OBJECTIVETo observe the therapeutic effect of Yangxue Tongluo Recipe (YTR) combined with immunosuppressive agents in the treatment of rheumatoid arthritis (RA).

METHODSTotally 88 RA patients were randomly assigned to the treatment group [47 cases, YTR combined Methotrexate (MTX) + Leflunomide (LEF) treatment] and the control group (41 cases, MTX + LEF therapy). All patients received 12-week treatment. Clinical symptoms and signs, laboratory tests [erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), and C reactive protein (CRP)], and adverse reactions were observed before and after treatment.

RESULTSThe total effective rate was 91.5% (43/47 cases) in the treatment group, and the total effective rate was 75.6% (31/41 cases) in the control group. There was statistical difference between the two groups (P < 0.05). The morning stiffness, the rest pain, the number of tender joints, the number of swollen joints, tender joint index, swollen joint index, ESR, RF, and CRP were significantly improved in the two groups after treatment (P < 0.01). Besides, clinical symptoms and signs, ESR, RF, and CRP were more improved in the treatment group after treatment, when compared with those in the control group (P < 0.05). Gastrointestinal discomfort was the main adverse reaction in the two groups, but the occurrence was lower in the treatment group than in the control group (P > 0.05).

CONCLUSIONSThe clinical efficacy of YTR combined MTX + LEF in the treatment of RA was better than using Western medicine alone. It was more safe with less adverse reactions.