平肝育阴清热方治疗睑板腺功能障碍所致蒸发过强型干眼症的实验分析

目的:评价平肝育阴清热方治疗睑板腺功能障碍导致蒸发过强且中医证属阴虚阳亢型干眼症患者的临床疗效及安全性。方法:连续的120例符合准的门诊患者被纳入试验,按照睑板腺功能的分级(1~3级)分别纳入轻中重三层,每层按照1∶1的比例随机分配为试验组或对照组。两组均予玻璃酸钠滴眼液治疗,1滴/眼/次,每日3次,试验组同时加服平肝育阴清热方配方颗粒,每日2次,两组均连续治疗8周。总体及分层比较两组患者治疗前后非侵入性泪膜破裂时间(NITBUT),角膜病变程度、睑板腺排出脂质难易度、睑板腺结构、眼部症状积分、眼表疾病指数(OSDI)量表得分及中医兼证证候积分。结果:纳入120例患者中脱落1例,剔除3例,116例纳入统计。治疗前后两组患者NITBUT,角膜病变程度,眼部症状积分,OSDI量表得分均表现为试验组优于对照组,差异具有统计学意义;睑板腺排出脂质难易度得分差异无统计学意义,试验组仅有优于对照组的趋势;两组治疗后中医兼证证候得分与治疗前相比差异均有统计学意义。全部纳入病例均无不良反应发生,无心电图或肝肾功能异常改变。结论:平肝育阴清热方可有效改善睑板腺功能障碍导致的蒸发过强,中医证属阴虚阳亢型干眼症患者的泪膜稳定性,眼干涩、灼热、眼痒、异物感等眼部症状及阴虚阳亢的中医症状,且以中重度患者改善效果更为明显;具有改善睑板腺功能的趋势,安全性佳,患者依从性较好。

Efficacy of Pinggan Yuyin Qingre Recipe for Treatment of Hyperevaporative Dry Eye Disease Caused by Meibomian Gland Dysfunction

Objective:To observe the therapeutical effect and the safety of Pinggan Yuyin Qingre recipe on the hyperevaporative dry eye disease(Yin deficiency and Yang hyperactivity type)caused by the meibomian gland dysfunction(MGD). Method:The 120 Consecutive outpatients who met the criteria were included in the trial and divided into three layers(mild,moderate and severe)according to the meibomian gland function classification(grade 1-3). The patients in each layer were randomly assigned to the experiment group and the control group at a ratio of 1∶1. Both groups were treated with sodium hyaluronate eye drops,1 drop/eye/time,3 times a day. In the experiment group,Pinggan Yuyin Qingre recipe was additionally prescribed two times a day.The treatment course was 8 weeks in both groups. All patients were evaluated at the beginning and end of the study mainly for noninvasive tear breakup time(NITBUT),corneal lesions score,meibomian gland exclusion score,meibomian gland structure,eye symptom score,the ocular surface disease index(OSDI)score,and the traditional Chinese medicine(TCM)syndrome scores at both overall and layered levels. Result:A total of 116 cases completed the study,with 1 drop-out case and 3 eliminated cases. Both before and after treatment,NITBUT,the corneal lesions score,the symptom score,and the OSDI score in the experiment group were significantly superior to the control group,but there was no significant difference in meibomian gland exclusion score between two groups,only with a superior tendency in experiment group. There were significant differences in the scores of the related TCM syndrome scores between two groups after treatment. There were no adverse reactions,no abnormal changes in electro cardiogram(ECG)or liver and kidney functions in all patients.Conclusion: Pinggan Yuyin Qingre recipe can effectively improve the hyperevaporative dry eye disease caused by meibomian gland dysfunction,the tear film stability,eye dryness,burning,itching,foreign body sensation and TCM symptoms of patients with dry eye syndrome of Yin deficiency and Yang hyperactivity. The improvement effect is more obvious in moderate and severe patients. It is an effective,safe,and well-tolerated treatment for the hyperevaporative dry eye.