山东大学耳鼻喉眼学报 ›› 2024, Vol. 38 ›› Issue (1): 21-26.doi: 10.6040/j.issn.1673-3770.0.2022.544

• 论著 • 上一篇    下一篇

联合应用奥马珠单抗在儿童中重度变应性哮喘合并慢性鼻窦炎中的疗效观察

崇维琨,王娟   

  1. 南京医科大学附属明基医院 儿科, 江苏 南京 210019
  • 发布日期:2024-01-12
  • 通讯作者: 王娟. E-mail:wangjuannj@126.com

Efficacy of Omalizumab in children with moderate and severe allergic asthma and chronic sinusitis

CHONG Weikun, WANG Juan   

  1. Department of Pediatrics, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing 210019, Jiangsu, China
  • Published:2024-01-12

摘要: 目的 探讨奥马珠单抗在儿童中重度变应性哮喘合并慢性鼻窦炎治疗中的疗效。 方法 分析2020年9月至2022年4月间使用奥马珠单抗治疗的儿童中重度变应性哮喘合并慢性鼻窦炎的临床资料,比较治疗前后儿童哮喘控制评分(childhood asthma control test,C-ACT)、呼出气一氧化氮(fractional concentration of exhaled nitric oxide, FeNO)浓度、第1秒用力呼气量占预计值百分比(first second percentage to predicted value, FEV1% pred)和小气道功能指标等肺功能检查的变化以及患儿慢性鼻窦炎症状改善情况。 结果 完成治疗随访的患儿共26例。奥马珠单抗治疗16周后患儿哮喘症状及肺功能均改善,C-ACT从(15.57±3.25)分升至(24.98±5.21)分(F=15.711 2,P<0.001);FeNO从(31.55±15.57)ppb降至(19.86±9.80)ppb(F=4.426 5,P=0.002 2);肺功能提示FEV1%pred、1秒率(FEV1/FVC)均升高,但差异无统计学意义(P=0.995 4,P=0.938 2);用力呼气峰流量占预计值百分比、呼出75%肺活量时的最大呼气流量占预计值百分比、呼出50%肺活量时的最大呼气流量占预计值百分比均升高,差异有统计学意义(P=0.047 7,P=0.0005,P<0.001)。患儿鼻窦炎症状显著改善,选择视觉模拟量表评分从(6.40±2.98)分降至(0.85±0.40)分(t=27.241 9,P<0.001)。 结论 奥马珠单抗可改善中重度变应性哮喘合并慢性鼻窦炎患儿的哮喘与鼻窦炎的临床表现、肺功能及生活质量。

关键词: 奥马珠单抗, 变应性哮喘, 慢性鼻窦炎, 肺功能

Abstract: Objective To investigate the efficacy of Omalizumab in the treatment of children with moderate to severe allergic asthma and chronic sinusitis. Methods The clinical data of children with moderate and severe allergic asthma and chronic sinusitis treated with Omalizumab from September 2020 to April 2022 were retrospectively analyzed. A comparison was performed on the changes of childhood asthma control test(C-ACT), fractional concentration of exhaled nitric oxide(FeNO), forced expiratory volume in the first second percentage to predicted value(FEV1% pred)and small airway function, the improvement of chronic sinusitis symptoms,before and after treatment with Omalizumab. Results A total of 26 children completed treatment and follow-up. After 16 weeks of Omalizumab treatment, asthma symptoms and lung function were improved. Compared to pre-treatment, the C-ACT score increased from(15.57±3.25)score to(24.98±5.21)score(F=15.711 2, P<0.001)and FeNO decreased from(31.55±15.57)ppb to(19.86±9.80)ppb(F=4.426 5, P=0.002 2). Lung function indicators showed that FEV1%pred and FEV1/forced vital capacity(FEV1/FVC)increased post-treatment, but the differences were not statistically significant(P=0.995 4, P=0.938 2). The maximal expiratory flow percentage of the predicted value, forced expiratory flow at 75% to predicted value, forced expiratory flow at 50% to predicted value all increased significantly(P=0.047 7, P=0.000 5, P<0.001). The symptoms of sinusitis were also significantly improved, and the visual analogue scale score increased from 6.40±2.98 pre-treatment to 0.85±0.40 post-treatment(t=27.241 9, P<0.001). Conclusion Omalizumab can significantly improve the clinical symptoms, lung function indicators and quality of life of children with moderate and severe allergic asthma and chronic sinusitis.

