奥马珠单抗联合RIT与糖皮质激素联合RIT的安全性比较  

Safety comparison of omalizumab and glucocorticoid in rush allergen immunotherapy

作　　者：高培 余文婷 周玥 祝婉婷 朱振潮 江银丽[3] 程庆 王彦君[1] 孔维佳[1] 朱新华[3] 邱前辉[2] 陈建军[1] GAO Pei;YU Wenting;ZHOU Yue;ZHU Wanting;ZHU Zhenchao;JIANG Yinli;CHENG Qing;WANG Yanjun;KONG Weijia;ZHU Xinhua;QIU Qianhui;CHEN Jianjun(Department of Otolaryngology Head and Neck Surgery,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,430022,China;Department of Otolaryngology Head and Neck Surgery,Zhujiang Hospital,Southern Medical University;Department of Otolaryngology Head and Neck Surgery,the Second Affiliated Hospital of Nanchang University)

机构地区：[1]华中科技大学同济医学院附属协和医院耳鼻咽喉头颈外科,武汉430022 [2]南方医科大学珠江医院耳鼻咽喉头颈外科 [3]南昌大学第二附属医院耳鼻咽喉头颈外科

出　　处：《临床耳鼻咽喉头颈外科杂志》2020年第7期610-614,共5页Journal of Clinical Otorhinolaryngology Head And Neck Surgery

基　　金：国家自然科学基金项目(No:81570898,No:81873693);科技部十二五科技支撑项目(No:2014BAI07B04)。

摘　　要：目的:比较奥马珠单抗联合冲击免疫治疗(RIT)与糖皮质激素联合RIT在剂量递增阶段的临床安全性。方法:回顾性研究88例行RIT治疗的变应性鼻炎患者的临床资料,包括性别、年龄、治疗前总VAS评分、血中EOS%、血清总IgE、局部及全身不良反应。88例中奥马珠单抗联合RIT(试验组)57例,激素/抗过敏药联合RIT(对照组)31例,比较2组在剂量递增阶段的治疗安全性。结果:试验组在剂量递增阶段住院期间、出院第1针、出院第2针均未出现Ⅰ级全身不良反应;出现Ⅱ级全身不良反应分别为4例(7.1%),2例(3.6%),0例(0);未出现局部瘙痒及硬结症状。对照组在住院期间、出院第1针、出院第2针的Ⅰ级全身不良反应分别为1例(3.4%)、2例(6.9%)、1例(3.4%);出现Ⅱ级全身不良反应分别为5例(17.2%)、1例(3.4%)、0例(0);在住院期间8例患者出现局部注射部位瘙痒(其中5例为轻度瘙痒,3例为中度瘙痒),4例(13.8%)患者出现局部硬结。结论:奥马珠单抗联合RIT不仅缩短了特异性免疫治疗剂量递增阶段的疗程,还增加了剂量递增阶段住院期间及出院后第1、2针的安全性,提高了患者的依从性。Objective:To observe the safety of omalizumab and glucocorticoid in the dose-increasing phase of rush allergen immunotherapy(RIT).Method:The clinical data of 88 patients with allergic rhinitis treated with RIT were retrospectively studied,including gender,age,pre-treatment total VAS score,blood EOS%,serum total IgE,local and systemic adverse reactions.Of all patients,fifty-seven were treated with omalizumab combined with RIT(experimental group)and thirty-one were treated with hormone/antiallergic drugs combined with RIT(control group).The safety of the two groups was compared in the dose-increasing phase.Result:There was no gradeⅠsystemic adverse reactions during the whole process in the experimental group,while GradeⅡsystemic adverse reactions were 4 cases(7.1%)during the period of hospitalization,2 cases(3.6%)after the first injection after discharge,zero(0)after the second injection after discharge.No local pruritus and induration were observed.During the period of hospitalization,the first and second injection after discharge,control group had gradeⅠlevel systemic adverse reactions were 1 case(3.4%),2 cases(6.9%),1 case(3.4%)at different time point,respectively.GradeⅡsystemic adverse reactions were 5 cases(17.2%),1 case(3.4%),zero(0)at different time point,respectively.Local injection site itching was observed in 8 patients(5 cases were mild and 3 cases were moderate)and 4 cases(13.8%)had induration during hospitalization.Conclusion:Omalizumab combined with RIT not only shortens the duration of dose-increasing phase of specific immunotherapy,but also increases the safety of the dose-increasing phase during hospitalization,the first and second injection after discharge and improves patient compliance.

关 键 词：鼻炎 变应性 奥马珠单抗 糖皮质激素 冲击免疫治疗 安全性 

分 类 号：R765.21[医药卫生—耳鼻咽喉科]