| Object ive1. Clinical Research:Through Randomized Controlled Blinded with large sample and multi-Center clinical trials to investigate the "TongfengkangⅡgranule" and "Tongfeng I external application" of topical side on acute gouty arthritis clinical 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 "Tongfengkang II granule" on rat model of acute gouty arthritis about the joint symptoms and serum (IL-1β, XOD) impact. Investigate "Tongfengkang II granule" on the treatment of acute gouty arthritis of the possible mechanism.Method1. Clinical Research:gathering 160 acute gouty arthritis patients which met the diagnostic requirements,80 patients were from the Guangzhou University of Traditional Chinese Medicine, First Affiliated Hospital outpatient departments and hospital cases of acute gouty arthritis and were randomly divided into treatment group and control group,40 patients in each group; 40 patients were from Guangzhou City First People's Hospital of acute gouty arthritis, were randomly divided into treatment group and control group, 20 patients in each group; 40 patients were from Guangdong Provincial People's Hospital, acute gouty arthritis, were randomly divided into treatment group and control group,20 patients in each group. Three centers a total of 160 patients were randomly divided into treatment group and control group,80 patients in each group.Each group was given the basic treatment and if the patients have to endure the pain is difficult to give patients atmosphere acid diclofenacsodium sustained-release tablets pain; paired with aluminum hydroxide compound, to prevent stomach discomfort. In addition, the treatment group were treated by "Tongfengkang II granule" and "Tongfeng I external application" that for topical treatment. The control group treated with placebo. There treatments in 5 days. Observing the index of the patients'joint pain; acute joint swelling and joint dysfunction on before and after the treatment day and the day three of the treatment. At 8 pm each day, the patients recorded the joint pain rating with 11-point pain rating scale by themselves. Before treatment and after treatment, the patients were processing the quality of life survey, that including the index of the quality of sensory activities and changes in overall health; and to check the level of blood test about Blood routine, Alanine ami notransf erase (ALT), urea nitrogen (BUN), creatinine (CREA), uric acid (UA), and the Urine test, Stool test, ECG test.2. Experimental Research:60 SPF SD rats were randomly divided into six groups (10 in each group), that belong to blank group, model group, control group, high dose of Chinese medicine group, middle dose of Chinese medicine group, low dose of Chinese medicine group. Blank group and model group were administered with normal saline. The control group was administered with diclofenac sodium. The other Chinese medicine groups were administered with " Tongfengkang II granule " that in different concentration different configuration solution orally,1 time per day. All administered total of 5 days. Before stomach irrigation on the third day, except the blank group, the other five groups were auricular injection of uric acid sodium to establishment of acute gouty arthritis model. The blank group injected the same volume of saline. Observe the index of inflammation and dysfunction after 8 hours and 72 hours of the modeling. Right ankle joint circumference measurements in rats before and after the model 1 hour,4 hours,8 hours,24 hours, and 72 hours. In the fifth day, after 2 hours of stomach irrigation, to collect the blood from the rats for testing the level of IL-1βand the activity level of XOD.Results1. Clinical Research:Participate in the trial of the two groups of patients in gender, age, body mass index, duration of disease, complications and so no significant difference (P> 0.05), with comparability. Before and after treatment, the treatment group, pain points and joint swelling points, joint dysfunction, scores were lower, with significant difference (P<0.01), In the control group showed no significant difference (P> 0.05); a various points after treatment compared to treatment group was lower than the control group with significant difference (P<0.01).Effective rate in treatment group reached 100%, whether from the perspective of the researchers or the perspective of the patient on the treatment of evaluated. Effective rate in control group, it has 57.89% in the perspective of the researchers and 56.14% in the perspective of the patient.In the safety evaluation, both groups were no significant difference (P > 0.05) about the data of the lymphocytes, red blood cells, hemoglobin and platelet count; Alanine aminotransferase (ALT), urea nitrogen (BUN), creatinine (CREA); and the Urine test, Stool test, ECG test. In the data about the WBC and neutrophil counts, the treatment group can lower than before treatment (P< 0.05). Therefore, it may have treatment effect, but the control groups were no significant difference with the treatment before.2. Experimental Research:After the modeling, the inflammation index and joint dysfunction index of each groups was only the model groups was higher than the other groups. But at 8 hours and 72 hours later, the index of the traditional Chinese medicine dose groups and control group were have significant lower(P< 0.05). The model group and blank group no significant change(P>0.05).The comparison of the joints perimeter between one to eight hours after the modeling, the model groups was larger than the others(P< 0.05). And then,24 hours and 72 hours later, in between each groups no significant difference (P> 0.05).The index of serum IL-1β, the model groups was significant higher (P<0.01)than the others, but no difference (P>0.05) in between others groups. The index of serum XOD, the model groups was significant Lower (P<0.01)than the others, but no difference(P>0.05) in between others groups.Conclusion1. Oral Topical Form of gout, which can be reduced the index about patients joint uncomfortable that about pain, swelling and dysfunction, on acute gouty arthritis. And prove the treatment of acute gouty arthritis can have eliminated swollen and relieve pain effect.2. Oral Topical Form of gout, which can be lowered patients with acute gouty arthritis uric acid and white blood cell, neutrophil count, and in the function of liver and renal, which had no significant side effect that can prove it had had significant effect and safety for the patients with acute gouty arthritis.3. "TongfengkangⅡgranule" can improve the syndromes of the acute gouty arthritis arthritis rats, and may decreased the level of IL-1βand XOD in serum of the acute gouty arthritis rats.
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