Objective  To evaluate safety and efficacy of iguratimod tablets combined with Leigongteng glucosides pills in non-menopausal female with rheumatoid arthritis (RA).

  Methods  A total of 108 non-menopausal RA female patients who received drug therapy for the first time were randomly divided into control group and observation group by random number table method, with 54 cases in each group. The control group was given iguratimod tablets orally, and the observation group was given iguratimod tablets combined with Leigongteng glucosides pills orally. Patients in both groups were treated with methotrexate or leflunomide for 3 months. Disease Activity Score using 28 joint counts (DAS28) score, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), interleukin-1 (IL-1), C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and nuclear transcription factor-κB (NF-κB) were compared between two groups before and after treatment. The clinical efficacy and drug safety of the two groups were evaluated.

  Results  After treatment, DAS28 score, RF, ESR, IL-1, CRP, TNF-α and NF-κB levels in two groups were significantly lower than before treatment, and the observation group was significantly lower than the control group (P < 0.05). The total effective rate for treatment in the observation group was significantly higher than that in the control group (P < 0.05). There was no drug toxicity of grade Ⅲ in both groups, and no obvious adverse reactions occurred in endocrine and reproductive system.

  Conclusion  Iguratimod tablets combined with Leigongteng glucosides pills has good safety and efficacy in the treatment of non-menopausal RA females.