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贝那鲁肽治疗重症嗜酸性粒细胞性哮喘患者的疗效:一项回顾性真实世界研究。

Efficacy of benralizumab for patients with severe eosinophilic asthma: a retrospective, real-life study.

机构信息

Division of Respiratory Diseases, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.

出版信息

BMC Pulm Med. 2020 Aug 3;20(1):207. doi: 10.1186/s12890-020-01248-x.

Abstract

BACKGROUND

Benralizumab, an anti-interleukin-5 (IL-5) receptor α monoclonal antibody, significantly reduces the number of annual exacerbations and oral corticosteroid (OCS) maintenance doses for patients with severe eosinophilic asthma (SEA). However, few studies on the efficacy of this biologic in real life are available. The aim was to elucidate the efficacy of benralizumab by evaluating changes in clinical parameters after benralizumab treatment in patients with SEA.

METHODS

From July 2018 to December 2019, 24 Japanese patients with SEA received benralizumab at Jikei University Hospital. We retrospectively evaluated the patients' characteristics, parameters, numbers of exacerbations and maintenance OCS doses.

RESULTS

Among the 24 patients, eleven patients had received mepolizumab treatment and were directly switched to benralizumab. The peripheral blood eosinophil and basophil counts significantly decreased after benralizumab treatment regardless of previous mepolizumab treatment. Pulmonary function, Asthma Control Test scores, the numbers of annual exacerbations and maintenance OCS doses in patients without previous mepolizumab treatment tended to improve without significant differences. Fourteen patients (58%) were responders according to the Global Evaluation of Treatment Effectiveness (GETE) score. The proportion of GETE responders among patients with aspirin-exacerbated respiratory disease (AERD) tended to be lower than that among patients without AERD (p = 0.085). After benralizumab treatment, the change in the forced expiratory volume in 1 s from baseline was 200 ml or greater in eight patients (33%), including three patients who were switched from mepolizumab.

CONCLUSION

Benralizumab treatment improved and controlled asthma symptoms based on the GETE score.

摘要

背景

贝那鲁肽是一种抗白细胞介素-5(IL-5)受体α单克隆抗体,可显著减少严重嗜酸性粒细胞性哮喘(SEA)患者的年恶化次数和口服皮质类固醇(OCS)维持剂量。然而,关于这种生物制剂在现实生活中的疗效的研究很少。本研究旨在通过评估 SEA 患者接受贝那鲁肽治疗后的临床参数变化来阐明贝那鲁肽的疗效。

方法

2018 年 7 月至 2019 年 12 月,24 例日本 SEA 患者在日本顺天堂大学医院接受贝那鲁肽治疗。我们回顾性评估了患者的特征、参数、恶化次数和 OCS 维持剂量。

结果

在 24 例患者中,有 11 例患者接受了美泊利单抗治疗,并直接转为贝那鲁肽治疗。无论是否接受过美泊利单抗治疗,外周血嗜酸性粒细胞和嗜碱性粒细胞计数在接受贝那鲁肽治疗后均显著下降。未接受过美泊利单抗治疗的患者的肺功能、哮喘控制测试评分、年恶化次数和 OCS 维持剂量均有改善趋势,但无统计学差异。根据全球治疗效果评估(GETE)评分,14 例患者(58%)为应答者。阿司匹林加重性呼吸道疾病(AERD)患者的 GETE 应答者比例低于无 AERD 患者(p=0.085)。接受贝那鲁肽治疗后,8 例患者(33%)的 1 秒用力呼气量从基线的变化值≥200ml,其中包括 3 例从美泊利单抗转为贝那鲁肽的患者。

结论

贝那鲁肽治疗可根据 GETE 评分改善和控制哮喘症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7fa/7398222/947760e4b8f2/12890_2020_1248_Fig1_HTML.jpg

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