中华临床免疫和变态反应杂志2017,Vol.11Issue(3):201-208,8.DOI:10.3969∕j.issn.1673-8705.2017.03.003
北京协和医院桦树花粉变应原点刺液对桦树花粉过敏症的诊断价值
Clinical Evaluation on Accuracy and Safety of Birch Pollen Extract Used for Skin Prick Test in the Diagnosis of Birch Pollen Allergy
摘要
Abstract
Objective To evaluate the accuracy and safety of birch pollen extract which was used for skin prick test ( SPT) in the diagnosis of birch pollen allergy. Methods Patients with diagnosis of allergic conjunctivitis, allergic rhinitis, allergic asthma, allergic dermatitis, urticaria and other allergic diseases were collected from the Outpatients of Department of Allergy, Peking Union Medical College Hospital since August 10, 2015 to October 20, 2016. All patients were prescribed birch pollen SPT, and the mean wheal diameter ( MWD) was measured after 15 minutes. Receiver operating characteristic curve ( ROC) analysis was performed based on the results of specific immunoglobulin E ( sIgE) detec-tion. The accuracy of SPT in the diagnosis of birch pollen allergy was evaluated under different diagnostic cutoff values. Adverse events were also recorded to evaluate the safety at the same time. Results A total of 1029 patients were enrolled in this study without drop-out case. There was 1007 patients in full analysis set (FAS), whose average age was (32. 14±13. 69) years-old. The area under the ROC curve of FAS is 0. 909 (95% CI: 0. 891 to 0. 928). Based on the ROC curve of FAS, the optimal and the 95% specificity diagnostic cutoff values of MWD were 4. 25 mm and 5. 75 mm respec-tively. Based on different diagnostic cutoff value (3, 4. 25 and 5. 75 mm), the sensitivities of birch pol-len allergen SPT were 0. 9061 (95% CI 0. 8840-0. 9282), 0. 7973 (95% CI 0. 7669-0. 8277) and 0. 6706 ( 95% CI 0. 6351-0. 7062 ) respectively, whereas the specificity was gradually increased in sequence, which was 0. 6905 (95% CI 0. 6410-0. 7399), 0. 9018 (95% CI 0. 8700-0. 9336) and 0. 9524 (95% CI 0. 9296-0. 9752) respectively. There were 1029 patients in save set (SS), totally 7 adverse events observed among 6 patients (rate: 0. 58%, 6/1029). The manifestation was nasal itching, sneezing, runny nose, nasal obstruction, ocular itching, and large local cutaneous re-action of SPT. There was no severe adverse event. Conclusions SPT with birch pollen extract is an accu-racy and safe tool for the diagnosis of birch pollen allergy. The accuracy of diagnosis could be improved based on integration of medical history and different diagnostic threshold value of SPT.关键词
白桦/花粉/超敏反应/皮肤点刺试验/特异性免疫球蛋白EKey words
Betula platyphylla/pollen/hypersensitivity/skin prick test/specific immunoglobulin E分类
医药卫生引用本文复制引用
顾建青,文利平,关凯,李丽莎,王子熹,徐涛,汤蕊,王瑞琦,周俊雄,尹佳,王良录,支玉香,孙劲旅,李宏..北京协和医院桦树花粉变应原点刺液对桦树花粉过敏症的诊断价值[J].中华临床免疫和变态反应杂志,2017,11(3):201-208,8.基金项目
国家重大新药创制科技重大专项 (2014ZX09102041), 北京市科技计划首都市民健康项目培育类 (Z131100006813047), 中国医学科学院公益性科研院所基本科研业务专项 (2014ZX09102041)