摘要
目的探讨新型靶向抗免疫球蛋白E(IgE)药物奥马珠单抗治疗儿童中重度变应性哮喘的临床疗效及安全性。方法回顾性分析2018年7月至2020年1月就诊于北京大学第一医院儿科并采用奥马珠单抗治疗的中重度变应性哮喘患儿的临床资料,比较治疗前后儿童哮喘控制评分(C-ACT)、儿童哮喘生活质量问卷(PAQLQ)、简易哮喘生活质量问卷(Mini-AQLQ)和哮喘全球疗效评估(GETE)等问卷,第1秒用力呼气量(FEV1)、FEV1占预计值百分比(FEV1%pred)和小气道功能指标等肺功能检查及呼出气一氧化氮浓度(FeNO)等的变化。结果完成16周治疗随访的患儿共15例。奥马珠单抗治疗16周,患儿C-ACT从(16.00±1.66)分升至(25.38±0.64)分(F=11.969,P<0.001),PAQLQ从(118.08±23.78)分升至(141.00±11.91)分(F=9.289,P=0.001),Mini-AQLQ从(78.93±7.43)分升至(97.92±3.12)分(F=4.145,P=0.042),GETE从(2.47±0.27)分降至(1.60±0.19)分(t=2.982,P=0.010)。FEV1从(1.96±0.12)L升至(2.17±0.21)L(F=0.425,P=0.789),FEV1%pred从(81.46±2.85)%升至(82.64±1.55)%(F=0.926,P=0.465);最大呼气流量占预计值百分比(PEF%pred)从(82.05±3.58)%升至(91.10±4.67)%(F=1.909,P=0.128),呼出25%肺活量时的最大呼气流量(MEF 75)从(60.36±7.43)%升至(76.94±4.65)%(F=2.120,P=0.096);呼出50%肺活量时的最大呼气流量(MEF 50)从(52.72±3.75)%升至(73.80±8.34)%(F=3.140,P=0.047),最大呼气中期流速(MMEF 75/25)从(60.05±8.47)%升至(74.86±10.85)(F=7.860,P=0.010)。FeNO从25.0(14.5,35.5)μg/L降至20.0(18.5,30.0)μg/L(Z=-0.206,P=0.840)。治疗期间1例患儿出现一过性头痛,2例患儿出现一过性皮疹。结论奥马珠单抗可显著改善中重度变应性哮喘患儿的临床表现、肺功能指标及生活质量,且其安全性较好,有望在治疗儿童中重度变应性哮喘中发挥重要作用。
Objective To explore the clinical efficacy and safety of the new targeted anti-immunoglobulin E(IgE)drug Omalizumab in the treatment of children with moderate and severe allergic bronchial asthma in China.Methods The clinical data of children with moderate and severe allergic asthma who were treated in the Department of Pediatrics of Peking University First Hospital from July 2018 to January 2020 and treated with Omalizumab were retrospectively analyzed.A comparison was performed on the changes of questionnaires,including childhood asthma control test(C-ACT),pediatric asthma quality of life questionnaire(PAQLQ),mini-asthma quality of life questionnaire(Mini-AQLQ)and global evaluation of asthma treatment effectiveness(GETE),pulmonary function test,including forced expiratory volume in the first second(FEV1),percentage to predicted value(FEV1%pred)and small airway function,fractional concentration of exhaled nitric oxide(FeNO)and so on,before and after treating with Omalizumab.Results A total of 15 pediatric patients completed 16 weeks of treatment follow-up.After 16 weeks of Omazumab treatment,the score of C-ACT increased from(16.001.66)scores to(25.38±0.64)scores(F=11.969,P<0.001),PAQLQ increased from(118.08±23.78)scores to(141.00±11.91)scores(F=9.289,P=0.001),Mini-AQLQ increased from(78.93±7.43)scores to(97.92±3.12)scores(F=4.145,P=0.042),and GETE decreased from(2.47±0.27)scores to(1.60±0.19)scores(t=2.982,P=0.010).The actual value of FEV1,FEV1%pred,the maximum expiratory flow percentage of the predicted value(PEF%pred),forced expiratory flow at 25%(MEF 75),forced expiratory flow at 50%(MEF 50)and maximum midexpiratory flow(MMEF 75/25),increased from(1.96±0.12)L to(2.17±0.21)L(F=0.425,P=0.789),(81.46±2.85)%to(82.64±1.55)%(F=0.926,P=0.465),(82.05±3.58)%to(91.10±4.67)%(F=1.909,P=0.128),(60.36±7.43)%to(76.94±4.65)%(F=2.120,P=0.096),(52.72±3.75)%to(73.80±8.34)%(F=3.140,P=0.047)and(60.05±8.47)%to(74.86±10.85)%(F=7.860,P=0.010),respectively.FeNO decreased from 25.0(14.5,35.5)μg/L to 20.0(18.5,30.0)
作者
虞琳
张慧珊
赵欣
丁玮
周燕霞
白玫
张宏菊
叶乐平
Yu Lin;Zhang Huishan;Zhao Xin;Ding Wei;Zhou Yanxia;Bai Mei;Zhang Hongju;Ye Leping(Department of Pediatrics,Peking University First Hospital,Beijing 100034,China;Department of Pediatrics,the Fourth Affiliated Hospital,Zhejiang University School of Medicine,Yiwu 322000,Zhejiang Province,China;Department of Infectious Disease,Children′s Hospital of Hebei Province,Shijiazhuang 050010,China)
出处
《中华实用儿科临床杂志》
CSCD
北大核心
2020年第8期617-621,共5页
Chinese Journal of Applied Clinical Pediatrics
基金
国家自然科学基金(81971424,81771635)。
