奥马珠单抗对以哮喘为首发症状的嗜酸性肉芽肿性多血管炎的疗效和安全性分析  

Efficacy of omalizumab in the treatment of eosinophilic granulomatous polyangiitis with asthma as the first symptom

作　　者：欧昌星 吴鹏辉 谢佳星[1] 张筱娴[1] 马健娟 邓振安 杨晓婧 李游 袁丁 薛玲娜 董聪 邓志楠 张清玲[1] Ou Changxing;Wu Penghui;Xie Jiaxing;Zhang Xiaoxian;Ma Jianjuan;Deng Zhen′an;Yang Xiaojing;Li You;Yuan Ding;Xue Lingna;Dong Cong;Deng Zhinan;Zhang Qingling(Pulmonary and Critical Care Medicine,Guangzhou Institute of Respiratory Health,State Key Laboratory of Respiratory Diseases,National Clinical Research Center for Respiratory Disease,National Center for Respiratory Medicine,the First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,China;Department of Pediatric Hematology,Affiliated Hospital of Guizhou Medical University,Guiyang 550000,China)

机构地区：[1]广州医科大学附属第一医院国家呼吸医学中心,国家呼吸系统疾病临床医学研究中心,呼吸疾病国家重点实验室,广州呼吸健康研究院呼吸与危重症医学科,广州510120 [2]贵州医科大学附属医院儿科血液专科,贵阳550000

出　　处：《中华医学杂志》2022年第34期2684-2689,共6页National Medical Journal of China

基　　金：国家自然科学基金(82070026);广东省基础与应用基础研究基金自然科学基金(2019A1515010622);广州市临床特色技术项目(2019TS24);广东省钟南山医学基金(ZNSA-2020013,ZNSA-2020003)。

摘　　要：目的探讨奥马珠单抗对以哮喘为首发症状的嗜酸性肉芽肿性多血管炎(EGPA)的疗效和安全性。方法回顾性分析2018年3月至2020年12月在广州医科大学附属第一医院接受奥马珠单抗治疗的以哮喘为首发症状的22例EGPA患者资料,比较患者治疗前后哮喘控制测试(ACT)评分、哮喘急性发作(AE)次数、伯明翰血管炎活动度评分(BVAS)、呼气峰值流速(PEF)变异率、PEF占预估值百分比(PEFpred%)及第一秒用力呼气容积(FEV_(1))占预估值百分比(FEV_(1)pred%)、口服皮质类固醇激素(OCS)维持用量等指标[M(Q_(1),Q_(3))]的变化,观察奥马珠单抗的疗效和不良反应。结果22例EGPA患者中位年龄42(22~70)岁,男11例。经奥马珠单抗治疗4个月后,EGPA患者的总体应答率为68.2%(15/22)。15例应答组患者ACT由治疗前的19.0(16.5,21.0)分上升至治疗后的23.0(21.5,24.0)分(P=0.001),AE次数从0.7(0.3,1.0)次/4个月下降至0(0,0.7)次/4个月(P<0.001),BVAS由4.0(2.0,6.0)分下降至2.0(2.0,4.0)分(P=0.007),PEF变异率由18.8%(14.0%,27.7%)下降到9.2%(6.8%,11.9%)(P=0.007),PEFpred%由80.8%(73.5%,90.7%)上升到100.5%(79.4%,114.0%)(P=0.005),OCS维持剂量从15.0(10.0,20.0)mg/d减少到8.8(5.0,10.0)mg/d(P=0.005);7例无应答组患者的基线外周血嗜酸性粒细胞比例为11.4%(9.2%,22.6%),高于应答组[3.4%(1.1%,6.5%),P<0.05]。22例患者共进行190次注射治疗,仅4例次(2.1%)在注射奥马珠单抗后出现头晕、注射部位肿胀伴瘙痒等不良反应,均可耐受。结论奥马珠单抗对EGPA哮喘样症状有较好的疗效,可减少OCS维持用量,安全性良好;外周血嗜酸性粒细胞比例较低的EGPA应答较好。Objective To investigate the efficacy,and safety of omalizumab in the treatment of eosinophilic granulomatous with polyangiitis(EGPA)with asthma as the first symptom.Method The clinical characteristics of 22 EGPA patients with asthma as the first symptom treated with omalizumab in the First Affiliated Hospital of Guangzhou Medical University from March 2018 to December 2020 were retrospectively analyzed.The asthma control test(ACT)score,the frequency of asthma exacerbation(AE),the Birmingham Vasculitis Activity Score(BVAS),the variation rate of peak expiratory flow(PEF),the percentage of PEF to predicted value of PEF(PEFpred%),the percentage of forced expiratory volume in first second(FEV_(1))to predicted value of FEV_(1)(FEV_(1)pred%),the dosage of oral corticosteroid(OCS)and other clinical data[M(Q_(1),Q_(3))]were collected before and after treatment,to observe the efficacy and adverse reactions of omalizumab.Results There were 22 subjects recruited in this study.The median age was 42(22-70)years.Eleven of the patients were males.After treated with omalizumab for 4 months,there were 68.2%(15/21)of patients who responded to the treatment.In the response group(n=15),the patients′ACT score increased from 19.0(16.5,21.0)to 23.0(21.5,24.0)(P=0.001).The frequency of AE decreased from 0.7(0.3,1.0)to 0(0,0.7)per four mouths(P<0.001).The BVAS decreased from 4.0(2.0,6.0)to 2.0(2.0,4.0)(P=0.007).The variation rate of PEF decreased from 18.8%(14.0%,27.7%)to 9.2%(6.8%,11.9%)(P=0.007).The PEFpred%increased from 80.8%(73.5%,90.7%)to 100.5%(79.4%,114.0%)(P=0.005).The maintenance dosage of OCS reduced from 15.0(10.0,20.0)mg/d to 8.8(5.0,10.0)mg/d(P=0.005).The level of baseline eosinophil in peripheral blood of patients in non-response group was higher than that in response group[11.4%(9.2%,22.6%)vs 3.4%(1.1%,6.5%),P<0.05].A total of 190 injections were performed in 22 patients,and only 4 patients(2.1%)had adverse reactions after a single injection of omalizumab,such as dizziness,swelling of injection site and pruritus.The adv

关 键 词：哮喘 奥马珠单抗 嗜酸性肉芽肿性多血管炎 治疗效果 随访研究 

分 类 号：R562.25[医药卫生—呼吸系统]