Chen Jianjun, Li Bin, Zhao Yan, Zhang Quanming, Wan Lijia, Liu Jun, Tian Xingde, Li Guoyi, Zhou Jie, Zhang Long, Wang Pengju, Cheng Qi, Liang Jianwei, Zhao Ping, Luo Zhihong, He Jingpei, Lu Haitao, Zhou Yi, Zhang Yuanfen, Chen Xiangjun, Pan Fangming, Zhang Zhimao, Zeng Ligang, He Benchao, Zeng Ying, Xu Xiaoyan, Kong Weijia
Department of Otorhinolaryngology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Am J Rhinol Allergy. 2014 Jan-Feb;28(1):e40-4. doi: 10.2500/ajra.2014.28.4005.
Standardized allergen-specific immunotherapy (SIT) has been used in China for years. However, there is no extensive study of the safety of standardized SIT in Chinese patients until now. The aim of the current study is to perform a prospective and multicenter study to evaluate the systemic reactions (SRs) of standardized SIT in Chinese patients.
The study was performed in 13 allergy centers in China, using the same vaccine and practice procedure. The length of observation period was 2 years. SRs were recorded and analyzed.
There were 666 patients included (261 children and 405 adults). All patients finished the initial phase and 47 patients withdrew during the maintenance phase. There were 0.47% (94/19,963) SRs in all injections (0.72% in children and 0.31% in adults); 8.26% (55/666) patients experienced SRs (12.26% children and 5.68% adults). The occurrence of SRs was significantly higher in children than that in adults (p < 0.01). A higher ratio of SRs was found among patients accompanied with asthma. There were 74.47% SRs of grade I, 15.96% SRs of grade II, 7.45% SRs of grade III, and 2.13% SRs of grade IV. There were 90.43% of SRs associated with the discomfort of lower respiratory tract.
This multicenter study showed that properly conducted standardized SIT was a safe treatment for allergic rhinitis in China. The incidence of SRs was higher in children than that in adults.
标准化变应原特异性免疫疗法（SIT）在中国已应用多年。然而，迄今为止，尚未对中国患者进行标准化SIT安全性的广泛研究。本研究的目的是进行一项前瞻性多中心研究，以评估中国患者标准化SIT的全身反应（SRs）。
该研究在中国的13个过敏中心进行，使用相同的疫苗和操作程序。观察期为2年。记录并分析SRs。
共纳入666例患者（261例儿童和405例成人）。所有患者均完成了初始阶段，47例患者在维持阶段退出。所有注射中SRs发生率为0.47%（94/19963）（儿童为0.72%，成人为0.31%）；8.26%（55/666）的患者发生SRs（儿童为12.26%，成人为5.68%）。儿童SRs的发生率显著高于成人（p<0.01）。哮喘患者中SRs的比例更高。I级SRs占74.47%，II级SRs占15.96%，III级SRs占7.45%，IV级SRs占2.13%。90.43%的SRs与下呼吸道不适有关。
这项多中心研究表明，在中国，正确实施的标准化SIT是治疗过敏性鼻炎的一种安全方法。儿童SRs的发生率高于成人。
