目的 观察双丹明目胶囊联合玻璃酸钠滴眼液治疗阴虚火旺型中度干眼的临床疗效。方法 纳入2023年6月—2024年5月在河南中医药大学第三附属医院眼科就诊的阴虚火旺型中度干眼患者120例，随机分为对照组和治疗组，每组各60例。对照组予以玻璃酸钠滴眼液，1～2滴/次，3次/d。治疗组在对照组基础上口服双丹明目胶囊，4粒/次，3次/d。两组疗程均为4周。观察两组患者临床疗效，比较治疗前后两组患者泪膜功能指标泪膜破裂时间（FBUT）、Schirmer Ⅰ试验（SⅠT）和角膜荧光素染色评分（FL），眼表疾病指数（OSDI）和中医证候评分，及炎症因子白细胞介素-6（IL-6）、IL-1β和IL-17水平。结果 治疗后，治疗组总有效率显著高于对照组（100% vs 90%，P＜0.05）。治疗后，两组泪膜功能指标FBUT和SIT比治疗前明显升高，而FL明显降低（P＜0.05），且治疗组泪膜功能明显优于对照组（P＜0.05）。治疗后，两组OSDI和中医证候评分均显著降低（P＜0.05），且治疗组疾病量表评分明显低于对照组（P＜0.05）。治疗后，两组IL-6、IL-1β、IL-17均显著降低（P＜0.05），且治疗组炎症因子水平明显低于对照组（P＜0.05）。结论 双丹明目胶囊联合玻璃酸钠滴眼液治疗阴虚火旺型中度干眼疗效高于玻璃酸钠滴眼液单用，对患者泪膜功能、临床症状及泪液炎症因子分泌改善明显。

Objective To observe the clinical efficacy of Shuangdan Mingmu Capsules combined with Sodium Hyaluronate Eye Drops in treatment of moderate dry eye of yin deficiency and fire hyperactivity type. Methods Patients (120 cases) with moderate dry eye of yin deficiency and fire hyperactivity type in Third Affiliated Hospital of Henan University of Traditional Chinese Medicine from June 2023 to May 2024 were randomly divided into control and treatment group, and each group had 60 cases. Patients in the control group were administered with Sodium Hyaluronate Eye Drops, 1 — 2 drops/time, three time daily. Patients in the treatment group were po administered with Shuangdan Mingmu Capsules on the basis of the control group, 4 grains/time, three time daily. Patients in two groups were treated for 4 weeks. After treatment, the clinical evaluations were evaluated, and the tear film function indexes of FBUT, SIT and FL, the scores of OSDI and TCM syndrome, and the levels of IL-6, IL-1β and IL-17 in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group was significantly higher than that in the control group (100% vs 90%, P < 0.05). After treatment, the tear film function indicators FBUT and SIT in two groups were significantly higher than those before treatment, while FL was significantly decreased (P < 0.05), and the tear film function in the treatment group was significantly better than that in the control group (P < 0.05). After treatment, the OSDI and TCM syndrome scores in two groups were significantly reduced (P < 0.05), and the disease scale score in the treatment group was significantly lower than that in the control group (P < 0.05). After treatment, IL-6, IL-1β, and IL-17 were significantly reduced in two groups (P < 0.05), and the level of inflammatory factors in the treatment group was significantly lower than that in the control group (P < 0.05). Conclusion The efficacy of Shuangdan Mingmu Capsules combined with Sodium Hyaluronate Eye Drops in treating moderate dry eye with yin deficiency and fire excess is higher than that of sodium hyaluronate eye drops alone. It significantly improves the patient's tear film function, clinical symptoms and secretion of tear inflammatory factors.

R988.1

中国中医科学院望京医院科研项目（WJZJ-202315）