Clinical Observation On Treatment Of Syndrome Of Intermingled Heat And Cold Rheumatoid Arthritis With Modified Guizhishaoyaozhimu Decoction

Objective:In this study,we observed the improvement of TCM symptoms,signs and inflammatory indexes of Guizhi Shaoyao Zhimu Decoction in treating rheumatoid arthritis of cold and heat type,to objectively evaluate the clinical effect of Guizhi Shaoyao Zhimu Decoction,analyze its safety and mechanism of action,and provide basis for clinical use.Methods : From December 2018 to December 2019,68 outpatients from famous traditional Chinese medicine studio and rheumatology department of Shanxi integrated hospital of traditional Chinese and Western medicine were randomly divided into treatment group(34 cases)and control group(34 cases).In the treatment group,Guizhi shaoyaozhimu Decoction plus Jianfang and leflunomide tablets and diclofenac sodium sustained-release tablets were taken orally.In the control group,leflunomide tablets and diclofenac sodium sustained-release tablets were taken orally.After 12 weeks of treatment,observe the TCM syndrome score,ESR,CRP,DAS28,VAS scores and other indicators before and after treatment in each group,and evaluate the clinical effect of Guizhi Shaoyao Zhimu Decoction Combined with leflunomide and diclofenac sodium sustained-release tablets in the treatment of rheumatoid arthritis.Results:1.In the curative effect evaluation of TCM syndrome integral: the effective rate of the treatment group is 91.18%,and that of the control group is 76.48%.The difference between the two groups is statistically significant(P < 0.05).The curative effect of the treatment group is higher than that of the control group.2.In the aspect of improving TCM syndrome score: the TCM syndrome score of the two groups decreased significantly after treatment.In the comparison of joint pain,morning stiffness,joint flexion and extension disadvantage,joint fever,chilly limbs,fatigue and other single scores,P < 0.05,the treatment group was better than the control group;in the aspect of improving joint swelling,P > 0.05,there was no difference between the two groups.3.In improving DAS28 score: after 12 weeks of treatment,the number of joint tenderness,the number of joint swelling,VAS score,ESR and DAS28 score in the two groups were compared,P < 0.05,and there were significant differences between the two groups before and after treatment.Compared with the control group,the treatment group was better than the control group in improving the number of tenderness and DAS28 score(P < 0.05).There was no difference in the number of joint swelling between the two groups(P > 0.05).4.Influence on laboratory indexes: after treatment,the laboratory indexes(ESR,CRP)in the group were compared with P < 0.05,indicating that both groups could significantly reduce the laboratory indexes.After treatment,CRP,P < 0.05,showed that there was difference between the two groups in reducing CRP,and the treatment group was better than the control group;ESR,P > 0.05,showed that there was no difference between the two groups in improving ESR.5.Safety and adverse events: before and after treatment,the blood routine test,liver and kidney function and other safety indicators were observed in the two groups.After treatment,one patient in the control group had abnormal liver function,which was relieved after taking medicine.There was no adverse event in the treatment group.Conclusion:1.Guizhi Shaoyao Zhimu Decoction plus Jianfang combined with leflunomide tablets and diclofenac sodium sustained-release tablets have obvious effect on the treatment of cold and heat mixed RA,which can effectively alleviate the symptoms of joint pain,morning stiffness,adverse flexion and extension,fatigue,chilly limbs,joint fever and so on.2.Guizhi shaoyaozhimu decoction can significantly improve the DAS28 score and reduce the C-reactive protein of RA patients with cold heat syndrome.3.There was no obvious adverse reaction in the treatment group.