| Objective: To study the clinical efficacy and safety of Tripterygium wilfordii glycosides tablets in patients with active rheumatoid arthritis.Methods: 60 patients with active rheumatoid arthritis were randomly divided into the research group 31 patients and the control group 29 patients.Research group patients were treated with Low-dose glucocorticoids,leflunomide 20 mg once a day and tripterygium wilfordii glycosides tablets 20 mg three times a day;meanwhile low-dose glucocorticoids and leflunomide 20 mg once a day with the control group patients.Before and 4,8,12,24 weeks after treatment,observed and recorded each index changes and adverse reactions.Observation indexes include of SJC,TJC,VAS score,HAQ score,CRP,ESR,RF,anti-CCP,blood routine,biochemical liver,kidney function,DAS28-ESR score of each treatment stage and ACR20/50/70 remission rate.Compare the changes of the wrist joints,MCP2,PIP2,knee joint synovial thickness and blood flow signal.The patients with pulmonary interstitial lesions were given HRCT semi-quantitative score,meanwhile compared the changes of the PO2、Sp O2 and lung function.Then data analyses use software of SPSS22.0.Result: Women accouted for 83.4% of the study group,which average age was64.32±10.35 years,average duration 8.33±6.52 years.The percentage of female was72.4% in the control group,whose average age was 62.24±11.02 years,average duration 8.29±7.14 years.There was no statistically significant difference between the two groups.The SJC of study group was lower than the control group at 4 and 24 weeks,the differences had statistical significance(P < 0.05).TJC,VAS score and CRP at 4,8,12,24 weeks were improved,but the differences between two groups had no statistical significance(P > 0.05).ESR and DAS28-ESR of study group fall faster than control group at 4,8,12,24 weeks,differences between them had statistical significance(P <0.05).ACR70 at 12 weeks and ACR50/70 at 24 weeks of study group were higher than the control group,difference had statistical significance(P < 0.05).At 24 weeks the HAQ scores differences between two groups had statistical significance(P < 0.05).Synovial thickness of wrists,MCP2,PIP2 study group were better than control group at24 week,and the differences had statistical significance(P < 0.05),but the difference between knee had no statistical significance(P > 0.05)。 Both 12 and 24 week,the differences of blood flow signal of wrists,MCP2,PIP2,knee between two groups had no statistical significance(P > 0.05)。 RF of the study group at 12,24 weeks and anti-CCP value at 24 week was lower than control group,and the differences had statistical significance(P < 0.05).For patients with pulmonary interstitial lesions at 24 weeks,the interstitial lung disease score,the PO2 and Sp O2 of study group improved obviously,the differences between two groups had statistical significance(P < 0.05);but the differences of FVC and FEV1/FVC had no statistical significance(P > 0.05).The total incidence of adverse reactions was respectively 29.03%、17.24% in the two groups,abnormal liver function,infection,digestive discomfort and leucopenia were the cardinal symptoms,there was no statistically significant difference between them(P >0.05).Conclusion: Tripterygium wilfordii glycosides tablets can reduce the activity of active rheumatoid arthritis,improve disease remission rate and joint function,inhibit the synovial hyperplasia,promote restoration of the pulmonary interstitial lesions,meanwhile improve oxygen partial pressure and oxygen saturation;but do not increase the risk of side effects. |