重度哮喘应用奥马珠单抗长期治疗及其减量方案疗效  

Efficacy of long-term treatment and dose-reduction regimen of omalizumab in patients with severe asthma

作　　者：蔡慧 朱桂萍 宋惜夕 墨玉清 朱梦婵 杨琤瑜[2] 曾莹莹 高鑫[1] 叶伶[1] 金美玲[1] CAI Hui;ZHU Gui-ping;SONG Xi-xi;MO Yu-qing;ZHU Meng-chan;YANG Cheng-yu;ZENG Ying-ying;GAO Xin;YE Ling;JIN Mei-ling(Department of Pulmonary and Critical Care Medicine,Department of Allergy,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Pulmonary and Critical Care Medicine,Huadong Hospital,Fudan University,Shanghai 200040,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、变态(过敏)反应科,上海200032 [2]复旦大学附属华东医院呼吸与危重症医学科,上海200040

出　　处：《中华临床免疫和变态反应杂志》2022年第4期343-350,共8页Chinese Journal of Allergy & Clinical Immunology

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

摘　　要：目的探讨重度哮喘患者应用奥马珠单抗长期治疗合理减量的可行性及有效性。方法收集本院经奥马珠单抗治疗满1年以上的12例重度过敏性哮喘患者的临床资料,对其中哮喘控制良好至少6个月(即常规治疗)的患者采用减量方案。每隔4周1次皮下注射奥马珠单抗≤300 mg的患者逐步延长给药间隔至6~8周;单次皮下注射奥马珠单抗>300 mg的患者减少至原给药剂量的12~23。比较上述患者经奥马珠单抗常规及减量治疗前后哮喘控制评分(asthma control test,ACT)、哮喘生活质量评分(asthma quality of life,AQLQ)、口服激素量、急性发作次数变化。结果12例患者经奥马珠单抗常规治疗后ACT从基线期(17.7±3.9)分升至(22.1±1.6)分(P<0.01);AQLQ从基线期(4.6±1.4)分升至(6.0±0.5)分(P<0.05);口服泼尼松剂量从基线期(15.0±6.9)mg d减至(0.0±7.5)mg d(P<0.01);急性发作次数从基线期(6.6±3.9)次年减至(1.8±1.7)次年(P<0.001)。常规治疗期间达到良好控制的9例患者予调整治疗方案(7例延长给药间隔、2例减少给药剂量),其中7例实现成功减量,2例因减量后出现哮喘急性发作,恢复至初始治疗方案。与基线期相比,减量期ACT仍显著改善者6例、无显著改善者2例、下降者1例;常规治疗期与减量期患者口服泼尼松剂量、急性发作次数变化均无明显统计学差异。结论奥马珠单抗减量方案需要个体化制定,常规治疗应答良好者可成功减量并仍可获益。Objective To explore the feasibility and effectiveness of dose-reduction regimen in long-term treatment with omalizumab for severe asthma.Methods The clinical data of 12 patients with severe allergic asthma were collected and analyzed,who received omalizumab treatment for more than one year in Zhongshan Hospital affiliated to Fudan University.Patients with good asthma control for at least 6 months(namely standard treatment)subsequently received dose-reduction regimen.Single subcutaneous injection of omalizumab≤300 mg every four weeks was gradually extended to every 6-8 weeks;single injection of omalizumab>300 mg were reduced to 12-23 of the original doses.The asthma control test(ACT),asthma quality of life(AQLQ),dose of oral steroids,and frequency of acute attacks before and after standard and step-down regimen of omalizumab were compared in this study.Results The ACT,AQLQ scores of 12 severe asthmatic patients increased from(17.7±3.9)at baseline to(22.1±1.6)(P<0.01),from(4.6±1.4)at baseline to(6.0±0.5)after standard treatment(P<0.05)respectively.Meanwhile,oral prednisone dose decreased from(15.0±6.9)mg d at baseline to(0.0±7.5)mg d(P<0.01);frequency of acute attack decreased from(6.6±3.9)at baseline to(1.8±1.7)per year(P<0.001).Nine patients achieved good control of asthma during standard treatment and then their regimens were optimized(extended administration interval among 7 patients and reduced dose in another 2 patients).The dose-reduction regimens of omalizumab were successfully maintained among 7 patients,while the other 2 patients returned to the initial treatment regimen because of acute attacks.Compared with baseline,ACT scores significantly increased among 6 patients,did not change in 2 and decreased in the remaining 1 during optimization.There was no statistically significant differences in dose of oral steroids and acute attacks between standard and dose-reduction treatment.Conclusion The omalizumab dose-reduction regimen should be individualized,and patients with good responses during stan

关 键 词：奥马珠单抗 重度哮喘 长期治疗 减量 疗效 

分 类 号：R562.25[医药卫生—呼吸系统]