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

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)% (Z=-3.626, P<0.001). The FEV1%pred after inhaled bronchodilator increased from 92.60(85.75, 96.90)% to 94.30(89.95, 98.15)% (Z=-2.178, P=0.029). The absolute value of improvement in FEV1 decreased from 150(95, 210)ml to 50(20, 125) ml (Z=-2.796, P=0.005), and the improvement rate decreased from 6.60(3.80, 7.85)% to 1.90(0.75, 4.85)% (Z=-2.922, P=0.003). After 12 months of treatment, the FEV1%pred before inhaled bronchodilator further increased to 92.90 (91.60, 98.15)% (Z=-3.575, -2.818, and P<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)% (Z=-3.622, -1.638, and P<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 (P=0.004, 0.842 before treatment and 6 months after treatment, respectively), and the improvement rate was 3.0(1.0, 5.0)% (Z=-2.960, -0.166, and P=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) (Z=-3.626,P<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.为探讨使用奥马珠单抗治疗中重度过敏性哮喘患者的症状控制、肺功能变化及安全性。本研究采取小样本治疗前后自身对照研究的方法，回顾性分析2020年1月至2021年12月期间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，比较患者治疗前、治疗6个月后和治疗12个月后临床症状、肺功能变化，并观察其他药物使用情况和不良反应等临床资料。数据采用中位数（四分位区间）即M（Q1，Q3）表示，对前后比较数据使用非参数配对Wilcoxon分析。结果显示，在使用奥马珠单抗治疗前，患者的FeNO值为79（58，121）ppb，血清总IgE为228（150.5，345.5）IU/ml。在使用奥马珠单抗治疗6个月后，患者吸入支气管扩张剂前的FEV1占预计值%由86.70（82.65，91.35）%上升至90.90（87.70，95.85）%（Z=-3.576，P<0.001），吸入支气管扩张剂后的FEV1占预计值%由92.60（85.75，96.90）%上升至94.30（89.95，98.15）%（Z=-2.178，P=0.029），FEV1改善绝对值由150（95，210）ml下降至50（20，125）ml（Z=-2.796，P=0.005），改善率由6.60（3.80，7.85）%下降至1.90（0.75，4.85）%（Z=-2.922，P=0.003）。经过治疗12个月后，患者吸入支气管扩张剂前的FEV1占预计值%进一步上升至92.90（91.60，98.15）%（与治疗前和治疗6个月后比较Z值分别为-3.575、-2.818，P分别为<0.001、0.005），吸入支气管扩张剂后的FEV1占预计值%上升至96.80（91.90，101.25）%（与治疗前和治疗6个月后比较Z值分别为-3.622、-2.638，P分别为<0.001、0.008），FEV1改善绝对值为70（35，120）ml（与治疗前和治疗6个月后比较Z值分别为-2.915、-1.999，P分别为0.004、0.842），改善率为3.0（1.0，5.0）%（与治疗前和治疗6个月后比较Z值分别为-2.960、-0.166，P分别为0.003、0.868）。治疗12个月后ACT由治疗前的13（10.5，18）提高到24（23，25）（Z=-3.626，P<0.001）。患者在治疗过程中，仅有1例出现注射部位皮肤反应。综上，使用奥马珠单抗治疗6个月和12个月时，肺功能得以持续改善，患者哮喘症状明显得以控制，并能有效预防哮喘急性发作。同时，奥马珠单抗治疗的安全性和耐受性较好，未发现奥马珠单抗对患者血压、血糖的影响。.