标准化螨变应原特异性免疫治疗维持期换瓶不减量方案在儿童气道过敏性疾病人群中的疗效和安全性研究  

Efficacy and safety study of standardized mite allergen specific immunotherapy with no reduction during maintenance in children with respiratory allergic disease

作　　者：梁英 钟奕 李云艳 祝铃萍 杨丽芬[1] 欧淑娴 陈壮桂[1] 张萍萍[1] Liang Ying;Zhong Yi;Li Yunyan;Zhu Lingping;Yang Lifen;Ou Shuxian;Chen Zhuanggui;Zhang Pingping(Department of Pediatrics,The Third Hospital of Sun Yat-sen University,Guangzhou 510630,China)

机构地区：[1]中山大学附属第三医院儿科,广州510630

出　　处：《中华预防医学杂志》2024年第6期768-777,共10页Chinese Journal of Preventive Medicine

基　　金：中山大学附属第三医院变应性(过敏)疾病全年龄段临床队列构建与研究(2023WW602)。

摘　　要：目的探讨儿童气道过敏性疾病标准化螨变应原免疫治疗的优化方案,观察其临床疗效、安全性和依从性。方法采用回顾性真实世界研究,选取2019年6月至2020年9月在中山大学附属第三医院儿科接受双螨变应原制剂皮下免疫治疗(Subcutaneous immunotherapy,SCIT)的变应性鼻炎(allergic rhinitis,AR)和(或)过敏性哮喘(支气管哮喘,bronchial asthma,BA)的5~16岁共156例患儿的临床资料,包括性别、年龄、不同时间节点(治疗前,启动脱敏治疗后4~6个月、1年、2年时)总VAS(视觉模拟量表)评分和CSMS(综合症状和用药评分)评分、外周血中嗜酸性粒细胞计数(EOS)、血清总IgE(tIgE)、特异性IgE(sIgE)、tIgG4、局部及全身不良反应发生率。所有患者在初始治疗阶段(剂量递增阶段)的方案一致,均按说明书进行。其中,81例(观察组)在剂量维持阶段持续继续每4~6周皮下注射1次,每次注射3号瓶1 ml;75例(对照组)维持阶段按照旧的传统方案进行(即换新瓶减半量3号瓶0.5 ml,1~2周后0.75 ml,再间隔1~2周1 ml)。比较两组患者治疗的临床疗效、安全性及依从性。结果156例患儿中观察组共纳入81例,其中AR患儿有58例,BA患儿15例,AR合并BA患儿有8例;常规对照组共纳入75例,AR患儿有52例,BA患儿16例,AR合并BA患儿有7例。在安全性方面,两组患者的局部和全身不良反应发生率差异均无统计学意义(局部不良反应对照组χ^(2)=1.541,观察组χ^(2)=0.718;全身不良反应对照组χ^(2)=0.483,观察组χ^(2)=0.179,P值均>0.05),且均无Ⅱ级以上全身不良反应发生。对照组随访2年脱漏15例,脱落率20.0%;观察组随访2年脱漏7例,脱落率8.6%,两组患者脱落率差异有统计学意义(χ^(2)=4.147,P<0.05)。血清学指标及疗效对比(在治疗后3个不同的时间节点即治疗4~6个月、1年及2年时与基线进行比较),观察组和常规对照组治疗4~6个月、1年及2年时CSMS评分较基线状态明显下降(常规组t值�Objective To explore the optimal regimen of standardized mite allergen immunotherapy for airway allergic diseases in children,and to observe the clinical efficacy,safety and compliance.Method Use a retrospective real-world study,clinical data from 156 children aged 5-16 years who received subcutaneous immunotherapy(SCIT)with double mite allergen preparation in the pediatrics department of the Third Affiliated Hospital of Sun Yat sen University from June 2019 to September 2020 were selected for allergic rhinitis(AR)and/or allergic asthma(bronchial asthma,BA),including gender,age,total VAS(visual analogue scale)score and CSMS(combined symptom and medication scores)score at different time points(before treatment,4-6 months,1 year,and 2 years after initiation of desensitization),peripheral blood eosinophil counts(EOS),serum total IgE(tIgE),specific IgE(tIgE),and serum IgE(tIgE),specific IgE(sIgE),tIgG4,and incidence of local and systemic adverse reactions.All patients had a consistent regimen during the initial treatment phase(dose-escalation phase),which was performed as directed.Among them,81 cases(observation group)continued to continue subcutaneous injection of 1 ml of vial No.3 every 4-6 weeks during the dose maintenance phase,while 75 cases(control group)followed the old traditional regimen during the maintenance phase(i.e.,change to a new vial to halve the amount of vial No.3 by 0.5 ml,and then 0.75 ml after 1-2 weeks,and 1 ml in a further interval of 1-2 weeks).The clinical efficacy,safety and adherence to the treatment were compared between the two groups.Results A total of 81 cases of 156 children were included in the observation group,of which 58 children with AR,15 children with BA,and 8 children with AR combined with BA;75 cases were included in the conventional control group,of which 52 children with AR,16 children with BA,and 7 children with AR combined with BA.In terms of safety,the difference in the incidence of local and systemic adverse reactions between the two groups was not statistically signifi

关 键 词：变应性鼻炎 过敏性哮喘 免疫治疗 依从性 

分 类 号：R725.9[医药卫生—儿科]