皮下注射标准化屋尘螨变应原疫苗治疗支气管哮喘和（或）变应性鼻炎的速发不良反应

摘要：目的分析应用标准化屋尘螨变应原对变应性哮喘和（或）变应性鼻炎进行皮下特异性免疫治疗（subcutaneous specific immunotherapy，SCIT）的速发不良反应。方法回顾性记录广州医科大学附属第一医院变态反应科2004年11月至2012年5月对屋尘螨过敏的哮喘和（或）变应性鼻炎患者接受SCIT过程中出现的速发不良反应，并分析速发不良反应与注射剂量、患者年龄、性别、患病种类和变态反应程度的关系。结果研究共纳入462例患者，其中452例（97．8％）出现速发局部不良反应，153例（33．1％）出现速发全身不良反应；所有患者共接受15645针次皮下注射，其中8523针次（54．5％）出现速发局部不良反应，397针次（2．5％）出现速发全身不良反应。速发局部不良反应发生率随剂量增加而增高，而速发全身不良反应主要分布在剂量上升阶段（2000～80000 SQU）。单纯哮喘及哮喘合并变应性鼻炎的速发不良反应（局部和全身）的发生率高于单纯变应性鼻炎（P〈0．01）。儿童速发局部不良反应发生率高于成人（P〈0．001），但速发全身不良反应的发生率在儿童及成人患者间差异无统计学意义（P〉0．05）。儿童患者中，男性速发不良反应发生率高于女性（P〈0．01）；而在成人患者中，女性速发不良反应发生率高于男性（P〈0．01）。速发不良反应（局部和全身）的发生率随着屋尘螨特异性IgE级别的增高而升高（P〈0．001）；在皮下注射过程中出现速发全身不良反应者治疗前总IgE[（634．24±883．91）U／ml]与未发生速发全身不良反应者治疗前总IgE[（416．60±438．59）U／ml]比较，差异有统计学意义（t=2．008，P=0．048）。结论对屋尘螨过敏的哮喘和（或）变应性鼻炎患者进行标准化屋尘螨变应原的SCIT时，速发局部不良反应常见，而速发全身不良反应少见，哮喘和鼻炎合并哮喘、少年男性、成年女性及屋尘螨特异性IgE和总IgE水平较高时，速发不良反应的发生率增高，且随注射变应原剂量递增而存在增高趋势，剂量快速上升阶段应警惕严重不良反应的发生。

Immediate Adverse Reactions during Subcutaneous Standardized House Dust Mite Specific Immunotherapy in Patients with Asthma and/or Rhinitis

To analyze immediate adverse reactions during subcutaneous specific immunotherapy （SCIT） in mite allergic patients with asthma and/or allergic rhinitis by using standardized house dust mite allergen vaccine. Method Data of immediate adverse reactions was collected and analyzed retrospectively in 462 patients who were prescribed subcutaneous standardized house dust mite specific immunotherapy from November 2004 to May 2012. The association between immediate adverse reactions and SCIT dosage, age, gender, diagnosis, and levels of serum IgE was analyzed. Result Among 462 patients who received SCIT, immediate local and systemic reactions were shown in 452 （97.8%） and 153 （33.1%） cases respectively. Among 15645 injections, immediate local and systemic adverse reactions occurred in 8523 （54.5%） and 397 （2.5%） injections respectively. Frequency of immediate local adverse reaction was increased with increasing of SCIT dosage. The immediate systemic adverse reactions were mainly occurred in the up-dosing phase between 2000 and 80000 SQU. The prevalence of immediate adverse reactions in patients with asthma with or without allergic rhinitis was significantly higher than that in patients with only allergic rhinitis （P 〈 0. 01 ）. The prevalence of immediate local adverse reaction in children （ ≤ 14 years） was significantly higher than that in adults （P 〈 0. 001 ）. The prevalence of immediate adverse reactions in boys was significantly higher than in girls （ P 〈 0.01 ）, whereas significantly higher in female than male in adults （P 〈 0.01 ）. Prevalence of immediate adverse reactions （local and systemic） increased significantly with the increasing of serum Dermatophagoides pteronyssinus IgE level （ P 〈 0. 001 ）. The total IgE level of patients who developed immediate systemic adverse reactions was significantly higher than those who did not （634. 24± 883.91 vs. 416.60 ± 438.59 IU/ml, P = 0. 048 ）. Conclusions Immediate local adverse reactions were common during subcutaneous specific immunotherapy with standardized house dust mite vaccine. However, immediate systemic adverse reactions were rare. Patients with asthma, adult female, juvenile male and high levels of house dust mite specific IgE and total IgE were risk factors for the development of immediate adverse reaction. More attention should be paid for monitoring severe systemic reactions during up-dosing phase.