| Objective: To observe the clinical efficacy and safety of Qingrexiezhuotongbi powder in the treatment of dampness-heat obstruction type knee osteoarthritis.Methods:Patients admitted to the Department of Rheumatology of Shijiazhuang Hospital of Traditional Chinese Medicine from February2020 to August 2020 were selected.A total of 70 subjects with clinical diagnosis of knee osteoarthritis of dampness-heat obstruction type were selected.According to random number table method,70 subjects were divided into treatment group and control group.Glucosamine hydrochloride capsule and diclofenac sodium sustained-release capsule were selected as the treatment drugs in the control group.In the treatment group,on the basis of drug treatment,local topical application of Qingrexiezhuotongbi powder(provided by Shijiazhuang Hospital of Traditional Chinese Medicine Pharmaceutical Preparation Room)to the disordered knee joint was applied externally every day.Two weeks is one treatment cycle,and one treatment cycle is performed.The data changes of VAS pain score,WOMAC knee joint score,Lysholm knee joint score,TCM syndrome score and safety indexes before and after treatment were observed and recorded.SPSS25.0 software was used to conduct relevant statistical analysis on the recorded data indicators.P<0.05 was considered statistically significant,and P<0.01 was considered statistically significant.To evaluated the clinical efficacy and safety of Qingrexiezhuotongbi powder for external use.Results:After 1 cycle of treatment,the VAS pain scores of subjects in the two groups were better than before after intra-group comparison,with statistically significant difference(P<0.01).Comparison between the two groups showed that the treatment group could relieve knee pain more effectively,with statistically significant difference(P<0.01).Total score and the individual scores in knee joint WOMAC score,including pain,stiffness and difficulty in daily life,compared with group respectively,better than ago,and has significant statistical significance(P<0.01),the contrast between the two groups,results show that the treatment group in terms of knee WOMAC score and pain,stiffness,has better treatment effect,There was significant statistical significance(P>0.05).In terms of knee Lysholm score,both groups of subjects were improved after intra-group comparison,with statistical significance(P<0.01).Comparison between the two groups showed that the treatment group could more effectively improve patients’ knee Lysholm score,and the difference between the two groups was statistically significant(P<0.05).In terms of TCM syndrome score,both groups of subjects were better than before after intra-group comparison,with statistically significant difference(P < 0.01).Comparison between the two groups showed that the treatment group could improve TCM syndrome score more effectively,with statistically significant difference(P < 0.01).In terms of efficacy evaluation,the total effective rate of the treatment group was 94.29%,and the total effective rate of the control group was 77.14%.Comparison between the two groups showed that the total effective rate of the treatment group was higher,and the difference was statistically significant(P<0.01).Safety analysis: During this clinical experiment,the basic observation indexes of subjects in the two groups,such as body temperature,pulse,heart rate and blood pressure,were not significantly abnormal;laboratory observation indexes,such as blood routine,liver function and renal function,were generally normal;electrocardiogram observation indexes,no obvious discomfort occurred;In terms of adverse events,the treatment group and control group respectively in 2 cases and 3patients with the epigastric was upset after taking this medicine,the treatment group in 2 patients with local skin itching,After symptomatic treatment,the symptoms of all the above subjects were improved,all of the subjects completed the clinical trials,no serious adverse reaction and side effects,no statistically significant difference between two groups(P>0.05).Conclusion: Qingrexiezhuotongbi powder for external use only,can significantly improve patients with knee joint pain,stiffness etc,to the improvement of the knee joint Lyshlom score and TCM symptoms integral aspect also has more obvious advantages,can improve the function of patients with knee joint,to strengthen the knee joint activity,promote clinical symptom relief,relieve patients’ pain.With less adverse reactions,the use of relatively safe,convenient,and significant effect and other characteristics. |