| Object:1.By observing the change of cartilage and joint function and the content of IL-1,IL-6,TNF-α,MMP-3 in serum and joint fluid after the knee osteoarthritis rabbit models taking Zhenggushenjin capsules to explore the effect and possible mechanism of Zhenggushenjin capsules on treating KOA.2.By observing the treatment of KOA clinical research combining glucosamine sulfate capsules with Zhenggushenjin capsules, to investigate the advantages of combining western medicine with Chinese patent medicine in treating of the disease.Methods:Animal experiment:30 Japanese white rabbits were randomly divided into normal group, model group and treatment group,10 cases in each group.Making models with knee joint cavity papain injection for model group and treatment group rabbits, after models established successfully the rabbits received gavage in the same dosage for 6 weeks continuously (normal group and model group was given saline, treatment group was given Zhenggushenjin capsule solution), and compared the knee joint scope of activity before and after the treatment, using enzyme linked immunosorbent assay(ELISA)method to test the content of IL-1,IL-6,TNF-α,MMP-3 in serum and joint fluid,observed the cartilage morphology with naked eyes largely and optical microscope.Clinical research:90 standard KOA patients were randomly divided into Zhenggushenjin capsule group,glucosamine sulfate capsule group and combination group, 30 cases in each group,6 weeks after treatment, compared respectively from the WOMAC osteoarthritis index score,TCM syndrome integral evaluation, the content of IL-1,IL-6,TNF-a,MMP-3 in joint fluid and the comprehensive efficacy and safety comparison.Results:Animal experiment:1.The rabbit’s joint activity of treatment group significantly improved compared with before,P<0.01;The articular cartilage scores of treatment group with naked eye and optical microscope were significantly better than the model group,P<0.01.2.The content of IL-1,IL-6,TNF-a,MMP-3 comparison of each group after treatment in rabbit’s serum and joint fluid:(1)The content of IL-1,TNF-a,MMP-3 comparison of each group,the difference was statistically significant (P<0.01);Compared between two groups,the normal group and the treatment group were lower than the model group,P<0.05,the treatment group was higher than the normal group,P<0.05.(2)The content of IL-6,the normal group was lower than the model group and the treatment group,P<0.05,there was no difference between the treatment group and the model group, P>0.05.Clinical Research:1.Except the TCM symptom integral of glucosamine sulfate capsule group without improved significantly(P>0.05),other symptoms observation indexes obviously improved compared with before,P<0.05;The integral improvement comparison of WOMAC total score, pain score,the difficulty of daily life, there was no significant difference between Zhenggushenjin capsule group and glucosamine sulfate capsule group,P>0.05;the combined group better than the other two groups,P<0.05;The integral improvement comparison of stiffness in the joints,TCM symptom score, combined group and Zhenggushenjin capsule group better than glucosamine sulfate capsule group,P<0,05, no significant difference between combined group and Zhenggushenjin capsule group,P> 0.05.2.Except glucosamine sulfate capsule group TNF-a and 1L-6 had no significant change (P>0.05), other groups IL-1,TNF-α, MMP-3 were decreased significantly,P<0.05; Combined group better than the other two groups in the inhibition of IL-1,MMP-3 producing,P<0.01,no significant difference between combined group and Zhenggushenjin capsule group in terms of inhibiting TNF-α,P>0.05.3.The comprehensive therapy efficacy of combination group was significantly better than the other two groups,P<0.01;no significant difference between glucosamine sulfate capsule group and Zhenggushenjin capsule group,P>0.05;The incidence of adverse reactions of combined group and Zhenggushenjin capsule group less than glucosamine sulfate capsule group,P<0.01.Conclusion:1.Zhenggushenjin capsule can significantly reduce the levels of IL-1,TNF-a in rabbit’s serum and synovial fluid and inhibit the expression of MMP-3, has obvious anti-inflammatory and analgesic effect, can effectively reduce the cartilage matrix destruction, promote the synthesis of matrix, inhibit articular cartilage degeneration, thereby increase the range of knee and improve joint function and delay osteoarthritis disease process, has exact therapeutic effect for KOA rabbit, which is the possible mechanism of Zhenggushenjin capsule arthritis on treating osteoarthritis.2,Both Zhenggushenjin capsules and glucosamine sulfate capsules have obvious therapeutic effect for KOA patients, but combination therapy not only has obvious advantages on reducing WOMAC score, inhibiting IL-1, TNF-α, MMP-3 production in synovial fluid, relieving clinical symptoms and improving joint function and improving patients’the ability of daily life, but also safety, no significant side effects. |
