儿童尘螨皮下特异性免疫治疗不良反应回顾性研究

Retrospective Study on Adverse Reactions of Subcutaneous Specific Immunotherapy for Dust Mites in Children

摘要: 目的：尘螨变应原皮下特异性免疫治疗目前被认为是一种有效和安全的治疗方法，但在其治疗过程中可能出现不良反应。本研究旨在评估SCIT后儿童的局部和全身反应表现以及可能与这些反应相关的因素。方法：选取2019年~2023年期间就诊于青岛大学附属医院儿科门诊，诊断为尘螨过敏且患有哮喘和/或过敏性鼻炎的患者，接受并完成了标准化SCIT治疗、对临床资料完备的儿童患者进行了回顾性研究。研究纳入了246名研究对象。从患者档案中分析了SCIT的性别、年龄、临床症状、实验室相关指标和不良反应特征的发展并进行了统计分析，探讨SCIT治疗过程中发生不良反应的相关因素。结果：246例患者中位年龄为10岁。其中男性177例(72%)，女性69例(28%)。共接受了10,355次SCIT注射。观察到不良反应例数86例，共97注射次。剂量上升阶段不良反应30 (0.29%)注射次，维持阶段不良反应67 (0.65%)注射次。每次注射不良反应发生率为0.94% (局部：0.72%，全身：0.22%)。不同诊断类型的不良反应发生率有显著差异，变应性鼻炎、变应性鼻炎合并哮喘的不良反应发生率显著高于哮喘(P < 0.05)。不良反应类型方面，变应性鼻炎合并哮喘的全身不良反应发生率更高(P < 0.05)。嗜酸性粒细胞百分比越高，越容易发生不良反应(P < 0.05)。发生不良反应患儿总IgE水平明显高于未发生不良反应患儿(P < 0.05)。根据过敏原分级，过敏原sIgE分级越高，越易发生不良反应(P < 0.05)。结论：螨特异性皮下免疫治疗治疗哮喘和/或过敏性鼻炎过程中SR的发生率低，安全性良好。对嗜酸性粒细胞比例水平高、高敏状态(尘螨sIgE 6级、总IgE升高)者发生不良反应的风险显著增高，特别是SR发生风险尤需关注。虽然本组患者未见严重的全身反应和死亡，但在儿童SCIT期间，应注意不良反应。

Abstract: Objective: Subcutaneous specific immunotherapy (SCIT) for mite allergies is currently recognized as an effective and safe therapeutic approach; however, adverse reactions may occur during treatment. This study aimed to evaluate the manifestations of local and systemic reactions in children following SCIT and identify potential factors associated with these reactions. Methods: A retrospective study was conducted on children diagnosed with dust mite allergy and asthma and/or allergic rhinitis who received standardized SCIT regimens with complete medical records at the Pediatric Outpatient Clinic of The Affiliated Hospital of Qingdao University between 2019 and 2023. A total of 246 subjects were included. Data on gender, age, clinical symptoms, laboratory parameters, and characteristics of adverse reactions were analyzed from patient records. Statistical analyses were performed to investigate factors associated with SCIT-related adverse reactions. Results: The median age of the 246 patients was 10 years, with 177 males (72%) and 68 females (28%). A total of 10,355 SCIT injections were administered. Adverse reactions were observed in 86 patients across 97 injections. During the dose-escalation phase, 30 adverse reactions (0.29% of injections) occurred, while 67 reactions (0.65% of injections) were recorded in the maintenance phase. The overall adverse reaction rate per injection was 0.94% (local: 0.72%, systemic: 0.22%). There are significant differences in the incidence of adverse reactions among different diagnostic types, and the incidence of adverse reactions in allergic rhinitis and allergic rhinitis combined with asthma is significantly higher than that in asthma (P < 0.05). In terms of adverse reaction types, the incidence of systemic adverse reactions in allergic rhinitis combined with asthma is higher (P < 0.05). The higher the percentage of eosinophils, the more likely adverse reactions are to occur (P < 0.05). The total IgE level in children with adverse reactions was significantly higher than that in children without adverse reactions (P < 0.05). According to allergen grading, the higher the sIgE grading of allergens, the more likely adverse reactions are to occur (P < 0.05). Conclusion: Mite-specific SCIT demonstrates a low systemic reaction (SR) rate and favorable safety profile in children with asthma and/or allergic rhinitis. Patients with elevated eosinophil percentage levels, high sensitization status (dust mite sIgE class 6, elevated total IgE), or concurrent allergic diseases require heightened vigilance for potential SRs. Although no severe systemic reactions or fatalities were observed in this cohort, close monitoring of adverse reactions remains critical during pediatric SCIT.