Objective: To explore the clinical effect of Chaihu Longgu Muli Decoction on breast hyperplasia of liver qi stagnation syndrome and its influence on immune function.Methods: A total of 110 patients with mammary hyperplasia with liver - qi stagnation syndrome admitted to the First Affiliated Hospital of Anhui University of Chinese Medicine from July 2023 to July 2024 were selected and divided into 2 groups according to treatment methods, with 55 cases each. The control group was treated with conventional Western medicine, and the observation group was treated with conventional Western medicine combined with bupleurum keel and oyster soup. The efficacy, TCM syndrome score, improvement of breast mass, serum neurotransmitter indexes [5 - hydroxytryptamine (5 - HT), dopamine (DA)], estrogen indexes[estradiol (E₂), prolactin (PRL), progesterone (P)], immune function indexes and drug safety were compared between the two groups.Results: Compared with the control group, the observation group had higher efficacy and less adverse reactions (P < 0.05). After treatment, the scores of main syndrome, secondary syndrome, mass maximum diameter and visual analogue scale (VAS) were decreased in both groups, and the decrease was more obvious in the observation group (P <0.05). After treatment, the levels of E₂, PRL, 5 - HT and DA were decreased in both groups, the decrease was more obvious in the observation group, the levels of P, CD3⁺ and CD4⁺/CD8⁺ were increased in both groups, and the increase was more obvious in the observation group (P < 0.05).Conclusion: Chaihu Longgu Muli Decoction is used for clinical treatment of mammary hyperplasia of liver qi stagnation syndrome. It can improve clinical symptoms, breast mass and sex hormone levels, regulate serum neurotransmitter and immune function, improve clinical efficacy and drug safety.

Breast hyperplasia  /  Chaihu Longgu Muli Decoction  /  Liver - qi stagnation syndrome  /  Sex hormone  /  Immune function  /  Safety