Diagnostic accuracy and safety of Dermatophagoides pteronyssinus extracts used for skin prick test  

作　　者：Rui Tang Xiaohong Lyu Yuxi Liu Ruiqi Wang Lianglu Wang Hong Li Jinlyu Sun Yuxiang Zhi Jianqing Gu Kai Guan Liping Wen Zixi Wang Lisha Li Le Cui Yingyang Xu Junxiong Zhou Tao Xu Jia Yin 

机构地区：[1]Department of Allergy,Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment of Allergic Diseases,National Clinical Research Center for Dermatologic and Immunologic Diseases,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100730,China [2]Eight-Year Program of Clinical Medicine,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100730,China [3]Department of Statistics,Institute of Basic Medical Sciences,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100730,China

出　　处：《Chinese Medical Journal》2022年第21期2563-2569,共7页中华医学杂志（英文版）

基　　金：National Science and Technology Major Projects(No. 2014ZX09102041-008);Beijing Science and technology plan(No. Z131100006813047);CAMS Innovation Fund for Medical Sciences(No. 2016-I2M-1-003)

摘　　要：Background:Dermatophagoides pteronyssinus is a common allergen causing allergic diseases in China.The aim of this study was to evaluate the efficacy and safety of D.pteronyssinus extracts produced by Peking Union Medical College Hospital(PUMCH)for the skin prick test(SPT)in the diagnosis of D.pteronyssinus allergy.Methods:A total of 910 subjects with allergic diseases were prescribed D.pteronyssinus SPT and specific sIgE(sIgE)test among the Outpatients of Department of Allergy,PUMCH from August 10,2015 to August 30,2017.Receiver operating characteristic curve(ROC)analysis was performed according to the results of D.pteronyssinus-sIgE detection.The accuracy of D.pteronyssinus extracts used for SPT in the diagnosis of D.pteronyssinus allergy was evaluated under different cutoff values.Adverse events after SPT were recorded to evaluate safety.Results:There were 796 and 618 subjects in the full analysis set(FAS)and the per protocol set(PPS),respectively.The areas under the curve of FAS and PPS were 0.871 and 0.873,respectively.According to the ROC of PPS,the optimal and 95%specificity diagnostic cutoff values of D.pteronyssinus SPT mean wheal diameter were 3.25 and 3.75 mm,respectively.No adverse events occurred.Conclusion:The extracts of D.pteronyssinus for SPT were simple,highly accurate,and safe and should be considered for recommendation in the clinical diagnosis of D.pteronyssinus allergy.

关 键 词：Dermatophagoides pteronyssinus Allergen extract allergy Skin prick test Immunoglobulin E ALLERGY 

分 类 号：R259[医药卫生—中西医结合]