| ObjectiveThis study investigates the clinical efficacy,safety and reliability of Guimu Shibixiao Granules in the treatment of Rheumatoid arthritis(RA)with mixed heat and cold,and investigates the mechanism of Guimu Shibixiao’s efficacy and its regulation of T helper cells(Th)1 and Th2 ratio,so as to develop new ideas for the treatment of rheumatoid arthritis with Chinese medicine.The results of the study will be used to develop new ideas for the treatment of rheumatoid arthritis.MethodsThe cases in this study were obtained from outpatients of the Department of Rheumatology,Shanxi Provincial Hospital of Traditional Chinese Medicine.A randomized controlled experimental method was used to divide the collected 60 patients who met the inclusion criteria into treatment and control groups,with 30 cases in each group.The control group was given oral leflunomide tablets 10 mg,Bid;the treatment group was given oral leflunomide tablets 10mg、Bid,Guimu Shibixiao Granules 3.9g in water、Tid,and the course of treatment was 12 weeks in both groups.Before and after treatment,the TCM syndrome score,VAS(Visual Analogue Scale)score of joint pain,C-Reactive Protein(CRP),Erythrocyte Sedimentation Rate(ESR)and Rheumatoid Factor(RF)were observed in both groups.These will be analyzed using SPSS26.0.ResultsDuring the treatment process,no cases were shed and removed from the treatment and control groups,and a total of 60 cases(30 cases in each group)completed the clinical study.1.Clinical efficacy comparison: After the end of treatment,the clinical efficacy of the treatment group was 90.0%,and the clinical efficacy of the disease in the control group was56.7%,and the treatment group was better than the control group(P<0.01).2.Chinese medicine symptoms efficacy Comparison: after the end of treatment,the Chinese medicine symptoms efficacy rate 90.0% in the treatment group and 66.7% in the control group(P<0.01).3.Comparison of TCM syndrome scores:After treatment,the TCM syndrome scores of both groups were lower than those before treatment(P<0.01).Guimu Shibixiao Granules group had better efficacy in improving the symptoms of cold and heat mismatch,and the difference between the two groups was statistically significant(P<0.01).4.Comparison of VAS scores of joint pain:After the end of treatment,the pain degree scores of both groups were lower than before treatment(P<0.01).Guimu Shibixiao Granules group was more effective in relieving pain,and the difference between the two groups was statistically significant(P<0.01).5.Comparison of laboratory results:After the end of treatment,the sedimentation、C-reactive protein,rheumatoid factor,and IFN-γ were all lower than before,the IL-4content were higher than before,and the Th1/Th2 ratio was lower than before in both groups.And the Guimu Shibixiao Granules group was superior to the control group in reducing inflammatory indexes and modulating immune function,and the difference between the two groups was statistically significant(P<0.01).6.Comparison of safety indicators:All indicators of blood routine,liver and kidney function were within normal limits in both groups during treatment,and none of the patients complained of discomfort related to the study medication during the drug administration.ConclusionGuimu Shibixiao Granules can significantly improve the clinical symptoms and signs of rheumatoid arthritis patients(cold-heat mixed type),such as joint pain、swelling,flexion and extension,control disease progression,reduce inflammatory indexes such as ESR,CRP,RF and wind-like activity indexes,stop inflammatvory response,regulate cellular immune function,down-regulate IFN-γ,promote IL-4 eleation and effectively regulate Th1/Th2 type cytokines to bring them to a balanced state. |
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