Observation On Therapeutic Effect Of Shengjin Grains On Syndrome Of Yin Deficiency And Collaterals Stagnation In Sjogren’s Syndrome And Study On Metabolism

Objective:To observe the clinical efficacy and safety of Shengjin granules in the treatment of Sjogren’s syndrome(SS)of yin deficiency and staganation of collaterals syndrome,and based on the previous clinical research work,the metabolomic method was used to obtain informations about endogenous small molecules in serum samples to understand the difference of serum endogenous metabolites in patients with Sjogren’s syndrome yin deficiency syndrome and healthy people,and to screen out relevant differential endogenous metabolites,in order to explore the basis for the treatment of Sjogren’s syndrome yin deficiency syndrome.Methods:(1)According to the principle of randomized controlled trial,43 patients with Sjogren’s syndrome were divided into treatment group(n-22)and control group(n=21).The patients in the treatment group were given Shengjin Granule(one dose per day,twice a day).Patients in the control group were treated with hydroxychloroquine tablets(Chloroquine,0.2g/one time,twice a day)for 12 weeks,the observation nodes were at the 0th week、4th week and the 12th week.The totasl curative effect,TCM syndrome integral,symptoms and signs,laboratory index,tear flow rate,saliva flow rate and safety index were evaluated before and after treatment.(2)40 patients with Sjogren’s syndrome with yin deficiency and collaterals syndrome w-ere selected as the disease group and 60 physical examiners at the physical examination center of our hospital as the normal group.Liquid chromatography/time of flight mass spe-ctrometry(LC/TOF-MS)was used.LC/TOF-MS was used to analyze the serum endogen-ous metabolite map of the two groups to find out the difference of serumendogenous m-etabolite between the patients with syndrome of yin deficiency and collaterals of Sjogren’s syndrome and the healthy population.Results:(1)In the treatment group and the control group,43 patients met the criteria.There were 2 cases in the treatment group due to loss of follow-up,I case in the control group due to irregular medication,and 40 cases in the actual group,20 cases in each group.After treatment with Shengjin granules and hydroxychloroquine tablets(Chloroquine),the total effective rate of the two groups was 85%and 45%,respectively,and the treatment group was superior to the control group.In the treatment group,the improvement of salivary flow rate in patients with dry mouth,dry eyes,dry stool,dry skin,tongue and other TCM symptoms was better than that of the control group(p<0.05),and the improvement of fatigue and joint pain was comparable to the control group;The treatment group improved Erythrocyte sedimentation rate(ESR)better than the control group(p<0.05);it was equivalent to the control group in improving the immunological index,immunoglobulin G(IgG).At the 0th week,4th week,and 12th week of treatment,the safety indexes such as blood routine,liver and kidney function were not obvious,and the safety was good.(2)There is a significant difference between serum and endogenous metabolites in patients with Sjogren’s syndrome yin deficiency and staganation of collaterals syndrome and healthy people.By metabolomics method,10 differential endogenous metabolites were finally identified,and the five most different endogenous metabolites were selected,namely L-formyl kynuric acid,serotonin,and bismuth.Aldehyde,coenzyme A,arachidonic acid.Conclusion:(1)Shengjin granules have a significant effect on the treatment of Sjogren’s syndrome with yin deficiency and staganation of collaterals,which can effectively improve dry symptoms such as dry mouth,dry eyes,dry stools and dry skin in patients with syndrome of yin deficiency and stagnation syndrome,and improve salivary flow rate of patients.The clinical curative effect is superior to hydroxychloroquine sulfate tablets(Chloroquine),and the safety is good,and it has certain immunomodulatory function,which deserves further research and promotion.(2)There is a significant difference between the serum endogenous metabolites of patients with Sjogren’s syndrome yin deficiency syndrome and healthy people.L-formyl kynuric acid,serotonin,acetaldehyde,coenzyme A,arachidonic acid may it is a potential biomarker for patients with dry syndrome and yin deficiency syndrome.