| BackgroundGout is a very old disease. In China, Yuan Dynasty, Zhu DanXi, physicians clearly for the first time the disease name of "gout". Danxi XinFa":gout, hundreds limbs walking the pain. Other writings called pattern of BaiHu LiJieFeng. Because of its abrupt onset, severe pain, often accompanied by swelling and self-healing, light when the symptoms for several hours on the mitigation of, Disease and cure like the wind, hence the name gout. Modern research suggests that gout is caused due to hereditary or acquired cause of a group of purine metabolism disorder and (or) excretion of uric acid obstacles caused by the disease. Gout is divided into both primary and secondary common first symptom of acute arthritis of primary gout. Epidemiological survey found that with the improvement of living standards and lifestyle changes, the prevalence of gout was a gradual upward trend. Different regions, age, gender, the prevalence is different, the economically developed areas, male, age50prevalence rate is relatively high, and gradually younger tendencies.At present, the etiology and pathogenesis of modern medicine for gout is not completely clear, no cure yet. However, acute gouty arthritis as an important stage in the pathogenesis of gout, is also an important stage of treatment, If the symptoms can be controlled in a timely, to reduce the number of attacks, not only can reduce the suffering of patients, and can effectively slow down the disease process. Western medicine for acute gouty arthritis attack mainly using colchicines, non-steroidal anti-inflammatory drugs, corticosteroids and other anti-inflammatory pain medication, although the efficacy is obvious, but for most recurrent patients in terms of side effects obvious samely. So integrative treatment in the maximum remission of disease, to reduce the toxic side effects have unique advantages.TCM characteristics of gout is exterior excess and interior deficiency, clinical treatment must be righting and taking into account the banishment of evil spirits, keeping in mind that the specimens of urgency. Gout period of joint pain, mainly for swelling, Due to dampness-heat in the spleen and stomach, hot and humid turbidity stasis to block Joint meridian. Professor Liu Youzhang to basic pathogenesis summed up as "hot and humid Blockage Ecchymosis stay "Expelling" is anxious to treat the symptoms, clearing heat and dampness, Huoxuetongluo mainly based on the above understanding, Professor Liu Youzhang within the method of clear interior pathogenic factors and outthrust through the exterior, clear interior pathogenic factors refers to the use of clear heat, dispel dampness, activate blood circulation, detoxification of drugs to clear the solution blood ecchymosed, outthrust through the exterior means with release the exterior with pungent, activate blood and resolve stasis of drugs through the pathogenic factors, the pathogenic factors there way out (to promote the degradation of urate)。And created a TongFengKang (TFK) Ⅰ, Ⅱ Oral side and gout Ⅰ topical side, the series of prescriptions in the drug group, the main clearing heat and dampness, together with the drug of release the exterior with pungent, a combination of traditional Chinese medicine prescription theoretical andmodern pharmacology research, drug refining, strict compatibility, achieved good efficacy in clinical applications. Pre-clinical observation has been initially confirmed to the method of clear interior pathogenic factors and outthrust through the exterior, can not only improve joint symptoms of acute gouty arthritis patients, but also to lower serum uric acid; Experimental studies also show that TFK significantly improved acute gouty arthritis of rat model inflammatory cell infiltration, improve blood vessel dilatation and congestion, reduce the damage of the synovial tissue, anti-swelling and analgesic effect, and to explore its possiblethe mechanism of action. In this study, relying on the Eleventh Five-Year National Science and Technology Support Program project on "gout Chinese optimize the sequence of treatment options"(2007BAI20B062). through the rigorous design of clinical trials to be clear the method of clear interior pathogenic factors and outthrust through the exterior, treatment of acute gouty arthritis, the clinical efficacy and safety.Object1. Clinical research:Through multi-center, randomized, double blind, placebo controlled clinical trials to explore the oral administration of gout within the the method of clear interior pathogenic factors and outthrust through the exterior, under the guidance of TFK II particles and TFK I topical scattered TCM treatment options for acute gouty arthritis patientsthe clinical efficacy and safety, to establish efficacy of the exact and drug side effects gouty arthritis TCM treatment optimization program provides a rigorous clinical research evidence.2. Experimental study:Observation on the content of a rat model of acute gouty arthritis by the particles before and after treatment of TFK II, joint symptoms and serum prostaglandin E2(PGE2), phospholipase A2(PLA2), to explore TFK II on acute goutarthritis of the possible mechanisms of the anti-inflammatory analgesic.Method1. Clinical research:In accordance with the case selection criteria, Collected from the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangdong Provincial People’s Hospital, Guangzhou First Municipal People’s Hospital, Nanfang Hospital, the outpatient and hospitalized patients of five hospitals in the Guangdong Provincial Hospital of200cases were randomly divided into treatmentand control groups, a ratio of1:1. Both groups received a basic treatment, In addition, the treatment group with oral administration of TFK II by scattered and TFK I of topical treatment; the control group with placebo, daily for5days. Before the start of treatment, three days of treatment, one day after treatment by the researchers checked the records of patients with joint pain, acute swelling and dysfunction of the degree; Patients with grade according to the records of the11-point pain rating scale joint pain; detected before and after treatment in patients with blood, liver and renal function changes every day to evaluate the safety of the treatment.2.Experimental study:SPF SD rats48were randomly divided into normal group (A), model group (B), colchicine group (C), TOMGFENG KANG II particles with low-dose group (D), TFK II particles of moderate dose group(E), TFK II particles of high-dose group (F).8rats in each group. TFK Ⅱ particles of high dose, Moderate doses, low-dose group were72g/kg/d,36g/kg/d18g/kg/d, colchicine