| Objective:The objective of this study is to evaluate the clinical efficacy and safety of the Compound Angelica Analgesic Ointment in treating knee osteoarthritis caused by colddampness obstruction.Additionally,this study aims to investigate the impact of ointment on inflammatory factors in synovial fluid.Through this research,we hope to provide a foundation for the ointment’s future clinical applications.Methods:A total of 68 patients with KOA of cold-dampness obstruction in the middle stage were enrolled from October 2022 to March 2023 in the outpatient department of Dongzhimen Hospital of Beijing University of TCM The patients were divided into a control group and an observation group according to the random number table method,with 34 cases in each group.The patients in the control group were treated with Flurbiprofen Cataplasms,40mg once,once a day from the 2nd day after the operation,The observation group was treated with an external application of Compound Angelica Analgesic plaster,which consisted of:30 g of radix sileris,30g of Aconitum alkaloids,30 g of prepared radix aconite,20 g of Angelica Sinensis,15 g of Heracleum hemsleyanum Diels,20 g of Moutan bark,20g of Rheum officinale,20 g of Tougucao,20 g of Chinese flowering quince and 20g of Safflower.The powder was prepared from a fully automated Chinese medicine pulverizer and blended with ginger juice and honey to form a cream,which was provided and unified by the Chinese pharmacy of Dongzhimen Hospital,Beijing University of Chinese Medicine.Specifications,plasters 3-4 mm in thickness,12*8 cm in area,and 15%drug content(based on the composition of traditional Chinese Medicine)The external application was applied to the painful part of the knee joint,once a day,one patch each time.The treatment period for both groups was 4 weeks.Observe and record the two groups of patients before and after The visual analogue scale(VAS),WOMAC osteoarthritis index score,and synovial fluid tumor necrosis factor α,interleukin 17,and nitric oxide levels,while strictly recording the adverse reactions in patients with medication process,according to the nimodipine method to calculate the two groups after treatment WOMAC total score reduction rate,evaluate the overall efficacy and safety of Compound Angelica Analgesic Ointment.Statistical analysis was performed on the relevant indicators using SPSS 25.0 software to directly and objectively compare the efficacy of the two groups,and the hypothesis test level was α=0.05.Results:1.During the study,3 patients in the test group dropped out,and the remaining 31 patients,including 12 males and 19 females,with an average age of(55.68.83±6.31)and an average disease year of(2.29±1.35).There were 21 patients in Kellgren-Lawrence Ⅱ and 10 patients in Kellgren-Lawrence Ⅲ.In the control group,4 cases dropped out,and the remaining 30 cases,10 males and 20 females,with an average age of(54.50±7.56),an average year of disease of(2.12±1.16),22 cases of Kellgren-Lawrence Ⅱ and 8 cases of Kellgren-Lawrence Ⅲ.After statistical analysis,there was no significant difference in age,gender,years of the disease,Kellgren-Lawrence grade,VAS score,WOMAC osteoarthritis index score,Tumor necrosis factor α(TNF-α),Interleukin 17(IL-17)and Nitric oxide(NO)levels between the two groups before treatment(P>0.05),which was comparable.The VAS score,WOMAC index score,and IL-17 level of the two groups before and after treatment accorded with the premise of normal distribution(P>0.05),The distribution of TNF-α and NO was skewed(P<0.05).2.Comparison within the control group:The mean VAS scores before and after treatment were 5.43 and 3.97,respectively,The difference between the two groups was statistically significant,with a t-value of 11.79 and P-value of less than 0.01.There was a significant difference in the mean WOMAC index scores before(42.20)and after(33.07)treatment,with a t-value of 9.51 and a P-value less than 0.01.TNF-α levels in the synovial fluid also showed a significant difference before(median=149.50)and after(median=127.30)treatment,with a Z-value of 4.78 and a P-value less than 0.01.Similarly,there was a significant difference in the mean of IL-17 levels in synovial fluid before(9.70)and after(7.16)treatment,with a tvalue of 9.27 and a P-value less than 0.01.Additionally,the median of NO content in synovial fluid showed a significant difference between pre-treatment(86.21)and post-treatment(72.52),with a Z-value of 4.68 and a P-value of less than 0.05.3.Within-group comparisons of observation groups:The mean VAS scores showed a significant difference between pre-treatment(5.16)and post-treatment(3.42),with a t-value of 11.79 and a P-value of less than 0.01.Similarly,the mean WOMAC index scores also showed a significant difference between pre-treatment(41.29)and post-treatment(31.00),with a t-value of 11.44 and a P-value less than 0.01.There was a significant difference between the levels of TNF-α in synovial fluid before(median=140.00)and after(median=106.13)treatment,with a Z-value of 4.86 and a P-value less than 0.01.Similarly,IL-17 levels in synovial fluid before(mean=9.47)and after(mean=6.03)treatment also showed a statistically significant difference,with a t-value of 14.82 and a P-value less than 0.01.The levels of NO in the synovial fluid also showed a significant difference between pre-treatment(median=85.34)and post-treatment(median=52.62),with a Z-value of 4.87 and a P-value less than 0.01.4.Comparison between groups:VAS score of the observation group after treatment was statistically significant compared with that of the control group(t=2.044,P<0.05),The WOMAC index scores of the two groups were significantly different after treatment(t=2.146,P=0.036<0.05),there were significant differences in the levels of TNF-α,IL-17,and NO in the synovial fluid between the two groups(P<0.05).Clinical efficacy evaluation of the two groups:4 patients in the control group were markedly effective,17 were effective,and 9 were ineffective,with a total effective rate of 70%.In the observation group,7 patients were markedly effective,21 were effective,and 3 were ineffective,with a total effective rate of 90.3%.A statistically significant difference between the two groups was observed(χ2=5.088,P=0.024<0.05).5.Adverse reactions:The two groups did not experience any adverse events such as joint infection or aggravation of pain after knee joint puncture.In the observation group,one patient reported red skin and itching at the joint during treatment.After careful inquiry,it was attributed to the prolonged application time.The patient was advised to reduce the duration of external application,and the symptoms resolved.No other patients reported skin allergies,aggravation of joint pain,or other adverse reactions.Conclusion:1.Compound Angelica Analgesic Plaster and Flurbiprofen Gel Plaster have certain clinical efficacy in the treatment of knee osteoarthritis.From the perspective of overall clinical efficacy evaluation,the therapeutic effect of Compound Angelica Analgesic Ointment is better,especially for the treatment of knee osteoarthritis of cold-dampness obstruction type.2.In a short period of time,compound angelica analgesic ointment can relieve knee joint pain to a greater extent and improve joint function.Compound Danggui Zhitong Ointment can effectively inhibit the expression of pro-inflammatory mediators TNF-α,IL-17 and NO in synovial fluid,further alleviate synovial inflammatory symptoms and improve the quality of life of patients with knee osteoarthritis.3.The safety of Compound Angelica Analgesic Ointment in the treatment of mid-term cold-dampness arthralgia type knee osteoarthritis is reliable,and patients do not need to worry too much about the adverse drug reactions during the use,which is worthy of clinical promotion. |
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