Tianjin Medical Journal ›› 2022, Vol. 50 ›› Issue (8): 883-887.doi: 10.11958/20212650

• Drug Clinical Evaluations • Previous Articles     Next Articles

Efficacy and safety analysis of tofacitinib and yisaipu combined with methotrexate in the treatment of refractory rheumatoid arthritis

LUO Huan(), ZHANG Xia, FENG Yarao, ZHAO Yue, REN Zhanfen, YANG Jinliang, ZHENG Xuejun   

  1. Department of Rheumatology, the First Affiliated Hospital of Hebei North University, Zhangjiakou 075000, China
  • Received:2021-11-28 Revised:2022-02-17 Published:2022-08-15 Online:2022-08-12

Abstract:

Objective To explore the effect and safety of tofacitinib and tumor necrosis factor-α receptor antagonist (yisaipu) combined with methotrexate in the treatment of refractory rheumatoid arthritis (RRA). Methods According to random number table method, 60 patients with RRA were divided into the group A, the group B and the group C, 20 cases in each group. The group A was treated with citrate tofacitinib (5 mg) and methotrexate (10 mg), the group B was treated with yisaipu (25 mg), and the group C was treated with yisaipu (25 mg) and methotrexate (10 mg). The clinical curative effects, clinical symptoms, disease activity indexes, inflammatory factors and adverse reactions were compared between different groups. Results After treatment, the clinical effective rate was significantly higher in the group A than that in the group B (P<0.05). However, there were no significant differences in indexes of clinical curative effect between the group A and the group C, and between the group B and the group C (P>0.05). After treatment, joint tenderness, joint swelling, levels of erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), C-reactive protein (CRP), serum interleukin (IL)-6, IL-1β and IL-17 were significantly decreased compared with before treatment in the three groups (P>0.05). The number of joint tenderness and joint swelling, morning stiffness time, levels of ESR, RF, CRP, IL-6, IL-1β and IL-17 were lower in the group A than those in the group B and the group C. The morning stiffness time, levels of ESR, RF, CRP, IL-6, IL-1β and IL-17 were lower in the group C than those in the group B (P<0.05). There was no significant difference in the incidence of adverse reactions during treatment between the three groups (P>0.05). Conclusion Tofacitinib combined with methotrexate has significant efficacy in the treatment of RRA, which is superior to yisaipu alone or yisaipu combined with methotrexate in clinical symptom improvement, disease activity index control and inflammatory factor level inhibition, with good safety.

Key words: arthritis, rheumatoid, Methotrexate, receptors, tumor necrosis factor, typeⅡ, Tofacitinib, curative effect, safety

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