| Objective:This study will observe the clinical efficacy and safety of traditional Chinese medicine Qing-Luo-Yin(QLY)in the treatment of active rheumatoid arthritis which belong to dampness and heat resistance syndrome;In this paper,to find the metabolic pathways and possible diagnostic metabolic markers of the active RA(TCM syndrome belong to dampness and heat resistance syndrome),we use the metabolomics method.The result will provide us the thought of the research on the material basis and compatibility of TCM QLY in the next step.Methods: 1.40 patients with rheumatoid arthritis with damp heat syndrome were collected for 12 weeks,before treatment,4 weeks,8 weeks and 12 weeks after treatment.The observation items included the clinical symptoms such as joint pain,swelling and the number of pressure pain;ESR,RF,CRP,PLT,HGB,7 joint ultrasound score(US7)and DAS28 and other laboratory indicators and imaging scores related to inflammation and activity,anti-cyclic citrullinated peptide antibody and immunoglobulin(including IgG,IgA,IgM,IgE),VAS score,HAQ score,TCM syndrome score,and other changes in the quality of life and other changes;electrocardiogram,liver and kidney function and adverse drug reactions.2.The first 20 patients(excluding patients taking Western medicine)were treated with 5 ml of blood before and after 12 weeks of treatment(centrifuged at 3500 rpm for5 minutes at 20 ℃ using an ultra-high performance liquid chromatography system(UPLC)and a high resolution time-of-flight mass spectrometer(Q–TOF)Perform metabolomic tests.Results: 1.Compared with pre-treatment,after 8 weeks of QLY treatment,the patient’s joint symptoms and signs improved more than before.There was a significant difference(P<0.05).Compared with before treatment,after 12 weeks of treatment,the patient’s joint symptoms,signs,ESR,RF,CRP,Anti-CCP,IgA all improved to some extent,the difference was statistically significant(P<0.05);IgG,IgM,IgE decreased no statistically significant difference(P>0.05);GSUS synovitis and PDUS synovitis index improved,the difference was statistically significant(P<0.05);DAS28 score decreased from 9.01 before treatment to 5.07;The scores decreased,the difference was statistically significant(P<0.05);HAQ decreased,the difference was statistically significant(P<0.05);the total effective rate was 72.5%,and gastrointestinal reactions,palpitation,pruritus and other total adverse reactions occurred rate of 7.5%.2.In the positive ion mode,there was a difference in the peak strength between the two groups before and after the treatment.In the OPLS-DA model,the groups were separated well and clustered into clusters.In the case of VIP value > 1,the difference metabolites in FC>2 were identified.Compared with before administration,29 serum metabolites showed significant changes in serum after 12 weeks of administration.Conclusion: 1.QLY has certain clinical efficacy and good security in the treatment of active rheumatoid arthritis patients which TCM syndromedamp is heat syndrome after12 weeks.2.The therapeutic effect of QLY mainly affects the metabolic markers such as glycerin phospholipid and fatty acid,and interferes with the metabolism of glycerine phospholipid,amino acid metabolism and fatty acid metabolism. |
