To explore the effect of Qingre Lishi Huoxue method combined with iguratimod tablets on bone metabolism and observe the clinical efficacy in treating primary rheumatoid arthritis.

Ninety patients with RA of damp-heat paralysis type who were treated for the first time in the rheumatology department of our hospital from June 2021 to December 2022 were selected and randomly divided into two groups, 45 cases in each group. The control group was treated with iguratimod tablets, while the treatment group was treated with Qingre Lishi Huoxue method in addition. At 12 weeks of treatment, the effective rate of TCM syndromes in the two groups was observed, and the changes of BMD and bone metabolism levels were measured, including serum osteocalcin (BGP), type I procollagen N-terminal propeptide (PINP), β-collagen special series (β-CTX), 25-hydroxy vitamin D (25(OH)D), and parathyroid hormone (PTH); at the same time, disease activity indicators were evaluated, including joint swelling number (SJC), tenderness number (TJC), the patient global assessment (PGA), disease activity index 28-CRP (DAS28-CRP), anti-cyclic citrullinated peptide antibody (ACPA), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and safety indicators such as blood and urine routine, liver and kidney function, and ECG.

At 12 weeks of treatment, the effective rate of TCM syndromes in the treatment group was significantly higher than that in the control group (χ²=5.07, P<0.05). The BMD level of the right forearm in both the treatment group and the control group was significantly improved compared with that before treatment (P<0.05). The BMD levels of the lumbar spine and left hip in the two groups were improved compared with those before treatment, but the difference was not statistically significant (P>0.05). The BMD level of the right forearm in the treatment group was significantly higher than that in the control group (P<0.05). The bone metabolism levels in the treatment group were significantly improved compared with those before treatment (P<0.05), however, for the control group only the levels of BGP and 25(OH)D were improved compared with those before treatment. The efficacy evaluation indexes in the treatment group were significantly improved compared with those before treatment (P<0.05), while in the control group, only TJC and ACPA were significantly decreased compared with those before treatment (P<0.05). The levels of ESR and CRP in the treatment group were significantly lower than those in the control group (P<0.05). Comparison of safety indicators showed that neither group experienced significant adverse reactions such as heart, liver, and kidney dysfunction or severe infections.

Qingre Lishi Huoxue method combined with iguratimod tablets can improve bone metabolism, promote bone formation, inhibit bone resorption, increase bone density, prevent and delay osteoporosis and even fractures while controlling RA disease and reducing inflammatory indicators, improve joint function, and improve the quality of life of patients, with good tolerance and safety.