Experimental Study And Clinical Observation Of "Liuwei Gubi Decoction" In The Treatment Of Knee Osteoarthritis

Objective:To explore the mechanism of action and observe the clinical effect and safety of "Liuwei Gubi Decoction" in the treatment of knee osteoarthritis(KOA),and provide reference and basis for its,clinical application.Methods:(1)Experimental Research:32 rabbits were randomly divided into normal group,model group,Liuwei Gubi Decoction control group and glucosamine sulfate control group,(n=8 each group).The OA models were established by injecting papain into rabbits knee joint cavity on days 1,4 and 7,and the model was completed at 4 weeks after the injection.Distilled water,Liuwei Gubi Decoction,glucosamine sulfate,were respectively given by lavage after modeling.Normal group was not treated.The rabbits were sacrificed 6 weeks later,and the model modeling hind knee joints were dissected for general observation of synovial membrane and cartilage,then Pelletier score.The articular cartilages were harvested,and the changes of histomorphology were observed under light microscope with HE staining,and Mankin’s score,then measure the Tumor necrosis factor alpha(TNF-a),Interleukin-1β(IL-1β)and Matrix metallo-proteinase-3(MMP-3)in serum in the way of ELISA method.(2)Clinical Research:60 patients with liver and kidney deficiency type of knee osteoarthritis were randomly divided into 2 groups(n=30 each group).Patients in the treatment group oral Liuwei Gubi Decoction,while the others in the control group oral glucosamine sulfate capsules,continuous treatment for 6 weeks.VAS score and Lequesne index were used as criteria for evaluation of curative effect.Compared the subjective pain in patients before and after therapy.Observed the improvement degree of knee symptoms including pain at rest and movement,tenderness,swelling,morning stiffness and walking ability,and record adverse reactions,vital signs and laboratory biochemical indexes during the treatment.Results:(1)Experimental Research:After treatment,the Pelletier score,Mankin’s score,serum TNF-,IL-1 and MMP-3 were compared between the two groups,the difference was statistically significant(F= 43.649,P=0.000;F= 88.023,P=0.000;F=292.290,P=0.000;F= 17.261,P=0.000;F=16.360,P=0.000);Model group respectively compared with normal group,Liuwei Gubi Decoction group and glucosamine sulfate group,the differences were statistically significant,Liuwei Gubi Decoction group and glucosamine sulfate groups were compared,the difference was not statistically significant(Pelletier score:P=0.000;P=0.000;P=0.000;P=0.669;Mankin’s score:P=0.000;P＝0.000;P=0.000;P=0.779;TNF-a:P=0.000;P= 0.000;P=0.000;P=0.883;IL-1β:P=0.000;P=0.000;P=0.000;P=0.925;MMP-3:P=0.000;P= 0.000;P= 0.000;P= 0.489).(2)Clinical Research:After treatment,the clinical scores of the treatment group and the control group were significantly lower than before(treatment group:VAS score:t=29.437;P＝0.0000;Lequesne index:Rest pain:t =11.804;P=0.0000;Motion pain:t=14.811;P=0.0000;Tenderness:t=16.368;P=0.0000;Swelling:t=8.848;P=0.0000;Morning stiffness:t=15.070;P=0.0000;Walking ability:t=14.000;P=0.0000;General index:t=13.460;P=0.0000;control group:VAS score:t=34.000;=0.0000;Lequesne index:Rest pain:t=14.559;P=0.0000;Motion pain:t=7.706;P＝0.0000;Tenderness:t=9.000;P=0.0000;Swelling:t=12.599;P=0.0000;Morning stiffness:t=10.648;P= 0.0000;Walking ability:t=21.981;P= 0.0000;General index:t =26.112;P=0.0000);There was no significant difference between the two groups(VAS score:t=0.2238;P=0.8235;Lequesne index:Rest pain:t = 0.3429;P=0.7368;Motion pain:t =0.2706;P=0.7907;Tenderness:t= 0.0686;P= 0.9463;Swelling:t= 0.1807;P= 0.8592;Morning stiffness:t = 0.1126;P=0.9120;Walking ability:t = 0.1897;P=0.8522;General index:t= 0.6901;P＝0.5014);There was no obvious adverse reaction in the treatment group,the adverse reaction rate was lower than that in the control group,the difference was not statistically significant(x2=2.368,P=0.124).Conclusion:"Liuwei Gubi Decoction" can improve the condition of KOA,promote the formation of cartilage cells,improve the structure of cartilage matrix,significantly reduce the Pelletier score and Mankin’s score,and can reduce the content of serum MMP-3,IL-1β,TNF-α,thereby reducing the damage to the articular cartilage matrix,directly or indirectly improve cartilage matrix metabolism,promote cartilage repair,and its effect have no obvious difference with glucosamine sulfate."Liuwei Gubi Decoction" can effectively reduce the VAS score and Lequesne index,which has good curative effect and high safety on the treatment of liver and kidney deficiency type of knee osteoarthritis,and is worthy of clinical application.