| Objective:1.To evaluate the efficacy and security of Kidney-tonifying and Blood-activating medicinal for kidney deficiency and blood stasis knee osteoarthritis through clinical study,provide the clinical evidence of Kidney-tonifying and Blood-activating medicinal for pain management of knee osteoarthritis.2.To evaluate the effect of Kidney-tonifying and Blood-activating medicinal for PGE2 and NGF of knee osteoarthritis patients’ blood,synovial fluid,cartilage and synovium through molecular experiment,to evaluate the effect of Kidney-tonifying and Blood-activating medicinal for PGE2,NGF,COX-2 and MMP-13 of knee osteoarthritis chondrocytes and synoviocytes through cell experiment.Exploring the mechanism of Kidney-tonifying and Blood-activating Medicinal for Kidney Deficiency and Blood Stasis Knee Osteoarthritis Pain.Methods:1.Clinical StudyThe patients of knee osteoarthritis were from January,2016 to December,2016,department of Orthopedics in Guangdong Second hospital.90 patients who match the inclusion criteria were randomly divided into Bushen Qiangjin capsule group and Celecoxib group by simple random method,45 patients in each group.The Bushen Qiangjin capsule group was treated with Bushen Qiangjin capsule,while the Celecoxib group was treated Celecoxib,in addition,we guided all the patients for quadriceps muscle power training,the courses of treatment in both groups were 4 weeks.The Chinese medicine symptom curative effect,VAS Scale,WOMAC Scale of two groups were compared before and 1 week,2 week,4 week after the treatment.The Lequesne Scale of two groups were compared before and 4 week after the treatment.Gastrointestinal adverse events in two groups were recorded and treated timely.To evaluate the efficacy and security of Kidney-tonifying and Blood-activating medicinal for kidney deficiency and blood stasis knee osteoarthritis through statistical analyze retrospectively the clinical data.2.Experimental Study40 patients who match the inclusion criteria and received total knee arthroplasty were randomly divided into Bushen Qiangjin capsule group and control group by simple random method,the Bushen Qiangjin capsule group was treated with Bushen Qiangjin capsule in 1 week before the surgery,while the control group was not treated any medicine.Venous blood was collected before total knee arthroplasty,while synovial fluid,synovial and cartilage were collected during total knee arthroplasty.Synovial and cartilage were divided into two parts,one was used for gene detection directly by RT-qPCR method,and the other was used for cell culture.After treated with Bushen Qiangjin capsule or Celecoxib drug serum,Synoviocytes and chondrocytes was used for gene detection.Level of PGE2 and NGF in venous blood was detected by ELISA method,level of PGE2 and NGF in synovial fluid was detected by ELISA method.Gene expression of PGE2 and NGF in synovial and cartilage were detected by RT-qPCR method,Gene expression of PGE2,NGF,COX-2、MMP13 in synovial and cartilage were detected by RT-qPCR method.To evaluate the mechanism of Kidney-tonifying and Blood-activating medicinal for kidney deficiency and blood stasis knee osteoarthritis through statistical analyze retrospectively the experimental data.Results:1.Clinical StudyAbout the Chinese medicine symptom curative effect,both the effective rate of Bushen Qiangjin capsule group and Celecoxib group were 93.33%,but the Chinese medicine certificate waits curative effect of Bushen Qiangjin capsule group was better than Celecoxib group(P<0.05).About the VAS Scale,there were no significant differences in VAS Scale of before the treatment between both groups.The VAS Scale of Bushen Qiangjin capsule group was worse than Celecoxib group after 1 week and 2 week of the treatment(P<0.05).There were significant differences in VAS Scale between before and 1 week after the treatment,1 week and 2 week after the treatment,2 week and 1 month after the treatment in both groups.Within 2 weeks,the therapeutic effect of improving VAS Scale of Bushen Qiangjin capsule was worse than Celecoxib.There were no significant differences in WOMAC pain,stiff and activity function Scale Scale of before the treatment between both groups.The WOMAC pain Scale of Bushen Qiangjin capsule group was worse than Celecoxib group after 1 week,2 week and 1 month of the treatment(P<0.05).There were no significant differences in WOMAC stiff Scale of different treatment time between both groups.The WOMAC activity function Scale of Bushen Qiangjin capsule group was better than Celecoxib group after 2 week