| Aim The purpose of this study is to investigate the traditional Chinese medicine Shuangfangyin’s pharmacological effects in adjuvant-induced rheumatoid arthritis(AA) in wistar rat and to evaluate the clinical therapeutic effects in active rheumatoid arthritis(RA) patients. Methods The pathological model of AA was reproduced in rats, the animals were then assigned into control group, AA model group or treatment groups(AA model with Shuangfangyin 2.2, 9.8 or 22.0 g/kg or with tripterygium0.06 g/kg). Each group contained 10 rats. Since the day of adjuvant injection, Shuangfangyin or triptervgium were given via gavarge for 28 day. At 3, 7, 14, 21 and 28 day, the arthritis index, pain threshold and paw swelling degree were assessed. At 28 day, the serum levels of C-reactive protein(CRP), interleukin(IL)-1, IL-6, IL-10 and tumor necrosis factor alpha(TNF-α) were measured with enzyme-linked immunosorbent assay(ELISA). For clinical assessments, 100 active RA patients were included according to the RA diagnosis standard by American College of Rheumatology(ACR).Patients were randomly assigned to Shuangfangyin treatment group(60 patients, one dose, 200 ml q.d.)or triptervgium treatment group(40 patients, 20 mg t.i.d.). During the six week treatment, the morning stiffness, joint swelling degree, joint range of motion and joint pain index were observed at 2, 4 and 6week time point. Total clinical effectiveness rate was calculated by adding the number of clinically benefited patients and that of clinically effective patients, and then divided by total number of patients.After six week treatment, the serum levels of rheumatoid factor(RF), erythrocyte sedimentation rate(ESR) and immunoglobulin gamma(Ig G) were measured. Hepatic and renal functions were assessed by measurement the levels of blood alanine aminotransferase(ALT), aspartate aminotransferase(AST),albumin, creatinine and blood urea nitrogen(BUN). Statistics were performed with SPSS 13.0.Results Since day 3 post adjuvant injection, the AA model group rats exhibited remarkably elevated arthritis index and paw swelling degree, while the pain threshold was significantly decreased relative to control group(P<0.01), and these parameters further deteriorated over time. Starting from treatment day 14, high dose Shuangfangyin effectively reversed all the three parameters observed(P<0.05).Meanwhile, middle and low dose of Shuangfangyin significantly decreased arthritis index relative to AA model group starting from treatment day 21(P<0.05). The positive control triptervgium exerted similar effects as of Shuangfangyin. Six week of gavarge treatment with middle or high dose of Shuangfangyin significantly decreased the serum level of TNF-α, IL-6, IL-1 and CRP, while significantly increased the level of IL-10 in AA rats(P<0.05). Clinically, among the 60 RA patients who received Shuangfangin, the total clinical effectiveness rate after 2, 4 and 6 week treatment were76.67%, 86.67% and 95.27%, respectively. In comparsion, triptervgium treatment resulted in total clinical effectiveness rate of 72.50%, 85.00% and 93.32% after 2, 4 and 6 week treatment, respectively.Both treatment significantly decreased serum RF, ESR and Ig G levels after six week treatment(P<0.05). ALT, AST, albumin, creatinine and BUN levels were not significantly altered after six week treatment(P>0.05). Conclusions Shuangfangyin treatment had therapeutic effects in AA rats,decreasing the arthritis index, paw swelling degree and increasing the pain threshold, which is associated with decreasing serum TNF-α, IL-6, IL-1 and CRP levels and increasing serum IL-10 levels.Shuangfangyin also exhibited therapeutic effects in RA patients, improving morning stiffness, joint swelling degree, joint range of motion and joint pain index, while decreasing RF, ESR and Ig G levels.No hepatic or renal damage were observed during treatment. |
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