Duman Senol Handan, Topyildiz Ezgi, Ekici Betul, Gulen Figen, Demir Esen
Ege University Faculty of Medicine, İzmir, Turkey.
Int J Pediatr Otorhinolaryngol. 2022 Nov;162:111292. doi: 10.1016/j.ijporl.2022.111292. Epub 2022 Aug 19.
Adverse reactions, which are mostly local and rarely systemic, can be seen during subcutaneous immunotherapy (SCIT). It was not possible to continue SCIT at times due to systemic reactions. The purpose of the present study was to identify the incidence and risk factors associated with adverse reactions during subcutaneous allergen-specific immunotherapy (AIT).
A total number of 344 patients under 18 years old with allergic rhinitis and/or asthma who underwent SCIT between 2005 and 2021 were included in the study. Demographic characteristics of the patients, laboratory findings [Total Immunglobulin E(IgE), aeroallergen prick test, inhaler, and allergen specific IgE(sIgE) and eosinophil counts], and adverse events observed during AIT were recorded retrospectively. Descriptive and univariate/multivariate logistic regression analyses were used to identify risk factors for adverse events.
Among 344 patients, 33.4% (n = 115) were female, mean age was 133.1 ± 41.0 months, and 42.2% (n = 145) were >12 years old. One hundred-thirty eight (40.1%) of the patients were mono-sensitized, 47 (13.7%) had asthma, 207 (60.2%) allergic rhinitis, and 90 (26.2%) asthma and allergic rhinitis. Single allergen content was administered to 187 (54.4%) patients (62 mite, 114 grass mix, 11 olea), and multiple allergens to 157 (45.6%) patients (121 pollen mix, 36 other (mite/alternaria)]. A total number of 33.008 injections were administered. 840 adverse reactions (262 (31.1%) at up-dosing phase, 578 (68.8%) at maintenance phase) in 195 (56.7%) patients were observed. Among the adverse reactions, 632 (75.2%) were local, 160 (19%) large local, and 48 (5.7%) (39 at maintenance, 9 at up-dosing) (in 31 patients) were systemic (28 Grade 1, 12 Grade 2, 8 Grade 3). Adrenalin was administered to 8 patients with Grade 3 systemic reaction (8/33008; %0.024). Adverse reactions, especially local ones, were seen more frequently in children under 12 years old (p < 0.001). Patients sensitized with grass pollen (p:0.01) and mite (p:0.004), and those who had received SCIT with pollen mixture had more adverse reactions than the others. More adverse reactions were observed in SCIT containing calcium-phosphate as adjuvant (p: 0.01). Local reactions were risk factors for large local (OR = 3.591, %95 CI:2.064-6.247, p < 0.001) and systemic (OR = 2.190, %95 CI:1.005-4.722 p = 0.046) reactions at univariate analyses. Total nasal symptom scores, Visual Analog Scale and asthma symptom control test decreased after one year of treatment (p < 0.01).
SCIT is a safe and effective treatment method in childhood that leads to improvements in all nasal symptoms and asthma after one year of treatment.
皮下免疫疗法（SCIT）过程中可见不良反应，大多为局部反应，很少出现全身反应。有时因全身反应无法继续进行SCIT。本研究旨在确定皮下变应原特异性免疫疗法（AIT）期间不良反应的发生率及相关危险因素。
本研究纳入了2005年至2021年间接受SCIT的344例18岁以下过敏性鼻炎和/或哮喘患者。回顾性记录患者的人口统计学特征、实验室检查结果[总免疫球蛋白E（IgE）、变应原皮肤点刺试验、吸入器、变应原特异性IgE（sIgE）及嗜酸性粒细胞计数]以及AIT期间观察到的不良事件。采用描述性及单因素/多因素逻辑回归分析确定不良事件的危险因素。
344例患者中，女性占33.4%（n = 115），平均年龄为133.1±41.0个月，42.2%（n = 145）患者年龄>12岁。138例（40.1%）患者为单致敏，47例（13.7%）有哮喘，207例（60.2%）有过敏性鼻炎，90例（26.2%）有哮喘和过敏性鼻炎。187例（54.4%）患者接受单一变应原制剂治疗（62例为螨，114例为混合草类，11例为油橄榄），157例（45.6%）患者接受多种变应原制剂治疗（121例为混合花粉，36例为其他（螨/链格孢））。共注射33008次。观察到195例（56.7%）患者出现840次不良反应（剂量递增阶段262次（31.1%），维持阶段578次（68.8%））。不良反应中，632次（75.2%）为局部反应，160次（19%）为大面积局部反应，48次（5.7%）（维持阶段39次，剂量递增阶段9次）（31例患者）为全身反应（28例1级，12例2级，8例3级）。8例3级全身反应患者使用了肾上腺素（8/33008；0.024%）。12岁以下儿童更常出现不良反应，尤其是局部反应（p < 0.001）。对草花粉（p：0.01）和螨（p：0.004）致敏的患者以及接受花粉混合制剂SCIT的患者比其他患者有更多不良反应。含磷酸钙作为佐剂的SCIT中观察到更多不良反应（p：0.01）。单因素分析显示，局部反应是大面积局部反应（OR = 3.591，95%CI：2.064 - 6.247，p < 0.001）和全身反应（OR = 2.190，95%CI：1.005 - 4.722，p = 0.046）的危险因素。治疗1年后，总鼻症状评分、视觉模拟量表评分及哮喘症状控制测试均有所下降（p < 0.01）。
SCIT是一种安全有效的儿童治疗方法，治疗1年后可改善所有鼻症状及哮喘症状。
