Influence of Tripterygium wilfordii Hook F and Caulis Sinomenii with traditional Chinese medicine directed drug delivery on CD3+, CD4+, CD8+ and joint function in rheumatoid arthritis patients

Background: Rheumatoid arthritis (RA) is characterised by persistent synovitis and progressive joint destruction, frequently accompanied by abnormal T-cell subsets. Tripterygium wilfordii Hook F (TwHF) and Caulis Sinomenii (CS) are widely used in China for “dispelling wind-dampness”, but their systemic toxicity limits dosage. Targeted drug delivery of traditional Chinese medicine (TCM) concentrates herbal actives in affected joints while reducing systemic exposure. Objectives: To evaluate whether TwHF plus CS combined with TCM improves peripheral CD3+, CD4+, and CD8+ T-cell counts, disease activity and joint function more effectively than oral TwHF plus CS alone. Methods: This randomized controlled trial (conducted from January 2020 to November 2023) enrolled 82 RA patients who were randomly assigned to either a medication group (receiving Tripterygium wilfordii and Caulis Sinomenii alone) or a combination group (herbal medicine plus TCM targeted drug delivery). Results: Clinical and immunological parameters were assessed before treatment, at 30 days, and at 60 days. The combination group demonstrated significantly greater reductions in inflammatory markers erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), as well as Disease Activity Score-28 (DAS28) scores, compared to the medication-only group (P < 0.05). Immune profiling showed notably higher levels of CD3+, CD4+, and CD8+ T-cell subsets in the combination therapy group. Furthermore, patients receiving combined treatment exhibited more substantial improvements in joint pain, morning stiffness, swelling, and cold intolerance, reflected by lower TCM syndrome scores (P< 0.05). Adverse events, including nausea, vomiting, diarrhea, elevated liver enzymes, and oral ulcers, were also significantly less frequent in the combination group. Conclusion: These findings suggest that integrating herbal treatment with TCM targeted drug delivery synergistically enhances immunomodulation, improves joint function, alleviates clinical symptoms and reduces side effects in RA patients.