Clinical Study On Treating Active-stage Rheumatoid Arthritis With Cold And Heat Complex By Guimu Shibixiao Granules

Objective:By using Guimu Shibixiao granule combined with leflunomide to treat cold-heat complex type rheumatoid arthritis,observe the TCM syndrome score,joint pain VAS score,laboratory indicators(erythrocyte sedimentation rate,C-reactive protein,rheumatoid factor,IL-17))before and after treatment.Changes in safety indicators,objectively evaluate the clinical efficacy and safety of Guimu Shibixiao granules combined with leflunomide in the treatment of rheumatoid arthritis with mixed heat and cold,and provide clinical basis and experimental basis for Guimu Shibixiao granule agent treatment of this disease.Method:From December 2019 to December 2020,60 patients with cold-heat complex type rheumatoid arthritis who were in the outpatient department of the Rheumatology Department of Shanxi Provincial Hospital of Traditional Chinese Medicine were collected and met the inclusion criteria.They were randomly divided into the experimental group and the control group.There were 30 cases in each group.The control group was treated with Leflunomide tablets,and the test group was treated with Guimu Shibixiao Granules on the basis of the control group.Before and after 8weeks of treatment,TCM syndrome score,joint pain VAS score,laboratory indicators(erythrocyte sedimentation rate,C-reactive protein,rheumatoid factor,IL-17),and safety indicators were observed and recorded,and perform data statistical analysis.Result:During the study,all 60 patients completed this clinical study.(1)Baseline comparison: There was no statistical difference in gender,age,course of disease,TCM syndrome score,joint pain VAS score,laboratory index,and safety index between the two groups before treatment(P>0.05),and they were comparable.(2)Comparison of clinical efficacy: After treatment,the effective rate of Guimu Shibixiao granule combined with leflunomide(93.33%)was higher than that of leflunomide alone(70%)(P<0.05).(3)Comparison of curative effect of TCM syndromes: After treatment,the effective rate of Guimu Shibixiao granule combined with leflunomide(90%)was higher than that of leflunomide alone control group(66.67%)(P<0.05).(4)Comparison of the total scores of TCM syndromes: After treatment,the two groups were significantly improved(P<0.01),and the test group was significantly better than the control group(P<0.05).(5)Comparison of joint pain VAS score: After treatment,both groups were significantly improved(P<0.01),and the test group was significantly better than the control group(P<0.01).(6)Comparison of laboratory indexes(erythrocyte sedimentation rate,C-reactive protein,rheumatoid factor,IL-17): After treatment,all indexes of the two groups were lower than before(P<0.05,P<0.01),and the test group was better than the control group(P<0.05).(7)Safety indicators: The incidence of adverse reactions in the Guimu Shibixiao granule combined with leflunomide group(3.33%)was lower than that of the control group(20%)(P<0.05).Conclusion:1.Guimu Shibixiao granules combined with leflunomide can significantly reduce the clinical symptoms of patients with cold-heat complex type rheumatoid arthritis in active stage,,and improve the joint pain VAS score and TCM syndrome score of patients.2.Guimu Shibixiao granules combined with leflunomide can reduce the expression level of serum IL-17 in patients with cold-heat complex type rheumatoid arthritis in active stage,and its pathogenesis may be related to IL-17.3.The curative effect of Guimu Shibixiao granule combined with leflunomide in the treatment of cold-heat complex type rheumatoid arthritis in active stage is significantly better than that of the control group,and the incidence of adverse reactions is lower.