中国循证儿科杂志 ›› 2021, Vol. 16 ›› Issue (2): 120-123.DOI: 10.3969/j.issn.1673-5501.2021.02.008

• 论著 • 上一篇    下一篇

吸入激素联合奥马珠单抗治疗中重度儿童过敏性哮喘合并过敏性鼻炎自身前后对照试验

彭俊争, 樊慧峰, 张彩凤, 陈容珊, 赵斯静, 何春卉   

  1. 广州医科大学广州市妇女儿童医疗中心 广州,510623
  • 收稿日期:2021-01-11 修回日期:2021-03-23 出版日期:2021-04-25 发布日期:2021-06-04
  • 通讯作者: 何春卉,email:sminthill@hotmail.com

Inhaled corticosteroids combined with omalizumab in the treatment of 35 children with moderate to severe allergic asthma and allergic rhinitis: A self-controlled trial

PENG Junzheng, FAN Huifeng, ZHANG Caifeng, CHEN Rongshan, ZHAO Sijing, HE Chunhui   

  1. Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, China
  • Received:2021-01-11 Revised:2021-03-23 Online:2021-04-25 Published:2021-06-04
  • Contact: HE Chunhui, email: sminthill@hotmail.com

摘要: 背景 国外研究显示奥马珠单抗对≥6岁儿童中重度过敏性哮喘疗效肯定,目前缺乏中国哮喘儿童临床数据。目的 评价奥马珠单抗治疗过敏性哮喘合并过敏性鼻炎儿童的有效性和安全性。设计 自身前后对照试验。方法 纳入符合中重度过敏性哮喘合并过敏性鼻炎诊断、年龄6~18岁、能够承受16周疗程费用、使用奥马珠单抗前血清IgE 75~1 500 IU·mL-1、生命体征平稳、处于哮喘非急性期发作状态的患儿。采用吸入激素+奥马珠单抗治疗方案,观察支气管哮喘控制、鼻炎和咳嗽症状、哮喘儿童生活质量、儿童生存质量、肺功能、身高和体重增长情况。观察指标于治疗开始前和完成16周时评估。主要结局指标 4~11岁患儿采用儿童哮喘控制测试(C-ACT)进行评分,≥12岁儿童采用ACT评分,C-ACT/ACT评分在治疗前后增长≥3分定义为治疗有效。结果 纳入35例中重度过敏性哮喘伴过敏性鼻炎患儿,体重(31±9.6)kg,身高(134.8±13.8)cm;符合哮喘3和4级治疗方案共32例、5级治疗方案3例,平均IgE水平340(168~583) IU·mL-1。吸入激素+奥马珠单抗治疗4周后患儿C-ACT/ACT评分、鼻炎和咳嗽VAS评分、PAQLQ/pedsQLTM3.0哮喘模块评估好转,差异均有统计学意义(P <0.05);16周后较治疗前C-ACT/ACT评分改善>3分,鼻炎和咳嗽VAS评分、PAQLQ/pedsQLTM3.0哮喘模块评估均较治疗4周后进一步改善。16周后肺功能和FeNO评估指标均较治疗前明显改善,差异有统计学意义(P<0.05)。治疗期间1例出现注射部位皮肤瘙痒。结论 吸入激素联合奥马珠单抗治疗儿童中重度过敏性哮喘合并过敏性鼻炎哮喘控制效果好,可改善用药期间的临床症状,且安全性良好。

关键词: 奥马珠单抗, IgE, 中国儿童, 过敏性哮喘, 过敏性鼻炎

Abstract: Background Omalizumab is effective in treating moderate to severe allergic asthma in children over 6 years old abroad, and there is a lack of clinical data of asthmatic children in China.Objective To evaluate the efficacy and safety of omalizumab in the treatment of children with allergic asthma and allergic rhinitis.DesignSelf-controlled trial.Methods We included those aged 6-18 years with moderate to severe allergic asthma and allergic rhinitis, who can afford 16 weeks of treatment and were in the non acute stage of asthma, whose serum IgE were 75-1,500 U·mL-1 before using omalizumab, and whose vital signs were stable. Inhaled corticosteroids combined with omalizumab was performed to observe asthma control, rhinitis and cough symptoms, and quality of life of asthmatic children, quality of life of asthmatic children lung function, height and weight gain. Outcome measures were evaluated before and 16 weeks after treatment.The main outcome measures Children aged 4 to 11 years old were scored by C-ACT. Children aged ≥12 years old were scored by ACT. The C-ACT/ACT score increasing by more than 3 points before and after treatment was defined as effective treatment.Results Thirty-five cases of moderate and severe allergic asthma with allergic rhinitis were included into the analysis. The weight was (31±9.6) kg and height was (134.8±13.8) cm. A total of 32 cases could use level 3 and 4 treatment plan, and there were 3 cases for level 5 treatment plan . The average IgE level was 340 (168~583) IU·mL-1. The C-ACT/ACT score, rhinitis and cough VAS score, PAQLQ/pedsQLTM3.0 asthma module evaluation were improved after 4 weeks of treatment with omalizumab, and the differences were statistically significant (P<0.05). The C-ACT/ACT score were improved by more than 3 points after 16 weeks of treatment, and the rhinitis and cough VAS score, PAQLQ/pedsQLTM3.0 asthma module evaluation were further improved after 4 weeks of treatment. After 16 weeks, the lung function and FeNO evaluation indexes were significantly improved compared with those before treatment (P<0.05). During the treatment, one patient developed pruritus at the injection site.Conclusion Inhaled corticosteroids combined with omalizumab in the treatment of children with moderate to severe allergic asthma and allergic rhinitis showed good effect and safety, and improved the clinical symptoms during medication.

Key words: Omalizumab, IgE, Chinese children, Allergic asthma, Allergic rhinitis