中华临床免疫和变态反应杂志2017，Vol.11Issue(3)：209-215,7.DOI:10.3969∕j.issn.1673-8705.2017.03.004
洋白蜡花粉变应原点刺皮试液用于诊断洋白蜡花粉过敏的临床评价
Clinical Evaluation on Accuracy and Safety of Fraxinus pennsylvanica Pollen Extract Used for Skin Prick Test in Diagnosis of Fraxinus pennsylvanica Pollen Allergy
摘要
Abstract
Objective To evaluate the accuracy and safety of Fraxinus pennsylvanica pollen extract which was used for skin prick test in diagnosis of Fraxinus pennsylvanica pollen allergy. Methods 1029 patients with diagnosis of allergic conjunctivitis, allergic rhinitis, allergic asthma, and allergic dermatitis were collected from the outpatients of Department of Allergy, Peking Union Medical College Hospital since 10th August 2015 to 25th April 2016. All patients were prescribed Fraxinus pennsylvanica pollen skin prick test ( SPT) , and the mean wheal diameter ( MWD) was measured and recorded. Receiver op-erating characteristic currve ( ROC ) analysis was performed based on the results of Fraxinus pennsylvanica pollen specific IgE ( sIgE) detection. The accuracy of Fraxinus pennsylvanica pollen extract used for SPT in diagnosis of Fraxinus pennsylvanica pollen allergy was evaluated under different diagnostic cutoff values. Adverse events were also recorded to evaluate the safety. Results 1029 patients were en-rolled without drop-out case. Elimination rate was 25. 75%(265/1029). There were 1029, 1006, and 764 patients in save set (SS), full analysis set (FAS) and per protocol set (PPS) respectively. The age range was 5. 7 to 65. 3 year-old. The area under curve (AUC) of FAS and PPS was 0. 852 (95% CI: 0. 829-0. 876) and 0. 870 (95%CI:0. 845-0. 894) respectively in ROC analysis. Based on ROC of PPS, the best and 95% specificity diagnostic cutoff value of Fraxinus pennsylvanica pollen SPT MWD was 3. 75, and 4. 75 mm respectively. Based on different diagnostic cutoff value (3, 3. 75 and 4. 75 mm), the sensitivity of Fraxinus pennsylvanica pollen extract used for SPT in diagnosis of Fraxinus pennsylvanica pollen allergy was of decrease in sequence, which was 0. 8602 (95% CI:0. 8287-0. 8917), 0. 7204 (95% CI:0. 6796-0. 7612), and 0. 5548 (95% CI:0. 5097-0. 6000) respectively, whereas the specificity was of increase in sequence, which was 0. 6890 (95%CI:0. 6365-0. 7414), 0. 8930 (95%CI:0. 8579-0. 9280) and 0. 9532 (95%CI:0. 9292-0. 9771) respectively. Totally 7 adverse events were observed among 6 patients ( rate:0. 583%, 6/1029) . The manifestation of adverse events was running nose, sneezing, nasal itching, nasal obstruction, ocular itching, and local cutaneous reactions of SPT. There was no severe adverse event. Conclusions SPT with Fraxinus pennsylvanica pollen extract is an accuracy and safe tool for the diagnosis of Fraxinus pennsylvanica pollen allergy. The accuracy of diagnosis could be improved based on integration of medical history and different diagnostic cutoff value.关键词
过敏反应/洋白蜡花粉/皮肤点刺试验/特异性免疫球蛋白EKey words
anaphylaxia/Fraxinus pennsylvanica pollen/skin prick test/specific immunoglobulin E分类
医药卫生引用本文复制引用
王瑞琦,顾建青,汤蕊,李丽莎,王子熹,徐涛,周俊雄,尹佳,王良录,支玉香,孙劲旅,李宏,文利平,关凯..洋白蜡花粉变应原点刺皮试液用于诊断洋白蜡花粉过敏的临床评价[J].中华临床免疫和变态反应杂志,2017,11(3):209-215,7.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）
