OBJECTIVE To investigate the association between serum expression levels of Toll-like receptor 4 （TLR4） and GATA-binding protein 3 （GATA-3） and disease severity in patients with allergic rhinitis, and to evaluate their diagnostic value for assessing disease severity.

METHODS A total of 120 patients with allergic rhinitis at Sichuan Friendship Hospital from Mar. 2022 to Mar. 2024 were included and divided into mild and moderate-to-severe groups according to disease severity. Another 120 healthy volunteers who underwent physical examinations during the same period were enrolled as the control group. The serum protein levels of TLR4 and GATA-3, as well as the mRNA expression levels of TLR4 and GATA-3, were measured in all subjects. Spearman's correlation analysis was employed to assess the correlation between serum TLR4 and GATA-3 levels and the Score For Allergic Rhinitis （SFAR）. Multivariate logistic regression was adopted to identify risk factors associated with disease severity in patients. Receiver operating characteristic （ROC） curves and decision curve analysis （DCA） were selected to evaluate the diagnostic value of serum TLR4 and GATA-3 levels for disease severity.

RESULTS The levels of TLR4 and GATA-3 proteins in the moderate-to-severe group were （74.46±12.86） ng/L and （107.83±18.34） ng/L, respectively, and the expression levels of TLR4 mRNA and GATA-3 mRNA were （1.79±0.35） and （1.87±0.38）, respectively, all significantly higher than those in the mild group and control group （P＜0.05）. The levels of serum TLR4 and GATA-3 in patients with allergic rhinitis were positively correlated with the SFAR （r_s=0.414 and 0.427, both P＜0.001）. Multivariate logistic regression analysis showed that, with moderate-to-severe disease vs. mild disease as the dependent variable, IgE （OR=1.449）, food allergy （OR=1.763）, TLR4 （OR=2.262） and GATA-3 （OR=2.511） were independent risk factors for moderate-to-severe allergic rhinitis. With mild disease vs. healthy controls as the dependent variable, TLR4 （OR=1.790） and GATA-3 （OR=1.910） were risk factors for mild allergic rhinitis. With moderate-to-severe disease vs. healthy controls as the dependent variable, TLR4 （OR=2.787） and GATA-3 （OR=3.165） were risk factors for moderate-to-severe allergic rhinitis. The AUCs of the combined TLR4 and GATA-3 model for diagnosing mild allergic rhinitis, moderate-to-severe allergic rhinitis, and for distinguishing mild from moderate-to-severe disease were 0.804, 0.954 and 0.939, respectively, all superior to those of either marker alone.

CONCLUSION Serum levels of TLR4 and GATA-3 are elevated in patients with allergic rhinitis and closely correlate with disease severity. The combination of these two markers exhibits high diagnostic efficacy for assessing the severity of the condition.