| Objective:1. Clinical research:Through randomized, controlled, blinded clinical trials to investigate the "Tongfengkang II granule" and "Tongfeng I external application" of topical side on acute gouty arthritis clinial efficacy and safety, to establish safty, effective, science, the standard TCM integrated treatment of gouty arthritis medicine, providing an important basis for optimization.2. Experimental Research:By observing the influence of "Tongfengkang II granule" on ratmodel of acute gouty arthritis and joint symptoms of serum IL-4 and TNF-a to explore the effect of "Tongfengkang II granule" treatment of acute gouty arthritis of the possible mechanisms.Method:1. Clinical Research:gathering 40 acute gouty arthritis patients which met the diagnostic requirements, from the Guangzhou University of Chinese Medicine, First Affiliated Hospital outpatient and inpatient. To randomly divided into treatment group and control group,20 patients in each group. Both groups were treated for infrastructure. In addition, the treatment group were treated by "Tongfengkang II granule" and "Tongfeng I external application" that treatment of topical. The control group treated with placebo. All treatment in 5 days. Observing the index of the patients'Joint pain; acute joint swelling and joint dysfunction on before and after the treatment and the 3 treatment day. At 8 pm each day, the patients recorded the joint pain rating with 11-point pain rating scale, blood test with alanine aminotransferase(ALT), urea nitrogen(BUN), creatinine(CREA) level after the treatment. perimeter joints in each group in 1 to 8 hours after modeling. Model group is greater than the other group (P<0.05). In 24 hours and 72 hours after the modeling, the comparison in each group is no significant difference between groups (P>0.05). The levels of IL-4 in serum of the model group was significantly reduced compared with the other 5 (P<0.01). The levels of TNF-a in serum in each group compared with the other 5 were significantly increased (P<0.01), traditional Chinese medicine the dose content of TNF-a compared with voltaren no significant difference (P> 0.05).Conclusion:1. "Tongfengkang II granule" and "Tongfeng I external application" can be reduced the index of patinets joint pain, joint swelling, joint dysfunction. On acute gouty of arthritis pain with swelling effect.2. "Tongfengkang II granule" and "Tongfeng I external application" may lower the leukocytes and neutrophil in the patients. On liver, and kidney function had no significant effect, "Tongfengkang II granule" and "Tongfeng I external application" had not side effect.3. "Tongfengkang II granule" can improve the acute gouty arthritis in rats.4. "Tongfengkang II granule" can raise the levels of the IL-4 in serum and lower the levels of the TNF-a in serum in the rats.
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