粉尘螨变应原点刺液在皮肤点刺试验中的应用价值

Application value of allergen extracts of Dermatophagoides farina in skin prick test

目的评估北京协和医院(PUMCH)粉尘螨变应原点刺液在使用皮肤点刺试验(SPT)方法诊断粉尘螨过敏症中的准确性和安全性。方法连续纳入2015年8月10日至2017年8月30日在PUMCH变态(过敏)反应科门诊确诊变应性疾病的910例受试者。使用PUMCH粉尘螨变应原点刺液对所有受试者进行SPT,用荧光酶联免疫方法检测血清粉尘螨特异性免疫球蛋白E(sIgE)。通过受试者工作特征曲线(ROC曲线)分析诊断准确性,诊断金标准为sIgE阳性。同时对不同诊断切点的准确性进行分析。该点刺液的安全性通过记录患者不良反应实现。结果本研究无脱落病例。全分析集(FAS)、符合方案集(PPS)、安全集(SS)分别为871例、670例和910例。ROC曲线下面积分别为0.902(FAS)和0.915(PPS)。在PPS中,使用点刺液诊断粉尘螨过敏的最佳诊断切点为平均风团直径3.25 mm,敏感性为85.77%(95%置信区间:82.71%~88.84%),特异性为86.55%(95%置信区间:81.44%~91.66%)。95%特异性的诊断切点为平均风团直径4.25 mm。SS中未有不良反应事件发生。结论PUMCH粉尘螨变应原点刺液在SPT中具有较高的敏感性和特异性,且安全性高,对粉尘螨过敏症的诊断具有较高的应用价值。

Objective To evaluate the effectiveness and safety of allergen extracts of Dermatophagoides farina used for diagnosing Dermatophagoides farina allergy by the skin prick test(SPT)in Peking Union Medical College Hospital.Methods A total of 910 patients with allergic diseases diagnosed in the outpatient department of allergy of Peking Union Medical College Hosptal during August 10,2015 and August 30,2017 were enrolled.The SPT was performed with allergen extracts of Dermatophagoides farina,and serum specific IgE(sIgE)to Dermatophagoides farina was detected by fluorescent enzyme immunoassay.The diagnostic accuracy was analyzed by the receiver operating characteristic(ROC)curve,and the gold standard was positive sIgE.Meanwhile,the accuracy of different diagnostic cut-off points was analyzed,and the safety of the allergen extracts was achieved by recording the adverse reactions of patients.Results There were no shedding cases in this study.The number of subjects in the full analysis set(FAS),per protocol set(PPS)and save set(SS)was 871,670 and 910,respectively.The areas under the ROC curve for FAS and PPS were 0.902 and 0.915,respectively.In PPS,the optimal cut-off point,sensitivity and specificity for the diagnosis of Dermatophagoides farina allergy with allergen extracts were 3.25 mm of average wind mass diameter,85.77%(95%CI:82.71%-88.84%)and 86.55%(95%CI:81.44%-91.66%),respectively.When the specificity was 95%,the diagnostic cut-off point was 4.25 mm of average wind mass diameter.No adverse event occurred in the SS.Conclusion The allergen extracts of Dermatophagoides farina has high sensitivity,specificity and safety in the SPT,and has high application value in the diagnosis of Dermatophagoides farina allergy.