and 1 month of the treatment(P<0.05).The WOMAC total Scale of Bushen Qiangjin capsule group was worse than Celecoxib group after 1 week of the treatment(P<0.05).There were significant differences in WOMAC pain,stiff and activity function Scale between before and 1 week after the treatment,1 week and 2 week after the treatment,2 week and 1 month after the treatment in both groups(P<0.05).About the Lequesne Scale,compared with before treatment,both groups could down-regulate the Lequesne Scale after 1 course after of treatment(P<0.05),there were no significant difference between the difference between before and 1 week after the treatment of the Lequesne Scale of both groups(P>0.05).In the process of the treatment,there were one case of gastrointestinal adverse events in Bushen Qiangjin capsule group and three cases in Celecoxib group,however,there were no significant difference between both groups(P>0.05).2.Experimental StudyAbout the result of serum ELISA detection,compared with control group,Bushen Qiangjin group could significantly down-regulated the level of PGE2 and NGF(P<0.05).About the result of synovial fluid ELISA detection,there were no significant difference between of the level of PGE2 and NGF between Bushen Qiangjin capsule group and control group(P>0.05).About the result of synovium gene expression by RT-qPCR detection,compared with control group,Bushen Qiangjin capsule group could significantly down-regulated PGE2 and NGF gene expression(P<0.05).About the result of cartilage gene expression by RT-qPCR detection,there were no significant difference of PGE2 and NGF gene expression between Bushen Qiangjin capsule group and control group(P>0.05).About the result of synoviocytes gene expression by RT-qPCR detection,compared with KOA group,control group and Bushen Qiangjin capsule group could significantly down-regulated the PGE2,NGF,COX-2,MMP-13 gene expression(P<0.05).There were no significant difference of PGE2,NGF,COX-2 and MMP-13 gene expression between Bushen Qiangjin capsule group and control group(P>0.05).About the result of chondrocytes gene expression by RT-qPCR detection,compared with KOA group,control group and Bushen Qiangjin capsule group could significantly down-regulated the PGE2,COX-2,MMP-13 gene expression(P<0.05).Compared with control group,the COX-2 gene expression in Bushen Qiangjin capsule group was up-regulated(P<0.05),but there were no significant difference of PGE2、MMP-13 gene expression between control group and Bushen Qiangjin capsule group(P>0.05).However,there were no significant difference of NGF gene expression among different groups(P>0.05).Conclusion:1.Clinical StudyFor Kidney Deficiency and Blood Stasis Knee Osteoarthritis,Bushen Qiangjin capsule could relieve pain score,it show therapeutic effects from 1 week after the treatment,but its analgesic effect was worse than that of Celecoxib.In addition,Bushen Qiangjin capsule could improve the symptoms of stiffness and alleviate knee osteoarthritis severity,its clinical curative effectthe was equal to Celecoxib.What is more,Bushen Qiangjin capsule could improve joint motion function,its therapeutic effect was better than Celecoxib.About the Chinese medicine symptom curative effect,both the effective rate of Bushen Qiangjin capsule group and Celecoxib group were 93.33%,but the Chinese medicine certificate waits curative effect of Bushen Qiangjin capsule group was better than Celecoxib groupand.In the process of the treatment,both groups had low incidence of adverse events.2.Experimental StudyAfter 1 week of the treatment,Bushen Qiangjin capsule could down-regulated the level of PGE2 and NGF of blood and the gene expression of PGE2 and NGF of synovium,But it couldn,t regulate the level of PGE2 and NGF of synovial fluid and the gene expression of PGE2 and NGF of cartilage.Bushen Qiangjin capsule play the effect of knee osteoarthritis pain relief in early stage of treatment may be related to regulate PGE2 and NGF of blood and synovium.To treat knee osteoarthritic synoviocyte and chondrocyte with Bushen Qiangjin capsule drug serum,the gene expression of PGE2,NGF,COX-2,MMP-13 of synoviocytes were down-regulated,the gene expression of PGE2,COX-2,MMP-13 of chondrocytes were down-regulated.However,no matter for what kind of intervention,the gene expression of NGF of chondrocytes were no significant change。That may be one important mechanism of Kidney-tonifying and Blood-activating Medicinal for Kidney Deficiency and Blood Stasis Knee Osteoarthritis Pain. |
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