奥马珠单抗治疗血清总IgE>1 500 IU/mL的中重度过敏性哮喘儿童的前瞻性研究

Clinical efficacy of omalizumab for treatment of moderate or severe allergic asthma in children with serum immunoglobulin E levels >1 500 IU/mL: a prospective study

摘要:

目的 评估奥马珠单抗治疗血清总免疫球蛋白E（immunoglobulin E, IgE）>1 500 IU/mL的中重度过敏性哮喘儿童的临床疗效。方法 前瞻性选择2020年12月—2022年5月在安徽省儿童医院呼吸内科诊治的中重度过敏性哮喘儿童95例为研究对象。根据血清总IgE水平及是否使用奥马珠单抗治疗分为对照组（总IgE>1 500 IU/mL，未使用奥马珠单抗治疗）、正常治疗组（总IgE水平在30~1 500 IU/mL之间，使用奥马珠单抗治疗）及超高IgE治疗组（总IgE>1 500 IU/mL，使用奥马珠单抗治疗）。分析3组患儿的临床特征和治疗前后儿童哮喘控制测试（Childhood Asthma Control Test, C-ACT）评分、急性发作患儿比例、IgE水平、肺功能指标、呼出气一氧化氮（fractional exhaled nitric oxide, FeNO）浓度的差异。结果 治疗第8周时，正常治疗组、超高IgE治疗组C-ACT评分、第1秒用力呼气量（forced expiratory volume in first second, FEV₁）占预测值百分比（FEV₁%pred）、FEV₁/用力肺活量（forced vital capacity, FVC）（FEV₁/FVC）、呼气流量峰值（peak expiratory flow, PEF）占预测值百分比（PEF%pred）较对照组高，急性发作患儿比例、FeNO浓度较对照组低（P<0.05）；超高IgE治疗组和正常治疗组各指标比较差异均无统计学意义（P>0.05）。治疗第16周时，正常治疗组、超高IgE治疗组C-ACT评分、FEV₁%pred、FEV₁/FVC、PEF%pred、用力呼出25％肺活量的呼气流量（forced expiratory flow at 25% of forced vital capacity exhaled, FEF₂₅）占预测值百分比（FEF₂₅%pred）较对照组高，急性发作患儿比例、FeNO浓度较对照组低（P<0.05）；超高IgE治疗组和正常治疗组各指标比较差异均无统计学意义（P>0.05）。结论 奥马珠单抗治疗血清总IgE水平超过1 500 IU/mL的中重度过敏性哮喘儿童有一定的临床疗效，与治疗血清总IgE水平在30~1 500 IU/mL之间的中重度过敏性哮喘儿童疗效无明显差异。

Abstract:

Objective To evaluate the clinical efficacy of omalizumab in the treatment of moderate or severe allergic asthma in children with serum total immunoglobulin E (IgE) levels >1 500 IU/mL.Methods A total of 95 children with moderate or severe allergic asthma, who were treated at the Department of Respiratory Medicine in Anhui Provincial Children's Hospital from December 2020 to May 2022, were enrolled. Based on their serum total IgE levels and whether they received omalizumab treatment, they were divided into a control group (IgE >1 500 IU/mL, no omalizumab treatment), a normal treatment group (IgE levels between 30 and 1 500 IU/mL, omalizumab treatment), and an ultra-high IgE treatment group (IgE >1 500 IU/mL, omalizumab treatment). The differences in clinical characteristics, Childhood Asthma Control Test (C-ACT) scores before and after treatment, the proportion of acute attacks, IgE levels, pulmonary function indicators, and fractional exhaled nitric oxide (FeNO) concentrations were analyzed among the three groups.Results At the 8th week of treatment, the normal treatment group and the ultra-high IgE treatment group had higher C-ACT scores, forced expiratory volume in first second (FEV₁) as a percentage of predicted value (FEV₁%pred), FEV₁/forced vital capacity (FVC) ratio (FEV₁/FVC), and peak expiratory flow (PEF) as a percentage of predicted value (PEF%pred), as well as a lower proportion of acute attacks and FeNO concentration compared to the control group (P<0.05). There were no statistically significant differences in the comparison of various indicators between the ultra-high IgE treatment group and the normal treatment group (P>0.05). At the 16th week of treatment, the normal treatment group and the ultra-high IgE treatment group had higher C-ACT scores and pulmonary function indicators including FEV₁%pred, FEV₁/FVC, PEF%pred, and forced expiratory flow at 25% vital capacity (FEF₂₅) as a percentage of predicted value (FEF₂₅%pred) compared to the control group (P<0.05). The proportion of acute attacks and FeNO concentration in the ultra-high IgE treatment group were lower than those in the control group (P<0.05). There were no statistically significant differences in the comparison of various indicators between the ultra-high IgE treatment group and the normal treatment group (P>0.05).Conclusions Omalizumab therapy has a certain clinical efficacy in children with moderate or severe allergic asthma and serum total IgE levels >1 500 IU/mL, with no significant difference in efficacy compared to children with serum total IgE levels between 30 and 1 500 IU/mL.