[Short-term efficacy of anti-IgE monoclonal antibody in patients with recurrent chronic rhinosinusitis with nasal polyps combined with asthma]

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2021 Oct 7;56(10):1035-1041. doi: 10.3760/cma.j.cn115330-20210608-00338.
[Article in Chinese]

Abstract

Objective: To investigate the short-term efficacy of anti-IgE monoclonal antibody (Omalizumab) in the treatment of recurrent chronic rhinosinusitis with nasal polyps (CRSwNP) complicated with asthma. Methods: Patients with recurrent CRSwNP and comorbid asthma in Beijing TongRen Hospital from May to December of 2020 were continuously recruited and received a 4-month therapy of stable background treatment plus Omalizumab. Results of visual analog scales (VAS) of nasal symptoms, sino-nasal outcome test-22 (SNOT 22) and nasal polyp scores were collected at baseline and post-treatment (1, 2, 3 and 4 months after treatment). Blood routine tests, total nasal resistances (TNR), minimum cross-sectional areas (MCA), total nasal cavity volumes (NCV), forced expiratory volumes in one second (FEV1)/forced vital capacity (FVC) and adverse events were collected at baseline and 4 months after treatment. All results were evaluated for short-term efficacy of Omalizumab. GraphPad Prism 8.2.1 was used for statistic analysis. Results: Ten patients were collected, including 3 males and 7 females, aged (41.13±12.64) years old (x¯±s). Compared to results at baseline, the VAS scores of nasal obstruction, rhinorrhea, hyposmia and headache after 4 months treatment were significantly decreased (1.80±1.48 vs 6.70±2.83, 2.40±1.27 vs 6.40±3.44, 2.70±2.91 vs 8.20±2.25, 0.60±1.08 vs 3.60±2.72, t value was 5.045, 4.243, 5.312, 3.402, respectively, all P<0.01). The scores of SNOT-22 (25.6±20 vs 61.3±33.32, t=4.127, P=0.002 6), nasal polyp scores (2.20±0.92 vs 4.60±0.84, t=9.000, P<0.01) and the count and percentage of eosinophils in peripheral blood were significantly decreased ((94.10±97.78)×109/L vs (360.00±210.80)×109/L, (32.90±27.06)% vs (64.40±20.73)%, t value was 3.678, 2.957, respectively, all P<0.05). NCV (0-5 cm and 0-7 cm) of patients were improved from baseline ((12.62±2.84) cm3 vs (10.40±2.09) cm3, (27.50±14.15) cm3 vs (16.81±6.40) cm3, t value was 2.371, 2.445, respectively, all P<0.05). Conclusions: The 4-month treatment of Omalizumab can significantly improve the nasal symptoms and quality of life of patients with recurrent CRSwNP complicated with asthma, shrink nasal polyps size and reduce the number of peripheral blood eosinophils. Omalizumab can be used as an alternative therapy for refractory CRSwNP patients in the future.

目的: 探究抗IgE单克隆抗体(奥马珠单抗)治疗合并哮喘的复发性慢性鼻窦炎伴鼻息肉(CRSwNP)患者的短期疗效。 方法: 2020年5—12月,连续入组就诊于首都医科大学附属北京同仁医院门诊的合并哮喘的复发性CRSwNP患者。使用奥马珠单抗治疗4个月,在基线和用药第1、2、3、4个月访视时,收集患者鼻部症状视觉模拟量表(VAS)评分、鼻腔鼻窦结局测试22(SNOT-22)评分及鼻息肉评分等;在基线和用药第4个月访视时,收集患者血常规、鼻功能等客观检查结果。对用药后鼻部症状评分及客观检查结果较基线的变化差异进行分析,评估奥马珠单抗治疗的短期疗效。使用GraphPad Prism 8.2.1进行统计学分析。 结果: 共收集符合条件的患者10例,其中男3例,女7例,年龄(41.13±12.64)岁(x¯±s)。经过4个月奥马珠单抗治疗后,患者鼻塞、流涕、嗅觉减退、头痛VAS评分较基线显著降低[(1.80±1.48)分比(6.70±2.83)分,(2.40±1.27)分比(6.40±3.44)分,(2.70±2.91)分比(8.20±2.25)分,(0.60±1.08)分比(3.60±2.72)分,t值分别为5.045、4.243、5.312、3.402,P值均<0.01];SNOT-22评分较基线显著降低[(25.60±20.00)分比(61.30±33.32)分,t=4.127,P=0.002 6];鼻息肉评分较基线显著降低[(2.20±0.92)分比(4.60±0.84)分,t=9.000,P<0.01];外周血嗜酸粒细胞计数、百分比均较基线显著降低[(94.10±97.78)×109/L比(360.00±210.80)×109/L,(32.90±27.06)%比(64.40±20.73)%,t值分别为3.678、2.957,P值均<0.05];鼻腔体积(距前鼻孔5 cm和7 cm处)均较基线有显著增大[(12.62±2.84)cm3比(10.40±2.09)cm3,(27.50±14.15)cm3比(16.81±6.40)cm3t值分别为2.371、2.445,P值均<0.05]。 结论: 使用奥马珠单抗治疗4个月可明显改善合并哮喘的复发性CRSwNP患者的鼻部症状、生活质量,缩小鼻息肉体积,降低外周血嗜酸粒细胞数量,可作为该类患者新的治疗选择。.

MeSH terms

  • Adult
  • Antibodies, Anti-Idiotypic
  • Asthma* / complications
  • Asthma* / drug therapy
  • Chronic Disease
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nasal Polyps* / complications
  • Nasal Polyps* / drug therapy
  • Omalizumab / therapeutic use
  • Quality of Life
  • Rhinitis* / complications
  • Rhinitis* / drug therapy

Substances

  • Antibodies, Anti-Idiotypic
  • anti-IgE antibodies
  • Omalizumab