| Objective:To observe the clinical efficacy and safety of Wenjing Qingluo Yishen Prescription in treating rheumatoid arthritis(RA)with mixed cold and heat syndrome,detect the serum concentration of OSCAR,and discuss the formula's effect on osteoclast-associated receptor(OSCAR).Methods:Sixty patients were randomly divided into two groups with rheumatoid arthritis(RA)who met the western medical diagnostic criteria and with mixed cold and heat syndrome who met TCM syndrome differentiation.Among them,30 patients in the treatment group were treated with Wenjing Qingluo Yishen Prescription+MTX?Meloxicam Suppository,and 30 in the control group were treated with Tripterygium Glycosides+MTX?Meloxicam Suppository.The course of treatment was 12 weeks.The symptoms and laboratory indexes of patients before and after treatment were observed,and the changes of TCM syndrome score,DAS28,inflammatory index,immunoglobulin and adverse reactions were compared.At the same time,the levels of serum OSCAR and IL-1,IL-6,TNF-a in the two groups were observed before and after treatment by enzyme linked immunosorbent assay(ELISA).Outcomes:1.There were a total of 30 cases in the treatment group,29 cases of them were completed,and l case was excluded;there were 30 cases in the control group,and 30 cases were completed,without detachment or rejection.2.The total effective rate of TCM syndromes in the treatment group was 93.1%,which was higher than that in the control group(80%,P<0.05).The scores of TCM syndromes in the treatment group were lower than those in the control group(P<0.01),and the scores of TCM syndromes,joint fever and secondary syndromes in the treatment group were lower than those in the control group(P<0.01).3.The effective rate of DAS28 was 83.3%in the treatment group and 80.0%in the control group,with no significant difference(P>0.05).After treatment,the DAS28 scores of both groups decreased(P<0.05).After treatment,the DAS28 scores of the treatment group were slightly lower than those of the control group,with no significant difference(P>0.05).4.After treatment,ESR,CRP and RF decreased in both groups,with significant difference(P<0.01).ESR and CRP decreased more significantly in the treatment group than in the control group(P<0.05).The decrease of RF was similar in the two groups after treatment(P>0.05).The anti-CCP level in the treatment group was lower than that before treatment,and the difference was statistically significant(P<0.05),but there was no significant difference between the treatment group and the control group(P>0.05).5.After treatment,the levels of IL-1,IL-6 and TNF-alpha in the two groups were lower than those before treatment,and the difference was statistically significant(P<0.01).The decrease of IL-1 and TNF-alpha in the treatment group was more obvious than that in the control group(P<0.05,P<0.01).The decrease of IL-6 after treatment was similar between the two groups(P>0.05).6.After treatment,Ig-G and Ig-M in the two groups were lower than those before treatment,with significant difference(P<0.01),while Ig-A had no significant difference(P>0.05).There was no significant difference between groups after treatment(P>0.05).7.The serum OSCAR of the two groups after treatment was higher than that before treatment,and the difference was statistically significant(P<0.01).The increase of OSCAR in the treatment group was more obvious than that in the control group(P<0.05).8.Mild adverse reactions occurred in both groups,including skin rash,gastrointestinal upset,elevated liver enzymes,and decreased WBC.The incidence in the control group was 30%,and that in the treatment group was 14%.Both groups improved after combined treatment.Conclusion:After clinical observation and laboratory tests,it is concluded that Wenjing Qingluo Yishen Prescription+MTX?Meloxicam Suppository and Tripterygium Glycosides+MTX?Meloxicam Suppository can play a good therapeutic effect on rheumatoid arthritis(RA)with mixed cold and heat syndrome.The former has a more significant advantage in improving clinical symptoms especially on fever of joints,low temperature of hands and feet,soreness of waist and knee,and heavy limbs,lowering the levels of ESR,CRP,IL-1,TNF-a,and increasing the level of serum OSCAR.There was no significant difference between the two regimens in reducing the levels of RF,anti-CCP,IL-6,Ig-G,Ig-M,and Ig-A.Wenjing Qingluo Yishen Prescription can increase the serum OSCAR concentration,which may be related to the reduction of OSCAR on the surface of osteoclasts,and may be able to inhibit osteoclast differentiation and slow bone destruction.The safety of the treatment group was better than that of the control group in a short period of clinical application. |
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