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目的通过皮肤点刺试验(skin prick test,SPT)评价北京协和医院桦树花粉变应原点刺液(简称协和桦树花粉变应原)诊断桦树花粉过敏症的有效性和安全性。方法选取2015年8月10日至2016年10月20日在北京协和医院变态(过敏)反应科就诊,患有过敏性鼻炎、过敏性哮喘、过敏性结膜炎、过敏性皮炎、荨麻疹等过敏性疾病的门诊患者。对所有受试者进行协和桦树花粉变应原SPT,15 min后测定平均风团直径(mean wheal diameter,MWD)。以桦树花粉血清特异性免疫球蛋白E(specific immunoglobulin E,sIgE)作为确认桦树花粉过敏症的诊断标准,进行受试者工作特征曲线(receiver operating characteristic curve,ROC曲线)分析,判断不同诊断界值下,协和桦树花粉变应原临床诊断桦树花粉过敏症的准确性;同时记录不良事件,评价协和桦树花粉变应原的安全性。结果本研究共计入组1 029例,无脱落病例。全分析集(full analysis set,FAS)1 007例,平均年龄(32.14±13.69)岁。FAS的ROC曲线下面积(area under curve,AUC)为0.909(95%可信区间0.891~0.928)。据FAS的ROC估算SPT诊断桦树花粉过敏的MWD最佳诊断界值为4.25 mm,特异度达95%时的MWD诊断界值为5.75 mm。分别以MWD3.00、4.25和5.75 mm为诊断界值,协和桦树花粉变应原SPT诊断桦树花粉过敏的敏感度依次降低,分别为0.906 1(95%可信区间0.884 0~0.928 2)、0.797 3(95%可信区间0.766 9~0.827 7)、0.670 6(95%可信区间0.635 1~0.706 2);而特异度依次升高,分别为0.690 5(95%可信区间0.641 0~0.739 9)、0.901 8(95%可信区间0.870 0~0.933 6)、0.952 4(95%可信区间0.929 6~0.975 2)。安全集(save set,SS)1 029例,6例出现7次不良事件,不良事件发生率0.58%(6/1 029),主要表现为SPT后鼻痒、喷嚏、流涕、鼻塞、眼痒以及点刺部位局部皮肤出现较大风团反应。所有受试者均未出现严重不良事件。结论协和桦树花粉变应原对于桦树花粉过敏症具有良好的诊断价值,安全性好。结合病史和不同的SPT诊断界值,可以提高诊断的准确度。
Objective To evaluate the efficacy and safety of skin prick test (SPT) in the diagnosis of birch pollen allergy in Beijing Union Medical College Hospital. Methods From August 10, 2015 to October 20, 2016, at the Peking Union Medical College Hospital metamorphic (allergy) reaction department for treatment, with allergic rhinitis, allergic asthma, allergic conjunctivitis, atopic dermatitis, urticaria and other allergies Outpatients with sexually transmitted diseases. Concord birch pollen allergen SPT was performed on all subjects and mean wheal diameter (MWD) was measured after 15 min. The birch pollen serum-specific immunoglobulin E (sIgE) was used as the diagnostic criteria to confirm the birch pollen allergy. The receiver operating characteristic curve (ROC curve) analysis was performed to determine the different diagnosis Under the cutoff value, Concord birch pollen allergen clinically diagnosed the accuracy of birch pollen allergy, meanwhile recorded the adverse events and evaluated the safety of the concordance birch pollen allergen. Results A total of 1 029 cases were included in the study, with no cases of shedding. A total analysis set (FAS) 1 007 cases, the average age (32.14 ± 13.69) years old. The area under the curve (AUC) for FAS was 0.909 (95% confidence interval 0.891-0.928). According to the FAS ROC, the best diagnostic value of MWD for diagnosing birch pollen allergy by SPT was 4.25 mm, and the diagnostic threshold of MWD was 5.75 mm when the specificity was 95%. The sensitivity of the concanavaline birch pollen allergen SPT to the diagnosis of birch pollen allergy decreased with the MWD of 3.00, 4.25 and 5.75 mm, respectively, which were 0.906 1 (95% confidence interval 0.884 0-0.928 2) , 0.797 3 (95% confidence interval 0.766 9 ~ 0.827 7) and 0.670 6 (95% confidence interval 0.635 1 ~ 0.706 2), while the specificity increased successively, reaching 0.690 5 (95% confidence interval 0.641 0 ~ 0.739 9), 0.901 8 (95% confidence interval 0.870 0 ~ 0.933 6) and 0.952 4 (95% confidence interval 0.929 6 ~ 0.975 2). There were 1029 cases of save set (SS), 7 cases of adverse events in 6 cases and 0.58% (6/1 029) of adverse events. The main symptoms were nasal itching, sneezing, runny nose, stuffy nose, As well as the local skin punctures larger wind group response. None of the subjects experienced a serious adverse event. Conclusion Concord birch pollen allergen has good diagnostic value and good safety for birch pollen allergy. Combined with medical history and different diagnostic threshold SPT, can improve the diagnostic accuracy.