Clinical Observation On The Treatment Of Primary Sjögren's Syndrome With Runzaoyi

Objective:To evaluate the clinical efficacy and safety of Run Zaoyin in the treatment of primary Sjogren’s Syndrome with spleen deficiency and fluid deficiency,provide a new idea and method for clinical treatment of this disease,and lay a foundation for the later development of new drugs.Methods:Using a randomized,double-blind,placebo-controlled method,the patients were randomly divided into the experimental group and the control group in the order of enrollment.The experimental group was given Run Zaoyin granules,while the control group was given placebo granules(5%Run Zaoyin ingredients).The method of administration was three times a day,one bag per time,and the trail lasted 12 weeks.Record the ESSPRI and TCM syndrome scores of the two groups of patients at 0,4,8,and 12 weeks,as well as the serological indicators(IgA,IgM,IgG,C3,C4,RF,and ESR),exocrine gland function indicators(lacrimal height,tear film rupture time,sugar test),ESSDAI,and safety indicators(liver and kidney function,blood routine,urine routine,and electrocardiogram)at 0,12 weeks,and conduct statistical analysis to evaluate the efficacy and safety of the two groups.Results:A total of 48 subjects were included in the study,including 24 in the experimental group and 24 in the control group,all of whom were female.41 cases(85.4%)were completed and 7 cases(14.6%)were shed.Among them,23 cases were completed in the experimental group,1 case was shed,18 cases were completed in the control group,and 6 cases were shed.There were no statistical differences between the two groups in terms of age,course of disease,concomitant medication,and baseline efficacy of all the indicators(P>0.05).1.Patient subjective sensation score(ESSPRI score)Intragroup comparison:The scores of the test group and the control group decreased from 4.06 ± 1.60 and 4.04 ± 1.60 at week 0 to 1.25 ± 0.94 and 3.98 ± 1.81 at week 12,respectively.Both groups were significantly lower than the baseline level(P<0.05);Inter group comparison:After 12 weeks of treatment,the ESSPRI score in the experimental group was significantly lower than that in the control group(P<0.05).2.TCM syndrome scoresAfter 12 weeks of treatment,in the experimental group,1 case was cured,8 cases were significantly effective,12 cases were effective,and 2 cases were ineffective,with a total effective rate of 91.30%;In the control group,0 cases were cured,0 cases were significantly effective,5 cases were effective,and 13 cases were ineffective.The effective rate was 27.78%.Intragroup comparison:After 12 weeks of treatment,the TCM syndrome scores of the two groups decreased compared to the baseline,with a statistically significant difference(P<0.05);Comparison between groups:After 12 weeks of treatment,the TCM syndrome scores in the experimental group were lower than those in the control group,with a statistically significant difference(P<0.05).3.Functional indicators of lacrimal gland(lacrimal river height,break-up time)Intragroup comparison:After 12 weeks of treatment,the height of bilateral lacrimal river height in the experimental group was significantly higher than the baseline level(P<0.05),while the height of bilateral lacrimal river height in the control group had no statistical difference compared to the baseline level(P>0.05).There was no statistical difference in the bilateral break-up time of two groups compared to the baseline level(P>0.05);Inter group comparison:After 12 weeks of treatment,the height of bilateral lacrimal tears in the test group was higher than that in the control group,with a statistically significant difference(P<0.05);There was no significant difference in bilateral break-up time between the experimental group and the control group(P>0.05).4.Salivary gland function indicators(sugar cube test)Intragroup comparison:After 12 weeks of treatment,the duration of the sugar test in the test group decreased significantly compared to the previous period(P<0.05),while the control group had no significant reduction effect(P>0.05);Inter group comparison:After 12 weeks of treatment,the test group’s sugar test time was significantly lower than the control group,with a statistically significant difference(P<0.05).5.Serological indicators(IgA,IgM,IgG,C3,C4,RF,ESR)Intragroup comparison:After 12 weeks of treatment,the IgG in the test group decreased significantly compared to the baseline level(P<0.05).There was no significant difference between the IgA,IgM,C3,C4,RF,ESR in the test group and the IgA,IgM,IgG,C3,C4,ESR,RF in the control group compared to the baseline level(P>0.05);Inter group comparison:After 12 weeks of treatment,there was no significant difference in IgA,IgM,IgG,C3,C4,RF,ESR between the experimental group and the control group(P>0.05).Comparison of abnormal ESR and IgG data between two groups:The experimental group showed a decrease in ESR,with a statistical difference compared to the baseline and control groups(P<0.05);The experimental group showed a significant decrease in IgG compared to the baseline(P<0.05),but there was no significant difference compared to the control group(P>0.05).6.Disease Activity(ESSDAI)Intragroup comparison:After 12 weeks of treatment,both groups decreased compared to the previous one,but there was no significant difference compared to the baseline(P>0.05);Inter group comparison:After 12 weeks of treatment,there was no significant difference between the test group and the control group(P>0.05).7.Safety indicatorsAfter 12 weeks of treatment,there were no abnormalities in drug related safety indicators,and no adverse events occurred during the entire trial process.Conclusion:Run Zaoyin can significantly reduce ESSPRI,TCM syndrome scores,and ESR levels,effectively increase the height of the lacrimal river and stimulate saliva flow,with good safety.