Runzhan Decoction In The Treatment Of Primary Dryness Syndrome Qi Deficiency And Jin Deficiency Syndrome Clinical Study

This article mainly studies the Moisturizing Dryness Decoction for the treatment of primary Sj6gren's Syndrome deficiency of jin kui the efficacy and safety of patients,were observed before and after treatment in patients with TCM syndrome score and the influence of the western medicine curative effect,etc.The following text is divided into two parts.The first part is the review of knowledge of Traditional Chinese Medicine(TCM)and Western medicine progress for Sjogren's Syndrome(SS).On one hand,introduce the traditional Chinese and western medicine understanding of Sjogren's syndrome origin,on the other hand introuduce the summary of Chinese and western medicine on the research progress of the disease at present.The second part is a clinical study:Objective:Observing the effectiveness and security of Moisturizing Dryness Decoction treating the Primary Sjogren's Syndrome(pSS).Methods:There were 60 patients with pSS,randomized,double blind and placebo controlled,divided into 2 groups.30in the experimental group and 30 in the placebo group with a treatment for 24 weeks,evaluation once every 4 weeks.The assessment points were the day,4th week,8th week,12th week,16th week,20th week and 24th week after joining the study.We will evaluate and record Syndrome score of Traditional Chinese Medicine syndrome of Sjogren's syndrome.TCM syndrome score includes the score of presenting symptom and minor symptom.The test items of related curative effect such as immune indicators(IgA,IgG,IgM,C3,C4),Schirmer I test,saliva flow rate that will be detected in the beginning,12th week and the end of the test.Security tests include the three frequent exams,liver function ALT,AST,kidney function Bun,Cr and ECG also will be detected in the beginning and the end of the test respectively.Result:1.Main outcome indicators:(1)Syndromes curative effect:Two groups of TCM syndrome total effective rate difference from 8 weeks have statistical significance(P<0.01),and 24 weeks of treatment group total effectiveness 96%,clinical control 12%.(2)TCM syndrome integral:Experimental group before and after treatment comparison difference was statistically significant(P<0.01),the control group there was no statistically significant difference compared before and after treatment(P>0.05).Experimental group 8 weeks different points compared with baseline difference had statistical significance(P<0.01).Since 8 weeks is compared between group difference was statistically significant(P<0.01).(3)Main symptom integral:Experimental group before and after treatment comparison difference was statistically significant(P<0.01),the control group before and after treatment comparison difference has no statistical significance(P>0.05).Experimental group 8 weeks different points compared with baseline differential difference had statistical significance(P<0.01).Since 8 weeks is compared between group difference was statistically significant(P<0.01).Taking Chinese traditional medicine at 8 weeks main symptom curative effect is distinct,and the forward curative effect is better.Dry mouth,dry eye,lack of power to improve comparison between group 4 weeks difference was statistically significant(P<0.01),dry throat,defecate is unable to improve comparison between groups 8 weeks difference was statistically significant(P<0.01).(4)Exocrine gland function index:experimental group Schirmer I index showed a trend of rise,Schirmer I(L)index in the group of 12 weeks,24 weeks compared with 0 weeks difference had statistical significance(P<0.05).Schirmer I(R)index in the group of 24 weeks compared with 0 weeks difference was statistically significant(P<0.01).Saliva flow rate test group there was no statistically significant difference compared before and after treatment(P>0.05),the control group before and after treatment the exocrine gland function indexes difference had no statistical significance(P>0.05).Between groups Schirmer I(L)index in 12,24 weeks difference had statistical significance(P<0.05),Schirmer I(R)index in 24 weeks difference was statistically significant(P<0.05),comparing differences between saliva flow rate and different point group had no statistical significance(P>0.05).2.Secondary efficacy index:(1)Secondary symptoms integral:differences between the two groups in the fourth week is statistically significant(P<0.05).Chinese traditional medicine group 0,4 weeks compared with other point has a significant difference(P<0.05),compared with 16 and 20 weeks 8 weeks there was no significant difference(P>0.05),compared with other time have significant difference(P<0.05),12,16,20,24 weeks two have no significant difference(P>0.05).When taking Chinese traditional medicine week 12 secondary symptom curative effect is distinct,and the long-term curative effect is better.(2)Immune indicators:IgA week 12 indicators test group compared with the baseline differential difference was statistically significant(P<0.05),the rest of the immune indicators in the two groups before and after treatment comparison had no statistical significance(P>0.05).3.Safety indicators:Stable vital signs before and after the two groups in the group does not appear after treatment of liver and kidney function,blood routine,electrocardiogram(ecg)and urine,stool routine abnormal case,no obvious adverse reactions.1 case of ALT,AST,returned to normal after treatment,1 case of Cr value is lower(higher than normal before treatment),consider dryness drinks may exist certain functions to protect the liver and kidney function.Conclusion:Moisturizing Dryness Decoction to ease the pSS jin kui type patients with dry mouth,dry eyes,fatigue has obvious curative effect.But it takes time to work,taking 2 month curative effect is distinct,and the long-term curative effect is better.Moisturizing Dryness Decoction for improving patient lacrimal gland secretion curative effect is obvious,and can play a control activity.The security of Moisturizing Dryness Decoction can be guaranteed.