A Clinical Trial Study Of Xitongkang In Treating Knee Osteoarthritis Of Kidney Deficiency And Blood Stasis

Purpose:We already have the experimental foundation from previous pharmacodynamics and acute toxicity studies.The aim of this trial is to observe the efficacy and safety of Xitongkang for the treatment of KOA caused by kidney deficiency and blood stasis syndrome,and to provide basis for further clinical application.Material and method:This is a randomized,double-blind,placebo-controlled,multicenter trial.A total of 176 patients at three hospitals will be randomly allocated in equal numbers to receive the Xitongkang treatment or the placebo control,each group has 88 patients.The treatment course is 4 weeks with 24 weeks follow-up.Follow-up evaluations will be performed on weeks 2,4,12,and 24 after completion of the 4-week treatment course.All patients will receive loxoprofen sodium tablets when they have intolerant pain at the guidance of a doctor.At the beginning and the end of the experiment,numeric rating scale(NRS),Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)score,activity of daily living(ADL)scale,curative effect of TCM syndrome evaluation,secondary response evaluation scores and the patients’ safety indexes were tested and the adverse reactions were closely observed in the trial.The clinical data were managed by CRF table,and statistical analysis was carried out with SPSS19.0 statistical software.Results:1 There were two patients who were not accordance with the inclusive criteria,so the number of entering the group was 174 with 88 in the treatment group and 86 in the control group.2 There were no significant differences in the comparison of general information and baseline data of the two groups(P>0.05).3 The differences of NRS,WOMAC,ADL and TCM syndrome evaluation within groups were statistically significant(P < 0.01).The differences between groups after treatment were statistically significant(P<0.01).4 Secondary response evaluation: in response to the dizziness and febrile symptoms of 2patients in the trial,the relevant personnel of the study group analyzed that the above symptoms were not related to the drug administration.5 Both of two groups had lower pain score through VAS change curve in 28 days,and the treatment group reduced more than the control group.6 The remission rate of treatment group was higher than control group,and the recurrence rate,reconsort rate and rehospitalization rate were all lower than control group.Conclusion:1 Xitongkang can effectively improve the knee joint pain and stiffness of KOA patients in kidney deficiency and blood stasis syndrome,and it can improve the patient’s daily activity ability.2 Xitongkang can control the disease of relapsing and it has long-term effect of KOA patients in kidney deficiency and blood stasis syndrome.3 Xitongkang is safety to treat KOA patients in kidney deficiency and blood stasis syndrome in clinic.4 Xitongkang has the characteristics of small drug composition,good efficacy,small side effect,strong pertinence and remarkable clinical application effect,which deserve clinical promotion and application.