高级检索
史婧, 孜丽努尔·阿不都许库尔, 蔡慧, 等. 奥马珠单抗治疗变应性支气管肺曲霉病的疗效与安全性:一项真实世界研究[J]. 中国临床医学, 2024, 31(2): 161-168. DOI: 10.12025/j.issn.1008-6358.2024.20240197
引用本文: 史婧, 孜丽努尔·阿不都许库尔, 蔡慧, 等. 奥马珠单抗治疗变应性支气管肺曲霉病的疗效与安全性:一项真实世界研究[J]. 中国临床医学, 2024, 31(2): 161-168. DOI: 10.12025/j.issn.1008-6358.2024.20240197
SHI Jing, ABUDUXUKUER Zilinuer, CAI Hui, et al. Efficacy and safety of omalizumab in the treatment of allergic bronchopulmonary aspergillosis: a real-world study[J]. Chinese Journal of Clinical Medicine, 2024, 31(2): 161-168. DOI: 10.12025/j.issn.1008-6358.2024.20240197
Citation: SHI Jing, ABUDUXUKUER Zilinuer, CAI Hui, et al. Efficacy and safety of omalizumab in the treatment of allergic bronchopulmonary aspergillosis: a real-world study[J]. Chinese Journal of Clinical Medicine, 2024, 31(2): 161-168. DOI: 10.12025/j.issn.1008-6358.2024.20240197

奥马珠单抗治疗变应性支气管肺曲霉病的疗效与安全性:一项真实世界研究

Efficacy and safety of omalizumab in the treatment of allergic bronchopulmonary aspergillosis: a real-world study

  • 摘要:
    目的 探讨奥马珠单抗治疗变态反应性支气管肺曲霉病(allergic bronchopulmonary aspergillosis, ABPA)的疗效与安全性。
    方法 回顾性分析2018年11月至2023年12月复旦大学附属中山医院收治的奥马珠单抗治疗的26例ABPA患者(奥马珠单抗组),以及同期收治的泼尼松联合伊曲康唑治疗的24例ABPA患者(对照组)的临床资料。主要观察指标是奥马珠单抗治疗后ABPA急性发作次数和口服糖皮质激素节约效应,次要观察指标是治疗后呼吸道症状、外周血嗜酸性粒细胞计数、血清总IgE水平、烟曲霉sIgE水平、肺功能第1秒用力呼气容积占预计值百分比(FEV1% pred)、呼出气一氧化氮(fraction of exhaled nitric oxide, FeNO)、胸部CT表现和治疗相关不良反应。
    结果 奥马珠单抗组用药6个月和12个月后的ABPA急性发作次数分别为0(0,0)次/6个月和0(0,1)次/6个月,差异无统计学意义(P=0.157),均较基线次数1(1,2)次/6个月显著降低(P<0.001)。口服泼尼松剂量由治疗前的10(5,15)mg/d减少至治疗6个月后的3.125(0,5)mg/d(P<0.001),治疗12个月后剂量为0(0,3.125)mg/d,显著低于基线剂量(P=0.003),但与治疗6个月的剂量差异无统计学意义(P=0.438)。与治疗前相比,奥马珠单抗治疗12个月后的FeNO水平显著降低26(13,36)×10-9 vs 30(18,56)×10-9P=0.049,血嗜酸性粒细胞计数、总IgE水平、烟曲霉sIgE水平和FEV1% pred治疗前后差异无统计学意义。奥马珠单抗治疗6个月后,23例(88.5%)患者呼吸道症状缓解,8例(8/16,50%)患者黏液栓明显吸收。与对照组相比,奥马珠单抗组治疗12个月后停用口服泼尼松的患者比例更高(P=0.035)。奥马珠单抗治疗期间,4例(15.4%)患者出现丙氨酸氨基转移酶轻度升高,1例患者合并肝细胞癌。
    结论 奥马珠单抗可有效减少ABPA急性发作次数,减少口服糖皮质激素的剂量,改善FeNO,有助于黏液栓吸收,具有较高的安全性。

     

    Abstract:
    Objective To explore the efficacy and safety of omalizumab in the treatment of allergic bronchopulmonary aspergillosis (ABPA).
    Methods The clinical data of 26 ABPA patients treated with omalizumab in Zhongshan Hospital, Fudan University from November 2018 to December 2023 and 24 ABPA patients treated with prednisone combined with itraconazole in the same period were analyzed retrospectively. The primary outcomes were exacerbation times and oral corticosteroid-sparing effect. The secondary outcomes were respiratory symptoms, circulating eosinophil count, total immunoglobin E (IgE) level, specific IgE for aspergillus, pulmonary function (the percentage value of forced expiratory volume in one second predicted FEV1%pred), fraction of exhaled nitric oxide (FeNO), thoracic computed tomography (CT) manifestation and adverse reactions.
    Results In omalizumab group, the exacerbation times of ABPA after 6 and 12 months of treatment were 0 (0, 0) times / 6 months and 0 (0, 1) times/6 months, there was no significant difference (P=0.157), which were significantly lower than those of the baseline (11, 2 times/6 months, P < 0.001). The oral dose of prednisone decreased from 10 (5, 15) mg/d (before treatment) to 3.125 (0, 5) mg/d (6 months after treatment, P < 0.001). After 12 months of treatment, the oral dose of prednisone was 0 (0, 3.125) mg/d, which was significantly lower than that of the baseline dose (P=0.003). After treatment with omalizumab for 12 months, the FeNO level decreased significantly (26 13, 36×10-9 vs 30 18, 56×10-9, P=0.049). There was no significant difference in blood eosinophil count, total IgE level, specific IgE for aspergillus and FEV1%pred before and after omalizumab treatment. After 6 months of treatment with omalizumab, respiratory symptoms were relieved in 23 patients (88.5%) and radiographic improvement was achieved in eight out of sixteen patients (50%) with mucus plugs. More patients successfully discontinued oral prednisone when treated with omalizumab for 12 months than those in control group (P=0.035). During the treatment of omalizumab, 4 (15.4%) patients had a slight increase in alanine aminotransferase (ALT), and 1 patient was complicated with hepatocellular carcinoma during follow-up.
    Conclusions Omazumab treatment can effectively reduce the number of acute episodes of ABPA, reduce the dosage of oral glucocorticoids, improve FeNO, facilitate the absorption of mucus plugs, and has high safety.

     

/

返回文章
返回