链格孢变应原皮试液用于链格孢变态反应性疾病诊断的有效性和安全性  

Accuracy and Safety of Alternaria alternata Extract Used for Intradermal Test in the Diagnosis of Alternaria alternata Allergy

作　　者：王瑞琦[1] 王良录[1] 李宏[1] 孙劲旅[1] 文利平[1] 顾建青[1] 关凯[1] 尹佳[1] 

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反应科,北京100730

出　　处：《中华临床免疫和变态反应杂志》2016年第1期33-39,共7页Chinese Journal of Allergy & Clinical Immunology

摘　　要：目的评价应用链格孢（Alternaria alternata）变应原注射原液1∶100稀释液进行皮内试验诊断链格孢变态反应的临床应用价值及安全性。方法回顾性分析2009年4月至2010年8月北京协和医院1043例门诊患者皮内试验结果,将链格孢变应原注射原液1∶100稀释液皮内试验结果分别与变态反应专科医生临床综合诊断及Thermo Fisher公司Immuno CAP系统血清特异性IgE（specific IgE,s IgE）检测结果进行对比,分别计算皮内试验诊断链格孢变态反应的特异度和灵敏度,以及与变态反应专科医生临床综合诊断和血清s IgE检测结果的一致性。同时记录链格孢变应原注射原液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生临床综合诊断作为金标准,以皮内试验结果≥＂＋＂作为诊断界值,链格孢变应原注射原液1∶100稀释液皮内试验灵敏度为0.8864,特异度为0.894 5,阳性预测值为0.500 0,阴性预测值为0.985 1,准确度为0.893 6;ROC曲线下面积为0.915,95%可信区间为0.874-0.956。以血清s IgE检测结果作为评价标准,以皮内试验结果≥＂＋＂作为诊断界值,链格孢变应原注射原液1∶100稀释液皮内试验的灵敏度为0.927 7,特异度为0.5313,阳性预测值为0.719 6,阴性预测值为0.850 0,准确度为0.755 1。链格孢血清sIgE阳性组中,血清s IgE水平与链格孢变应原注射原液1∶100稀释液的阳性反应程度的等级相关系数为0.628 00（P〈0.0001）。1043例受试者中,与链格孢变应原皮内试验有关的局部不良反应发生率为0.48%（5/1043）,未发现与链格孢变应原有关的全身不良反应。结论使用链格孢变应原注射原液1∶100稀释液进行皮内试验,可以安全、有效地诊断链格孢引起的变态反应性疾病。Objective To evaluate the accuracy and safety of Alternaria alternata extract which was used for intradermal test in the diagnosis of Alternaria alternata allergy. Methods 1 043 patients who had been prescribed both intradermal skin tests（ IDT） and serum specific IgE（ s IgE）. Detections were collected and reviewed from Department of Allergy,PUMC hospital since Apr. 10 thto Aug. 10th2009. The accuracy ofIDT with Alternaria alternata extract was evaluated byusing clinical diagnoses of allergists and s IgE detection results as golden standards and relative golder standard respectively. Adverse reactions were also recorded.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 was 0. 886 4,0. 894 5,0. 500 0,0. 985 1,0. 893 6,0. 915（ 95% confidence interval 0. 874,0. 956） respectively by using clinical diagnoses of allergists as gold standard. Whereas s IgE results ≥ 0. 35 KUA / L was defined as the cutoff threshold for diagnosing,sensitivity,specificity,positive predictive value,negative predictive value and accuracy was 0. 927 7,0. 531 3,0. 719 6,0. 850 0 and 0. 755 1 respectively by using s IgE results as standard. Coefficient of rank correlation between s IgE and IDT results was 0. 628 00（ P 〈0. 000 1）in serum s IgE positive group. Local adverse reactions were recorded in 0. 48%（ 5 /1043） patients,none of them was attacked by type Ⅰ systemic adverse reaction. Conclusion IDT with Alternaria alternata extract is anaccuracy and safe tool for the diagnosis of Alternaria alternata allergy.

关 键 词：链格孢 皮内试验 有效性 安全性 

分 类 号：R593.1[医药卫生—内科学]