、P=0.128、P=0.092);治疗干眼体征(SPK):轻、中、重症亚组总有效率分别为75.4%、74.0%、38.2%和64.9%、44.2%、22.9%。两组轻、中、重症亚组间的比较,轻症亚组中两者差异无统计学意义(P=0.118),在中症及重症亚组中两者差异有统计学意义(P=0.001,P=0.034)。结论rhEGF滴眼液在治疗、促进中、重度干眼所引起的角膜上皮损伤(SPK)优于硫酸软骨素滴眼液,特别是中度者的疗效更为明显,并具有较好的耐受性和安全性。
Objective To investigate the clinical efficacy and safety of recombinant human epidermal growth factor derivative (rhEGF) eye drops in the treatment of corneal epithelial injury-surface punctate keratopathy (SPK) caused by dry eye. Methods According to the randomized double-blind principle, 337 eyes (337 eyes) with dry eye were divided into two groups according to the method of prospective evaluation: 336 eyes (168 eyes) with rhEGF eye drop test group, of which mild, moderate and severe subgroup Followed by 146,122,68 eyes; control group 338 eyes (169 cases) with chondroitin sulfate eye drops (artificial tears), of which 154,114,70 eyes were followed by mild, moderate and severe subgroups, respectively, for efficacy and poor The reaction was observed and evaluated. Results The symptoms of dry eye were alleviated (eye pain, photophobia, tearing, foreign body sensation): There was no significant difference between the two groups in the test group and in the control group (P = 0.118, P = 0.128, P = 0.092). The total effective rate of light, moderate and severe subgroups was 75.4%, 74.0%, 38.2% and 64.9%, 44.2% and 22.9% respectively. There was no significant difference between the two subgroups of mild, moderate and severe subgroups (P = 0.118), but there was no significant difference between subgroups of moderate and severe subgroups (P = 0.001 , P = 0.034). Conclusion rhEGF eye drops are superior to chondroitin sulfate eye drops in the treatment and promotion of moderate and severe dry eye corneal epithelial injury (SPK), especially those with moderate and severe symptoms, with better tolerability Sexuality and safety.