奥马珠单抗3年长疗程治疗重度激素依赖型过敏性哮喘的疗效及安全性  

The efficacy and safety of omalizumab for a 3-year long course of treatment for severe hormone dependent allergic asthma

作　　者：朱桂萍 蔡慧 曾莹莹 高鑫[1,2] 朱梦婵 杨琤瑜[1,2] 宋惜夕 彭文珺 叶伶[1,2] 金美玲[1,2] ZHU Gui-ping;CAI Hui;ZENG Ying-ying;GAO Xin;ZHU Meng-chan;YANG Cheng-yu;SONG Xi-xi;PENG Wen-jun;YE Ling;JIN Mei-ling(Department of Pulmonary and Critical Care Medicine,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Allergy,Zhongshan Hospital,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属中山医院呼吸与危重症医学科,上海200032 [2]复旦大学附属中山医院变态(过敏)反应科,上海200032

出　　处：《复旦学报（医学版）》2023年第1期1-7,共7页Fudan University Journal of Medical Sciences

基　　金：复旦大学附属中山医院临床研究专项基金(2020ZSLC26);上海市临床重点专科建设项目(shslczdzk02201)。

摘　　要：目的探讨长疗程应用奥马珠单抗治疗重度激素依赖型过敏性哮喘的临床疗效及安全性。方法纳入复旦大学附属中山医院呼吸科接受奥马珠单抗治疗≥3年的7例重度激素依赖型过敏性哮喘患者,比较其治疗前后口服糖皮质激素(oral corticosteroid,OCS)剂量、急性发作次数变化以及哮喘控制评分(asthma control test,ACT)、哮喘生活质量评分(asthma quality of life questionnaire,AQLQ)、肺通气功能参数用力肺活量(forced vital capacity,FVC)、第一秒用力呼气容积(forced expiratory volume in 1s,FEV_(1))、FEV_(1)占预计值百分比(FEV_(1)%pred)、1秒率(FEV_(1)/FVC)的变化。结果经奥马珠单抗治疗3年后,7例患者口服泼尼松剂量从基线期15.0(15.0~22.5)mg/d减至2.5(0~10.0)mg/d(P<0.01),哮喘急性发作次数从6(4~7)次/年减至0(0~1)次/年(P<0.01);7例重度哮喘患者ACT评分从18.0(13.0~20.0)分升至22.0(18.0~24.0)分,AQLQ评分从(4.5±1.4)分升至(5.1±1.1)分;7例患者治疗3年的FEV_(1)从基线期(2.2±1.0)L升高至(2.5±1.3)L,FEV_(1)%pred从基线期74.4%±29.2%升高至77.5%±27.2%,FEV_(1)/FVC(%)从基线期68.4%±11.9%升高至69.8%±16.3%。1例患者有注射部位红肿,其余在奥马珠单抗长期治疗期间均未见明显不良反应。结论奥马珠单抗长疗程治疗重度激素依赖型过敏性哮喘,可以显著减少哮喘患者口服激素剂量及急性发作次数,持续有效控制哮喘症状,改善患者生活质量,改善或稳定肺通气功能,且安全性良好。Objective To investigate the clinical efficacy and safety of long-term application of omalizumab in the treatment of severe hormone dependent allergic asthma. Methods Seven cases of severe hormone dependent allergic asthma treated with omalizumab for 3 years were collected from Department of Respiratory Medicine,Zhongshan Hospital, Fudan University. Results of oral corticosteroid(OCS) doses, acute attack frequency, asthma control test(ACT), asthma quality of life(AQLQ), forced vital capacity(FVC), forced expiratory volume in first second(FEV_(1)) and percentage to predicted value(FEV_(1)% pred), and forced expiratory volume in the first second over forced vital capacity(FEV_(1)/FVC) before and after omalizumab treatment were compared in this study. Results After treatment of omalizumab for 3 years, the oral prednisone doses of the 7 cases decreased from 15.0(15.0-22.5) mg/d to 2.5(0-10.0) mg/d(P<0.01), and acute attack frequency decreased from 6(4-7) per year to 0(0-1) per year(P<0.01). The ACT scores of 7 patients with severe asthma increased from 18.0(13.0-20.0) to 22.0(18.0-24.0), and AQLQ scores increased from(4.5±1.4) to(5.1±1.1). After treatment of omalizumab for 3 years, FEV_(1)increased from baseline(2.2±1.0) L to(2.5±1.3) L, FEV_(1)% pred increased from baseline 74.4%±29.2% to 77.5%±27.2%, FEV_(1)/FVC(%) increased from baseline 68.4%±11.9% to 69.8%±16.3%. One case had swelling at the injection site, and the rest had no obvious adverse reactions during the long-term treatment with omalizumab. Conclusion Long-term application of omalizumab in the treatment of severe hormone dependent allergic asthma could effectively reduce oral prednisone doses and acute attack frequency, control asthma symptoms and improve pulmonary ventilation function of patients and also has good safety.

关 键 词：奥马珠单抗 重度哮喘 激素依赖 长期疗效 安全性 

分 类 号：R256.12[医药卫生—中医内科学]