| Objective:1.To investigate the anti-inflammatory and analgesic efficacy and mechanism of action of Juanbi granule in the treatment of RA from the indexes of inflammatory factors(IL-6,TNF-ɑ).2.To further evaluate the efficacy and safety of Juanbi granule in the treatment of cold-damp paralysis in RA.Method:Using the random number table method for grouping,66 patients with RA(cold-damp paralysis type)who met the inclusion criteria and were seen at the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine from December 2019 to January2021 were divided into a test group and a control group,with 33 cases in each group.Both groups were given basic Western medical treatment(MTX + folic acid tablets),and the experimental group was treated with Juanbi granule on top of this,while the control group was treated with Wangbi Pian,and the treatment course was 12 weeks,with observation once every 4 weeks.Changes in efficacy indexes(ACR20 compliance rate,TCM evidence score,HAQ score),clinical symptoms and signs indexes(time to morning stiffness,number of joint pain/swelling,VAS score)and inflammation evaluation indexes(ESR,CRP,IL-6,TNF-ɑ)and safety indexes(three major routine,liver function,kidney function)were observed before and after treatment.Result:1.Time of morning stiffness: The duration of morning stiffness was significantly reduced in both groups after 12 weeks compared with that at 0 weeks(P < 0.05),but the test group was better than the control group(P < 0.05).2.Number of joint pressure pain/swelling: The number of joint pain/swelling decreased significantly in both groups after 12 weeks of treatment compared with the baseline level(P < 0.05).There was no difference in the degree of improvement in the number of joint swelling between groups(P > 0.05),but the degree of improvement in the number of joint pressure pain in the test group was significantly better than that in the control group(P < 0.05).3.Patient pain evaluation and overall patient/physician evaluation: After 12 weeks of treatment in both groups,patient pain and overall patient/physician evaluation scores were significantly lower(P < 0.05),with no significant difference between groups(P > 0.05).4.HAQ score and TCM syndrome score: The HAQ scores and TCM syndrome scores decreased significantly in both groups after 12 weeks of treatment compared with those at week 0(P < 0.05).There was no significant difference in HAQ scores between the two groups at the end of treatment(P > 0.05),but the improvement of TCM symptoms score in the test group was better than that in the control group(P < 0.05).5.Chinese medicine symptoms efficacy: After 12 weeks of treatment,the total effective rate of Chinese medicine symptoms efficacy was 86.67% and 70.00% in the test group and the control group,respectively,and the Chinese medicine symptoms efficacy of the test group was better than that of the control group at this time(P < 0.05).6.Inflammation evaluation indexes(ESR,CRP,IL-6,TNF-ɑ): ESR,CRP,IL-6,and TNF-ɑ decreased significantly in both groups after 12 weeks of treatment compared to at week 0(P < 0.05).There was no significant difference in the four values between groups at the end of treatment in the two groups(P > 0.05).7.ACR20 attainment rate: The ACR20 attainment rate was 83.33% in the test group and 66.67% in the control group after 12 weeks of treatment.Comparison between groups:The improvement of ACR20 compliance rate in the test group was better than that in the control group,but it was not statistically significant(P>0.05).8.Safety indexes: for intra-group comparison,there was no statistical significance(P>0.05)in the two groups after treatment(4 weeks,8 weeks and 12 weeks)compared with that before treatment.Conclusion:1.Juanbi granule can significantly improve the clinical symptoms and signs(morning stiffness time,number of joint pain/swelling,VAS score),reduce the inflammation index(ESR,CRP,IL-6,TNF-ɑ),improve the quality of life(HAQ score)of patients with RA(cold and damp paralysis obstruction type),with good clinical efficacy(ACR20 attainment rate,Chinese medicine evidence of efficacy evaluation),and high safety..2.Compared with the efficacy of Wangbi Pian,the improvement of time to morning stiffness,number of joint pains,TCM symptoms and efficacy of Juanbi granule was better,and the efficacy of both was comparable in terms of ACR20 attainment rate,number of joint swelling,VAS score,reduction of inflammation index and improvement of patients’ quality of life.3.The anti-inflammatory and analgesic effect by lowering IL-6 and TNF-ɑ levels may be one of the mechanisms of action of Juanbi granule to improve the condition of RA. |
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