吸入变应原提取液诊断儿童过敏性疾病安全性和一致性评估  

Evaluation of safety and consistency of inhaled allergen extracts in the diagnosis of allergic diseases in children

作　　者：沙莉[1] 关凯 朱雯靓[1] 李月霞[1] 赵京[1] 刘传合[1] 尹佳 Sha Li;Guan Kai;Zhu Wenjing;Li Yuexia;Zhao Jing;Liu Chuanhe;Yin Jia(Department of Allergy,Children′s Hospital Affiliated to Capital Institute of Pediatrics,Beijing 100020,China;Department of Allergy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment of Allergic Disease,National Clinical Research Center for Dermatologic and Immunologic Diseases,Beijing 100730,China)

机构地区：[1]首都儿科研究所附属儿童医院变态反应科,北京100020 [2]中国医学科学院北京协和医院变态(过敏)反应科,过敏性疾病精准诊疗研究北京市重点实验室,国家皮肤与免疫疾病临床医学研究中心,北京100730

出　　处：《中华实用儿科临床杂志》2021年第12期921-925,共5页Chinese Journal of Applied Clinical Pediatrics

基　　金：北京市医院管理局科研培育计划(PX2021051);北京市医院管理局重点医学专业发展计划(ZYLX201829)。

摘　　要：目的探讨国产吸入变应原提取液在儿童过敏性疾病诊断中应用的安全性和与血清检测结果的一致性。方法选取2018年9月至2020年6月在首都儿科研究所附属儿童医院诊断为过敏性疾病的9563例患儿为研究对象,对所有患儿进行皮肤点刺试验(SPT),并对其中415例进行血清特异性IgE(sIgE)检测。记录并分析SPT操作过程中的不良事件,比较SPT与血清sIgE检测结果的一致性。结果9563例患儿中14例发生不良事件,不良事件发生率为0.15%。其中1~5岁组发生率为0.07%(2/2581例),6~11岁组为0.19%(12/6197例),12~17岁组为0。严重程度分级均为Ⅰ级。14例发生不良事件的患儿中,仅1例为与变应原制剂相关的不良反应,其发生率为0.01%(1/9563例)。Kappa指数显示,屋尘螨、粉尘螨、链格孢霉和艾蒿采用SPT和sIgE的检测结果几乎完全一致;树木花粉和豚草具有高度一致性(P<0.01);烟曲霉具有中等一致性(P<0.01)。以血清sIgE检测结果为诊断标准,SPT检测结果的约登指数为0.76~0.89,烟曲霉(0.76)和树木花粉混筛(0.79)最低;阳性似然比除树木花粉混筛(7.12)和粉尘螨(9.10)较低外,其余均>10;阴性似然比除烟曲霉最高(0.19)外,其余均≤0.1。结论国产吸入变应原提取液制剂在过敏性疾病患儿的SPT临床应用中安全性高,且与血清sIgE检测一致性好,有助于儿童过敏性疾病的诊断与评估。Objective To investigate the safety and consistency of domestic inhaled allergen extracts in the diagnosis of allergic diseases in children.Methods Nine thousand five hundred and sixty-three children diagnosed with allergic diseases from September 2018 to June 2020 in Children′s Hospital Affiliated to Capital Institute of Pedia-trics were selected in this study,and all of them were subjected to skin prick test(SPT),and 415 of them were subjected to serum specific IgE(sIgE)test at the same time.The adverse events during SPT were recorded and the consistency of the results between SPT and sIgE test was analyzed.Results There were 14 cases with adverse events in 9563 patients,and the overall incidence was 0.15%.The incidence of adverse events was 0.07%(2/2581 cases)in the 1-5 years old group,0.19%(12/6197 cases)in the 6-11 years old and 0 in the 12-17 years old group.The severity of all these events was gradeⅠ.Out of the 14 cases with adverse events,only 1 case was considered to be related to allergen preparations,with the incidence being 0.01%(1/9563 cases).The Kappa index showed that the results of dermatophagoides pteronyssinus,dermatophagoides farinae,alternaria and artemisia measured by SPT and sIgE were almost the same.There was high consistency between tree pollens and ragweed(P<0.01),and moderate consistency between aspergillus fumigatus(P<0.01).When the results of sIgE were used as the diagnostic criteria,the Youden index for the results of SPT ranged from 0.76 to 0.89,with aspergillus fumigatus(0.76)and tree pollens mixture(0.79)as the lowest.The positive likelihood ratio for most of the inhaled allergens was more than 10 except for tree pollens mixture(7.12)and dermatophagoides farinae(9.10).The negative likelihood ratio for most of the inhaled allergens was less than or equal to 0.1 except for aspergillus fumigatus(0.19).Conclusions The domestic inhaled allergen extracts had high safety in the clinical application of SPT,and their results of SPT had good consistency with those of serum sIgE,which was

关 键 词：过敏性疾病 吸入变应原 皮肤点刺试验 血清特异性IGE 一致性 

分 类 号：R725.9[医药卫生—儿科]