Key words: Omalizumab, Allergic asthma, Chronic sinusitis, Lung function

中图分类号: 

  • R276.1
[1] 全国儿科哮喘协作组, 中国疾病预防控制中心环境与健康相关产品安全所. 第三次中国城市儿童哮喘流行病学调查[J]. 中华儿科杂志, 2013, 51(10): 729-735. doi: 10.3760/cma.j.issn.0578-1310.2013.10.003
[2] 中华医学会变态反应分会呼吸过敏学组(筹), 中华医学会呼吸病学分会哮喘学组. 中国过敏性哮喘诊治指南(第一版, 2019年)[J]. 中华内科杂志, 2019, 58(9): 636-655. doi:10.3760/cma.j.issn.05781426.2019.09.004
[3] 虞琳, 张慧珊, 赵欣, 等. 奥马珠单抗治疗儿童中重度变应性哮喘疗效及安全性病例系列研究[J]. 中华实用儿科临床杂志, 2020, 35(8): 617-621. doi:10.3760/cma.j.cn101070-20200330-00529 YU Lin, ZHANG Huishan, ZHAO Xin, et al. Case series study on efficacy and safety of Omalizumab in the treatment of moderate-to-severe allergic asthma in children[J]. Chinese Journal of Applied Clinical Pediatrics, 2020, 35(8): 617-621. doi:10.3760/cma.j.cn101070-20200330-00529
[4] 国家呼吸系统疾病临床医学研究中心, 中华医学会儿科学分会呼吸学组哮喘协作组, 中国医药教育协会儿科专业委员会, 等. 奥马珠单抗在儿童过敏性哮喘临床应用专家共识[J]. 中华实用儿科临床杂志, 2021, 36(12): 881-890. doi:10.3760/cma.j.cn101070-20210531-00621
[5] Morales-Múnera O, Pedraza á, Niño-Serna L. Omalizumab in children with uncontrolled asthma: a real-life study carried out in Colombia[J]. Rev Alerg Mex, 2018, 65(3): 222-232. doi:10.29262/ram.v65i3.510
[6] 中华医学会儿科学分会呼吸学组, 《中华儿科杂志》编辑委员会. 儿童支气管哮喘诊断与防治指南(2016年版)[J]. 中华儿科杂志, 2016, 54(3): 167-181. doi:10.3760/cma.j.issn.0578-1310.2016.03.003
[7] 中华耳鼻咽喉头颈外科杂志编辑委员会, 中华医学会耳鼻咽喉头颈外科学分会小儿学组、鼻科学组. 儿童鼻-鼻窦炎诊断和治疗建议(2012年, 昆明)[J]. 中华耳鼻咽喉头颈外科杂志, 2013, 48(3): 177-179. doi:10.3760/cma.j.issn.1673-0860.2013.03.001
[8] 中华耳鼻咽喉头颈外科杂志编辑委员会鼻科组, 中华医学会耳鼻咽喉头颈外科学分会鼻科学组. 中国慢性鼻窦炎诊断和治疗指南(2018)[J]. 中华耳鼻咽喉头颈外科杂志, 2019, 54(2): 81-100. doi:10.3760/cma.j.issn.1673-0860.2019.02.001
[9] Xiang L, Zhao J, Zheng YJ, et al. Uncontrolled asthma and its risk factors in Chinese children: a cross-sectional observational study[J]. J Asthma, 2016, 53(7): 699-706. doi:10.3109/02770903.2016.1144199
[10] 王雪艳, 王梦娟, 刘长山. 儿童过敏性哮喘[J]. 中国临床医生杂志, 2022, 50(12): 1402-1405. doi:10.3969/j.issn.2095-8552.2022.12.005 WANG Xueyan, WANG Mengjuan, LIU Changshan. Allergic asthma in children[J]. Chinese Journal for Clinicians, 2022, 50(12): 1402-1405. doi:10.3969/j.issn.2095-8552.2022.12.005
[11] Orlandi RR, Kingdom TT, Smith TL, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021[J]. Int Forum Allergy Rhinol, 2021, 11(3): 213-739. doi:10.1002/alr.22741
