集群免疫治疗轻中度过敏性哮喘的临床疗效及安全性分析

Efficacy and Safety of Cluster Immunotherapy for Patients with Mild to Moderate Allergic Asthma

目的评价标准化屋尘螨变应原集群免疫治疗轻度至中度过敏性哮喘的疗效及安全性。方法 68例轻度至中度过敏性哮喘患者,随机分为治疗组和对照组各34例,对照组给予抗组胺药物、布地奈德气雾剂和沙丁胺醇气雾剂治疗,治疗组在应用上述药物的同时给予剂量累加阶段为期7周的集群免疫治疗,而后每4周给予1次维持治疗,疗程为1年。分别于治疗前及疗程完成时对患者进行症状评分、药物用量评分并记录患者治疗过程中的不良反应。结果治疗组34例患者均完成了集群免疫治疗和维持治疗,疗程共1年。治疗组疗程完成后症状评分(1.38±0.49)和药物用量总评分(0.89±0.21)较治疗前明显减少(P≤0.01),与对照组症状评分(1.74±0.57)和药物用量总评分(1.39±0.31)相比较,显著减少(P≤0.01)。34例治疗组患者3例,共8次发生全身不良反应,其发生率占患者例数8.82%,占注射次数的0.84%,其中Ⅰ级不良反应5次,Ⅱ级不良反应3次,无Ⅲ级和Ⅳ级不良反应。结论标准化屋尘螨变应原集群免疫治疗轻度至中度过敏性哮喘是一种安全、有效的病因治疗方法。

Objective To evaluate the efficacy and safety of cluster immunotherapy with standardized dermatophagoides pteronyssinus allergen vaccine for the mild to moderate allergic asthma.Methods Sixty patients with mild to mediate allergic asthma to dermatophagoides pteronyssinus were randomly divided into treatment group and control group（each 34 cases）.The patients in control group were treated with antihistamine,budesonide aerosol and salbutamol aerosol;while the patients in treatment group were treated with antihistamine,budesonide aerosol,salbutamol aerosol and the specific immunotherapy in a 7-week cluster schedule during the incremental-dose phase with standardized aluminum-adsorbed dermatophagoides pteronyssinus allergen vaccine.Thereafter,patients in treatment group received maintenance-dose injection at 4-week intervals until the end of one-year of treatment.The clinical efficacy was evaluated by symptom scores and medication scores in the baseline and after one year treatment,and compared with control group.Adverse reactions were recorded.Results All patients in treatment group were completed the study.The cluster immunotherapy significantly reduced the symptom scores and medication scores of patients in treatment group as compared to that of pre-treatment and that of the control group.During one-year immunotherapy,there were 8 systemic adverse reactions（0.84% of the total injections） in 3 patients（8.82%） and no fatal systemic reactions occurred.Conclusion The cluster immunotherapy with standardized dermatophagoides pteronyssinus allergen vaccine for mild to moderate asthma is an effective and safe treatment.