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作 者:杨建伟 YANG Jian-wei(Certification Center for Licensed Pharmacist of National Medical Products Administration,BEIJING 100061,China)
机构地区:[1]国家药品监督管理局执业药师资格认证中心,北京100061
出 处:《中国新药与临床杂志》2024年第9期657-660,共4页Chinese Journal of New Drugs and Clinical Remedies
摘 要:阿尔茨海默病(AD)是一种进行性发展的中枢神经系统退行性疾病。lecanemab是一种人源化IgG1单克隆抗体,优先靶向可溶性β-淀粉样蛋白聚集体,减缓AD的进展。2023年1月,美国食品和药物管理局批准lecanemab用于治疗有轻度认知障碍或轻度痴呆的早期AD。lecanemab常见不良反应为输液相关反应、头痛和淀粉样蛋白相关影像学异常水肿。本文对lecanemab的作用机制、药动学、临床研究、经济学评价、安全性评价等进行综述,为临床合理用药提供参考。Alzheimer’s disease(AD)is a progressive degenerative disease of the central nervous system.Lecanemab is a humanized IgG1 monoclonal antibody that preferentially targets soluble amyloidβ-protein aggregates and can slow down the progression of AD.In January 2023,the U.S.Food and Drug Administration approved lecanemab to treat AD patients with mild cognitive impairment or mild dementia stage of disease.The common adverse drug reactions of lecanemab were infusion-related reactions,headache,and amyloid-related imaging abnormalities with edema.The mechanism of action,pharmacokinetics,clinical research,economic evaluation,and safety evaluation of lecanemab were reviewed in this article,so as to provide reference for rational clinical drug use.
关 键 词:lecanemab 阿尔茨海默病 临床研究 Β淀粉样蛋白
分 类 号:R745.7[医药卫生—神经病学与精神病学]
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