[12] 杨一帆, 程雷. 儿童鼻窦炎与哮喘: 统一气道疾病[J]. 山东大学耳鼻喉眼学报, 2019, 33(6): 10-15. doi:10.6040/j.issn.1673-3770.1.2019.061 YANG Yifan, CHENG Lei. Rhinosinusitis and asthma in children: united airway disease[J]. Journal of Otolaryngology and Ophthalmology of Shandong University, 2019, 33(6): 10-15. doi:10.6040/j.issn.1673-3770.1.2019.061
[13] Mulinda C, Yang N, Gudis DA. Pediatric unified airway: chronic rhinosinusitis and lower-airway disease[J]. Otolaryngol Clin North Am, 2023, 56(1): 137-146. doi:10.1016/j.otc.2022.09.010
[14] Licari A, Andrenacci B, di Cicco ME, et al. Respiratory comorbidities in severe asthma: focus on the pediatric age[J]. Expert Rev Respir Med, 2023, 17(1): 1-13. doi:10.1080/17476348.2023.2168261
[15] Humbert M, Bousquet J, Bachert C, et al. IgE-mediated multimorbidities in allergic asthma and the potential for omalizumab therapy[J]. J Allergy Clin Immunol Pract, 2019, 7(5): 1418-1429. doi:10.1016/j.jaip.2019.02.030
[16] Poddighe D, Brambilla I, Licari A, et al. Pediatric rhinosinusitis and asthma[J]. Respir Med, 2018, 141: 94-99. doi:10.1016/j.rmed.2018.06.016
[17] 敬尚林, 林楠, 陈继昌. 儿童鼻-鼻窦炎诊疗规范化探讨[J]. 山东大学耳鼻喉眼学报, 2014, 28(5): 91-94. doi:10.6040/j.issn.1673-3770.0.2014.105 JING Shanglin, LIN Nan, CHEN Jichang. Diagnosis and treatment of standardization of rhinitis and sinusitis in children[J]. Journal of Otolaryngology and Ophthalmology of Shandong University, 2014, 28(5): 91-94.doi:10.6040/j.issn.1673-3770.0.2014.105
[18] Perikleous EP, Steiropoulos P, Nena E, et al. Biologic therapies in pediatric asthma[J]. J Pers Med, 2022, 12(6): 999. doi:10.3390/jpm12060999
[19] Chen L, Chen YP. Effects of omalizumab in children with asthma: a protocol for systematic review and meta-analysis[J]. Medicine, 2021, 100(22): e26155. doi:10.1097/MD.0000000000026155
[20] Balbino B, Conde E, Marichal T, et al. Approaches to target IgE antibodies in allergic diseases[J]. Pharmacol Ther, 2018, 191: 50-64. doi:10.1016/j.pharmthera.2018.05.015
[21] Bachert C, Nan Z, Cavaliere C, et al. Biologics for chronic rhinosinusitis with nasal polyps[J]. J Allergy Clin Immunol, 2020, 145(3): 725-739. doi:10.1016/j.jaci.2020.01.020
[22] 隋海晶, 胡艳, 陈玉迪, 等. 抗IgE单克隆抗体治疗难治性鼻窦炎伴鼻息肉三例[J]. 中华耳鼻咽喉头颈外科杂志, 2021, 56(2): 150-152. doi:10.3760/cma.j.cn115330-20201112-00864 SUI Haijing, HU Yan, CHEN Yudi, et al. Three cases of refractory sinusitis with nasal polyps treated with anti IgE monoclonal antibody[J]. Chinese Journal of Otorhinolaryngology Head and Neck Surgery, 2021, 56(2): 150-152. doi:10.3760/cma.j.cn115330-20201112-00864
