2022 年第 11 期 第 17 卷

奥马珠单抗治疗中重度过敏性哮喘的临床效果及安全性研究

Clinical effect and safety study of omalizumab in treatment of moderate and severe allergic asthma

作者：李建英1刘毅1罗岚1宋思瑶1张明强2

英文作者：Li Jianying1 Liu Yi1 Luo Lan1 Song Siyao1 Zhang Mingqiang2

单位：1民航总医院呼吸内科，北京100123；2清华大学附属北京清华长庚医院呼吸与危重症医学科，北京102218

英文单位：1Department of Respiratory Medicine Civil Aviation General Hospital Beijing 100123 China; 2Department of Respiratory and Critical Care Medicine Beijing Tsinghua Changgung Hospital Affiliated to Tsinghua University Beijing 102218 China

关键词：过敏性哮喘；奥马珠单抗；哮喘控制测试问卷

英文关键词：Allergicasthma;Omalizumab;Asthmacontroltestquestionnaire

• 摘要：

• 目的 研究奥马珠单抗治疗中重度过敏性哮喘的临床效果及安全性。方法 回顾性选取2020年5—12月民航总医院收治的46例中重度过敏性哮喘患者，均给予奥马珠单抗治疗，根据治疗时间分为中断治疗组和治疗16周组。比较2组治疗后哮喘控制测试问卷（ACT）评分、外周血成分指标、肺通气和弥散功能指标及呼出气一氧化氮（FeNO）水平。记录患者奥马珠单抗皮下注射治疗期间不良反应发生情况。结果 治疗16周组治疗后ACT评分高于中断治疗组［（21.4±2.1）分比（16.5±3.5）分］，差异有统计学意义（P＜0.001）。治疗后，治疗16周组白细胞计数、中性粒细胞计数、中性粒细胞比例均低于中断治疗组，肺活量、肺活量占预计值百分比、第1秒用力呼气容积、呼气峰值流速占预计值百分比、呼气25%、50%肺活量时的最大呼气流量均高于中断治疗组，差异均有统计学意义（均P＜0.05）。治疗后，治疗16周组FeNO水平低于中断治疗组，但差异无统计学意义（P＞0.05）。46例患者104例次奥马珠单抗皮下注射治疗期间出现2例次不良反应，发生率为1.9%（2/104），1例次为皮肤瘙痒，1例次为皮疹，反应程度均为轻度，均未经特殊处理症状自行消失。结论 中重度过敏性哮喘患者应用奥马珠单抗治疗16周后ACT评分改善，哮喘及过敏症状减轻，肺功能明显改善，且不良反应发生率较低。

• Objective To study the clinical effect and safety of omalizumab in treatment of moderate and severe allergic asthma. Methods Totally 46 patients with moderate or severe allergic asthma admitted to Civil Aviation General Hospital from May to December 2020 were retrospectively selected. All of patients were given omalizumab treatment. According to the treatment duration, they were divided into the interrupted treatment group and the 16 weeks treatment group. The asthma control test questionnaire (ACT) score, peripheral blood component index, pulmonary ventilation and diffusion function index and fractional exhaled nitric oxide (FeNO) level were compared between the two groups after treatment. The incidence of adverse reactions during subcutaneous injection of omalizumab was recorded. Results The ACT score of the 16 weeks treatment group was higher than that of the interrupted treatment group after treatment［(21.4±2.1) vs (16.5±3.5)］ (P＜0.001). The white blood cell count, neutrophil count and neutrophil ratio of the 16 weeks treatment group were lower than those of the interrupted treatment group, and the vital capacity, percentage of vital capacity to predicted value, forced expiratory volume in the first second, percentage of peak expiratory flow rate to predicted value, maximum expiratory flow at 25% and 50% of vital capacity were higher than those of the interrupted treatment group (all P＜0.05). The FeNO level in the 16 weeks treatment group was lower than that in the interrupted treatment group, but the difference was not statistically significant (P＞0.05). Among the 46 patients, 104 times of omalizumab were subcutaneously injected, and 2 times of adverse reactions occurred, 1 time of skin itching and 1 time of skin rash, with an incidence rate of 1.9%(2/104). Those degree were mild, and the symptoms disappeared without special treatment. Conclusion After 16 weeks of treatment with omalizumab, the ACT score of patients with moderate or severe allergic asthma is improved, asthma and allergic symptoms are alleviated, lung function is significantly improved, and the incidence of adverse reactions is low.