The Clinical Research Of Jinxueyuan Granules For Treatment Of Sj(o|")gren’s Syndrome And Anxiety

Objective:To evaluate the efficiency of Jinxueyuan granules combined with hydroxychloroquine (HCQ) sulfate tablets on the remission of clinical manifestation and anxiety in patients diagnoses with primary Sj(?)gren’s Syndrome (SS) accompanied by anxiety.Methods:Forty patients with SS and anxiety who received treatment in Jiangsu Province Hospital of TCM were included in our study, and were divided into two groups randomly, with 20 patients in every group. Patients in Jinxueyuan granule group received lOg of Jinxueyuan granules 3 times a day and 0.2g HCQ, while the control group only received 0.2g HCQ during the period of 8 weeks. The immune and inflammation index, clinical symptoms and anxiety scoring were compared between two groups before and after treatment. We also evaluated the safety of Jinxueyuan granules by comparing the liver and renal functions of the two groups.Results:1. The distribution of patients’s age, gender and disease duration was not different between two groups. The immune index, clinical symptom scoring and anxiety scoring showed no difference before treatment between two groups.2. Efficiency on improving clinical symptom:The overall efficiency was 85% in Jinxueyuan group and 55% in the control group, and the difference was statistically different (P<0.05). The decrease of erythrocyte sedimentation rate (ESR), C reactive protein (CRP) and immunoglobulin (IgG) was significantly different in two groups (P<0.05). The decrease of immune and inflammation index in Jinxueyuan group was more apparent (P<0.05). Patients in both groups benefited from treatment and had remission of TCM symptoms (P<0.05). The scoring of dry mouth and eye symptom decreased significantly only in patients in Jinxueyuan group (P<0.05).3. Efficiency on improving anxiety:The change of anxiety scoring of patients in HCQ group was not significantly different. However, the decrease of anxiety scoring of patients in Jinxueyuan group was significantly different (P<0.05).4. Evaluation of safety:No adverse event occurred in both groups. The routine blood, urine, stool test, liver functions and renal functions showed no abnormalities (P>0.05).Conclusion:The combined treatment of HCQ and Jinxueyuan granules was effective in improving the clinical symptom and anxiety in SS patients accompanied by anxiety. Jinxueyuan granules did not induce adverse events and showed good safety in short terms of application.