几种户尘螨过敏原点刺液的临床评价

Evaluation of several Dermatophagoides pteronyssinus allergen extracts for skin prick test

目的评价户尘螨过敏原点刺皮试液用于诊断和筛查尘螨过敏的意义。方法对219例患者进行户尘螨过敏原点刺试验和户尘螨sIgE检测。点刺试验所用点刺液为本课题组研制的点刺液(A组)、ALK公司的户尘螨点刺液(B组)和ALK公司的混合螨(户尘螨和粉尘螨)点刺液(C组),以sIgE为诊断标准。统计分析采用SPSS11.0软件,对3组户尘螨过敏原点刺试验进行ROC曲线评价。结果A、B和C组风团平均直径中位数分别为0.43cm、0.35cm和0.28cm。所有入选者点刺试验后1h,A组有5例点刺试验后出现局部反应,2h左右自行缓解;有2例出现迟发反应,需1d左右才消退;B组和C组各有3例点刺试验后出现局部反应,B组和C组各有2例有迟发反应。所有患者均无局部皮疹、全身性不良反应。3组户尘螨过敏原点刺试验的ROC曲线下面积分别为0.765、0.801和0.782,说明户尘螨过敏原点刺皮试液对诊断户尘螨过敏具有较高准确性。以户尘螨sIgE为标准的点刺试验灵敏度和特异度:A、B和C组点刺液的灵敏度分别为92.4%、87.0%和81.5%,特异度分别为60.6%、73.2%和74.8%。结论户尘螨点刺液可作为尘螨过敏的诊断试剂,有良好的灵敏度和特异度,具有临床筛查和诊断意义。

Objective To evaluate the significance of several different house dust mite allergen extracts with skin prick test （SPT） in the diagnosis of allergic patients to Dermatophagoides pteronyssinus. Methods Two hundred and nineteen patients underwent SPT and serum specific IgE assay to house dust mite. Three kinds of house dust mite allergen extracts were used for SPT, respectively. Extract A group was prepared by our laboratory, extract B group was extract of Dermatophagoides pteronyssinus manufactured by ALK Corporation, and extract C group was the mixed extract of Dermatophagoides pteronyssinus and Dermatophagoides farinae manufactured by ALK Corporation. Human serum specific IgE was regarded as reference of allergy to Dermatophagoides pteronyssinus. The ROC curves of these three groups were made and evaluated. Results （ 1 ） The medium of wheal diameter of SPT with A group, B group and C group was 0. 45 cm,0. 35 cm and 0. 30 cm, respectively. （2） There was no local urticaria and systemic urticaria, no running nose and sneezing, no cough, asthma and allergic shock observed. Local reactions after SPT were observed in 5 （ group A）, 3 （ group B）, 3 patients （ group C）. The delayed reactions were observed in 2 patients in each group. （3） The area under ROC curve of SPT with extract A group, B group and C group was 0. 765,0. 801 and 0. 782. The coefficient of linear correlation was 0. 771,0. 786 and 0. 784, respectively （P 〈0. 01 ）, the coefficient was statistically significant. （4）Based on serum specific IgE, the sensitivity of SPT with extract A group, B group and C group was 92. 4%, 87.0% and 81.5%, and the specificity was 60. 6%, 73.2% and 74. 8%, respectively. Conclusion The house dust mite allergen extract prepared in our laboratory is a proper extract for diagnoses of house dust mite allergy. The sensitivity and specificity of the extract was qualified for potentially clinical diagnosis.