The Clinical Effect And Safety Of Qi Zheng Patch And Its Modified Dosage Forms On Knee Osteoarthritis

Object To observe the clinical effect and safety of qi zheng patch and its modified dosage forms on knee osteoarthritis at different times.Methods 132 cases of patients with knee osteoarthritis were recruited in the Orthopedics Clinic.This study is conducted through a completely randomized controlled,double-blind experimental study.These patients were randomly divided into four groups:Group A: qi zheng patch applied to the affected area for 24 hours;Group B: qi zheng patch applied to the affected area for 8 hours;Group C: Modified qi zheng patch applied to the affected area for 8 hours;Group D: Modified qi zheng patch applied to the affected area for24 hours.The patients’ VAS pain score,tenderness score,WOMAC osteoarthritis index score both respectively and totally recorded before treatment,and at time points 1 week after treatment,2 weeks after treatment and 1 week after the end of treatment(after 3 weeks).Before treatment,the general situation of patients including vital signs and blood,urine,liver and kidney function,ECG and other safety indicators were observed.Two weeks after treatment,the above indicators were observed again.SPSS17.0 statistical software was used for pocessing and analysis.Results A total of 132 patients with knee osteoarthritis were recruited in this study.Four patients(2 from group B,1 from group A and 1 from group C)fell off during the observation period.A total of 128 patients completed the observation process in this study(32cases from group A,31 cases from group B,33 cases from group C,32 cases from group D,the off rate <15%.There was no significant difference(P> 0.05)in baseline scores including gender composition,age,body weight,VAS pain score,tenderness score and WOMAC osteoarthritis index between the four groups before treatment.The VAS score,tenderness score and WOMAC osteoarthritis index pain,activity score and total score were recorded at time points of after treatment for 1 week,2 weeks and 3 weeks(1 week after drug withdrawal)were compared with those before treatment and after repeated measures of variance test,analysis showed that: the time value presented P <0.05,indicating that the data at each time point was statistically significant difference in the time point,the time * group P> 0.05,indicating that the time and group no interactions and time factors(ie,1 week,2 weeks and 3weeks of treatment)did not differ with the grouping(ie,groups A,B,C and D);the WOMAC Osteoarthritis Index Stiff Score was presenting value P = 0.108> 0.05,indicating no significant difference in data at all time Points,that is,WOMAC stiffness score changes little between different time Points,indicating that the treatment of joint stiffness in improving the curative effect is not significant;four groups.The total effective rate(A: 87.5% 、B: 83.87%、C: 84.85%、D: 81.25%),the rank sum test showed that there was no statistically significant difference between the four groups(P <0.05)No significant abnormalities of vital signs,blood and urine,liver and kidney function were observed during the course of treatment.The incidences of skin allergic reaction in the four groups were 12.5%,6.5%,0%,0%,Significance value P = 0.023 <0.05Conclusions 1.Modified qi zheng patch and the traditional qi zheng patch on market has the same effect,both of them have the effect of improving the clinical symptoms of knee osteoarthritis,and modified qi zheng patch with the replacement of the backing material can effectively reduce the incidence of skin adverse reactions for patients;2.Modified qi zheng patch and the market qi zheng patch both improving the WOMAC osteoarthritis index score,the main improvement in Patients with joint pain and daily activity,but the symptoms improvement of morning stiffness is not obvious;3.Comparison between qi zheng patch application 8 hours and application of 24 hours has no significant difference in treatment effects,while the incidence of skin allergies has significantly reduced.