Objective To observe the clinical effect of self-made＂Bi Zheng No.1＂ Fumigation Prescription combined with western medicine on early mild and moderate rheumatoid arthritis patients.Methods A total of 140 patients with early mild to moderate rheumatoid arthritis treated in the Department of Rheumatology and Immunology,Dalian Municipal Central Hospital from January 1,2021 to December 31,2022 were selected as the research subjects.They were divided into fumigation group(70 cases)and non-fumigation group(70 cases)according to random number table method.The fumigation group was treated with the ＂Bi Zheng No.1＂ Fumigation Prescription combined with conventional western medicine,while the non-fumigation group was treated with conventional western medicine.The clinical indicators such as joint symptoms,signs,morning stiffness time,visual analogue scale (VAS)score,health assessment questionnaire (HAQ)and the medical outcomes study 36-item short form health survey(SF-36)were compared between the two groups before and after treatment.Rheumatoid factor (RF),erythrocyte sedimentation rate (ESR),C-reactive protein (CRP),interleukin-1 (IL-1),interleukin-6 (IL-6),tumor necrosis factor-α (TNF-α),interleukin-4 (IL-4),interleukin-10 (IL-10),hand joint ultrasound score,disease activity score 28(DAS 28),simplified disease activity index(SDAI),clinical disease activity index(CDAI) and other indicators were detected in the two groups.Results After 12 weeks of treatment,the tender joint counts (TJC),swollen joint counts (SJC),and hand joint ultrasound scores of the fumigation group were lower than those of the non-fumigation group,and the differences were statistically significant (P＜0.05).After 4 and 12 weeks of treatment,the VAS score,HAQ score and DAS 28 score of the fumigation group were lower than those of the non-fumigation group,and the SF-36 score was higher than that of the non-fumigation group,and the differences were statistically significant (P＜0.05).The SDAI and CDAI of the fumigation group were lower than those of the non-fumigation group after 12 weeks of treatment,and the differences were statistically significant (P＜0.05).After 12 weeks of treatment,CRP in the fumigation group was lower than that in the non-fumigation group,and the difference was statistically significant (P＜0.05).There were no statistically significant differences in RF,IL-1,IL-6,TNF-α,IL-4 and IL-10 between the two groups before treatment and at 4 and 8 weeks after treatment (P＞0.05).The total effective rate of the fumigation group was higher than that of the non-fumigation group,and the difference was statistically significant(P＜0.05).Conclusion ＂Bi Zheng No.1＂Fumigation Prescription has significant clinical effect in the treatment of early mild to moderate rheumatoid arthritis,with obvious anti-inflammation,swelling and analgesic effect.