圆柏花粉点刺液诊断圆柏花粉过敏的临床价值

关凯; 周俊雄; 王瑞琦; 尹佳; 王良录; 支玉香; 孙劲旅; 李宏; 文利平; 顾建青; 汤蕊; 王子熹; 李丽莎; 徐涛

doi:10.13201/j.issn.1001-1781.2018.03.001

圆柏花粉点刺液诊断圆柏花粉过敏的临床价值

- 1. 中国医学科学院北京协和医学院北京协和医院变态(过敏)反应科过敏性疾病精准诊疗研究北京市重点实验室中国医学科学院临床免疫研究中心(北京, 100730);
- 2. 中国医学科学院基础医学研究所北京协和医学院基础学院统计学教研室
基金项目:
国家重大新药创制科技重大专项（No：2014ZX09102041-008）；北京市科技计划首都市民健康项目培育类（No：Z131100006813047）；中国医学科学院公益性科研院所基本科研业务专项（No：2015SQ00136）

详细信息

通讯作者: 尹佳,E-mail:doctoryinjia@163.com

中图分类号: R765.21

收稿日期: 2017-12-27

The clinical value of China Savin pollen extract used for skin prick test

- 1. Department of Allergy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College;Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment of Allergic Diseases;Clinical Immunology Center, Chinese Academy of Medicial Sciences, Beijing, 100730, China;
- 2. Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College

More Information

Corresponding author: YIN Jia, E-mail: doctoryinjia@163.com

Received Date: 27 December 2017

摘要

摘要: 目的：通过皮肤点刺试验（SPT）评价使用北京协和医院圆柏花粉变应原点刺液（简称协和圆柏花粉点刺液）进行临床诊断的有效性和安全性。方法：北京协和医院变态反应科就诊的过敏性疾病患者，知情同意后接受协和圆柏花粉点刺液SPT 15 min后测量平均风团直径（MWD），以圆柏花粉sIgE为标准分析受试者工作特征曲线（ROC），分析在不同诊断界值下协和圆柏花粉点刺液用于诊断圆柏花粉过敏的准确性并评价安全性。结果：入组1 029例全部进入安全数据集，全分析集（FAS）共1 007例，符合方案集（PPS）共765例，剔除率25.66%。FAS的ROC曲线下面积为0.814（95%CI：0.788~0.839），PPS的ROC曲线下面积为0.829（95%CI：0.801~0.857）。根据PPS的ROC曲线得到：3.25 mm为最佳诊断界值，4.75 mm为95%特异度的诊断界值。分别以圆柏花粉SPT结果MWD 3.00、3.25及4.75 mm为诊断界值，协和圆柏花粉点刺液用于诊断圆柏花粉过敏的敏感度依次降低，分别为0.740 0（95%CI：0.701 6~0.778 4）、0.700 0（95%CI：0.659 8~0.740 2）、0.532 0（95%CI：0.488 3~0.575 7）；特异度依次升高，分别为0.769 8（95%CI：0.719 1~0.820 5）、0.826 4（95%CI：0.780 8~0.872 0）、0.950 9（95%CI：0.924 9~0.976 9）。6例受试者出现7次不良事件，发生率0.583%（6/1 029），表现均为轻度，无严重不良事件发生。结论：协和圆柏花粉点刺液具有较好的临床诊断价值且安全性好，如将不同的诊断界值结合病史分析可进一步提高准确性。
- 鼻炎,变应性 /
- 圆柏 /
- 花粉 /
- 皮肤点刺试验 /
- 特异性免疫球蛋白E
Abstract: Objective: The aim of this study is to evaluate the effectiveness and safety of China Savin pollen extract which was used for skin prick test (SPT) in the diagnosis of China Savin pollen allergy.Method: Patients with diagnosis of allergic diseases were collected from Allergy Department of Peking Union Medical College Hospital. All patients were given SPT with China Savin pollen extract, and the mean wheal diameter (MWD) was measured after 15 minutes. Receiver operating characteristic curve (ROC) analysis was performed based on the results of serum specific immunoglobulin E (sIgE). The effectiveness of SPT in the diagnosis of China Savin pollen allergy was evaluated under different diagnostic cutoff values. Adverse events were also recorded to evaluate the safety.Result: A total of 1 029 patients were enrolled in this study without drop out case. There were 1 007 patients in full analysis set (FAS) and 765 patients in per protocol analysis set (PPS). The elimination rate was 25.66%. The area under the ROC curve of FAS is 0.814 (95%CI:0.788-0.839); which of PPS is 0.829 (95%CI:0.801-0.857). Based on the ROC curve of PPS, the optimal and the 95% specificity diagnostic cutoff values of MWD were 3.25 mm and 4.75 mm respectively. Based on different diagnostic cutoff value (3.00, 3.25 and 4.75 mm), the sensitivities of SPT with China Savin pollen extract were 0.740 0 (95%CI:0.701 6-0.778 4), 0.700 (95%CI:0.659 8-0.740 2) and 0.532 (95%CI:0.488 3-0.575 7) respectively, whereas the specificity was gradually increased in sequence, which was 0.769 8 (95%CI:0.719 1-0.820 5), 0.826 4 (95%CI:0.780 8-0.872 0) and 0.950 9 (95%CI:0.924 9-0.976 9) respectively. There were 7 adverse events observed among 6 patients (rate:0.583%, 6/1 029). The manifestation was mild. There was no severe adverse event.Conclusion: SPT with China Savin pollen extract is an effective and safe tool for the diagnosis of China Savin pollen allergy. The effectiveness of diagnosis could be improved based on integration of medical history and different diagnostic threshold values of SPT.
- rhinitis, allergy /
- China Savin /
- pollen /
- skin prick test /
- specific immunoglobulin E

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