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OA
Effect of modified Shijueming San formula combined with artificial tears for treating dry eye with stagnation-heat pattern in the liver meridian
目的 探讨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与安全性.方法 采用前瞻性、单盲、随机对照设计,将74例肝经郁热型干眼患者随机分为试验组与对照组,每组37例.2组患者双眼均使用0.1%玻璃酸钠滴眼液治疗,1滴/次,6次/d,共治疗8周.试验组加服石决明散加减方颗粒,13.1 g/次,2次/d.于治疗前及治疗2、4、8周时记录主要指标[眼表疾病指数(OSDI)、非侵入性泪膜破裂时间(NITBUT)及中医症状积分]、次要指标[角膜荧光素染色(CFS)评分、角膜敏感度、泪河高度(TMH)、泪膜脂质层厚度(TFLL)]、安全性评价指标[最佳矫正视力(BCVA)、眼压(IOP)、角膜内皮细胞密度(ECC)、不良反应(视力变化、眼部不适及全身性不适等)发生情况].采用t检验或χ2检验比较2组治疗后各项指标的差异.结果 与治疗前比较,治疗后2组患者OSDI、NITBUT及中医症状积分显著改善(均P<0.05).与对照组相比,试验组改善OSDI(治疗4、8周时)、NITBUT(治疗8周时)及中医症状积分(治疗2、4、8周时)效果更显著(均P<0.05).此外,试验组治疗4、8周时CFS评分较治疗前显著改善(P<0.05),但组间差异无统计学意义(P>0.05).而2组角膜敏感度、TMH与TFLL治疗前后及组间比较差异均无统计学意义(P>0.05).2组均未发生不良反应.结论 石决明散加减方联合人工泪液可有效改善肝经郁热型干眼患者症状,稳定泪膜,且安全性良好.
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.
刘子铭;蒲宗明;赵磊;安元龙;张东蕾;何伟
辽宁中医药大学第一临床学院,沈阳 110847||沈阳何氏眼科医院尖端医疗技术部,沈阳 110034沈阳何氏眼科医院尖端医疗技术部,沈阳 110034||大连医科大学附属第二医院,辽宁 大连 116044辽宁中医药大学附属第二医院眼科,沈阳 110034辽宁何氏医学院药学院,沈阳 110163辽宁何氏医学院药学院,沈阳 110163沈阳何氏眼科医院尖端医疗技术部,沈阳 110034
医药卫生
干眼肝经郁热石决明散加减方疗效
dry eyestagnation-heat in the liver meridianmodified Shijueming San formulaefficacy
《中国医科大学学报》 2026 (2)
109-114,121,7
国家自然科学基金(82104714)
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