Objective: To observe the therapeutic effect and safety of Xiaobi powder fumigation and washing combined with ointment application in the treatment of patients with rheumatoid arthritis (RA) of cold-dampness-blocking type. Methods: Totally 80 cases of RA patients with cold-dampness blockage type were divided into the control group (40 cases, treated with methotrexate and leflunomide) and observation group (40 cases, given Xiaobi powder fumigation and washing combined with ointment application on the basis of the control group) according to the random number table method, all treated for 2 mo. The clin. efficacy after treatment, symptom score, joint VAS score, the percentage of serum CD4+CD25+CD127-Treg, CD4+IL-17A+Th17 cells and the levels of related laboratory indexes before and after treatment were compared between the two groups. Results: The total effective rate after treatment in the observation group was higher than that in the control group (P < 0.05). Compared with before treatment, the syndrome scores, the joint VAS score, serum levels of CRP, IL-6, ESR, RF and anti-CCP after treatment in the two groups decreased (P < 0.05), and the above indicators in the observation group were lower (P < 0.05). After treatment, the ratio of CD4+CD25+CD127-Treg in the two groups increased than before, while the ratio of CD4+IL-17A+Th17 and Th17/Treg decreased than before (P < 0.05), and those indicators in the observation group were more obvious than before (P < 0.05). There was no statistical difference in the incidence of total adverse reactions between the two groups (P > 0.05). Conclusion: Xiaobi powder fumigation and washing combined with ointment application on the basis of conventional treatment can more obviously alleviate the local inflammatory reaction in patients with cold-dampness-blocking RA, relieve pain, restore normal immune function of the body, and has good efficacy and high safety.