中国医科大学学报2026，Vol.55Issue(2)：109-114,121,7.DOI:10.12007/j.issn.0258-4646.2026.02.003
石决明散加减方联合人工泪液治疗肝经郁热型干眼的效果
Effect of modified Shijueming San formula combined with artificial tears for treating dry eye with stagnation-heat pattern in the liver meridian
摘要
Abstract
Objective To evaluate the efficacy and safety of modified Shijueming San formula combined with artificial tears in patients with dry eye with stagnation-heat pattern in the liver meridian.Methods This prospective,single-blind,randomized controlled trial enrolled 74 patients who were randomly assigned to either an experimental group or a control group(37 patients each).Both groups received 0.1%sodium hyaluronate eye drops bilaterally(one drop each time,6 times daily)for 8 weeks.The experimental group addi-tionally received granules of the modified Shijueming San formula(13.1 g per dose,twice daily).Related indicators were assessed before treatment and at 2,4,and 8 weeks after the treatment.The major indicators included ocular surface disease index(OSDI),non-invasive tear breakup time(NITBUT),and traditional Chinese medicine symptom(TCM)scores.The secondary indicators included corneal fluores-cein staining(CFS),corneal sensitivity,tear meniscus height(TMH),and tear film lipid layer thickness(TFLL).Safety indicators included best-corrected visual acuity,intraocular pressure,corneal endothelial cell density,and adverse events.Independent-samples t test or χ2 tests were used to identify differences in the indicators.Results Both groups showed significant improvements in OSDI,NITBUT,and TCM scores after treatment compared to baseline(all P<0.05).Compared with the control group,the experimental group exhibited signif-icant improvements in OSDI(weeks 4 and 8 after treatment),NITBUT(weeks 8 after treatment),and TCM scores(weeks 2,4,and 8 after treatment;all P<0.05).In addition,the CFS significantly improved at weeks 4 and 8 after treatment in the experimental group(P<0.05).No significant differences in the CFS were observed between the two groups.No significant changes in corneal sensitivity,TMH,or TFLL were observed within or between the groups(P>0.05).No adverse events were also observed in either group.Conclusion The modified Shijueming San formula combined with artificial tears effectively and safely improved the symptoms of dry eye with stagnation-heat pattern in the liver meridian and enhanced tear film stability.关键词
干眼/肝经郁热/石决明散加减方/疗效Key words
dry eye/stagnation-heat in the liver meridian/modified Shijueming San formula/efficacy分类
医药卫生引用本文复制引用
刘子铭,蒲宗明,赵磊,安元龙,张东蕾,何伟..石决明散加减方联合人工泪液治疗肝经郁热型干眼的效果[J].中国医科大学学报,2026,55(2):109-114,121,7.基金项目
国家自然科学基金(82104714) （82104714）
