脾氨肽口服溶液对季节性过敏性鼻炎预防与治疗的应用研究

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

目的开展内蒙古呼和浩特地区季节性过敏性鼻炎防治的研究,探讨脾氨肽口服溶液对季节性过敏性鼻炎的预防与治疗作用,以及其相关机制。方法于2023年4—5月首都医科大学附属北京世纪坛医院变态反应科牵头,呼和浩特市第一医院协助开展的内蒙古呼和浩特地区过敏性疾病流行病学调查项目的流调人群中,选取392例季节性过敏性鼻炎患者,按3∶1随机分为脾氨肽治疗组(296例)和对照组(96例),并在2023年6月1—14日完成入组。治疗组在花粉播散期前4~6周(±7 d)开始应用脾氨肽口服溶液治疗12周,对照组应用脾氨肽口服溶液模拟剂,治疗组和对照组在花粉播散期间均按需使用口服抗组胺药物和/或鼻用糖皮质激素治疗。通过对比两组人群的症状评分、药物评分和生活质量评分评估疗效,并检测血清中多种细胞因子的表达水平。采用独立样本t检验/Kruskal-Wallis检验、χ^(2)检验/Fisher精确检验比较症状评分、生活质量评分、药物评分和实验室检查。结果与对照组相比,脾氨肽治疗12周可显著改善鼻塞[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H值=6.308,P<0.05]、鼻痒[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H值=4.966,P<0.05]、喷嚏[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H值=5.245,P<0.05]、流涕[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H值=5.41,P<0.05]、流泪[M(Q_(1),Q_(3)):1(0,2)vs.1(0,3),H值=4.664,P<0.05]症状。治疗12周时对照组和试验组鼻部症状及眼部症状评分与基线相比均升高(P<0.05),试验组鼻塞[M(Q_(1),Q_(3)):1(0,1)vs.1(0,2),H值=4.042,P<0.05]、眼痒/异物感/眼红[M(Q_(1),Q_(3)):1(0,2)vs.1(0,2),H值=5.302,P<0.05]症状评分及总评分[M(Q_(1),Q_(3)):4(-1,9)vs.5(0,12.5),H值=3.958,P<0.05]升高的幅度低于对照组。脾氨肽治疗组治疗6周抗组胺药物评分低于对照组(H值=4.232,P<0.05);治疗12周时,抗组胺药物评分[M(Q_(1),Q_(3)):10(0,24)vs.19(2,36.5),H值=6.67,P<0.05]及药物总评分[M(Q_(1),Q_(3)):28.5(5,77.5)vs.46(6,155.5),H值=3.995,P<0.05]均低于对照组。在脾氨肽治疗6周(0.7±1.77vs.0.85±1.67,H值=10.08,P<0.05)和12周(0.81±1.63vs.0.94±1.73,H值=5.196,P<0.05)时,治疗组血清IL-17A水平均低于对照组。结论脾氨肽口服溶液早期干预治疗可能改善患者季节性过敏性鼻炎的鼻部症状和眼部症状,减少发作期用药,改善患者的生活质量,其可能通过降低患者血清中IL-17A的表达水平从而发挥免疫调节作用。

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 andχ^(2)test/Fisher′s exact test.Results Compared with the control group,spleen aminopeptide treatment for 12 weeks significantly improved symptoms of nasal congestion[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H=6.308,P<0.05],nasal itching[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H=4.966,P<0.05],sneezing[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H=5.245,P<0.05],runny nose[M(Q_(1),Q_(3)):2(1,2)vs.2(1,3),H=5.41,P<0.05]and tearing[M(Q_(1),Q_(3)):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(Q_(1),Q_(3)):1(0,1)vs.1(0,2),H=4.042,P<0.05],eye itching/foreign body sensation/redness symptom scores[M(Q_(1),Q_(3)):1(0,2)vs.1(0,2),H=5.302,P<0.05]and total scores[M(Q_(1),Q_(3)):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(Q_(1),Q_(3)):10(0,24)vs.19(2,36.5),H=6.67,P<0.05]and the total drug score[M(Q_(1),Q_(3)):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.