Observation On The Clinical Efficacy Of Xirecunjin Granule In Treating Primary Sjogren's Syndrome Of Yin Deficiency And Dry Heat Type

Objective: To evaluate the clinical effect and the safety of Cherecunjin granules in the treatment of primary Sj?gren's syndrome(p SS)with Yin deficiency and dryness heat syndrome.Methods: 60 cases of p SS were randomly divided into the experimental group and the control group with 30 cases each,Cherecunjin granules and Shashenmaidong granules were given orally respectively for two months.The therapeutic effects were evaluated from TCM syndrome score,gland secretion function(Schimer test,salivary flow rate),disease activity score(ESSDAI,ESSPRI),immunoglobulin(Ig G)and inflammation index(CRP,ESR),and the safety was evaluated.Results: Efficacy comparison results:(1)After treatment,the effective rate of TCM syndrome integral in the Cherecunjin group was 93.33% while it in the Shashenmaidong group was 69.23%.There was statistical difference in the effective rate between the two groups(P<0.05).After treatment,there was statistical difference in the TCM syndrome scores between the two groups(P<0.05).(2)After treatment,the effective rate of ESSPRI score in the Cherecunjin group was 86.67% while it in the Shashenmaidong group was 53.87%.There was statistical difference in the effective rate between the two groups(P<0.05).After treatment,there was statistical difference in the ESSPRI scores between the two groups(P<0.05),and there was no statistical difference in ESSDAI scores between the two groups(P>0.05).(3)Gland secretion function:After treatment,there was statistical difference in the salivary flow rate between the two groups(P<0.05),and there was no statistical difference in the results of Schirmer test between the two groups(P>0.05).(4)Immunoglobulin and inflammation index: After treatment,there was no statistical difference in Ig G and ESR between the two groups(P>0.05).After treatment,there was statistical difference in CRP between the two groups(P<0.05),but the difference has no clinically significant.Safety: There was no statistical difference in the incidence of adverse events between the two groups(P>0.05).There were no definite adverse reactions and side effects in the course of the experiment,and the two drugs have good safety.Conclusion: The therapeutic effect of Cherecunjin granules is better than that of Shashenmaidong granules,which can significantly improve the TCM syndromes,gland secretion function and quality of life with p SS patients.The method of removing heat and reserving fluid is more suitable for the patients of p SS with Yin deficiency and dryness heat syndrome.