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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 effectiveness and safety of foreign white wax pollen allergens puncture skin test solution for diagnosis of albino pollen allergy. Methods From August 10, 2015 to April 25, 2016, outpatients with allergic diseases such as allergic conjunctivitis, allergic rhinitis, atopic dermatitis and allergic dermatitis were treated at Department of Allergy, Peking Union Medical College Hospital 1 029 cases. All subjects underwent skin prick test (SPT) with the mean wheal diameter (MWD) interpretation of the results. The foreign body wax pollen s Ig E was used as the receiver operating characteristic curve (ROC curve) analysis. At different diagnostic cutoffs, the accuracy of foreign white wax pollen allergens puncture skin test solution for the diagnosis of foreign wax pollen allergy was analyzed. Record adverse events and evaluate safety. Results A total of 1 029 cases were included in this study, with no shedding and a rate of 25.75% (265/1 029). There were 1 029 cases of save set (SS), 1 006 cases of full analysis set (FAS) and 764 cases of per protocol set (PPS). The youngest 5.7 years old, maximum 65.3 years old. The area under the curve (AUC) for FAS was 0.852 (95% confidence interval 0.829-0.876) and the AUC for PPS was 0.870 (95% confidence interval 0.845-0.894). According to the RPS curve of PPS, the best diagnostic value of MWD was 3.75 mm for MWT and 4.75 mm for MWD when the specificity was 95%. Respectively with MWD of 3,3.75 and 4.75 mm as cut-off value, the sensitivities of foreign wax pollens allergens prick test to the diagnosis of pollination allergy to pollination decreased 0.860 2 (95% confidence interval 0.828 7 ~ 0.891 7), 0.7204 (95% confidence interval 0.679 6 ~ 0.761 2), and 0.554 8 (95% confidence interval 0.509 7 ~ 0.600 0). The specificity increased successively and were 0.689 0 (95% confidence interval 0.636 5 ~ 0.741 4), 0.893 0 (95% confidence interval 0.857 9 ~ 0.928 0) and 0.953 2 (95% confidence interval 0.929 2 ~ 0.977 1). There were 7 adverse events in 6 subjects, and the incidence of adverse events was 0.583% (6/1 029). The main symptoms were runny nose, sneezing, nasal itching, nasal congestion, itchy eyes and local prick skin reaction. No serious adverse events. Conclusion Western white wax pollen allergens prick test solution for the diagnosis of albacore pollen allergy has a better diagnostic value, good safety. Combined with medical history and different diagnostic boundaries, can improve the diagnostic accuracy.