目的 觀察雙丹明目膠囊聯(lián)合玻璃酸鈉滴眼液治療陰虛火旺型中度干眼的臨床療效。方法 納入2023年6月—2024年5月在河南中醫(yī)藥大學(xué)第三附屬醫(yī)院眼科就診的陰虛火旺型中度干眼患者120例，隨機(jī)分為對(duì)照組和治療組，每組各60例。對(duì)照組予以玻璃酸鈉滴眼液，1～2滴/次，3次/d。治療組在對(duì)照組基礎(chǔ)上口服雙丹明目膠囊，4粒/次，3次/d。兩組療程均為4周。觀察兩組患者臨床療效，比較治療前后兩組患者淚膜功能指標(biāo)淚膜破裂時(shí)間（FBUT）、Schirmer Ⅰ試驗(yàn)（SⅠT）和角膜熒光素染色評(píng)分（FL），眼表疾病指數(shù)（OSDI）和中醫(yī)證候評(píng)分，及炎癥因子白細(xì)胞介素-6（IL-6）、IL-1β和IL-17水平。結(jié)果 治療后，治療組總有效率顯著高于對(duì)照組（100% vs 90%，P＜0.05）。治療后，兩組淚膜功能指標(biāo)FBUT和SIT比治療前明顯升高，而FL明顯降低（P＜0.05），且治療組淚膜功能明顯優(yōu)于對(duì)照組（P＜0.05）。治療后，兩組OSDI和中醫(yī)證候評(píng)分均顯著降低（P＜0.05），且治療組疾病量表評(píng)分明顯低于對(duì)照組（P＜0.05）。治療后，兩組IL-6、IL-1β、IL-17均顯著降低（P＜0.05），且治療組炎癥因子水平明顯低于對(duì)照組（P＜0.05）。結(jié)論 雙丹明目膠囊聯(lián)合玻璃酸鈉滴眼液治療陰虛火旺型中度干眼療效高于玻璃酸鈉滴眼液?jiǎn)斡茫瑢?duì)患者淚膜功能、臨床癥狀及淚液炎癥因子分泌改善明顯。

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

中國(guó)中醫(yī)科學(xué)院望京醫(yī)院科研項(xiàng)目（WJZJ-202315）