变应性鼻炎患儿皮下免疫治疗全身不良反应的临床观察

目的了解<14岁变应性鼻炎(AR)患儿行标准化屋尘螨变应原注射液皮下免疫治疗(SCIT)后全身不良反应发生情况及其相关因素。方法回顾性分析2016年1月至2020年1月在常州市第三人民医院耳鼻咽喉科变态反应疾病专科门诊,进行3年疗程的标准化屋尘螨变应原注射液SCIT的321例屋尘螨过敏患儿的临床资料。321例患儿年龄5~14岁,其中男性180例,女性141例;年龄5~9岁者154例,10~14岁者167例。使用屋尘螨变应原注射液在上臂伸侧肘上12~15 cm处行皮下注射,321例共行13053针次皮下注射,其中男性患儿共注射7305针次,女性患儿共注射5748针次;5~9岁患儿共注射6342针次,10~14岁患儿注射6711针次。记录患儿每次发生不良反应的发生时间、症状体征及其处理,分析全身不良反应与患儿年龄、性别、疗程及变应原注射剂量的关系。结果(1)321例患儿中,共56例(17.45%)、115针次(0.88%)发生不良反应。其中速发型55针次(47.83%),迟发型60针次(52.17%);全身Ⅰ级不良反应92针次(80.00%),Ⅱ级21针次(18.26%),Ⅲ级2针次(1.74%),无Ⅳ级者。(2)分别以病例数和注射针次统计不良反应发生率,男、女性患儿间差异均无统计学意义(32比24例,χ²=0.03,P=0.86;66比49针次,χ²=0.10,P=0.76);5~9岁患儿不良反应发生率均明显高于10~14岁患儿22.08%(34/154)比13.17%(22/167),1.14%(72/6342)比0.64%(43/6711)],差异均有统计学意义(χ²=4.41,P=0.04;χ²=9.13,P<0.01);疗程方面,2~3年组(105~156周)不良反应发生率3.74%(12/321)与0.41%(12/2912)]明显低于<1年组(≤52周)14.64%(47/321)与0.89%(64/7154)]和1~<2年组(53~104周)10.90%(35/321)与1.31%(39/2987)],差异均有统计学意义(χ²=22.86,P<0.01;χ²=6.43,P=0.01;χ²=12.14,P<0.01;χ²=13.74,P<0.01)。(3)在100000转导单位(SQ-U)高剂量阶段的不良反应发生率明显高于<100000 SQ-U的低剂量阶段1.01%(85/8440)比0.65%(30/4613)],差异有统计学意义(χ²=4.35,P=0.04)。结论螨虫过敏的AR患儿行标准化屋尘螨变应原注射液SCIT的注射针次不良反应发生率<1%,严重程度多为Ⅰ级不良反应,总体安全性和耐受性良好;不良反应的发生与患儿低龄、治疗疗程早期及注射高剂量变应原有关。

Systemic adverse reactions of subcutaneous immunotherapy in children with allergic rhinitis

Objective To investigate the frequency and severity of systemic adverse reactions in children with allergic rhinitis(AR)undergoing subcutaneous immunotherapy(SCIT).Methods The clinical data of 321 children with allergic rhinitis receiving SCIT at Department of Otorhinolaryngology,Changzhou Third People′s Hospital from January 2016 to January 2020 were retrospectively analyzed.There were 180 boys and 141 girls aged 5 to 14 years.Patients were injected subcutaneously with standardized dust mites allergen extract.The onset time,symptoms and signs and treatment of adverse reactions were documented.The relationship of adverse reactions with gender,age,treatment course and dosage of allergen injection were analyzed.Results Patients received total 13053 injections,and 115 adverse reactions(0.88%)occurred in 56 cases(17.45%).The incidence of adverse reactions in children aged 5-9 years was higher than in those aged 10-14 years,for both the number of cases and injections(χ²=4.41,P=0.04;χ²=9.13,P<0.01),but no significant differences were observed in gender of patients.The incidence of adverse reactions in the age group 2-3 years was lower than that in age groups<1 year and 1-<2 years in both of cases and injections(χ²=22.86,P<0.01;χ²=6.43,P=0.01;χ²=12.14,P<0.01;χ²=13.74,P<0.01).The incidence of adverse reactions in the high-dosage phase(100000 SQ-U)was higher than that in the low-dosage phase(<100000 SQ-U)(χ²=4.35,P=0.04).Conclusions The study shows that the incidence of adverse reactions in children with allergic rhinitis receiving subcutaneous immunotherapy is less than 1%in the number of injections and most of them are gradeⅠadverse reactions.The study also shows that younger age,the early course of treatment and the high dosage of allergens are risk factors for adverse reactions.