目的 探讨重组牛碱性成纤维细胞生长因子眼用凝胶联合环孢素滴眼液治疗中重度干眼症的效果。方法 选取2020年5月—2023年4月天长市人民医院就诊的88例中重度干眼症患者，使用随机数字表法将所有患者分为对照组和治疗组，每组各44例。对照组给予环孢素滴眼液，每眼1滴/次，4次/d。治疗组在对照组治疗基础上给予重组牛碱性成纤维细胞生长因子眼用凝胶，涂于患眼，早晚各1次。两组疗程均为8周。考察两组患者的临床疗效，比较治疗前后眼表状况指标、眼表疾病指数量表（OSDI）、简式抑郁–焦虑–压力量表（DASS-21）评分、视觉质量指标和血清白细胞介素-6（IL-6）水平。结果 治疗后，治疗组总有效率是95.45%，显著高于对照组的81.82%（P＜0.05）。治疗后，两组SⅠt（无麻醉）、荧光素染色泪膜破裂时间（FBUT）显著增加，而角膜荧光素染色（FL）评分、睑板腺缺失面积评分显著降低（P＜0.05）；治疗后，治疗组眼表状况指标改善优于对照组（P＜0.05）。治疗后，两组OSDI、DASS-21评分均显著降低（P＜0.05）；且以治疗组显著更低（P＜0.05）。治疗后，两组调制传递函数截止频率（MTF cut off）、斯特列尔比（SR）均显著增高，而泪膜动态客观散射指数（TF-OSI）、血清IL-6水平均显著下降（P＜0.05）；治疗后，治疗组患者视觉质量指标和血清IL-6水平改善更明显（P＜0.05）。结论 重组牛碱性成纤维细胞生长因子眼用凝胶联合环孢素滴眼液治疗中重度干眼症可取得显著效果，能有效改善患者泪液分泌功能，促进眼表损伤和症状缓解，对心理状态改善具有积极作用，值得临床应用和推广。

Objective To investigate the effect of Recombinant Bovine Basic Fibroblast Growth Factor Eye-Gel combined with Cyclosporin Eye Drops in treatment of moderate to severe dry eye. Methods A total of 88 patients with moderate to severe dry eye treated in Tianchang People’s Hospital from May 2020 to April 2023 were selected, and all patients were divided into control group and treatment group using random number table method, with 44 cases in each group. Patients in the control group were given Cyclosporin Eye Drops, 1 drop/time per eye, four times daily. Patients in the treatment group were given Recombinant Bovine Basic Fibroblast Growth Factor Eye-Gel on the basis of the control group, applied to affected eye once in the morning and once in the evening. The treatment course of both groups was 8 weeks. After treatment, the clinical efficacy was evaluated, and eye surface condition indicators, eye surface disease index (OSDI), simplified depression anxiety stress scale (DASS-21) scores, visual quality indicators, and serum interleukin-6 (IL-6) levels between the two groups before and after treatment were compared. Results After treatment, the total effective rate of the treatment group was 95.45%, which was significantly higher than that of the control group (81.82%, P < 0.05). After treatment, the tear film rupture time (FBUT) of SⅠt (without anesthesia) and fluorescein staining were significantly increased in both groups, but the score of corneal fluorescein staining (FL) and the score of missing area of meibomian gland were significantly decreased (P < 0.05). After treatment, the improvement of ocular surface indexes in the treatment group was better than that in the control group (P < 0.05). After treatment, OSDI and DASS-21 scores were significantly decreased in both groups (P < 0.05). It was significantly lower in the treatment group (P < 0.05). After treatment, MTF cut off frequency (MTF cut off) and Streller ratio (SR) were significantly increased in both groups, while dynamic objective scattering index (TF-OSI) and serum IL-6 levels were significantly decreased in both groups (P < 0.05). After treatment, the visual quality index and serum IL-6 level were improved more significantly in the treatment group (P< 0.05). Conclusion Recombinant Bovine Basic Fibroblast Growth Factor Eye-Gel combined with Cyclosporin Eye Drops has significant effect in treatment of moderate to severe dry eye, and can effectively improve the tear secretion function of patients, promote the ocular surface injury and symptom relief, and has a positive effect on the improvement of psychological state, which is worthy of clinical application and promotion.

R988.1

江苏省医学科技攻关计划项目(202103018)