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

作　　者：王瑞琦 周俊雄 尹佳 王良录 支玉香 孙劲旅 李宏 文利平 关凯 顾建青 汤蕊 李丽莎 王子熹 徐涛[2] 

机构地区：[1]中国医学科学院北京协和医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中国医学科学院临床免疫研究中心,北京100730 [2]中国医学科学院基础医学研究所北京协和医学院基础学院统计学教研室,北京100005

出　　处：《中华临床免疫和变态反应杂志》2017年第3期209-215,共7页Chinese Journal of Allergy & Clinical Immunology

基　　金：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

摘　　要：目的评价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有效性和安全性。方法选择2015年8月10日至2016年4月25日,于北京协和医院变态反应科就诊的患有过敏性结膜炎、过敏性鼻炎、过敏性哮喘、过敏性皮炎等过敏性疾病的门诊患者1 029例。所有受试者接受洋白蜡花粉皮肤点刺试验(skin prick test,SPT),以平均风团直径(mean wheal diameter,MWD)判读结果。以洋白蜡花粉s Ig E为标准,做受试者工作特征曲线(receiver operating characteristic curve,ROC曲线)分析。在不同诊断界值下,分析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准确性。记录不良事件,评价安全性。结果本研究共计入组1 029例,无脱落,剔除率25.75%(265/1 029)。安全集(save set,SS)1 029例,全分析集(full analysis set,FAS)1 006例,符合方案集(per protocol set,PPS)764例。年龄最小5.7岁,最大65.3岁。FAS的ROC曲线下面积(area under curve,AUC)为0.852(95%可信区间0.829~0.876),PPS的AUC为0.870(95%可信区间0.845~0.894)。据PPS的ROC曲线估算洋白蜡花粉SPT的最佳诊断界值为MWD 3.75 mm,特异度达95%时的诊断界值为MWD 4.75 mm。分别以MWD 3、3.75、4.75 mm为诊断界值,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敏感度依次降低,分别为0.860 2(95%可信区间0.828 7~0.891 7)、0.720 4(95%可信区间0.679 6~0.761 2)、0.554 8(95%可信区间0.509 7~0.600 0);特异度依次升高,分别为0.689 0(95%可信区间0.636 5~0.741 4)、0.893 0(95%可信区间0.857 9~0.928 0)、0.953 2(95%可信区间0.929 2~0.977 1)。6例受试者出现7次不良事件,不良事件发生率0.583%(6/1 029),主要表现为流鼻涕、打喷嚏、鼻痒、鼻堵、眼痒、点刺局部皮肤反应等。无严重不良事件。结论洋白蜡花粉变应原点刺皮试液用于诊断洋白蜡花粉过敏有较好的诊断价值,安全性好。结合病史和不同的诊断界值,可以提高诊断的准确性。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 1 029 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 operating 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 1 029 patients were enrolled without drop-out case. Elimination rate was 25. 75% （265/1 029）. There were 1 029, 1 006, 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. 860 2 （95% CI： 0. 828 7-0. 891 7）, 0. 7204 （95% CI： 0. 679 6- 0. 761 2）, and 0. 554 8 （95% CI： 0. 509 7-0. 600 0） respectively, whereas the specificity was of increase in sequence, which was 0. 689 0 （

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E 

分 类 号：R593.1[医药卫生—内科学]