葎草花粉变应原皮试液诊断葎草花粉变态反应的临床评价

Clinical Evaluation on Accuracy And Safety of Humulus Pollen Extract Used for Intradermal Test in the Diagnosing of Humulus Pollen Allergy

目的评价应用葎草花粉变应原注射液原液1:1000稀释液进行皮内试验诊断葎草花粉变态反应的临床应用价值及安全性。方法回顾性观察2009年2月10日至7月10日北京协和医院1043例门诊患者皮内试验结果,将葎草花粉变应原注射原液1:1000稀释液皮内试验结果分别与变态反应专科医生临床综合特异性诊断及血清特异性IgE(specific IgE,sIgE)诊断结果进行对比,分别计算皮内试验诊断葎草花粉变态反应的特异度和敏感度及与变态反应专科医生临床综合特异性诊断和血清sIgE诊断结果的一致性。同时记录葎草花粉变应原注射原液1:1000稀释液用于皮内试验的不良反应。结果将皮内试验结果≥"+"作为诊断界值,以变态反应专科医生临床综合特异性诊断结果作为金标准,葎草花粉变应原注射原液1:1000稀释液皮内试验灵敏度为88.08%,特异度为86.03%,阳性预测值为72.24%,阴性预测值为94.59%,准确度为86.63%;ROC曲线下面积为0.92,95%可信区间为(0.896,0.943)。以Pharmacia Uni-CAP系统血清sIgE诊断结果作为相对金标准,将sIgE≥1级作为诊断界值,葎草花粉变应原注射原液1:1000稀释液皮内试验的灵敏度为87.60%,特异度为56.86%,阳性预测值为83.27%,阴性预测值为65.17%,准确度为78.69%。葎草花粉血清sIgE阳性组中,血清sIgE水平与葎草花粉变应原注射原液1:1000稀释液的阳性反应程度的等级相关系数为0.69143。1043例受试者中,与葎草花粉变应原有关的局部不良反应为2.59%(27/1043);Ⅰ类全身不良反应仅1例,该患者同时合并蒿属花粉、圆柏花粉过敏。结论使用葎草花粉变应原注射原液1:1000稀释液进行皮内试验,可以有效、安全地诊断葎草花粉引起的变态反应性疾病。

Objective To evaluate the accuracy and safety of 1： 20 000 w/v Humulus pollen extract which was used for intradermal test in the diagnosing of Humulua pollen allergy. Methods 1043 cases who had been prescribed both intradermal skin tests （IDT） and serum specific IgE （sIgE） tests were collected and reviewed from Department of Allergy, PUMC hospital since Feb. 10th to Jul. 10th 2009. The accuracy of IDT with Humulus pollen extract was evaluated by using clinical diagnoses of allergists and sIgE detection results as gold standards 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 88. 08%, 86. 03%, 72. 24%, 94. 59%, 86. 63% and 0. 92 （95% confidence interval： 0. 896, 0. 943 ） respectively by using clinical diagnoses of allergists as gold standard. Whereas sIgE results ≥0. 35 KUA/L was defined as the cutoff threshold for diagnosing. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy was 87. 60%, 56. 86%, 83. 27%, 65. 17% and 78. 69% respectively by using sIgE results as gold standard. Coefficient of rank correlation between sIgE detection and IDT results is 0. 69143 in serum sIgE positive group. Local adverse reactions were recorded in 2. 59% （27/1043） patients. There was only one case who was attacked type I systemic adverse reaction, and the patient was also allergic to Artemisia and Sabina chinensis pollen. Conclusions IDT with 1：20 000 w/v Humulus pollen extract is an accuracy mad safe tool for the diagnosis of Humulus pollen allegy.