大籽蒿花粉变应原皮试液诊断大籽蒿花粉过敏的临床评价

目的评价应用蒿属花粉变应原注射液原液1：1000稀释液进行皮内试验诊断蒿属花粉过敏的有效性和安全性。方法回顾性分析2009年2月至7月于北京协和医院变态反应科就诊的1043例患者皮内试验结果，将蒿属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（specificIgE，sIgE）诊断结果进行对比，评价皮内试验诊断蒿属花粉过敏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。同时评价蒿属花粉变应原注射原液1：1000稀释液用于皮内试验的安全性。结果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，将蒿属花粉皮内试验结果≥“＋”作为诊断界值，蒿属花粉变应原注射原液1：1000稀释液皮内试验灵敏度为95．99％，特异度为84．36％，阳性预测值为85．01％，阴性预测值为95．79％，准确度为89．95％，ROC曲线下面积为0．956，95％的可信区间为（0．943—0．970）。当以蒿属花粉皮内试验结果≥“＋＋”为诊断界值时，蒿属花粉皮内试验灵敏度为79．29％，特异度为97．33％，阳性预测值为96．48％，阴性预测值为83．57％，准确度为88．66％。次要评价指标以PhadiaUni-CAP系统血清蒿属花粉变应原sIgE诊断结果作为标准，将蒿属花粉皮内试验结果≥“＋”作为诊断界值时，蒿属花粉变应原注射原液1：1000稀释液皮内试验的灵敏度为95．23％，特异度为45．98％，阳性预测值为88．97％，阴性预测值为67．80％，准确度为86．39％。如以蒿属花粉皮内试验结果≥“＋＋”为诊断界值时，则皮内试验灵敏度78．89％，特异度为96．55％，阳性预测值为99．05％，阴性预测值为50．00％，准确度为82．06％。蒿属花粉血清sIgE阳性组中，血清sIgE水平与蒿属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0．68728。1043例受试者中，与蒿属花粉变应原有关的局部不良反应为7．01％（73／1043）；仅有1例患者出现全身不良反应，该患者同时合并律草花粉、圆柏花粉过敏。结论使用蒿属花粉变应原注射原液1：1000稀释液进行皮内试验，可以有效、安全地诊断蒿属花粉引起的过敏性疾病。

Clinical Evaluation on Accuracy and Safety of Artemisia sieversiana Pollen Extract Used for Intradermal Test in the Diagnosis of Artemisia Pollen Allergy

Objective To evaluate the accuracy and safety of Artemisia sieversiana pollen extract 1：1 000 dilution which was used for intradermal test in the diagnosing of Artemisia pollen allergy. Methods 1043 cases who had been prescribed both intradermal skin test （IDT） and serum specific IgE （sIgE） test from Departmentof Allergy, PUMC hospital were collected and reviewed since Feb. to Jul. 2009. The accuracy Artemisia sieversiana pollen extract 1 ： 1 000 dilution was evaluated by using clinical integrated of IDT with diagnosses which were made by allergists and sIgE results as golden standards respectively. Adverse reactions were also recorded. Results By using clinical integrated diagnoses of allergists as gold standard, sensitivity, specificity, positive predictive value, negative predictive value , accuracy and area under ROC curve was 95.99% , 84.36% , 85.01% , 95.79%, 89.95% and 0. 956 （95% confidence interval： 0. 943, 0. 970） respectively when IDT results ≥＂ ＋ ＂ was defined as the cutoff threshold for diagnosing. Whereas sensitivity, specificity, positive predictive value, negative predictive value and accuracy was 79.29%, 97.33%, 96. 48%, 83.57% and 88.66% respectively when IDT result≥ ＂ ＋＋ ＂ was defined as the cutoff threshold for diagnosing. By using slgE results as golden standard, sensitivity, specificity, positive predictive value, negative predictive value and accuracy was 95.23%, 45.98%, 88.97%, 67. 80% and 86.39% respectively when IDT results ≥ ＂ ＋ ＂ was defined as the cutoff threshold for diagnosing. Whereas sensitivity, specificity, positive predictive value, negative predictive value and accuracy was 78.89%, 96.55%, 99. 05%, 50. 00% and 82. 06% respectively when IDT results ≥＂ ＋＋ ＂ was defined as the cutoff threshold for diagnosing. Coefficient of rank correlation between slgE detection and IDT results is 0. 68728 in serum slgE positive group. Local adverse reactions were recorded in 7.01% （73/1043） patients. There was only one case who was attacked type I systemic adverse reaction, and the patient was also allergic to Humulus and Sabina chinertsis pollen. Conclusion IDT with Artemisia sieversiana pollen extract 1：1 000 dilution is an accuracy and safe tool for the diagnosis of Artemisia pollen allergy.