维生素A棕榈酸酯眼用凝胶联合玻璃酸钠治疗干眼临床研究

Clinical effect of Vitamin A palmitate eye ophthalmic gel combined Ellie eye drops for treatment of dry eye

目的评估应用维生素A棕榈酸酯眼用凝胶治疗干眼的安全性和疗效。方法临床病例对照研究。对2015年2月至2015年12月在中山大学中山眼科中心门诊就诊的患者57例（57只眼）。随机分为三组：A组，予以维生素A棕榈酸酯眼用凝胶（4次/d）；B组，予以0．1％玻璃酸钠滴眼液（4次/d）；C组，予以0．1％玻璃酸钠滴眼液联合维生素A棕榈酸酯眼用凝胶（4次／d）。分别于治疗前、治疗后2周、4周观察患者眼表疾病指数（OSDI）评分、丽丝胺绿染色、角膜素荧光染色（FL）、泪膜破裂时间（BUT）、泪液分泌测试（schirmertest）和结膜印迹细胞检测，各项指标比较采用配对t检验和单因素方差分析。结果治疗后2周，A、C组较治疗前OSDI评分明显降低，差异有统计学意义（P〈0．05）；治疗后4周，C组较其它两组OSDI评分平均值最低，差异有统计学意义（P〈0．05）。治疗后4周，A、C组丽丝胺绿染色和FL评分与治疗前比较明显降低，差异有统计学意义（P〈0．05）；C组较B组丽丝胺绿染色评分更低，差异有统计学意义（P〈0．05）。治疗后4周，A、C组与治疗前相比，ST均增加，差异有统计学意义（P〈0．05）；并且A、C组与B组之间比较，sT均增加，差异有统计学意义（P〈0．05）。C组患者中的9例轻度干眼患者经治疗4周后，结膜杯状细胞密度与治疗前相比均有所增加，差异有统计学意义（P〈0．05）。结论局部应用维生素A棕榈酸酯眼用凝胶联合玻璃酸钠滴眼液治疗干眼安全且有效。

Objective To observe the efficacy and safety of Vitamin A palmitate eye ophthalmic gel for the treatment of dry eye. Methods Totally 57 dry eye patients （57 eyes） enrolled in our hos- pital from February 2015 to December 2015 were randomly divided into three groups： group A, Vita- min A palmitate eye ophthalmic gel; group B, 0.1% Ellie eye drops; group C, Vitamin A palmitate eye ophthalmic gel combined with Ellie eye drops. Each eye drops was used 4 times a day. Ocular surface disease index （OSDI）, lissamine green staining, fluorescent staining （FL）, tear break-up time （BUT）, Schirmer I test and conjunctival impression cytology （IC） was observed in these patients be- fore the treatment, in 2 weeks and 4 weeks after treatment. The mean of the results were compared by Paired t test and One-Way ANOVA. Results After 2 weeks of the treatment, the mean score of OSDI was significantl lower than that before the treatment in group A and C （P 〈0.05）. After 4weeks of the treatment, the mean score of OSDI was the lowest in group C. The lissamine green staining and FL in group A and C were significantly lower than that before the treatment （P 〈0.05）. Furthermore, the lissamine green staining in group C was significantly lower than group B. After 4 weeks of the treatment, the mean score of ST in group A and C was significantly expanded than that before the treatment （P 〈0.05） and those two groups were significantly expanded than group B. There were 9 mild dry eye patients in group C. After 4 weeks of the treatment, the average density of the goblet cells in these patients were significantly increased than that before the treatment （P 〈 0.05）. Conclusions Topical Vitamin A palmitate eye ophthalmic gel combined Ellie eye drops is safe and effective for the treatment of dry eye.