重度哮喘治疗药物benralizumab的药理及临床评价
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摘要
benralizumab是一种IgG1k型人源化单克隆抗体,具有抗白介素-5α受体作用。2017年11月14日,FDA批准本品上市,用于12岁及以上重度哮喘患者的附加维持治疗。本文就其作用机制、药效学、药动学、临床评价、安全性、用法用量等进行综述,旨在为临床合理使用提供参考。
Benralizumab is a humanized monoclonal antibody of IgG1k type which is able to bind to the IL-5 receptor(IL-5R) α chain. It was approved by FDA in November 2017,which is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older. In this paper,the action mechanism,pharmacokinetics,drug interactions,clinical evaluation,safety,pharmacokinetics and applications of benralizumab are summarized for the purpose of providing reference for clinical treatments.
Benralizumab is a humanized monoclonal antibody of IgG1k type which is able to bind to the IL-5 receptor(IL-5R) α chain. It was approved by FDA in November 2017,which is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older. In this paper,the action mechanism,pharmacokinetics,drug interactions,clinical evaluation,safety,pharmacokinetics and applications of benralizumab are summarized for the purpose of providing reference for clinical treatments.
引文
[1]黄丹,王蕾,王刚.2016年美国胸科学会年会重症哮喘最新研究进展[J].中国呼吸与危重监护杂志,2017,16(2):196-203.
[2]LANG DM.Severe asthma:epidemiology,burden of illness,andheterogeneity[J].Allergy Asthma Proc,2015,36(6):418-424.
[3]FDA.Benralizumab[EB/OL].[2017-11-14][2018-03-22].https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.
[4]杨潇,沈金花.支气管哮喘发病机制的研究进展[J].世界最新医学信摘,2016,16(64):34.
[5]FITZGERALD JM,BLEECKER ER.Benralizumab,an anti-interleukin-5 receptorαmonoclonal antibody,as add-on treatment for patients with severe,uncontrolled,eosinophilic asthma(CAL-IMA):a randomised,double-blind,placebo-controlled phase 3trial[J].Lancet,2016,(16)3:1322-1328.
[6]FITZGERALD JM,BLEECKER ER.Benralizumab,an anti-interleukin-5 receptorαmonoclonal antibody,as add-on treatment for patients with severe,uncontrolled,eosinophilic asthma(CAL-IMA):a randomised,double-blind,placebo-controlled phase 3trial[J].Lancet Respir Med,2018,388(10056):2128-2141.
[7]PARK HS,KIM MK,IMAI N,et al.A phase 2a study of benralizumab for patients with eosinophilic asthma in south Korea and Japan[J].Int Arch Allergy Immunol,2016,169(3):135-145.
[8]TIAN BP.Efficacy and safety of benralizumab for eosinophilic asthma:A systematic review and meta-analysis of randomized controlled trials[J].J Asthma,2018,55(9):956-965.
[9]FITZGERALD JM,BLEECKER ER.Predictors of enhanced response with benralizumab for patients with severe asthma:pooled analysis of the SIROCCO and CALIMA studies[J].Lancet Respir Med,2018,6(1):51-64.
[10]OHTA K,ADACHI M.Efficacy and safety of benralizumab in Japanese patients with severe,uncontrolled eosinophilic asthma[J].AllergolInt,2018,67(2):266-272.
[2]LANG DM.Severe asthma:epidemiology,burden of illness,andheterogeneity[J].Allergy Asthma Proc,2015,36(6):418-424.
[3]FDA.Benralizumab[EB/OL].[2017-11-14][2018-03-22].https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.
[4]杨潇,沈金花.支气管哮喘发病机制的研究进展[J].世界最新医学信摘,2016,16(64):34.
[5]FITZGERALD JM,BLEECKER ER.Benralizumab,an anti-interleukin-5 receptorαmonoclonal antibody,as add-on treatment for patients with severe,uncontrolled,eosinophilic asthma(CAL-IMA):a randomised,double-blind,placebo-controlled phase 3trial[J].Lancet,2016,(16)3:1322-1328.
[6]FITZGERALD JM,BLEECKER ER.Benralizumab,an anti-interleukin-5 receptorαmonoclonal antibody,as add-on treatment for patients with severe,uncontrolled,eosinophilic asthma(CAL-IMA):a randomised,double-blind,placebo-controlled phase 3trial[J].Lancet Respir Med,2018,388(10056):2128-2141.
[7]PARK HS,KIM MK,IMAI N,et al.A phase 2a study of benralizumab for patients with eosinophilic asthma in south Korea and Japan[J].Int Arch Allergy Immunol,2016,169(3):135-145.
[8]TIAN BP.Efficacy and safety of benralizumab for eosinophilic asthma:A systematic review and meta-analysis of randomized controlled trials[J].J Asthma,2018,55(9):956-965.
[9]FITZGERALD JM,BLEECKER ER.Predictors of enhanced response with benralizumab for patients with severe asthma:pooled analysis of the SIROCCO and CALIMA studies[J].Lancet Respir Med,2018,6(1):51-64.
[10]OHTA K,ADACHI M.Efficacy and safety of benralizumab in Japanese patients with severe,uncontrolled eosinophilic asthma[J].AllergolInt,2018,67(2):266-272.