| ObjectiveChinese medicine is common for the prevention of venous thrombosis embolism.However,by far there is little trial for its generalization and application.This prospective,randomized study was aimed to evaluate effective and safety following Chinese medicine and Rivaroxaban for patients after total knee arthroplasty.MethodsRandomized control study was conducted in Guangdong Provincial hospital of Chinese Medicine,with 66 patients who were diagnosed as knee osteoarthritis and ready to perform total knee arthroplasty that divided into two groups.Two groups were treated by taking internal Chinese medicine or Rivaroxaban once a day and continued for two weeks.The amount of deep vein embolism were measured using color Doppler ultrasonography at 7 days after surgery.Furthermore,coagulation function,liver function and renal function were obtained.ResutsSixty-six patients were included and 60 patients were analyzed.Deep vein embolism were not found in neither groups.Both Yiqi-huoxue Fang and Rivaroxaban can effectively help decreasing prevention of venous thrombosis embolism.And no significant difference was found between the groups.Patients in experimental group had a lower incision drainage than control groups.No adverse event(massive hemorrhage or pathological changes of liver and kidney function)was happened.There was no statistically significant difference between the effects of the group of Chinese Medicine and the Rivaroxaban on the liver function,and the AST value of the two groups increased slightly with time and the difference was statistically significant(P<0.05).However,the ALT value was not statistically significant between the two groups during the experiment(p>0.05).The two groups in the course of the use of creatinine were slightly elevated,the difference is statistically significant(p<0.05),group effect variance analysis suggest the difference between the two treatment methods on renal function is not statistically significant(p>0.05).As for blood coagulation function,PT of two groups has increased during the treatment,the difference is statistically significant(p<0.05),in the 3rd day of treatment,the value of both groups was decreased,inter-group effect variance analysis suggest p>0.05;both groups in the treatment process,value of FIB have changed and the difference was statistically significant,the group effect variance analysis suggest the value of APTT changed in two groups in the treatment process(p>0.05),the APTT gradually increased and the experimental group showed a trend of slight downward in the first three days,and the value was obviously raise after the third day;The difference is statistically significant(p<0.05).Inter-group effect variance analysis suggest p>0.05,the two groups in the treatment of the process,the value of D-dimmer has changed,the difference was statistically significant(p<0.05),the 1th day after the operation,value of two groups reached the highest level during observations,and then began to decline,group effect variance analysis suggest p>0.05;PLT have changed in both groups in the procedure of treatment,the difference is statistically significant(p<0.05),three days after surgery,the observation values of the two groups decreased,the effect variance of the group suggest p>0.05;The effects of the treatments on PT,FIB,APTT,INR,D-dimmer and PLT were not statistically significant(p>0.05)between groups.As for inflammatory indicators,WBC was changed in two groups during the procedure,and the difference was statistically significant(p<0.05),the value rose to the peak in the 1th day after the operation,and then began to decline,the group effect variance analysis suggest that effects of the two treatment methods on participants' WBC,ESR and CRP,the difference is not statistically significant(p>0.05).ESR was changed during treatment,the difference was statistically significant(p<0.05),the observation value of the 3rd day was decreased,the amplitude and peak value of ESR increased in the Chinese medicine group were smaller than that of the observational group,but the difference was not statistically significant(p>0.05).However,the effect of the two methods on ESR was not statistically significant in effect variance analysis(p>0.05).CRP also changes during the procedure with statistically significant difference(p<0.05),at the 3rd day after surgery,the two groups of observations reached to peak,and then began to decline,the highest level of value was lower in the experimental group compared to observational group,but the difference was not statistically significant(p>0.05).The effect of two methods on CRP was not statistically significant in the analysis of effect variance(p>0.05).As for quality of life,PCS and MCS in both groups improved after surgery(p<0.05),the experimental group was higher than control group in PCS(p<0.05),but no statistical significant difference was found between groups in MCS.Difference of the circumference of lower limb in experimental groups was not statistically significant between post-operative day 1 and day 7(p>0.05).However,there is statistical difference between 1 day and 7 days after surgery in the control group(p<0.05).The experimental group can better decrease lower limb swelling than control group(p<0.05).ConclusionOur result showed Yiqi-huoxue Fang can effectively and safely decrease the occurrence rate of VTE for patients after TKA.Moreover,compared with Rivaroxaban,Yiqi-huoxue Fang can decrease lower limb swelling after surgery and improve quality of life of participants',moreover,it may potentially reduce inflammation after surgery.However,more trials with well design and big sample were needed to confirm our results. |
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