Objective

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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

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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

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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

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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.