Clinical Observation On The Treatment Of Primary Sjogren’s Syndrome With Modified Danzhi Xiaoyao Powder

Objective:The purpose of this study is to observe the effect of Danzhi Xiaoyao Powder on the TCM syndrome score,ESSDAI score,ESSPRI score,mouth and eye dry VAS score,bilateral Schirmer test,salivary flow rate(SFR),immunoglobulin G(Ig G)and inflammatory indicators(ESR,C-reactive protein)of patients with primary Sjogren’s syndrome of liver-qi stagnation and fire-transforming type.To preliminarily explore the effectiveness and safety of Danzhi Xiaoyao Powder in treating primary Sjogren’s syndrome of liver-qi stagnation and fire-transforming type,provide clinical data for further study of Danzhi Xiaoyao Powder in treating primary Sjogren’s syndrome of liver-qi stagnation and fire-transforming type,and provide new ideas for the treatment of primary Sjogren’s syndrome with traditional Chinese medicine.Method:A total of 60 patients were included in the randomised controlled trial,with 30 in each group.The experimental group was given hydroxychloroquine sulfate tablets plus danzhiyao san and the control group was given hydroxychloroquine sulfate tablets for a total of eight weeks.The main efficacy indicators were TCM syndromes score,ESSPRI,ESSDAI score,binocular Schirmer test,saliva flow rate,dry eye and mouth VAS score and immunoglobulin G(Ig G)and inflammatory markers(hemoglobin,C-reactive protein),safety indicators:blood,urine,poop routine,liver and kidney function,EKG.To evaluate the clinical efficacy and safety of Danzhiyao powder in the treatment of primary sjogren’s syndrome induced by liver depression.Result:1.Efficacy observation:(1)Immunoglobulin G(Ig G),inflammatory markers(erythrocyte sedimentation rate,Creactive protein): the test group was able to reduce the inflammatory indicators CRP and ESR(P < 0.05),the control group had no significant effect on the reduction of ESR(P >0.05),the test group had better effect on CRP and ESR(P < 0.05);Both groups were able to reduce immunoglobulin(Ig G)(P < 0.05)without significance(P > 0.05).(2)Mouth dryness and eye dryness VAS scores: both the test group and the control group could improve the mouth dryness and eye dryness VAS scores(P <0.05),but the test group was superior to the control group(P <0.05).(3)Gland secretion function(bilateral Schirmer test,salivary flow rate): Both groups were able to improve salivary flow rate,binocular Schirmer test(P <0.05)and the test group improved salivary flow rate,binocular Schirmer test better than the control group(P <0.05).(4)TCM Syndrome Score: Both experimental group and control group could improve TCM Syndrome Score(P < 0.05),and experimental group was better than control group(P< 0.05).(5)ESSPRI score and ESSDAI score: both groups can improve ESSPRI score and ESSDAI score(P<0.05),and the ESSPRI score trial group was superior to the control group(P < 0.05),ESSDAI score no significant difference between the two groups(P > 0.05).2.Safety index:There was no difference between the two groups in all safety indicators before and after treatment(P > 0.05),and no significant adverse reactions or side effects occurred during the trial.Conclusion:1.The clinical efficacy of Danzhi Xiaoyao Powder plus hydroxychloroquine sulfate in the treatment of primary Sjogren’s syndrome of liver-qi stagnation and fire-transforming type is more significant than that of hydroxychloroquine sulfate alone.The test group has improved the TCM syndrome score,ESSPRI score,mouth and eye VAS score,bilateral Schirmer test,salivary flow rate(SFR)and inflammatory indicators(ESR,C-reactive protein)of primary Sjogren’s syndrome of liver-qi stagnation and fire-transforming type,and better than the control group.2.Danzhi Xiaoyao powder has few adverse reactions to primary sjogren’s syndrome.It is effective in clinical application,can improve clinical symptoms and quality of life,and deserves further study and popularization in clinic.