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贝那鲁肽治疗嗜酸性粒细胞性哮喘的疗效和安全性:一项随机安慰剂对照试验的荟萃分析。

Efficacy and safety of benralizumab in patients with eosinophilic asthma: a meta-analysis of randomized placebo-controlled trials.

机构信息

Department of Respiratory Medicine, West China Hospital, Sichuan University, Chengdu, 610041, China.

出版信息

Front Med. 2018 Jun;12(3):340-349. doi: 10.1007/s11684-017-0565-0. Epub 2017 Oct 30.

DOI:10.1007/s11684-017-0565-0
PMID:29086236
Abstract

Benralizumab is a monoclonal antibody that targets interleukin-5 receptor α to deplete blood eosinophils and improve the clinical outcomes of allergic asthma. We conducted a meta-analysis to evaluate the safety and efficacy of different doses of benralizumab in patients with eosinophilic asthma. All randomized controlled trials involving benralizumab treatment for patients with eosinophilic asthma, which were searched in PubMed, Embase, and the Cochrane Library published until January 2017, as well as the rate of asthmatic exacerbation, pulmonary functionality, asthma control, quality of life scores, and adverse events were included. Randomized-effect models were used in the meta-analysis to calculate the pooled mean difference, relative risks, and 95% confidence intervals. Five studies involving 1951 patients were identified. Compared with the placebo, benralizumab treatment demonstrated significant improvements in the forced expiratory volume in 1 s (FEV1), Asthma Quality of Life Questionnaire scores, decreased asthmatic exacerbation and Asthma Control Questionnaire-6 (ACQ-6) scores. Benralizumab treatment was also not associated with increased adverse events. These findings indicated that benralizumab can be safely used to improve FEV1, enhance patient symptom control and quality of life, and reduce the risk of exacerbations and ACQ-6 scores in patients with eosinophilic asthma. Furthermore, our meta-analysis showed that benralizumab with 30 mg (every eight weeks) dosage can improve the health-related quality of life and appear to be more effective than 30 mg (every four weeks) dosage. Overall, data indicated that the optimal dosing regimen for benralizumab was possibly 30 mg (every eight weeks).

摘要

贝那鲁肽是一种靶向白细胞介素-5 受体 α 的单克隆抗体,可消耗血液中的嗜酸性粒细胞,改善过敏性哮喘的临床结局。我们进行了一项荟萃分析,以评估不同剂量贝那鲁肽治疗嗜酸性粒细胞性哮喘患者的安全性和有效性。所有纳入的随机对照试验均涉及贝那鲁肽治疗嗜酸性粒细胞性哮喘患者,检索了 PubMed、Embase 和 Cochrane Library 中截至 2017 年 1 月发表的研究,以及哮喘恶化率、肺功能、哮喘控制、生活质量评分和不良事件发生率。荟萃分析采用随机效应模型计算合并均数差、相对风险和 95%置信区间。共纳入 5 项研究,共计 1951 例患者。与安慰剂相比,贝那鲁肽治疗可显著改善 1 秒用力呼气容积(FEV1)、哮喘生活质量问卷评分,降低哮喘恶化率和哮喘控制问卷-6(ACQ-6)评分。贝那鲁肽治疗与不良反应增加无关。这些结果表明,贝那鲁肽可安全用于改善 FEV1,增强患者症状控制和生活质量,降低嗜酸性粒细胞性哮喘患者的恶化风险和 ACQ-6 评分。此外,我们的荟萃分析表明,30 mg(每 8 周)剂量的贝那鲁肽可改善健康相关生活质量,且似乎比 30 mg(每 4 周)剂量更有效。总体而言,数据表明贝那鲁肽的最佳剂量方案可能为 30 mg(每 8 周)。

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