【摘要】 目的 探讨抗IgE单克隆抗体（奥马珠单抗）治疗过敏性哮喘（或合并其他过敏性疾病）患者的长期疗效，并比较完成12个月治疗后两种药物减量方案的临床疗效。方法 回顾性分析2020年1月至2022年8月于中日友好医院接受奥马珠单抗治疗的58例患者临床资料。在患者完成12个月治疗后，进行药物减量评估，符合药物减量条件的患者采取减量方案继续治疗，其中16例减少给药剂量，6例延长给药间隔，其余36例患者继续原剂量维持治疗。比较治疗前后和减量前后的哮喘控制评分（asthma control test, ACT）、第1 s用力呼气容积（forced expiratory volume in one second, FEV₁）、呼出气一氧化氮（fractional exhaled nitric oxide, FeNO）和外周血嗜酸性粒细胞（eosinophil, EOS）计数变化。结果 与治疗前相比，奥马珠单抗治疗12个月后，平均ACT从（19.40±2.56）分上升至（24.88±0.33）分（P<0.05）;FEV₁占预计值的百分比从（75.94±8.31）%上升至（90.96±6.39）%（P<0.05）;FeNO从（39.28±21.64）ppb下降至（12.44±4.90）ppb（P<0.05）;外周血EOS计数从（0.64±0.26）×10⁹/L下降至（0.28±0.14）×10⁹/L（P<0.05）。与治疗12个月后相比，两种减量方案组患者治疗16个月时的ACT、FEV₁均可维持良好控制；炎症标志物FeNO和外周血EOS计数也可保持稳定，减少给药剂量组的FeNO从（11.88±3.34）ppb下降至（8.89±3.02）ppb（P<0.05）。结论 奥马珠单抗可显著改善过敏性哮喘（或合并有其他过敏性疾病）患者的哮喘控制和肺功能，并可降低炎症标志物水平。对于符合药物减量条件的患者，两种减量方案均可维持良好的哮喘控制和肺功能，而减少给药剂量在降低炎症标志物FeNO上更具优势。更多还原

【Abstract】 Objective To investigate the long-term efficacy of anti-IgE monoclonal antibody（omalizumab） for the treatment of allergic asthma, with or without other allergic diseases, and to compare the efficacy of two tapering schedules for omalizumab after 12 months of standard treatment.Methods A retrospective analysis was performed on 58 patients who received omalizumab treatment at the China-Japan Friendship Hospital from January 2020 to August 2022 for allergic asthma, with or without other allergic diseases.Eligibility for tapering was assessed after 12 months of standard treatment.Those eligible for tapering continued the treatment following a tapering schedule.Sixteen patients received tapering to a reduced dosage, and another 6 received extended interval dosing.The remaining 36 patients continued the maintenance therapy under the original dosage.Changes in the following parameters were compared before and after the standard treatment and tapering: asthma control test（ACT） score, forced expiratory volume in 1 second（FEV₁）,fractional exhaled nitric oxide（FeNO）,and peripheral blood eosinophil count（EOS）.Results Compared with the pre-treatment values, the average ACT score increased from 19.40±2.56 to 24.88±0.33 after 12 months of standard omalizumab treatment（P<0.05）.The FEV₁ as a percentage of the predicted value（FEV₁% predicted） increased from 75.94±8.31% to 90.96±6.39%（P<0.05）.FeNO decreased from 39.28±21.64 ppb to 12.44±4.90 ppb（P<0.05）.peripheral blood EOS decreased from 0.64±0.26×10⁹/L to（0.28±0.14）×10⁹/L（P<0.05）.Compared with the values immediately after 12 months of standard treatment, the ACT score and FEV₁ were properly controlled after 16 months of treatment with either one of the two tapering schemes.As for inflammatory markers, FeNO and peripheral blood EOS remained stable.FeNO was even lower under tapering to a reduced dosage（from 11.88±3.34 ppb to 8.89±3.02 ppb, P<0.05）.Conclusion Standard omalizumab treatment effectively improved asthma control and lung function, and decreased the levels of inflammatory markers in allergic asthmawith or without other allergic diseases.For those eligible for tapering, both tapering schedules maintained good asthma control and lung function.Tapering to a reduced dosage was more effective than extended interval dosing in reducing the level of FeNO,which is an inflammatory marker.However, small sample size was one of the major limitations of the present study.更多还原