应用圆柏花粉变应原皮试液诊断圆柏花粉过敏性疾病的有效性和安全性  

Accuracy and Safety of Sabina chinensis Pollen Extract Used for Skin Intradermal test in Diagnosis of Sabina chinensis Pollen Allergy

作　　者：李宏 程璇 尹佳 王瑞琦 王良录 孙劲旅 文利平 顾建青 关凯 岳凤敏 徐涛 LI Hong;CHENG Xuan;YIN Jia;WANG Ri-qi;WANG Liang-lu;SUN Jin-lü;WEN Li-ping;GU Jian-qing;GUAN Kai;YUE Feng-min;XU Tao(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,Clinical Immunology Center, Chinese Academy of Medical Sciences,Beijing 1007)

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4期351-357,共7页Chinese Journal of Allergy & Clinical Immunology

基　　金：十一五国家支撑计划(2008BAI59B04);国家重大新药创制科技重大专项(2014ZX09102041);北京市科技计划(Z131100006813047)

摘　　要：目的应用圆柏花粉变应原注射原液1∶100稀释液进行皮内试验,评价其诊断圆柏花粉过敏的临床应用价值和安全性。方法回顾性分析2009年2月至7月北京协和医院1 043例门诊患者皮内试验结果,将用圆柏花粉变应原注射原液1∶100稀释液进行皮内试验的结果分别与变态反应专科医师临床综合诊断及Thermo Fisher公司Immuno CAP系统血清特异性IgE(specific IgE,sIgE)检测结果进行对比,分别计算用皮内试验诊断圆柏花粉过敏的特异度和灵敏度,以及其与变态反应专科医师临床综合诊断和血清sIgE检测结果的一致性。同时记录圆柏花粉变应原注射原液1∶100稀释液用于皮内试验的不良反应。结果以变态反应专科医师临床综合诊断为金标准,以皮内试验结果≥(+)为诊断界值时,圆柏花粉变应原注射原液1∶100稀释液皮内试验的灵敏度为0.957 4,特异度为0.714 5,阳性预测值为0.401 8,阴性预测值为0.988 2,准确度为0.755 0;ROC曲线下面积为0.891,95%可信区间为(0.864,0.918)。以Uni-CAP sIgE诊断为金标准,以皮内试验结果≥(+)为诊断界值时,皮内试验的灵敏度为0.954 9,特异度为0.150 5,阳性预测值为0.616 5,阴性预测值为0.700 0,准确度为0.623 9。与圆柏花粉变应原注射原液1∶100稀释液皮内试验有关的全身不良反应1例,属轻度,占0.095 9%。结论使用圆柏花粉变应原注射原液1∶100稀释液进行皮内试验,可以安全有效地诊断圆柏花粉变应原引起的过敏性疾病。Objective To evaluate the accuracy and safety of Sabina chinensis pollen extract which was used for intradermal test(IDT)in the diagnosis of Sabina chinensis pollen allergy.Methods 1 043 Patients were collected and reviewed from Department of Allergy,Peking Union Medical College Hospital since 2009 Feb to 2009 Jul.All patients were prescribed IDT with Sabina chinensis pollen extract and sIgE detection of Juniperus sabinoides(t6,UniCAP,Phadia).The IDT results were recorded and clinical integrated diagnosis was made by allergists.The accuracy of IDT with Sabina chinensis pollen extract was evaluated by using clinical integrated diagnoses of allergists and sIgE detection results as golden standards respectively.Adverse reactions were also recorded for the evaluation of safety.Results IDT results≥(+)was defined as the cutoff threshold for diagnosing.Sensitivity,specificity,positive predictive value,negative predictive value,accuracy,and area under ROC curve,were 0.957 4,0.714 5,0.401 8,0.988 2,0.755 0 and 0.891,95%confidence interval(0.864,0.918)respectively by using clinical integrated diagnoses of allergists as gold standard.Whereas sIgE results≥0.35 kUA/L was defined as the cutoff threshold for diagnosing,sensitivity,specificity,positive predictive value,negative predictive value,and accuracy were 0.954 9,0.150 5,0.616 5,0.700 0,and 0.623 9 respectively.Only 1(0.095 9%)case was attacked by typeⅠmild systemic adverse reaction during IDT with Sabina chinensis pollen extract.Conclusion IDT with Sabina chinensis pollen extract is an accuracy and safe tool for the diagnosis of Sabina chinensis pollen allergy.

关 键 词：圆柏花粉 皮内试验 有效性 安全性 

分 类 号：R593.1[医药卫生—内科学]