To observe the clinical efficacy and safety of self-designed Yiqi Yangyin Tongluo Formula combined with intestinal microecological regulators in the treatment of rheumatoid arthritis.

A prospective cohort study was conducted on 120 patients with rheumatoid arthritis admitted to Xinyang Central Hospital from January 2022 to January 2025, using a random number table method. Both groups received leflunomide tablets. The conventional group was treated with intestinal microecological modulators, while the combined group received self-designed Yiqi Yangyin Tongluo Formula combined with intestinal microecological modulators. Microbiome diversity metrics (evenness and richness), anti-cyclic citrullinated peptide (CCP) antibody levels, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels were measured in both groups. Clinical efficacy outcomes were statistically analyzed.

There was no difference in the uniformity and richness of the microbiome flora between the two groups before treatment (P >0.05). Before and after treatment, the uniformity and richness of the microbiome in both groups increased, and the uniformity and richness of the microbiome in the comprehensive group after treatment were higher than those in the conventional group (P <0.05). There was no difference in the relevant scores between the two groups before treatment (P >0.05). Before and after treatment, the scores of the Arthritis Quality of Life Scale 2 (AIMS2-SF) in both groups increased, and the comprehensive group was higher than the conventional group after treatment (P < 0.05). The TCM symptom scores, DAS28 scores and VAS scores of both groups decreased, and the comprehensive group was lower than the conventional group (P < 0.05). There was no difference in anti-CCP antibody, ESR and CRP between the two groups before treatment (P > 0.05). Before and after treatment, the anti-CCP antibody, ESR and CRP in both groups decreased, and the comprehensive group was lower than the conventional group after treatment (P <0.05). The improvement rate of ACR20 in the comprehensive group was 61. 67%, which was higher than 43. 33% in the conventional group. The improvement rates of ACR50 and ACR70 were 46. 67% and 15. 00% respectively, and there was no difference compared with 31. 67% and 6. 67% in the control group (P >0.05).

The Self-designed Yiqi Yangyin Tongluo Formula combined with intestinal microecological regulators in the treatment of rheumatoid arthritis can reduce the levels of anti-CCP antibody, ESR and CRP, alleviate symptoms.