| Objective: In clinical practice",Fu yuan rong gu tang"has a great effect in treating primary osteoarthritis of the knee (which is abbreviated osteoarthritis of the knee below, KOA),ameliorating symptoms above all pain and greatly improving quality of life. The investigation is to observe through clinic and experiment: 1.the change of inflammatory cytokinein interleukin-1 (IL-1) in synovial fluid of KOA patient and superoxide dismutase (SOD), which resist oxyradical and protect articular cartilage and promote cartilaginous repair, as well as score change of severity index of KOA (ISOA) in pro-treatment and post- treatment. 2.the change of superoxide dismutase (SOD) in blood serum of knee osteoarthritis rabbit model and interleukin-1 (IL-1) in synovial fluid, and reveal the mechanism of Fu yuan rong gu tang action, and provid evidence for exploiting new prescription of the traditional Chinese medicine and generalizing in clinic.Methods: Include clinical and experimental investigation1. Experimental investigation1.1 Experimental animals: 37 well-being New Zealand white rabbits were offered by Experimental Animals Breeding Field of Luquan, and body weight 3000g±100g, and age 6-8 months, and the sex is ignored.1.2 Animals subgroup: According to the principle of interclass equilibrium, experimental animals are divided into N,M,F,P four groups by random, 8 rabbits in each group, 5 rabbits surplus for disease principle and candidate donor by random. Group N is normal group, group M is model reference group, group F is Fu yuan rong gu tang group, group P is ibuprofen group.1.3 Fabrication Method of animal model: According to Japanese Guitoukangyan's fabrication method of animal model of KOA with vermizym, the rabbits double hindlegs knee joint cavity are injected with 4℃,1.6% vermizym and saline, first time are injected into 2ml, second time are injected into 1ml after three days, third time are injected into 1ml after six days.1.4 Operation Method: The rabbits are injected with Fu yuan rong gu tang through intragastric administration, twice quotidie, 100ml toties quoties, 15 days is one course, two courses in total.1.5 Detect marker: Content of SOD in blood serum and IL-1 in synovial fluid in pro-treatment,meta- treatment and post- treatment, and pathomorphology transformation of articular cartilage under optical microscop.1.6 Data processing: Experimental data are analyzed with software SAS.2. Clinical investigation2.1 Component and preparation: According to the therapeutic principle of cultivating archaeus and nourishing cartilage, Fu yuan rong gu tang is composed of prepared rhizome of rehmannia 30g,caulis cistanchis 20g,milkvetch root 30g, Chinese angelica 20g,tangshen 10g,tuckahoe 10g, radix aconiti lateralis preparata 15g, ephedra 9g, golden thread 10g and radix achyranthis bidentatae from Henan of China 15g.All the traditional Chinese medicine are bought from the traditional Chinese medicine hospital of Hebei province, made in preparation department of hospital with frying machine of Korea. Every dose is filled with two pockets, 100ml every pocket.2.2 Received object: According to the diagnosis standard made by Rheumatism Association of American and the latest clinic diagnosis standard had already reported, the data have 120 cases of orthopedics, include clinical and hospitalized patients, were selected from 2005.11-2007.2 of the traditional Chinese medicine hospital of Hebei province. 47 male patients and 73 female patients, age from 46 to 75 years, average age is 63 years. Elimination case:⑴rheumatic arthritis.⑵those use analgesic and glucocorticoid 2 weeks pretherapy.⑶liver and renal function malfunction, severity disease of brain and heart.⑷drug allergy patient.⑸gravida and lactation women.⑹secondary KOA.2.3 Cases subgroup: All cases are divided into F,P groups by random, 60 cases every groups. Group F is Fu yuan rong gu tang group, group P is ibuprofen group.2.4 Operation Method: Patients of group F take orally Fu yuan rong gu tang, twice quotidie, 100ml toties quoties, group P take orally ibuprofen, thrice quotidie, 0.3g toties quoties. 15 days is one course, two courses in total. All patients are prohibited to use any other KOA medicine during treatment period, but the affected limbs demand to strengthen functional exercise.2.5 Detect marker: Content of SOD,IL-1 in synovial fluid and integra of ISOA in pro-treatment,meta- treatment and post- treatment.2.6 Data processing: Experimental data are analyzed with software SAS.Result1. Experimental investigation1.1 Pro-treatment: 4 groups concentration data of SOD in blood serum and IL-1 in synovial fluid, statistical analysis results of F test through completely random design disclosed, according to the standard ofа=0.05, P<0.05, these is statistics significant difference; Redo SNK-q test disclosed, the comparison between group N and group M,F,P, according to the standard ofа=0.05, P<0.05, these is statistics significant difference, the comparison among group M,F,P, according to the standard ofа=0.05, P>0.05, these isn't statistics significant difference. These demonstrate