目的：探讨氟米龙联合玻璃酸钠滴眼液治疗干眼的效果及对泪液中炎症因子的影响。

方法：采用前瞻性随机对照研究设计，连续收集2017-02/2019-12我院眼科收治的干眼患者116例232眼作为研究对象，采用随机数字表法将患者分为两组，对照组58例116眼给予玻璃酸钠滴眼液治疗，观察组58例116眼在对照组基础上给予0.1%氟米龙滴眼液治疗。于治疗前及治疗2、4wk时进行眼表疾病评分指数(OSDI)评分，测定泪膜破裂时间(BUT)、基础泪液分泌试验(SⅠt)、角膜荧光素染色(FL)评分，进行眼表综合分析测定泪河高度(TMH)、非侵入性泪膜破裂时间(NIKBUT)，采用结膜印记试验测定上皮细胞分级及杯状细胞密度，测定泪液中白细胞介素-1β(IL-1β)、白细胞介素-6(IL-6)、转化生长因子-β1(TGF-β1)水平，评估两种治疗方法的疗效及安全性。

结果：观察组及对照组总体有效率分别为94.8%、82.8%(P<0.05)。治疗4wk时，观察组SⅠt、BUT、NIKBUT高于对照组，FL评分、OSDI评分低于对照组(P<0.05)； 观察组杯状细胞密度高于对照组(P<0.05)。观察组治疗2、4wk时泪液中IL-6、IL-1β显著低于对照组，治疗4wk时TGF-β1显著高于对照组(P<0.05)。两组患者不良反应发生率分别为3.4%、1.7%(P>0.05)。

结论：氟米龙联合玻璃酸钠可显著改善干眼患者临床症状，提高泪膜稳定性，其机制可能与其对眼表炎症因子的调节作用相关。

METHODS: A prospective randomized controlled study was conducted in 116 patients(232 eyes)with xerophthalmia who were treated between February 2017 and December 2019. They were randomly divided into observation group and control group, 58 cases(116 eyes)in each group. The control group was treated with sodium hyaluronate eye drops, while the observation group was treated with 0.1% fluorometholone eye drops based on the treatment for the control group. Ocular Surface Disease Index(OSDI)scoring was carried out before treatment and after 2wk and 4wk of treatment. The tear film break-up time(BUT), Schirmer I test(SⅠt)and corneal fluorescent staining(FL)scores were measured. The tear meniscus height(TMH)and noninvasive keratograph tear breakup time(NIKBUT)were determined by eye surface comprehensive analyzer. Conjunctival impression cytology was performed to determine epithelial cell grading score and goblet cell density. Levels of interleukin 1β(IL-1β), interleukin -6(IL-6)and transforming growth factor β1(TGF-β1)in tears were determined. Meanwhile, efficacy and safety were evaluated.

RESULTS: The overall response rates of the observation group and the control group were 94.8% and 82.8%(P<0.05). The observation group had higher SⅠt, BUT and NIKBUT, lower FL scores and OSDI scores than the control group at 4wk(P<0.05). The goblet cell density was higher in the observation group than in the control group at 4wk(P<0.05). IL-6 and IL-1β in the observation group were significantly lower than those in the control group at 2wk and 4wk, and TGF-β1 was significantly higher than that in the control group at 4wk(P<0.05). The incidences of adverse reactions in the two groups were 3.4% and 1.7%(P>0.05).

CONCLUSION: Fluorometholone combined with sodium hyaluronate can significantly improve clinical symptoms as well as tear film stability in patients with xerophthalmia, which may be related to regulating effect on ocular surface inflammatory factors.