group dose0.3mg/kg/d, normal group and model group were treated with saline, and treatment for5days. Adopted injection in right tibiotarsus articular of Sodium urate solution to establish acute gouty arthritis model in the third days of medication,, the normal group were injected with the same volume of saline. Multiple measure the rat ankle joint circumference, observed in rat arthritis index, dysfunction index. Observed the rat synovial pathological changes by HE staining. Determinate of levels of serum PLA2and PGE2by the enzyme-linked immunosorbent assay (Elisa,).Results1. Clinical research:The actual into the group of patients in this study is198cases (due to the breakage of the test drug to decrease two cases), of which98cases in the control group, treatment group (n=100). The two groups were no significant differences (P>0.05) in the baseline characteristics of age, height, weight, medical history, complications, with high comparability.The statistical results showed that the joint pain was reduced75.21%,19.76%in the control group. Acute joint swelling disappeared of treatment group was80.56%,25.56%in the control group, the chi-square test, the difference between the groups was statistically significant (P<0.05). Limited of joint mobility was disappear with rate of83.36%,19.50%in the control group. The efficacy of clinical remission rate in the treatment group was70%in the control group was6.67%, the overall efficacy of the distribution groups has apparent difference, it has statistically significant (P<0.05). Safety evaluation, treatment and control groups of patients the ALT, BUN,, CREA, there was no significant (P>0.05); Treatment group on the WBC, neutrophil count decreased (P<0.05), no significant difference in the control group before and after treatment (P>0.05). The two groups had no effect on red blood cell and platelet counts.2. Experimental study:(1) Compared with normal group, model group,2,8,24,72-hour joint swelling was significantly increased (P<0.01). Compared with model group, colchicine group after the modeling2,8,24,72-hour joint swelling significantly reduce the (2h:P<0.05;8h:P<0.05;24h:P<0.05;72h:P<0.01); TFK II particles of high dose, moderate doses, low-dose group2,8,24hours after modeling, joint swelling mitigation.72hours of joint swelling significantly reduce (TFK Ⅱ particles of high dose:P<0.01; TFK II particles of moderate dose:P<0.01; TFK II particles of low dose:P<0.01). No significant difference compared with the colchicine group (TFK II particles of high dose:P>0.05; TFK Ⅱ particles of moderate dose:P>0.05; TFK Ⅱ particles of low dose:P>0.05), TFK G II particles of high dose, moderate doses, low-dose group, joint swelling index decreased by the lower dose group.The model group8h showed significant swelling of arthritis,24h,72h showed a trend of gradually ease; Compared with model group, colchicine group, TFK II particles of high dose, moderate doses, low-dose group arthritis swelling was significantly reduced, till72h joints showed only slight swelling.The model group showed significant joint dysfunction8h,24h,72h gradually ease;Compared with model group, colchicine group, TFK II particles of high dose, moderate doses, low-dose group joint dysfunction was significantly reduced, till72h joint dysfunction disappeared.(2) HE staining shows the apparent rat model of joint synovitis, synovial cell hyperplasia, accompanied by inflammatory cell infiltration, proliferation of small blood vessels and fibroblasts, suggesting that the model was successful. After TFK II particles and colchicine treatment, the above-mentioned pathological changes reduced.(3) The results showed that the enzyme-linked immunosorbent assay (Elisa,) the determination of PGE2in serum, less PGE2content in the normal group, model group compared with significantly increased. TFK II particles of high dose, moderate doses, low-dose group compared with model group, can be significantly lowered serum levels of PGE2in the content (P<0.01); There is a significant difference (P<0.05) compared with the colchicine group, the effect of low-dose group is less than the colchicine group, but in the moderate doses, high dose group is better than the colchicine group. Each group of TFK II Particles, the low dose group compare with the moderate doses, high dose group it was a statistically significant difference (P<0.01); moderate dose group compared with the high dose group was no significant difference (P>0.05).(4) The results show that the enzyme-linked immunosorbent assay (Elisa,) the determination of serum PLA2content and PLA2content is less, in the normal group, model group compared with significantly increased. TFK II particles of high dose, moderate doses, low-dose group compared with model group, can be significantly lowered serum PLA2content (P<0.01); There is a significant difference (P<0.05) compared with the colchicine group, the effect of low-dose group is less than the colchicine group, but in the moderate doses, high dose group is better than the colchicine group. Each group of TFK II Particles, the low dose group compare with the moderate doses, high dose group it was a statistically significant difference (P<0.01); moderate dose group compared with the high dose group was no significant difference (P>0.05).Conelusion1.The basic pathogenesis of acute gouty arthritis in TCM is" obstruction of dampness-heat and agonizing arthralgia, blood stasis and toxicity stationaryUnder. Treatment is clear heat and drain dampnessthe, detoxification and dissipation blood stasis. The method of clear interior pathogenic factors and outthrust through the exterior is consistent with the disease key. Method of clear interior pathogenic factors and outthrust through the exterior, the guidance of TCM treatment programs based on TONGFENGKANG II particles and TONGFENGKANG I topical side can be significantly reduced in patients with acute gouty arthritis and joint pain, joint swelling, joint dysfunction points to improve the comprehensive efficacy score, swelling and pain of acute gouty arthritis. The study found no adverse events, with good security.2. TFK II particles can significantly improve the MSU acute gouty arthritis in rats, joint swelling, redness and swelling, and dysfunction to improve the pathological changes of synovial tissue inflammation. TFK II particles may by lowering of PLA2and PGE2concentration affect the inflammatory cascade, in order to play its anti-inflammatory analgesic. And low, medium and high dose group showed some dose-effect relationship trends, which in the high dose group more visible role. |
PDF Full Text Request