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三种新型抗白细胞介素-5单克隆抗体疗法治疗重度哮喘的综述

A Review of Three New Anti-interleukin-5 Monoclonal Antibody Therapies for Severe Asthma.

作者信息

Agumadu Vivian C, Ramphul Kamleshun, Mejias Stephanie G, Sonaye Ruhi, Sombans Shaheen, Lohana Petras

机构信息

Medicine, International University of the Health Sciences School of Medicine, Basseterre, KNA.

Pediatrics, Shanghai Jiao Tong University School of Medicine/Shanghai Xin Hua Hospital, Shanghai, CHN.

出版信息

Cureus. 2018 Aug 27;10(8):e3216. doi: 10.7759/cureus.3216.

DOI:10.7759/cureus.3216
PMID:30416896
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6223665/
Abstract

Asthma is a chronic respiratory condition that is characterized by reversible airflow obstruction. Interleukin-5 (IL-5) is involved in the pathophysiology of the disease and drugs targeting IL-5 have been studied for years as a possible treatment option for severe asthma. In this review, the authors searched PubMed for major drug therapies and clinical trials against IL-5. A total of 29 articles met the criteria for selection and were shortlisted; of these, 10 papers were on benralizumab, 14 on mepolizumab, and five on reslizumab. The three drugs proved to be safe and efficacious for patients with severe asthma, leading to decreased rates of asthma exacerbations, lowered levels of eosinophils, and improved pulmonary functions in various studies. Patients also reported an improvement in the quality of life. The side effects of these three drugs were mild and no deaths directly linked to the drug were reported. However, longer duration studies are required to draw firm and strong conclusions on the safety of these therapeutic agents.

摘要

哮喘是一种慢性呼吸道疾病,其特征为可逆性气流阻塞。白细胞介素-5(IL-5)参与了该疾病的病理生理过程,多年来,针对IL-5的药物一直作为重度哮喘的一种可能治疗选择进行研究。在本综述中,作者在PubMed上搜索了针对IL-5的主要药物疗法和临床试验。共有29篇文章符合入选标准并被列入候选名单;其中,10篇关于贝那利珠单抗,14篇关于美泊利单抗,5篇关于瑞利珠单抗。在各项研究中,这三种药物对重度哮喘患者均证明是安全有效的,可降低哮喘发作率、降低嗜酸性粒细胞水平并改善肺功能。患者还报告生活质量有所改善。这三种药物的副作用轻微,未报告与药物直接相关的死亡病例。然而,需要进行更长时间的研究才能对这些治疗药物的安全性得出确凿有力的结论。

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本文引用的文献

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Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma.瑞利珠单抗治疗嗜酸性粒细胞性哮喘患者的长期安全性和疗效。
J Allergy Clin Immunol Pract. 2017 Nov-Dec;5(6):1572-1581.e3. doi: 10.1016/j.jaip.2017.08.024.
2
The association between blood eosinophil count and benralizumab efficacy for patients with severe, uncontrolled asthma: subanalyses of the Phase III SIROCCO and CALIMA studies.严重未控制哮喘患者血液嗜酸性粒细胞计数与贝那利珠单抗疗效之间的关联:III期SIROCCO和CALIMA研究的亚组分析
Curr Med Res Opin. 2017 Sep;33(9):1605-1613. doi: 10.1080/03007995.2017.1347091. Epub 2017 Jul 19.
3
Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial.贝那鲁肽治疗轻中度持续性哮喘患者(BISE):一项随机、双盲、安慰剂对照、3 期临床试验。
Lancet Respir Med. 2017 Jul;5(7):568-576. doi: 10.1016/S2213-2600(17)30190-X. Epub 2017 May 22.
4
Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma.贝那鲁肽在重症哮喘中的糖皮质激素节省作用。
N Engl J Med. 2017 Jun 22;376(25):2448-2458. doi: 10.1056/NEJMoa1703501. Epub 2017 May 22.
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Efficacy and safety of mepolizumab in Japanese patients with severe eosinophilic asthma.美泊利珠单抗在日本重度嗜酸性粒细胞性哮喘患者中的疗效和安全性。
Allergol Int. 2017 Jul;66(3):445-451. doi: 10.1016/j.alit.2016.11.006. Epub 2017 Jan 16.
6
Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial.贝那鲁肽治疗高剂量吸入性皮质激素和长效β-agonists 控制不佳的严重哮喘患者的疗效和安全性(SIROCCO):一项随机、多中心、安慰剂对照的 3 期临床试验。
Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.
7
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Clin Ther. 2016 Sep;38(9):2058-2070.e1. doi: 10.1016/j.clinthera.2016.07.010. Epub 2016 Aug 21.
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Lancet Respir Med. 2016 Jul;4(7):549-556. doi: 10.1016/S2213-2600(16)30031-5. Epub 2016 May 10.
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Pharmacokinetics and pharmacodynamics of mepolizumab, an anti-interleukin 5 monoclonal antibody, in healthy Japanese male subjects.美泊利珠单抗(一种抗白细胞介素 5 单克隆抗体)在健康日本男性中的药代动力学和药效学研究。
Clin Pharmacol Drug Dev. 2016 Mar;5(2):102-8. doi: 10.1002/cpdd.205. Epub 2015 Aug 18.