The Clinical Research Of Primary Sjogren’s Syndrome Of Liver-qi’s Stagnation And Qin Deficiency Syndrome Complicated With Hyperglobulinemia Treated By Zishui Qinggan Decoction

Objective:Evaluating Zishui Qinggan Decoction’s clinical effect of treating primary Sjogren’s Syndrome(pSS)of liver-qi’s stagnation and yin deficiency syndrome combined with hyperglobulinemia treated surveying the change of the secretion of the salivary glands and lacrimal glands,dryness in mouth and eyes,erythrocyte sedimentation rate(ESR),cross-reacting protein(CRP),rheumatoid factor(RF),γ-Globulin,anti-Syndrome A antibody(SSA),anti-Syndrome B antibody(SSB),objectively evaluate Zishui Qinggan Decoction’s short-term efficacy,safety and tolerance.Methods:According to the principle of parallel open controlled trial,60 patients are divided into treatment group Ⅰ(n = 20),treatment group Ⅱ(n = 20)and control group(n = 20)。The course of treatment was 12 weeks,and the observation point was for a period of 0 weeks(before treatment)and after treatment for 12 weeks.The treatment group Ⅰ was treated with Zishui Qinggan Decoction I;The treatment group Ⅱ take Zishui Qinggan Decoction Ⅱ;The control group take hydroxychloroquine.Observing three groups’s treatment effective indexes and adverse reactions before and after treatment and using Using statistical software for analysis and comparison.Results:The total effective rate of the treatment group I,the treatment group Ⅱ and the control group is 85%,65%,and 40%.Difference between the three groups of TCM syndrome’s total score before and after treatment is significant(P<0.01),The clinical effect of the treatment group Ⅰ is obviously better than that of the treatment group Ⅱ and the control group(P<0.01)and treatment group Ⅱ is better than that of the treatment group Ⅱ and the control group(P<0.05).There is a significant difference between the treatment group Ⅰ and the treatment group Ⅱbefore and after the treatment of dryness in mouth and eyes,constipation VAS dry score(P<0.01).There is a significant difference in mouth VAS dry score in the control group before and after treatment(P<0.05).After treatment,the treatment group Ⅰ and the treatment group Ⅱ are both significantly better than those in the control group(P<0.01)in the improvement of dryness in mouth and eyes,constipation VAS dry score.Treatment group Ⅰ has a significant difference in the treatment of globulin(G),IgG,IgA,and tear flow measurement before and after treatment(P<0.01)and significantly better than the control group(P<0.01),also has a difference in salivary flow measurement before and after treatment(P<0.05).Treatment group Ⅱ has a significant difference in the treatment of IgG,tear flow measurement before and after treatment(P<0.01)and significantly better than the control group(P<0.01),also has a difference in IgA,and salivary flow measurement before and after treatment(P<0.05).There is a significant difference in the control group on globulin(G)and IgA before and after treatment(P<0.01).There is a difference in globulin(G)between the treatment group I and the treatment group Ⅱ(P<0.05)and also a significantly difference in IgG,IgA and left tear flow measurement(P<0.01).After treatment ESR,CRP,RF,anti SSA(Ro)antibody,anti SSB(La)antibody,WBC,RBC,PLT,AST,ALT,BUN,Scr has no difference(P>0.05).Conclusion:Zishui Qinggan Decoction can improve the secretion of the salivary glands and lacrimal glands,dryness in mouth and eyes.There is no obvious effect on improving ESR,CRP,RF.Tripterygium wilfordii has a significant effect on reducing serum globulin,but needs to be validated prospectively.Results in present period show that Zishui Qinggan Decoction has good efficacy,safety and tolerance and deserves further clinical research.