| OBJECTIVE: Based on the understanding of the key to the pathogenesis of primary Sj?gren’s syndrome,"Zao and Du",combined with the research background of the previous QZBJ therapeutic method,with reference to the current research progress of western medical drugs,To explore the efficacy and safety of QZBJ therapeutic method combined with iguratimod in the treatment of primary Sj?gren’s syndrome,compare the clinical efficacy of iguratimod and traditional drug hydroxychloroquine in the treatment of p SS,and provide a basis for the future treatment of p SS with integrated Chinese and Western medicine.Methods: Using random number table method,80 patients who met the inclusion criteria were divided into 3 groups,namely,experimental group 1(QZBJ Decoction)in 26 cases,experimental group 2(QZBJ Decoction combined with iguratimod)in 27 cases,and the control group(QZBJ Decoction combined with hydroxychloroquine)in 27 cases,every 6 weeks is 1 course,a total of 2 courses.Patients were examined or scored before and after treatment: 1.Inflammation and immune laboratory tests(ESR,Ig G,RF),2.Objective indicators(Schirmer test,saliva flow rate test),3.Overall disease score(TCM syndrome score,ESSDAI score,ESSPRI score),4.Main TCM symptom scores(dry mouth,dry eyes,dry skin,joint pain),5.Anxiety(SAS),depression(SDS),Fatigue(FSS)score 3.Safety tests(blood RT,urine RT,liver and kidney function,electrocardiogram).After the completion of the experiment,the data were statistically analyzed.The differences in the results between the three groups before and after treatment were compared.The total effective rate of the three groups was calculated and the efficacy and safety were evaluated.Results: 1.The experiment lost 5 cases eventually,of which 1 case was lost in the experimental group 1,and 2 cases were lost in the experimental group 2 and the control group.75 patients completed the experiment,and 25 patients in each of the three groups.The clinical efficacy evaluation: The total effective rate of the control group was 88%,the total effective rate of the experimental group 1 was 84%,and the total effective rate of the experimental group 2 was 96%.TCM syndrome efficacy evaluation: The total effective rate of the control group was 92%,the total effective rate of the experimental group 1 was 88%,and the total effective rate of the experimental group 2 was 96%.The efficacy of the experimental group 2 was better than that of the control group(P<0.05),and the efficacy of the control group was better than that of the experimental group 1(P<0.05).2.In terms of inflammation and immune index,the three groups were significantly improved after treatment compared with before treatment(P<0.01);The comparison between the groups(1)Reduction of ESR: The experimental group 2 was better than control group(P<0.05),while the control group was better than the experimental group 1(P <0.05).(2)Reduction of Ig G: The experimental group 2 was superior to the control group(P<0.05),and the control group was superior to the experimental group 1(P<0.05).(3)Reducing RF: The experimental group 2 had the same effect as the control group(P>0.05),and both were significantly better than the experimental group 1(P<0.01).3.In terms of objective test indicators,the results of Schirmer test in the three groups were significantly improved compared with those before treatment(P<0.01).The salivary flow rate of the experimental group 1 was improved after treatment(P<0.05),and the experimental group 2 and the control group were significantly improved compared with the treatment before treatment(P<0.01).The comparison between the groups(1)Improved Schirmer test results: The experimental group 2 was significantly better than the control group(P<0.01),while the control group was superior to the experimental group 1(P<0.05).(2)Improvement of salivary flow rate: The experimental group 2 was significantly better than the control group(P<0.01),and the control group was significantly better than the experimental group 1(P<0.01).4.In terms of overall disease score,the three groups were significantly improved after treatment(P<0.01);The comparison between the groups(1)The reduction of TCM syndrome scores: The control group was not as good as the experimental group 2(P<0.05),but better than the experimental group 1(P <0.05).(2)Reduction of ESSDAI score: The experimental group 2 was superior to the control group(P<0.05),and the control group was superior to the experimental group 1(P<0.05).(3)In terms of lowering the ESSPRI score,The experimental group 2 was significantly better than the control group(P<0.01),and the experimental group 1 was not as good as the control group(P<0.05).5.In the main TCM symptom scores,the three groups were significantly lower than those before treatment(P<0.01);The comparison between the groups(1)Improved dry mouth and dry eyes: The experimental group 2 was significantly better than the control group(P<0.01).The control group was superior to the experimental group 1(P < 0.05).(2)Improvement of skin dryness: The control group was not as good as the experimental group 2(P<0.05),but better than the experimental group 1(P<0.05).(3)Improvement of joint pain: The experimental group 2 was significantly better than the control group(P<0.01),and the control group was significantly better than the experimental group 1(P<0.01).6.In terms of anxiety,depression and fatigue score,the three groups were significantly lower than those before treatment(P<0.01).The comparison between the groups(1)Improvement of anxiety and depression: The control group was better than the experimental group 1(P<0.05),but not as good as the experimental group 2(P < 0.05).(2)Improvement of fatigue: The experimental group 2 was equivalent to the control group(P>0.05),and both were superior to the experimental group 1(P<0.05).7.The safety of the three groups was good,and the difference was not significant(P>0.05).Conclusion: 1.QZBJ therapeutic method is effective in the treatment of p SS,especially in relieving the clinical symptoms of dry mouth and dry eye,reducing TCM syndrome scores,inhibiting immune inflammation,improving anxiety,depression,fatigue,etc.,and fewer adverse reactions.2.QZBJ therapeutic method combined with iguratimod is the best treatment for p SS,which can significantly control the disease and greatly improve the evaluation indicators.It is safe and reliable and worthy of clinical promotion.3.The efficacy of iguratimod is obviously superior to the traditional drug hydroxychloroquine,especially in improving the subjective and objective evaluation index of dry eye,reducing joint pain,reducing ESR,Ig G,ESSDAI,ESSPRI,etc.,and the safety difference is few. |
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