| Objective : To observe the clinical efficacy and safety of Wenjing Tongyang Han bi ointment in the treatment of rheumatoid arthritis of cold-dampness obstruction type,so as to clarify the clinical application value of Wenjing Tongyang Hanbi ointment.Methods: Seventy-six patients who met the inclusion criteria were randomly divided into a test group(38 cases)and a control group(38 cases)by stratified random grouping method according to the X-ray stratification of both hands.The control group was treated with methotrexate tablets + folic acid tablets + etoricoxib tablets;the experimental group was treated with Wenjing Tongyang Hanbi ointment on top of the control group for 12 weeks as one course of treatment.The efficacy was evaluated before treatment,at the 4th week of treatment,at the 8th week of treatment,and after the 12 th week of treatment,and the TCM evidence score,laboratory indexes(ESR,CRP),visual analog score(VAS score),disease activity index(DAS28),the number of people taking etoricoxib tablets,and the nail fold microcirculation score(morphology score,flow score,total score)were recorded before treatment and at the 12 th week of treatment in both groups.,tabular circumferential score,total score)and the safety of the study were evaluated separately.Results: During treatment,2 cases were shed in both the test and control groups,and a total of 72 cases were finally included to complete the study,36 cases in each of the two groups.(1)Comparison of baseline data of the enrolled groups: duration of disease,age,gender,X-ray staging of both hands,VAS score,TCM evidence score,DAS28 score,nail fold microcirculation score and laboratory indexes(ESR,CRP)of patients in both groups before treatment were statistically analyzed,P > 0.05,and were comparable.(2)Comparison of the efficacy of TCM symptoms: After 12 weeks of treatment,the total efficacy of TCM symptoms in the test group was 88.9%;the total efficacy of the control group was 66.7%,and the total efficacy of the test group was significantly better than that of the control group(P<0.05).(3)Comparison of laboratory indexes: The laboratory indexes(ESR and CRP)of the two groups decreased at the 4th,8th and 12th weeks of treatment compared with those before treatment(P < 0.05),and the level of decrease in the test group was significantly better than that in the control group(P < 0.05).(4)Comparison of DAS28 scores: The DAS28 scores of patients in both groups decreased at week 4,week 8 and week 12 compared with those before treatment(P < 0.05),and the level of decrease in the test group was significantly better than that in the control group(P < 0.05).(5)Comparison of TCM syndrome scores: The TCM syndrome scores of patients in both groups decreased at week 4,week 8 and week 12 compared with those before treatment(P <0.05),and the level of decrease in the test group was significantly better than that in the control group(P < 0.05).(6)Comparison of nail fold microcirculation scores: After treatment,the nail fold microcirculation scores(morphology score,flow score,tabular circumferential score and total score)in both groups were lower than before treatment(P < 0.05),and the level of reduction in the test group was significantly better than that in the control group(P < 0.05).(7)Comparison of the number of patients taking oral etoricoxib tablets: Both groups were taking etoricoxib tablets before treatment,and the number of patients taking etoricoxib tablets decreased relatively with the treatment cycle after treatment,and the number of patients in the test group decreased better than that in the control group(P < 0.05).(8)Evaluation of adverse reactions: In this study,there were three cases of nausea and vomiting and one case of diarrhea in the control group,which improved after symptomatic treatment with acid suppression and gastric protection,and did not affect this study.No serious adverse reactions occurred in either group during the course of treatment.Conclusion: Wenjing Tongyang Hanbi ointment combined with with methotrexate can significantly improve the TCM symptoms,DAS28 and nail fold microcirculatory s tatus,and reduce the laboratory indexes(ESR,CRP)in patients with cold-damp paraly tic RA with good safety,and can be used as a safe and effective drug for the clinical treatment of cold-damp paralytic RA. |