OBJECTIVE To investigate the clinical efficacy of Peiyuan Liaoti Formula (PYLTF) in treating patients with allergic rhinitis (AR) of primordial qi deficiency type.

METHODS A total of 80 patients with AR of primordial qi deficiency type from Henan Province Hospital of Traditional Chinese Medicine were enrolled and randomly assigned to a control group and an observation group (40 cases each). Finally, 38 cases were included in each group for statistical analysis. The control group received standard Western medical therapy for AR (cetirizine tablets plus mometasone furoate nasal spray), while the observation group was administered PYLTF; both groups were treated for 4 weeks. Before treatment and 2 and 4 weeks after treatment, the TCM syndrome scores, Visual Analogue Scale (VAS) scores, and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores of the two groups of patients were observed to assess clinical efficacy. Nasal resistance levels were measured using the anterior nasal measurement method, and the mucociliary transport velocity and rate of nasal mucus were observed using the saccharin test. Serum levels of IFN-γ, IL-2, IL-4, IL-5, IL-10, IL-13, TGF-β, and tIgE were detected using ELISA. The CD4⁺/CD8⁺ cell ratio in peripheral blood mononuclear cells (PBMCs) was detected by flow cytometry. Adverse reactions were monitored in both groups during treatment.

RESULTS After 2 and 4 weeks of treatment, the TCM syndrome scores, VAS and RQLQ scores, and most nasal resistance indices of both groups decreased (P<0.05, P<0.01). After 2 weeks of treatment, the main nasal syndrome score of the control group was better than that of the observation group (P<0.01). After 4 weeks of treatment, the total TCM syndrome score and VAS score of the observation group were better than those of the control group (P<0.05). After 4 weeks of treatment, both groups showed increased ciliary transport rate and clearance speed (P<0.05, P<0.01), with the control group showing better results than the observation group (P<0.01). Serum levels of tIgE, IL-4, IL-5, and IL-13 decreased in both groups, while levels of IFN-γ, IL-2, IL-10, and TGF-β, and the CD4⁺/CD8⁺ ratio in PBMCs increased (P<0.05, P<0.01). The observation group had higher levels of IFN-γ, IL-2, IL-10, and TGF-β, and a higher CD4⁺/CD8⁺ ratio than the control group (P<0.01), while IL-4 and IL-13 levels were lower in the observation group (P<0.01). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05).

CONCLUSION PYLTF can regulate the immune function of patients, effectively improve the clinical symptoms of patients with AR due to primordial qi deficiency, and has good safety.