目的 探讨牛碱性成纤维细胞生长因子滴眼液联合维生素A棕榈酸酯眼用凝胶治疗干眼症的临床效果。方法 选取2020年12月—2021年12月濮阳市油田总医院收治的494例（988眼）干眼症患者，按随机数字表法分成对照组和治疗组，每组各247例。对照组予以维生素A棕榈酸酯眼用凝胶，每眼1滴/次，4次/d。治疗组在对照组基础上予以牛碱性成纤维细胞生长因子滴眼液，每眼1滴/次，4次/d。两组均连续治疗4周。观察两组的临床疗效，比较治疗前后两组相关量表[中国干眼问卷量表、眼表疾病指数（OSDI）量表、视功能相关生存质量量表-25（NEI VFQ-25）]评分、眼表功能指标[荧光素染色泪膜破裂时间（FBUT）、泪河高度、无麻醉下SchirmerⅠ试验（SⅠt）、角膜荧光素染色（FL）评分]及泪液肿瘤坏死因子（TNF）-α、白介素细胞（IL）-1β、IL-6和基质金属蛋白酶9（MMP-9）水平。结果 治疗后，治疗组总有效率为91.1%，显著高于对照组的83.0%（P＜0.05）。治疗后，两组中国干眼问卷量表评分、OSDI量表评分均显著低于治疗前，NEI-VFQ-25评分均显著高于治疗前（P＜0.05）；且均以治疗组的改善更显著（P＜0.05）。两组治疗后FBUT均显著延长，泪河高度和SⅠt（无麻醉）均显著增加，FL评分均显著降低（P＜0.05）；且治疗后，治疗组对FBUT、泪河高度、SⅠt（无麻醉）和FL评分的改善作用较对照组更显著（P＜0.05）。两组治疗后泪液TNF-α、IL-1β、IL-6、MMP-9水平均显著下降（P＜0.05）；且治疗后，治疗组泪液TNF-α、IL-1β、IL-6、MMP-9水平均显著低于对照组（P＜0.05）。结论 牛碱性成纤维细胞生长因子滴眼液联合维生素A棕榈酸酯眼用凝胶治疗干眼症能安全有效地减轻患者干眼症状、改善眼表功能、促进病情缓解及提高生活质量，并可进一步下调泪液TNF-α、IL-1β、IL-6及MMP-9的水平，值得临床推广。

Objective To investigate the clinical effect of Recombinant Bovine Basic Fibrolast Growth Factor Eye Drops combined with Vitamin A Palmitate Eye Gel in treatment of dry eye syndrome. Methods A total of 494 patients (988 eyes) with dry eye syndrome admitted to Puyang Oilfield General Hospital from December 2020 to December 2021 were selected and divided into control group and treatment group according to the random number table method, with 247 cases in each group. Patients in the control group were given Vitamin A Palmitate Eye Gel, 1 drop/eye, 4 times daily. Patients in the treatment group were given Recombinant Bovine Basic Fibrolast Growth Factor Eye Drops on the basis of the control group, 1 drop/eye, 4 times daily. Both groups were treated for 4 weeks. The clinical efficacy of the two groups was observed. The related scales[China Dry Eye Questionnaire, Ocular Surface Disease Index (OSDI) scale, Visual function related Quality of Life Scale-25 (NEI) VFQ-25)] score, ocular surface functional indicators[fluorescein stained tear film rupture time (FBUT), lacrimal river height, SchirmerⅠ test without anesthesia (SⅠt), corneal fluorescein staining (FL) score], tumor necrosis factor-α(TNF)-α, interleukin-1β, IL-6 and matrix metalloproteinase-9 (MMP-9)) level of two groups before and after treatment were compared. Results After treatment, the total effective rate of the treatment group was 91.1%, which was significantly higher than that of the control group (83.0%, P<0.05). After treatment, the scores of Chinese Dry Eye Questionnaire and OSDI in the two groups were significantly lower than before treatment, and the scores of NEI-VFQ-25 were significantly higher than before treatment (P<0.05). The improvement in treatment group was more significant (P<0.05). After treatment, FBUT was significantly prolonged, lacrimal river height and SⅠt (without anesthesia) were significantly increased, and FL score was significantly decreased in both groups (P<0.05). After treatment, the improvement of FBUT, height of lacrimal river, SⅠt (without anesthesia) and FL score in the treatment group were more significant than those in the control group (P<0.05). After treatment, the levels of TNF-α, IL-1β, IL-6 and MMP-9 in tear fluid of the two groups were significantly decreased (P<0.05). After treatment, the levels of TNF-α, IL-1β, IL-6 and MMP-9 in tear of the treatment group were significantly lower than those of the control group (P<0.05). Conclusion Recombinant Bovine Basic Fibrolast Growth Factor Eye Drops combined with Vitamin A Palmitate Eye Gel in treatment of dry eye syndrome can safely and effectively relieve dry eye symptoms, improve ocular surface function, promote disease remission and improve quality of life, which can further down-regulate the expression levels of TNF-α, IL-1β, IL-6 and MMP-9 in tears.

R988.1

濮阳市科技局科技攻关项目（193068）