| Objective: 1.To evaluate the clinical efficacy and safety of Gubi Mixture in the treatment of knee osteoarthritis,and to explore the effect of Gubi Mixture in improving the clinical symptoms and quality of life of patients with knee osteoarthritis.(2)On the basis of the recognition of traditional Chinese medicine constitution about knee osteoarthritis patients,to observe the effect and the influencing of Gubi Mixture on the blood stasis constitution and hemorheology,to explore the advantages of traditional Chinese medicine combined regulate constitution in the treatment of knee osteoarthritis.Methods: 1.Using multi-center,open,randomized and positive drug control clinical research methods,to distributed the standard of knee osteoarthritis patients according to the treatment group and the control group 2: 1,the total number is 150 cases.Treatment group is 100 cases,with GUbi mixture,2 times a day,100 ml a times;control group is 50 cases,with Etoricoxib Tablets,1 times a day,100 ml a times.After Four weeks,we calculated the VAS score,symptom grading quantification table,the Short-Form 36 questionnaire and the laboratory indexes of liver function and kidney function in two groups of knee osteoarthritis patients,to determine the clinical efficacy and safety of the two therapeutic drugs.2.On the basis of the results of recognition constitution of knee osteoarthritis patients in the same period,the five centers were included in the study of 150 patients who were eligible for standard blood stasis constitution,30 cases in the treatment group,30 cases in the control group,blood stasis quantitative intergral and hemorheology indexes were calculate both before and after the whole treatment.Results: 1.Multi-center efficacy evaluation:(1)Total effective rate: 4 weeks after the intervention,There are 100 cases in treatment group,95 cases completed,10 cases were inefficient,60 cases were inefficient,21 cases were excellent,4 cases were clinical control,the total effective rate is 89.5%,the control group is 50 cases,48 cases were completed,12 cases were inefficient,28 cases were excellent,8 cases were excellent,0 cases clinical control,the total effective rate is 75.0%,the treatment group was better than the control group(P <0.05);(2)Symptom grading quantification table comparison: The symptom scores both of two groups were improved compared with treatment before(P<0.01),compared two groups,Gubi Mixture was better than Etoricoxib Tablets(P <0.05).The pain night and walk in the treatment group was lower than that in the control group(P <0.05),To improve the morning stiffness,the pain when standing from the sitting,the maximum walking distance,daily activities,up and down the stairs,squatting,walking on the uneven side of the treatment group is better than the control group(P<0.05,P<0.01),the difference was statistically significant.(3)Visual Analogue Scales: the pain scores of the two groups were improved compared with before treatment(P <0.01);but after treatment between the treatment group was inferior to the control group(P <0.01),the difference was statistically significant.(4)Short-Form 36 questionnaire: After treatment the treatment group scores were higher than before(P <0.01),physical pain,physiological function,physiological function,overall health,energy of control group improved than before(P <0.01),There were no significant differences in the other dimensions(P> 0.05).the body pain control group was superior to the treatment group(P <0.05).There was no significant difference between the two groups in the physiological function dimension(P <0.05),the other dimensions treatment group were superior to the control group(P <0.05,P <0.01).(5)Safety indicators evaluation: After the test the liver and kidney function was no significant difference than before(P> 0.05).About adverse reactions,the treatment group found 1 case with rash,1 case with gastrointestinal re-action;the control group 4 cases of gastrointestinal adverse reacti-ons.2.In the treatment group,the average conversion of blood stasis constitution was lower than before,The difference was statistically significant(P <0.05),indicating that the treatment group may be effective on improving blood stasis constitution,indicating that the control group may have no improvement in blood stasis constitution.In the treatment group,The whole blood viscosity,whole blood low-shear viscosity,plasma viscosity and erythrocyte sedimentation rate were significantly improved in the hemorheology indexes after treatment(P <0.05,P <0.01),In the control group,only ESR decreased(P <0.05).There was no significant decrease in hematocrit between the two groups after treatment,indicating that the improvement of hemorheology in the treatment group may be better than that in the control group.Conclusion: The treatment of knee osteoarthritis with Gubi Mixture and Etoricoxib Tablets can relieve pain,improve the function and quality of life.The total effective rate of the Gubi Mixture group was better than that of the Etoricoxib Tablets,The pain improvement in the Gubi Mixture group was not better than that of the Etoricoxib Tablets group,however,the improvement of function and quality of life,the Gubi mixture group is better than the Etoricoxib Tablets,and side effects are small and treatment is safe.At the same time,Gubi Mixture can improve the blood stasis constitution and hemorheology related indexes of knee osteoarthritis patients. |
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