| Objective:Our project proposed to ensure the clinical efficacy and safety of Tonifying Kidney and Bone Pill and Strengthen Muscle Tonifying Kidney and Bone Paste through classify the traditional Chinese medicine discriminately,and by using randomized controlled trial of combination treatment of Tonifying Kidney and Bone Pill and Strengthen Muscle Tonifying Kidney and Bone Paste on mild to moderate liver and kidney deficient type patellofemoral joint arthritis.It lay the foundation of the promotion and application of the traditional Chinese medicine normalized diagnosis and therapy as well as the rehabilitation of mild to moderate liver and kidney deficient type patellofemoral joint arthritis.Methods:The BM SPSS Statistics 20.0 software was used for randomly grouping.The patients were split into experimental group with 30 cases and control group with 30 cases.The age,gender,BMI,the Kellgren-Lawrence radiological grade of the affecte d side knee joint in these two groups were compared,and the baseline information as well as the prior treatment score have nosignificant difference(P>0.05).The intra-grou p has comparability.The patients in experimental group were treated with Tonifying Ki dney and Bone Pill with oral administrationand Strengthen Muscle Tonifying Kidney a nd Bone Paste with external application;whereas the patients in control group were ad ministrated with sodium hyaluronate articular injection binding with acetaminophen oral administration.When the patients were under treatment,they should avoid the exercise of 30°-60° bearing load and bending knees,and the treatment duration was total four weeks.These two groups were under VAS,WOMAC score comparison according to pri or treatment,the 0 week,5th week and 10 th week after treatment after treatment.Mea nwhile,the clinical efficacy was calculated after treatment.The general physical condit ion of the patients prior or after treatment was observed by using SF-36 health questi onnaire inquiry abridged table.B-type high frequency color ultrasound examination wa s used to evaluate the change of the joint after treatment.And the drug safety was ass essed according to the venous blood examination of ALT,AST,CREA,BUNand the adve rse reaction during the drug administration.Finally,the data was collected and statistically analyzed.Results:(1)60 patients were in the two groups,and all of them accomplish the treatment and follow-up visit in accordance with the requirements for experiment.The baseline information before treatment in the two groups had no obvious difference(P>0.05).(2)In intra-group comparison,the VAS score and grade of WOMAC score and traditional Chinese medicine symptoms classification and quantitative score had statistical significance compared with the completion of the treatment in both two groups(P < 0.05).The scores mentioned above in different time quantum of both groups in intra-group comparison had statistically significant difference(P<0.05).The experimental group was better than control group in improvement of the VAS score,quantitative WOMAC score and traditional Chinese medicine symptoms classification and quantitative score.(3)The B type high frequency color ultrasound examination demonstrated thatthe articular cavity effusion reduced in 10 weeks after the treatment of the patients in both groups(P< 0.05),the improvement in experimental group was significant than control group.However,the cartilage thickness in the inner-thighbone condyle bearing load area and synovial membrane thickness in 10 weeks after the treatment in intra-group comparison had no significant change in these two groups(P > 0.05).And in the comparison between groups,the cartilage thickness in the inner-thighbone condyle bearing load area and synovial membrane thickness in 10 weeks after the treatment had no significant difference(P> 0.05).(4)In intra-group comparison,the RF,RP,BP,GH,VT,SF,RE,EWB of the patients in both two groups were obvious improved compared with that before treatment(P<0.01).In comparison between groups,the RF,RP,BP,GH,VT,SF,RE,EWB of the patients in experimental group improved more significantly than the patients in control group(P<0.05),however,after treatment for 10 weeks,the GH of the patients in both two groups had no obvious improvement(P>0.05).(5)After treatment,there were no adverse reaction in both of the groups,except that three patients in control group had local hyperpigmentation;after the treament,in intra-group comparison,the four indicators of liver and kidney function in both two groups had no statistically significant difference(P>0.05).Conclusion:(1)The combination treatment of Tonifying Kidney and Bone Pill and Strengthen Muscle Tonifying Kidney and Bone Paste had good curative effect on the mild to moderate liver and kidney deficient type patellofemoral joint arthritis.Meanwhile,the curative efficacy of combination treatment of Tonifying Kidney and Bone Pill and Strengthen Muscle Tonifying Kidney and Bone Paste was more lasting and obvious than control group.(2)In improvement of the joint mobility,traditional Chinese medicine syndrome and living quality,the experimental group had more obvious advantages than control group.(3)In the process of research,there were no toxic side effect or adverse reaction in the patients in both of the two groups,which indicated that Tonifying Kidney and Bone Pill oral administration and Tonifying Kidney and Bone Pill external application had higher clinical safety. |
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