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目的评价标准化屋尘螨变应原制剂治疗儿童哮喘的安全性。方法195例轻、中度过敏性哮喘患儿,男性122例,女性73例,年龄(7.7±s 2.8)岁。采用常规免疫注射疗法,给予皮下注射标准化屋尘螨变应原制剂治疗,疗程1～3年。观察治疗过程中不良反应的表现和处理情况,以及可能与全身不良反应相关的危险因素。结果195例病人共完成6 004次注射。其中全身不良反应人均发生率为26.7%(52/195),每注射发生率为2.55%(153/6 004);局部不良反应人均发生率为89.7%(175/195),每注射发生率为29.20%(1 753/6 004)。剂量递增阶段全身不良反应每注射发生率为0.53%(18/3 374),明显低于维持阶段(5.13%,135/2 630,P<0.01)。所有不良反应均较轻微,经对症处理缓解。Logistic回归分析全身不良反应的相关危险因素提示,维持治疗阶段与全身不良反应发生相关(P<0.05)。结论标准化屋尘螨变应原制剂用于治疗儿童哮喘全身不良反应发生率相对较低,安全性较高,维持阶段是免疫治疗的一个独立危险因素。
Objective To evaluate the safety of standard house dust mite allergen preparations in the treatment of childhood asthma. Methods A total of 195 children with mild to moderate allergic asthma were enrolled in this study. There were 122 males and 73 females, with an average age of 7.7 ± 2.8 years. Using conventional immunotherapy, subcutaneous injection of standardized house dust mite allergen preparation for treatment, treatment of 1 to 3 years. Observe the manifestation and treatment of adverse reactions during treatment, as well as the risk factors that may be related to systemic adverse reactions. Results A total of 6 004 injections were completed in 195 patients. The incidence of systemic adverse reactions per capita was 26.7% (52/195), the incidence of each injection was 2.55% (153/6 004); the average incidence of local adverse reactions was 89.7% (175/195), the incidence of each injection was 29.20% (1 753/6 004). The incidence of systemic adverse reactions during dose escalation was 0.53% (18/3 374) per injection, significantly lower than the maintenance phase (5.13%, 135/2 630, P <0.01). All adverse reactions are minor, alleviated by symptomatic treatment. Logistic regression analysis of systemic risk factors associated with adverse events suggested that the maintenance treatment phase associated with systemic adverse reactions (P <0.05). Conclusion The standard house dust mite allergen preparation for the treatment of children with asthma has a relatively low incidence of systemic adverse reactions and high safety. Maintenance phase is an independent risk factor for immunotherapy.