尘螨皮下免疫治疗应用于儿童过敏性哮喘疗效与安全性的前瞻性随机对照研究

Efficacy and safety of dust mite subcutaneous immunotherapy in children with allergic asthma： a prospective randomized controlled study

摘要:

目的 探讨尘螨皮下免疫治疗（subcutaneous immunotherapy, SCIT）应用于儿童过敏性哮喘的疗效和安全性。方法 采用前瞻性随机对照研究，将98例尘螨过敏哮喘患儿按随机数字表法分为对照组和SCIT组，每组49例。对照组吸入激素治疗；SCIT组除吸入激素治疗外，加用3年标准化SCIT。比较两组治疗前、治疗后6个月、治疗后1年、治疗后2年、治疗后3年外周血嗜酸性粒细胞百分比、视觉模拟评分、总用药评分、哮喘控制测试评分/儿童哮喘控制测试评分、呼出气一氧化氮和肺功能的差异。记录注射后不良反应，评估SCIT的安全性。结果 与治疗前相比，SCIT组3年后外周血嗜酸性粒细胞百分比、视觉模拟评分、总用药评分和呼出气一氧化氮显著下降，肺功能显著改善，哮喘控制水平更佳（P<0.05）；与对照组相比，SCIT组3年后各评估指标改善较对照组更明显（P<0.05）。共完成2 744次注射，发生局部不良反应157次（5.72%），全身不良反应4次（0.15%），无严重全身不良反应发生。结论 SCIT是一种有效、安全的儿童过敏性哮喘治疗方法。

Abstract:

Objective To investigate the efficacy and safety of subcutaneous immunotherapy (SCIT) using dust mites in children with allergic asthma.Methods In a prospective randomized controlled study, 98 children with dust mite-induced allergic asthma were randomly divided into a control group (n=49) and an SCIT group (n=49). The control group received inhaled corticosteroid treatment, while the SCIT group additionally received a standardized three-year SCIT regimen. The two groups were compared based on peripheral blood eosinophil percentage, visual analogue score (VAS), total medication score, Asthma Control Test/Childhood Asthma Control Test scores, fractional exhaled nitric oxide (FeNO), and lung function before treatment, and at 6 months, 1 year, 2 years, and 3 years after treatment. Adverse reactions were recorded post-injection to evaluate the safety of SCIT.Results Compared with pre-treatment levels, the SCIT group showed a significant reduction in the percentage of peripheral blood eosinophils, VAS, total medication score, and FeNO, while lung function significantly improved, and asthma control levels were better 3 years after treatment (P<0.05). Compared with the control group, the SCIT group showed more significant improvement in all evaluated indicators 3 years after treatment (P<0.05). A total of 2 744 injections were administered, resulting in 157 cases (5.72%) of local adverse reactions and 4 cases (0.15%) of systemic adverse reactions, with no severe systemic adverse events.Conclusions SCIT is an effective and safe treatment for allergic asthma in children.