摘要Objective: To observe the effectiveness and safety of a therapy combining disease with syndrome on rheumatoid arthritis.Methods: Eighty patients with rheumatoid arthritis belonging to syndrome of damp-heat obstruction were randomly divided into a treatment group and a control group according to stratified blocked randomization method.Forty cases in the control group orally took Loxoprofen Sodium Tablet and Leifumite Tablet and the other 40 cases in the treatment group orally took a Chinese medicine for 12 weeks as a course of treatment. ACR therapeutic effect was used as the standard for evaluating the total therapeutic effect.Results: After 12 weeks of treatment, there was a statistical difference (P<0.01) in the improvement of VAS score, morning stiffness time, number of swelling joints, index of swelling joints, number of joints with tenderness, index of joints with tenderness, average grip strength of both hands, DSA28 score, HAQ, patient's assessment, physician's assessment, ESR, CRP and RF in both groups. The improvement of morning stiffness time, number of swelling joints, index of swelling joints, grip strength, HAQ and patient's assessment in the treatment group was much better than that in the control groups with statistical difference (P<0.05). ACR20, ACR50 and ACR70 was 27.5% (11/40),37.5% (15/40) and 22.5% (9/40) respectively in the treatment group and 40% (16/40), 27.5% (11/42) and 10.0% (4/40) respectively in the control group with statistical difference (P<0.05) in the superiority of the treatment group over the control group. The incidence of adverse reaction in the control group was higher than that in the treatment group (P<0.05).Conclusion: Definite therapeutic effect and high safety can be achieved in using the therapy combining disease with syndrome to treat rheumatoid arthritis belonging to syndrome of damp-heat obstruction.