To investigate the clinical efficacy of Tengmei decoction combined with leflunomide and methotrexate in the treatment of patients with rheumatoid arthritis.

From February 2015 to February 2017, 72 patients with heat-tolerant rheumatoid arthritis were enrolled in Linhai Hospital of Traditional Chinese Medicine (TCM). They were randomly divided into treatment group and control groupaccording to the digitaltable, with 36 cases in each group.The control group was given leflunomide (20mg/time, 1 time/d) combined with methotrexate (15mg/time, 1 time/week). The treatment group was given Tengmei decoction on the basis of the control group.Both two groups were treated for 12 weeks.TCM symptom scores, erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), C-reactive protein (CRP), platelet (PLT), joint disease activity (DAS) score, tender joint count (TJC) and swollen joint count(SJC)before and after treatment were compared between the two groups.The clinical efficacy and adverse reactions after treatment were observed.

The total effective rate of the treatment group was 88.89%, which was significantly higher than that of the control group (69.44%), the difference was statistically significant (χ²=4.126, P=0.042). After treatment, the TCM symptom scores (morning stiffness, joint swelling and joint pain etc.), DAS score, TJC and SJC levels in the two groups, were significantly decreased(t_{treatment group}=28.935, 26.430, 25.824, 6.889, 9.222, 5.437; t_{control group}=23.790, 21.704, 21.685, 3.312, 8.134, 2.379, all P<0.05), and those in the treatment group decreased more significantly (t=10.004, 5.488, 7.593, 3.511, 2.554, 3.764, all P<0.05). After treatment, the ESR, RF, CRP, PLT levels of the treatment group and ESR, RF, CRP levels of the control group were significantly decreased (t_{treatment group}=3.969, 2.821, 5.970, 2.791, t_{control group}=5.240, 2.246, 5.452, all P<0.05), and the ESR and CRP levels in the treatment group were significantly lower than those in the control group (t=2.394, 3.895, all P<0.05).

The efficacy of Tengmei decoction combined with leflunomide and methotrexate in the treatment of patients with heat-toxic phlegm-restricted rheumatoid arthritis is effective, which can effectively reduce inflammatory indicators and improve TCM symptom scores, and is safe and reliable.

Arthritis, rheumatoid; Tengmei decoction; Leflunomide; Methotrexate; Curative effect observation