| Objective: To evaluate the efficacy and safety of external application of gel patch of Xiaoding ointment in the treatment of knee osteoarthritis at early and middle stage through clinical observation and study,and to provide evidence for the clinical application and further research of gel patch of Xiaoding ointment.Methods: Seventy KOA patients who met the inclusion and exclusion criteria in the Department of Orthopedics,Affiliated Hospital of Gansu University of Traditional Chinese Medicine from December 2021 to November 2022 were selected.According to the random number table method,they were randomly divided into treatment group and control group,with 35 cases in each group.The treatment group was treated with external application of gel patch of Xiaoding ointment,and the control group was treated with external application of Xiaoding ointment,once every 2 days,every 2 weeks as a course of treatment,a total of two courses of treatment.The visual analogue scale(VAS)score of knee pain,Western Ontario and Mc Master Universities Osteoarthritis Index(WOMAC)score,quantitative score of TCM syndrome score,and adverse reactions such as skin allergy during treatment were observed and recorded before treatment,2 weeks and 4 weeks after treatment,and 1 month after drug withdrawal in the two groups.The patients were followed up for 1 month after drug withdrawal.The data were collected and analyzed by SPSS26.0 statistical software.Results: A total of 70 KOA patients who met the inclusion and exclusion criteria were enrolled in this clinical study,with 35 cases in the treatment group and 35 cases in the control group.A total of 3 cases dropped out during the treatment,including 1case in the treatment group and 2 cases in the control group.Finally,67 cases were completed,34 cases in the treatment group and 33 cases in the control group.There were 24 females and 10 males in the treatment group,with an average age of(58.06±5.46)years and an average course of disease of(30.18±16.68)months.There were 22 females and 11 males in the control group,with an average age of(60.42±5.21)years and an average course of(36.91±15.55)months.Before treatment,the basic data of the two groups were comparable,including gender,age,course of disease,and K-L grade(P>0.05).The results of comparative analysis of observation indicators between the two groups were as follows:(1)VAS score comparison: there were statistically significant differences in VAS scores at each time point before treatment,2 weeks into treatment and 4 weeks into treatment(P<0.05);There was no significant difference in VAS score between the control group and the treatment group(P>0.05).The interaction between time and group was not statistically significant(P>0.05).(2)Comparison of WOMAC index:there were significant differences in WOMAC scores at each time point before treatment,2weeks of treatment and 4 weeks of treatment(P<0.05).There was no significant difference in WOMAC score between the control group and the treatment group(P>0.05).The interaction between time and group was not statistically significant(P>0.05).(3)Comparison of quantitative scores of TCM syndrome: the TCM syndrome scores after 2 weeks and 4 weeks of treatment were significantly different from those before treatment(P<0.05),but there was no significant difference between 2 weeks and 4 weeks of treatment(P>0.05).There was no significant difference in WOMAC score between the control group and the treatment group(P>0.05).The interaction between time and group was not statistically significant(P>0.05).(4)Comparison of clinical efficacy evaluation: After 4 weeks of treatment,the total effective rate of the control group was 75.76%,and the total effective rate of the treatment group was 79.41%.There was no significant difference between the two groups after 4 weeks of treatment,P>0.05,there was no significant difference in the clinical efficacy between the treatment group and the control group.Comprehensive clinical efficacy evaluation comparison: after 4 weeks of treatment,the total effective rate of the control group was75.76%,the total effective rate of the treatment group was 79.41%,the comprehensive clinical efficacy evaluation comparison between the two groups,P>0.05,the difference was not statistically significant,there was no significant difference between the two groups.(5)Follow-up results: There was no significant difference in VAS score,WOMAC score and TCM syndrome score between the control group and the treatment group after 4 weeks of treatment.The control group and the treatment group had high stability of curative effect and low short-term recurrence rate.(6)Safety evaluation: during the treatment,there was 1 case of mild skin irritation in the treatment group and the control group,both of which showed mild pruritus,which disappeared spontaneously after 1 day without treatment and treatment.There were no side effects such as edema and rash in the two groups,and no serious adverse events occurred in the two groups,and the safety level was relatively safe.Conclusions:(1)Gel patch of Xiaoding ointment has a significant clinical effect in the treatment of knee osteoarthritis in the early and middle stage.It can effectively relieve knee pain and improve knee joint function.(2)The clinical efficacy of gel patch of Xiaoding ointment and Xiaoding ointment in the treatment of early and middle KOA is similar.(3)Gel patch of Xiaoding ointment has high safety and stable short term efficacy,which is worthy of clinical application. |
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