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奥马珠单抗治疗中重度过敏性哮喘患者一年的临床疗效观察

[Clinical efficacy observation of omalizumab on patients with moderate to severe allergic asthma for one year].

作者信息

Xu Y, Zhou D X, Hu P, Gong P H

机构信息

Pulmonary and Critical Care Medicine, Beijing Jishuitan Hospital, Beijing 100035, China.

Pulmonary and Critical Care Medicine, Peking University People's Hospital, Beijing 100044, China.

出版信息

Zhonghua Yu Fang Yi Xue Za Zhi. 2023 Mar 6;57(3):427-432. doi: 10.3760/cma.j.cn112150-20221016-00998.

Abstract

To observe the symptom control, pulmonary function changes and safety of use of omalizumab in patients with moderate to severe allergic asthma for 1 year. A small sample self-controlled study before and after treatment was conducted to retrospective analysis involved 17 patients with moderate to severe asthma who received omalizumab therapy for 12 months in Peking University People's Hospital and Beijing Jishuitan Hospital from January 2020 to December 2021. The clinical symptoms and pulmonary function changes were compared before treatment, after 6 months and 12 months of treatment, and the clinical data such as the use of other drugs and adverse reactions were observed. Statistical data are collected using the median method, and non-parametric paired Wilcoxon analysis was used for pairwise comparison. Before treatment with omalizumab, the patients' FeNO value was 79(58, 121) ppb, and the total serum IgE was 228(150.5, 345.5) IU/ml. After 6 months of omalizumab therapy, the percent predicted value of the forced expiratory volume in 1 second (FEV1%) before inhaled bronchodilator increased from 86.70(82.65, 91.35)% to 90.90(87.70, 95.85)% (=-3.626, <0.001). The FEV1%pred after inhaled bronchodilator increased from 92.60(85.75, 96.90)% to 94.30(89.95, 98.15)% (=-2.178, =0.029). The absolute value of improvement in FEV1 decreased from 150(95, 210)ml to 50(20, 125) ml (=-2.796, =0.005), and the improvement rate decreased from 6.60(3.80, 7.85)% to 1.90(0.75, 4.85)% (=-2.922, =0.003). After 12 months of treatment, the FEV1%pred before inhaled bronchodilator further increased to 92.90 (91.60, 98.15)% (=-3.575, -2.818, and <0.001, 0.005 compared with before treatment and 6 months after treatment, respectively). The FEV1%pred after inhaled bronchodilator increased to 96.80 (91.90, 101.25)% (=-3.622, -1.638, and <0.001, 0.008 compared with before treatment and after 6 months of treatment, respectively). The absolute value of improvement in FEV1 was 70 (35, 120) ml (=0.004, 0.842 before treatment and 6 months after treatment, respectively), and the improvement rate was 3.0(1.0, 5.0)% (=-2.960, -0.166, and =0.003, 0.868, compared with before treatment and after 6 months of treatment, respectively). After 12 months of treatment, ACT increased from 13 (10.5, 18) before treatment to 24 (23, 25) (=-3.626,<0.001). Only 1 patient experienced an injection site skin reaction during treatment. Therefore, after 6 months and 12 months of treatment with omalizumab, the patient's lung function improved and symptoms were relieved, which could effectively prevent the acute exacerbation of asthma. Omalizumab treatment is safe and well tolerated, and no effect on blood pressure and blood glucose was observed.

摘要

观察中重度过敏性哮喘患者使用奥马珠单抗1年的症状控制情况、肺功能变化及用药安全性。采用治疗前后自身对照的小样本研究方法,对2020年1月至2021年12月在北京大学人民医院和北京积水潭医院接受奥马珠单抗治疗12个月的17例中重度哮喘患者进行回顾性分析。比较治疗前、治疗6个月及12个月后的临床症状和肺功能变化,并观察使用其他药物及不良反应等临床资料。采用中位数法收集统计数据,采用非参数配对Wilcoxon分析进行两两比较。奥马珠单抗治疗前,患者呼出气一氧化氮(FeNO)值为79(58,121)ppb,血清总IgE为228(150.5,345.5)IU/ml。奥马珠单抗治疗6个月后,吸入支气管扩张剂前第1秒用力呼气容积占预计值百分比(FEV1%pred)从86.70(82.65,91.35)%升至90.90(87.70,95.85)%(Z=-3.626,P<0.001)。吸入支气管扩张剂后FEV1%pred从92.60(85.75,96.90)%升至94.30(89.95,98.15)%(Z=-2.178,P=0.029)。FEV1改善绝对值从150(95,210)ml降至50(20,125)ml(Z=-2.796,P=0.005),改善率从6.60(3.80,7.85)%降至1.90(0.75,4.85)%(Z=-2.922,P=0.003)。治疗12个月后,吸入支气管扩张剂前FEV1%pred进一步升至92.90(91.60,98.15)%(Z=-3.575,与治疗前比较P=-2.818,<0.001;与治疗6个月后比较P=0.005)。吸入支气管扩张剂后FEV1%pred升至96.80(91.90,101.25)%(Z=-3.622,与治疗前比较P=-1.638,<0.001;与治疗6个月后比较P=0.008)。FEV1改善绝对值为70(35,120)ml(与治疗前比较P=0.004,与治疗6个月后比较P=0.842),改善率为3.0(1.0,5.0)%(与治疗前比较Z=-2.960,P=0.003;与治疗6个月后比较Z=-0.166,P=0.868)。治疗12个月后,哮喘控制测试(ACT)评分从治疗前的13(10.5,18)升至24(23,25)(Z=-3.626,P<0.001)。治疗期间仅1例患者出现注射部位皮肤反应。因此,奥马珠单抗治疗6个月及12个月后,患者肺功能改善、症状缓解,可有效预防哮喘急性加重。奥马珠单抗治疗安全且耐受性良好,未观察到对血压和血糖的影响。

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