Clinical Study On The Treatment Of Dryness (primary Sjogren's Syndrome) With Bushen Yuyin Qingre Method

Objective This study aims to through the kidney heat yuk Yin method treatment of primary sjogren’s syndrome,multicenter,randomized,controlled clinical study to evaluate the efficacy and safety,with dry eye VAS,dry mouth VAS,laboratory examination,blood sedimentation and serum IgG)as the main curative effect evaluation index,raise the clinical curative effect of traditional Chinese medicine treatment of the disease,evidence-based medical evidence for the Chinese medicine treatment of the disease.Methods Basis based on previous research,according to the sample size calculation method,determine the sample size of 120 cases,the treatment group and the control group(n=60),three research centers,respectively for treatment group(20 cases,20 cases were clinical observation mission.Using computer algorithms to block random,block size of 4.Treatment group was treated by kidney heat yuk Yin method,the control group treated by hydroxychloroquine sulfate,clinical observation time of 3 months,3 months follow-up time.Dry eye VAS,dry mouth,VAS,laboratory examination,blood sedimentation and serum IgG)main efficacy index,joint pain,EULAR sjogren’s syndrome,disease activity index(ESSDAI),the filter paper test for secondary efficacy index,such as liver and kidney function,blood routine,urine routine,electrocardiogram(ecg)for security indicators.After the end of the study to evaluate efficacy and safety.Results This topic mainly studies kidney heat yuk Yin method treatment of primary sjogren’s syndrome in patients with kidney qi and Yin deficiency syndrome curative effect.According to the curative effect of standard,the results shown in 12 weeks after treatment,the treatment group of 59 cases,dry eye VAS to assess the total effective rate was 71.19%(42 cases)and control group of 53 cases,dry eye VAS to assess the total effective rate was 49.06%(26 cases).Treatment group total effective rate was better than control group,the difference was statistically significant(P<0.05);Treatment group dry mouth VAS to assess the total effective rate was 76.3%(45 cases)and control group dry mouth VAS to assess the total effective rate was 54.72%(29 cases),treatment group total effective rate was better than control group,the difference was statistically significant(P<0.05);12 weeks after treatment,the treatment group of TCM syndrome to assess the total effective rate was 91.53%(54 cases).Control group of traditional Chinese medicine syndrome to assess the total effective rate was 62.26%(33 cases).Treatment group total effective rate was better than control group,the difference was statistically significant(P<0.05);Treatment group laboratory indicators(ESR)to assess the total effective rate was 45.76%(27 cases).Conclusion Tonifying kidney,clearing heat and nourishing Yin Decoction of sjogren’s syndrome kidney qi and Yin deficiency syndrome curative effect significantly,can significantly improve the symptoms of dry mouth,dry eye,in improving ESSDAI score,dry mouth VAS score,dry eye VAS score,TCM syndrome integral,the ESR and CRP is better than that of hydroxychloroquine sulfate;Kidney heat yuk Yin treatment of sjogren’s syndrome kidney qi and Yin deficiency syndrome has a good security.