[23] Rodrigo GJ, Neffen H. Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents[J]. Pediatr Allergy Immunol, 2015, 26(6): 551-556. doi:10.1111/pai.12405
[24] Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody(omalizumab)[J]. Pediatrics, 2001, 108(2): E36. doi:10.1542/peds.108.2.e36
[25] Oliveira MJ, Vieira M, Coutinho D, et al. Severe asthma in obese patients: improvement of lung function after treatment with omalizumab[J]. Pulmonology, 2019, 25(1): 15-20. doi:10.1016/j.pulmoe.2018.01.005
[26] Licari A, Castagnoli R, Denicolò C, et al. Omalizumab in children with severe allergic asthma: the Italian real-life experience[J]. Curr Respir Med Rev, 2017, 13(1): 36-42. doi:10.2174/1573398X13666170426094536
[27] Odajima H, Ebisawa M, Nagakura T, et al. Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma[J]. Allergol Int, 2017, 66(1): 106-115. doi:10.1016/j.alit.2016.06.004
[1] 王明明,罗洋,贺少娟,张现兴,李学忠. 慢性鼻窦炎鼻息肉基底干细胞转录组生物信息学分析[J]. 山东大学耳鼻喉眼学报, 2023, 37(5): 6-15.
[2] 王晓嫒,张欠欠,程翔宇,李志鹏,张维天,叶海波. 翼管神经切断术治疗2型慢性鼻窦炎伴过敏性鼻炎的临床疗效分析[J]. 山东大学耳鼻喉眼学报, 2023, 37(5): 42-49.
[3] 朱玉,朱新华. TH2细胞因子在2型慢性鼻窦炎伴鼻息肉中的作用机制研究进展[J]. 山东大学耳鼻喉眼学报, 2023, 37(5): 156-161.
[4] 袁玥,付圣尧,姜彦,陈敏. 细胞焦亡在慢性气道炎症性疾病中的研究进展[J]. 山东大学耳鼻喉眼学报, 2023, 37(4): 166-171.
[5] 李卓君,宋西成,陈秀梅. 阻塞性睡眠呼吸暂停低通气综合征患者的肺功能变化分析[J]. 山东大学耳鼻喉眼学报, 2023, 37(2): 45-50.
[6] 敖天, 程雷. 慢性鼻窦炎伴鼻息肉的内型研究及其指导下的精准控制与治疗[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 7-14.
[7] 熊攀辉,沈暘,杨玉成. 基于表型和内在型的慢性鼻窦炎诊治进展[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 15-19.
[8] 姚爽,娄鸿飞. 慢性鼻窦炎的内在型研究进展及精准医疗[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 20-29.
[9] 石帅,郑泉,程雷. 度普利尤单抗在慢性鼻窦炎伴鼻息肉治疗中的研究进展[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 36-42.
[10] 王欢,胡俐,余洪猛. 慢性鼻窦炎相关嗅觉功能障碍研究进展[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 43-49.
[11] 宜若男,陈福权. 嗜酸性粒细胞与嗅觉功能障碍[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 50-55.
[12] 谷钰,万鑫,肖自安. 中性粒细胞和嗜酸性粒细胞在慢性鼻窦炎中的相互影响及临床治疗思考[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 56-63.
[13] 林海,朱莹,张维天. 慢性鼻窦炎发病中离子通道作用研究进展[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 64-70.
[14] 乔新杰,赵玉林. 慢性鼻窦炎中上皮间质转化信号转导通路及其他相关因子的研究进展[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 71-77.
[15] 黄丹怡,张婷,陈静,张薇. 上皮屏障在慢性鼻窦炎伴鼻息肉中的研究进展[J]. 山东大学耳鼻喉眼学报, 2022, 36(3): 78-83.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
No Suggested Reading articles found!