[Application study on the prevention and treatment of spleen aminopeptide oral solution on seasonal allergic rhinitis]

Methods: A total of 392 patients with seasonal allergic rhinitis were selected from the population of the epidemiological investigation project of allergic diseases in Hohhot, Inner Mongolia. The project was led by Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, and assisted by Hohhot First Hospital from April to May 2023. The patients were randomly divided into a spleen aminopeptide group (296 cases) and control group (96 cases) at a ratio of 3∶1, and the enrollment period was from June 1 to 14, 2023. The treatment group was treated with spleen aminopeptide oral solution for 12 weeks starting from 4-6 weeks (±7 days) before the pollen dispersal period, while the control group was treated with a simulated agent of spleen aminopeptide oral solution. Both the treatment group and the control group were treated with oral antihistamines and/or nasal glucocorticoids as needed during the pollen dispersal period. Evaluate the therapeutic effect by comparing the symptom scores, drug scores and quality of life scores of the two groups, and detect the expression levels of cytokines in serum. Symptom scores, quality of life scores, drug scores and laboratory results were compared by independent sample t test/Kruskal-Wallis test and χ² test/Fisher's exact test. Results: Compared with the control group, spleen aminopeptide treatment for 12 weeks significantly improved symptoms of nasal congestion [M(Q₁,Q₃):2(1, 2) vs. 2(1, 3), H=6.308, P<0.05], nasal itching [M(Q₁,Q₃):2(1, 2) vs. 2(1, 3), H=4.966, P<0.05], sneezing [M(Q₁,Q₃):2(1, 2) vs. 2(1, 3), H=5.245, P<0.05], runny nose [M(Q₁,Q₃):2(1, 2) vs. 2(1, 3), H=5.41, P<0.05] and tearing [M(Q₁,Q₃):1(0, 2) vs. 1(0, 3), H=4.664, P<0.05]. At 12 weeks of treatment, the scores of nasal symptoms and ocular symptoms in control group and experimental group were significantly increased compared with baseline (P<0.05). In experimental group, nasal congestion [M(Q₁,Q₃):1(0, 1) vs. 1(0, 2), H=4.042, P<0.05], eye itching/foreign body sensation/redness symptom scores [M(Q₁,Q₃):1(0, 2) vs. 1(0, 2), H=5.302, P<0.05] and total scores [M(Q₁,Q₃):4(-1, 9) vs. 5(0, 12.5), H=3.958, P<0.05] were significantly increased. The antihistamine drug score of the splenic peptide treatment group at 6 weeks were lower than that of the control group (H=4.232, P<0.05). After 12 weeks of treatment, the antihistamine drug score [M(Q₁,Q₃):10(0, 24) vs. 19(2, 36.5), H=6.67, P<0.05] and the total drug score [M(Q₁,Q₃):28.5(5, 77.5) vs. 46(6, 155.5), H=3.995, P<0.05] were significantly lower than those of the control group. The serum IL-17A levels of the treatment group were significantly lower than those of the control group after 6 weeks (0.7±1.77 vs. 0.85±1.67,H=10.08, P<0.05) and 12 weeks (0.81±1.63 vs. 0.94±1.73,H=5.196, P<0.05) of splenic aminopeptide treatment. Conclusions: Early treatment with spleen aminopeptide oral solution can significantly improve nasal and ocular symptoms of patients with seasonal allergic rhinitis, reduce the use of drugs during the onset period, and improve the quality of life. It may exert an immunomodulatory effect by reducing the expression level of IL-17A in the serum of patients. Objects: To conduct a study on the prevention and treatment of seasonal allergic rhinitis in Hohhot, Inner Mongolia, evaluate the preventive and therapeutic effects of spleen aminopeptide oral solution on seasonal allergic rhinitis, and explore its related mechanisms.