that it was successful that fabricated animal model.1.2 After a course: 4 groups concentration data of SOD in blood serum and IL-1 in synovial fluid, statistical analysis results of F test through completely random design disclosed, according to the standard ofа=0.05, P<0.05, these is statistics significant difference; Redo SNK-q test disclosed, the comparison between group N and group M,F,P, according to the standard ofа=0.05, P<0.05, these is statistics significant difference, the comparison between group M and group F, according to the standard ofа=0.05, P<0.05, these is statistics significant difference, the comparison between group M and group P, according to the standard ofа=0.05, SOD P>0.05, these isn't statistics significant difference, IL-1 P<0.05, these is statistics significant difference, the comparison between group F and group P, according to the standard ofа=0.05, SOD P<0.05, these is statistics significant difference, IL-1 P>0.05, these isn't statistics significant difference.1.3 After two course: The results of F test and SNK-q test are identical with the results after a course.1.4 The lengthways comparison among pro-treatment,meta- treatment and post- treatment do F test through completely random design: Group N,M, according to the standard ofа=0.05, P>0.05, these isn't statistics significant difference, group F, according to the standard ofа=0.05, P<0.05, these is statistics significant difference, group P, according to the standard ofа=0.05, SOD P>0.05, these isn't statistics significant difference, IL-1 P<0.05, these is statistics significant difference.1.5 Pathomorphology transformation of articular cartilage under optical microscop exist significant difference in pro-treatment,meta- treatment and post- treatment.2. Clinical investigation2.1 Lengthways comparison in pro-treatment,meta- treatment and post- treatment: Concentration data of SOD,IL-1 in synovial fluid, statistical analysis results of F test through completely random design disclosed, according to the standard ofа=0.05, group F P<0.05, these is statistics significant difference, redo SNK-q test disclosed, all comparisons have statistics significant difference; Group P, SOD P>0.05, these isn't statistics significant difference, IL-1 p<0.05, these is statistics significant difference, redo SNK-q test disclosed, all comparisons have statistics significant difference.2.2 Chiastic comparison in pro-treatment,meta- treatment and post- treatment: Group F,P do T test through ganged design, the pro-treatment results disclosed, according to the standard ofа=0.05, P>0.05, these isn't statistics significant difference; After a course, IL-1 P>0.05, these isn't statistics significant difference, SOD P<0.05, these is statistics significant difference; After two course, the results are identical with the aforesaid.2.3 The multiple linear regression analysis of ISOA integra disclosed that there is the negative correlation between pain score changes and X-ray diagnosis grade in group F pro-treatment and post- treatment, and there is the negative correlation between pain score changes and body weight, in other words X-ray diagnosis grade shrink or body weight lighten, then the pain score changes wax; The influence of X-ray diagnosis grade exceed body weight.Conclusion1. There are great effects between Fu yuan rong gu tang and ibuprofen in decreasing level of IL-1 in synovial fluid, and aren't significant differences; The former obviously exceed the latter in boosting the level of SOD come from rabbit blood serum and patient synovial fluid. These demonstrate: Fu yuan rong gu tang not only can eliminate inflammation and relieve joint pain, but also can nourish and protect articular cartilage,boost cartilage cells function,promote cartilage repair,delay cartilage cataplasia; Meanwhile demonstrate: There aren't significant differences between Fu yuan rong gu tang and ibuprofen in the near future therapeutic effect, and the former exceed the latter in long-dated therapeutic effect.2. Profuse oxyradicals can promote articular cartilage breakdown in joint and blood serum, and accelerate its destruction and cataplasia, but SOD is its genuine opponent ,and can eliminate profuse oxyradicals, boost antioxyradical system potentia, delay cartilage cataplasia, nourish and protect articular cartilage,promote cartilage repair and so on. Fu yuan rong gu tang can remarkably boost the level of SOD in experiment and clinic, these adequately demonstrate: The therapeutic principle is surely feasible that cultivate archaeus and nourish cartilage.3. The correlation between the therapeutic effect of Fu yuan rong gu tang and X-ray diagnosis grade,body weight, it demonstrate: Fu yuan rong gu tang has great therapeutic effect with regard to KOA morning,metaphase and X-ray diagnosis grade 1-3, and relatively no good with regard to X-ray diagnosis grade 4. Meanwhile demonstrate: Body weight has determinate influence with regard to KOA therapeutic effect, and can boost therapeutic effect through controlling body weight properly.
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