To observe the clinical efficacy of Yangyin Yiqi mixture combined with hydroxychloroquine sulfate in the treatment of Sjgren's syndrome of qi and yin deficiency type. Methods:Seventy cases of primary Sjgren's syndrome patients of qi and yin deficiency who were treated in our hospital from January 2015 to December 2016 were randomly divided into a treatment group (36 cases) and a control group (34 cases). The treatment group took Yangyin Yiqi mixture combined hydroxychlor sulfate, and the control group took hydoxychloroquine sulfate. After 12 weeks, the clinical efficacy and safety of the two groups were compared. Results:The total effective rate of the treatment group was 805%, and the total effective rate of the control group was 529%, There was statistical significance between the two groups (P<005). The scores of dry mouth, dry eye, fatigue symptom and saliva flow rate of the two groups after treatment were better than those before treatment (P<005). And the treatment group was better than the control group in improving dry mouth and fatigue (P<001). After treatment, the dynamic erythrocyte sedimentation rate, C reactive protein and immunoglobulin G levels in the two groups were decreased compared with before treatment (P<005)，But there was no statistical difference between the two groups. Conclusion:Effects of Yangyin Yiqi mixture combined with hydroxychloroquine sulfate in the treatment of Sjgren's syndrome with qi and yin deficiency are significant, which can better improve the symptoms of patients with dry mouth and fatigue compared with hydroxychloroquine sulfate.