The Study Of BiQi Capsule On Clinical Efficacy And Osteoprotective Effect Evaluation In Knee Osteoarthritis

ObjectivesTo evaluate the clinical efficacy and safety of Biqi Capsule in the treatment of knee osteoarthritis and explore the mechanism of bone protection through randomized controlled clinical trials.Methods1.To evaluate the theoretical basis and compatibility of Biqi Capsule in the treatment of knee osteoarthritis by consulting relevant literature.2.49 eligible patients were randomly divided into the experimental group"Biqi Capsule+celecoxib" and the control group "calcitriol+calcine+celecoxib".The Western Ontario and Mc Master Universities Osteoarthritis Index(WOMAC),syndrome score of traditional Chinese medicine,health assessment questionnaire(HAQ),joint pain score,joint swelling score,the patients’self-assessment pain VAS score(VAS),morning stiffness time,NF-κB receptor activator ligand(RANKL),hs-CRP,matrix metalloproteinase-3,osteoprotegerin and safety index before and after treatment were evaluated at 0,4,12 and 24 weeks respectively.Results1.Literature review:Biqi Capsule has a reasonable compatibility which is suitable for the etiology and pathogenesis of knee osteoarthritis.It has clinical and potential osteoprotective effect.2.Clinical study49 patients were included in this clinical study,including 23 in the experimental group and 26 in the control group.The statistical results showed that there was statistically significant(P<0.01)in the WOMAC pain and the WOMAC physical function of the two groups which were improved at each time point after treatment.Both of groups were was no significant difference in the WOMAC pain at 4,12 and 24 weeks(P>0.05).At 24 weeks,there was statistical significance in the evaluation of WOMAC physical function between the two groups(P<0.05),and there was no difference in the other time points(P>0.05).After 12 weeks and 24 weeks of treatment,the evaluation of WOMAC stiffness in the experimental group had significant alleviate effect than before treatment(P<0.01).There was no significant difference between the two groups at other time points(P<0.05).The M-HAQ scores of the experimental group were improved at all time points after treatment(P<0.05),and the M-HAQ scores of the control group and morning stiffness of joints at 12 weeks and 24 weeks after treatment were statistically significant(P<0.05).There was no difference in M-HAQ between both of groups at each time point(P>0.05).After 4,12 and 24 weeks of treatment,the TCM syndrome scores of the two groups were improved significantly(P<0.01).There was no significant difference in TCM syndrome score between the two groups at each time point(P>0.05).The joint tenderness scores of the two groups were significantly improved at 4,12 and 24 weeks after treatment(P<0.01).The joint swelling scores of the experimental group were significantly improved at 12 weeks and 24 weeks(P<0.05).There was no significant change in the joint swelling score of the control group at each time point compared with that before treatment(P>0.05).There was no significant difference in joint tenderness and swelling scores between the two groups at each time point(P>0.05).The morning stiffness of the joints in the experimental group was significantly improved at 4 weeks,12 weeks and 24 weeks(P<0.05).The control group in 12 weeks,24 weeks than before the treatment was significantly improved(P<0.05).There was statistical difference between the two groups at 24 weeks after treatment(P<0.05).There were statistically significant differences in patients’self-assessment pain VAS score and hs-CRP between the two groups(P<0.05).There was no significant difference between the two groups in the scores of patients’ self-assessment pain VAS score and hs-CRP(P>0.05).There was no significant change in OPG,RANKL,MMP-3 between the two groups at 12 and 24 weeks after treatment compared with before treatment,and the difference was not statistically significant(P>0.05).There was no statistical difference between the two groups at each time point after treatment between OPG,RANKL,and MMP-3 groups(P>0.05).ConclusionBiqi Capsule is effective and safe in the treatment of KOA.It has great potential to improve the joint function and bone protection of patients in the long term.It is worth recommending in the clinical treatment of KOA.