To observe the efficacy and safety of salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of allergic rhinitis (AR) complicated with small airway dysfunction (SAD) in children.

Children with AR and SAD were divided into control group and treatment group using a random number table method. Both groups were given montelukast sodium chewable tablets as basic treatment, taken before bedtime, 4 mg each time, once a day; children in the control group were additionally treated with cetirizine oral solution on the basis of the basic medication, 2.5~10 mL per dose according to age once a day, for 12 consecutive weeks. The treatment group was given salmeterol/fluticasone propionate inhalation powder inhalation powder by oral inhalation on the basis of the control group’s treatment, 1 inhalation each time, twice a day, for 12 consecutive weeks. The clinical efficacy, lung function, eosinophil (Eos) count, inflammatory response indicators, recurrence rate were compared between the two groups, and safety evaluation was conducted.

A total of 83 cases were enrolled, with 39 cases in the control group and 44 cases in the treatment group. After treatment, the total effective rates of the control group and the treatment group were 74.36% (29 cases/39 cases) and 90.91% (40 cases/44 cases), respectively, with statistically significant difference (P<0.05). After treatment, the forced expiratory volume in 1 second (FEV₁) of the control group and the treatment group were 88.75±3.20 and 90.49±3.26, respectively; FEV₁/maximal vital capacity (VC_max) were 89.47±10.83 and 94.57±10.21, respectively; maximal mid-expiratory flow (MMEF) pred were (61.06±6.72)% and (64.39±6.34)%, respectively; Eos counts were (4.81±0.72)% and (4.45±0.68)%, respectively; fraction of exhaled nitric oxide (FeNO) were (24.92±3.30) and (22.86±3.18) ppb, respectively; T-cell immunoglobulin domain and mucin domain protein-1 (Tim-1) were (125.08±20.19) and (113.27±18.06) ng·L^-1, respectively; high mobility group box 1 protein (HMGB1) were (5.12±0.94) and (4.65±0.79) ng·L^-1, respectively, with statistically significant differences (P<0.05, P<0.01). The main adverse drug reactions in the control group were headache, drowsiness, nausea and vomiting, and the main adverse drug reactions in the treatment group were nausea and vomiting, headache and oropharyngeal candidiasis. The total incidence of adverse reactions in the control group and the treatment group were 7.69% (3 cases/39 cases) and 11.36% (5 cases/44 cases), respectively, and the difference was not statistically significant (P>0.05). The recurrence rates of the control group and the treatment group were 33.33% (13 cases/39 cases) and 13.64% (6 cases/44 cases), respectively, with statistically significant difference (P<0.05).

Salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of children with AR complicated with SAD can significantly improve efficacy, relieve clinical symptoms, improve lung function, reduce inflammation levels, and has good safety and a low recurrence rate.