| Objective:To evaluate the relativity of Traditional Chinese medicine (TCM) syndromes with the therapeutic effects of Tripterygium wilfordii (TW) tablets and Yishen juanbi pills in patients with rheumatoid arthritis (RA).Methods:A randomized clinic trial of patients with RA was carried out. Patients were treated by Chinese medicine including TW ablets and Yishen juanbi pills (n=28) for 24 weeks. Assessments included pain VAS, morning stiffness, joint count for tenderness and swelling, health assessment questionnaire, and the global assessments about disease activity of patients and physicians. TCM syndromes were observed including local joint symptoms, identified complexion, tongue, pulse, chill and fever, thirst, sweat, stool and so on. Efficacy was assessed using the American College of Rheumatology criteria for 20%(ACR20) improvement, and clinical and laboratory adverse reactions of the drugs were observed. The relationship between TCM syndromes and efficacy was analyzed.Results:The ACR20 of RA patients after treated by Chinese medicines at the 12th and 24th week were 53.57% and 67.86%, and the incidence of adverse reactions was 50.00%.There were many TCM syndromes associated with the therapeutic effect. Conclusion:TW tablets and Yishen juanbi pills have a clear therapeutic effect with low incidence of adverse reactions. There were many TCM syndromes associated with the therapeutic effects. If choose the right population, we might improve the therapeutic effect of the traditional Chinese medicine. Objective:To evaluate the efficacy and safety of Chinese medicine in rheumatoid arthritis (RA) patients with specific Traditional Chinese Medicine (TCM) syndromes compared to western medicine.Methods:A randomized double-blind clinic trial of patients with RA was carried out. Patients were divided into Chinese medicine group treated by Tripterygium wilfordii (TW) tablets and Yishen juanbi pills (n=53) and western medicine group treated by methotrexate and Sulfasalazine (n=52), for 24 weeks. TCM syndromes were added to inclusion criteria and exclusion criteria. Assessments included pain VAS, morning stiffness, joint count for tenderness and swelling, health assessment questionnaire, and the global assessments about disease activity of patients and physicians. Efficacy was assessed using the ACR20 improvement, and clinical and laboratory adverse reactions of the drugs were observed in both groups.Results:ACR20 in Chinese medicine group at the 12th and 24th week were 62.26% and 79.24%. Compared to western medicine, the therapeutic effects of Chinese medicine group had no statistical difference at the 12th and 24th week (P>0.05). However, there was no significant difference between the total incidence of adverse reactions of two groups (P>0.05). If we excluded the menstrual, the incidence of adverse reactions had statistical difference between two groups (P<0.05), which Chinese medicine was safer.Conclusion:After TCM syndromes were added to inclusion criteria and exclusion criteria Global assessment of the efficacy and safety in both groups were evenly matched. If choose the right population, the Chinese medicine could play a greater role in treatment of RA. Object:To investigate metabolic biomarkers related to therapeutic effects of Tripterygium wilfordii(TW) tablets on collagen-induced arthritis (CIA) rats using’H nuclear magnetic resonance (1H NMR) based serum and urine metabolomic analysis.Methods:CIA rats developed rapidly after immunized with collagen and treated by TW tablets 1.50mg/kg daily for 4 weeks. The clinical signs and the histopathological features of CIA were observed to evaluate the therapeutic effects. Collected urine and serum samples were analyzed using 600M 1H NMR for spectral binning after treatment. The urine and serum spectras were assigned by software and multivariate data analyses were carried out to recognize the spectral pattern of endogenous metabolites related to the spectra.Results:There were different clusterings of urine and serum 1H NMR spectra between responsive(n=20) and non-responsive(n=11) groups. In targeted profiling,13 endogenous metabolites in urine and 6 in serum were selected as putative biomarkers for predicting therapeutic response of TW tablets.Conclusions:The therapeutic effects of TW tablets can be predicted using 1H NMR based metabolomic study, and several metabolites may relat to the therapeutic action. |