| Objective:To observe the clinical efficacy and safety of Qing Zao Bu jin prescription in the treatment of primary Sjogren’s syndrome,and to provide the basis for the clinical efficacy and safety of prescription in the treatment of primary Sjogren’s syndrome.Methods:According to the digital table method,90 patients with primary Sjogren’s syndrome were randomly divided into traditional Chinese me dicine group(Qingxanbujin recipe),western medicine group(hydroxychl oroquine sulfate)and Chinese and western medicine group(Qingxanbujin recipe hydroxychloroquine sulfate).Each group had 30 patients,with a t otal course of 12 weeks.The scores of TCM syndromes,TCM symptom s,disease activity(ESSDAI),subjective symptom self-assessment(ESSPR I),fatigue self-assessment(FSS),exocrine glands of the three groups w ere included.Function,immune inflammation index(Ig G,Ig A,Ig M,ES R,CRP,RF)and safety index(blood routine,urine routine,stool routin e,electrocardiogram,liver function and kidney function)were evaluatedonce before and after treatment.Results:1.In terms of improving TCM symptoms,the total effective rate of TCM and WM group was 96.4%,which was better than 78.6% of TCM group and 66.7% of WM group(P < 0.05).There were significant differences in dry mouth,dry eye,dry throat,dry skin,dry stool,fatigue and joint pain before and after treatment among the three groups(P < 0.01).WM group was better than TCM group and WM group in improving the above symptoms(P < 0.01).05,P < 0.01),Chinese medicine group was superior to western medicine group in improving dry mouth and stool symptoms(P < 0.05),and was superior to western medicine group in improving dry skin and joint pain symptoms(P <0.01);in terms of clinical efficacy,the total effective rate of Chinese andWestern medicine group was 89.3%,71.4% and 62.9% respectively.There were significant differences between the two groups(P < 0.05),and the Chinese and Western medicine group was superior to the Chinese medicine group and the Western medicine group(P < 0.05).Western medicine group(P< 0.05),Chinese medicine group was better than western medicine group(P <0.05).2.In terms of improving ESSPRI,ESSDAI and FSS scores,the scores of ESSPRI,ESSDAI and FSS in the three groups decreased significantly after treatment compared with those before treatment(P < 0.01).The scores of ESSPRI in the Chinese and Western medicine group were lower than those in the Western medicine group(p < 0.01),and the scores of ESSDAI in the Chinese and Western medicine group were better than those in the Chinese and Western medicine group(P < 0.05),and the scores of FSS in the Chinese and Western medicine group were better than those in the Chinese and Western medicine group(P < 0.05,P < 0.05,P < 0.The improvement of ESSDAI score and FSS product in traditional Chinese medicine group was better than that in western medicine group(P < 0.05).3.Analysis of the Functional Indicators of Exocrine GlandsAfter 12 weeks of treatment,saliva flow and tear flow were increased in both groups(P < 0.01).There was no significant difference in saliva flow and tear flow between groups before and after treatment(P > 0.05),and there was significant difference between groups(P < 0.05).The improvement of saliva flow and tear flow in both groups was better than that in traditional Chinese medicine group and Western medicine group(P < 0.05,P < 0.01).The drug group was better than the western medicine group(p < 0.05,P < 0.01).4.Analysis of Laboratory IndicatorsAfter 12 weeks of treatment,the indexes of Ig G,Ig A and Ig M were improved in the Chinese and Western medicine group(p < 0.01,P < 0.05,P <0.01),the indexes of Ig G and Ig A were improved in the Chinese medicine group(p < 0.05,P < 0.01),and the RF was improved in the Western medicine group(P < 0.05).There were statistical differences in the indexes of Ig G and Ig A among the three groups(P < 0.01).There was no statistical significance among the Ig M,ESR,CRP and RF groups(P > 0.05).The improvement of Ig Gand Ig A index in the Chinese and Western medicine group was better than that in the Chinese and Western medicine group(P < 0.05,P < 0.01),and the improvement of Ig A index in the Chinese medicine group was better than that in the Western medicine group(P < 0.05).5.Safety analysis showed that there were no side effects in the three groups.Conclusion:1.Qingzao Bujin Decoction can improve the symptoms of dry mouth,dry skin,dry stool and arthralgia in patients with p SS,and can reduce ESSDAI and FSS scores.It has a certain effect on improving the function of exocrine glands and can improve the laboratory indexes of Ig G and Ig A.2.Qingzao Bujin Prescription combined with hydroxychloroquine sulfate can effectively reduce the scores of symptoms and symptoms of primary Sjogren’s syndrome,ESSDA,ESSPRI,FSS and improve the function of exocrine glands and Ig G,Ig A,Ig M laboratory indicators,which are superior to those of traditional Chinese medicine group and Western medicine group.3.The method of clearing dryness and Bujin is safe and effective in the treatment of primary Sjogren’s syndrome... |