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中国临床药理学与治疗学 ›› 2024, Vol. 29 ›› Issue (4): 406-414.doi: 10.12092/j.issn.1009-2501.2024.04.007

• 慢性气道疾病药物治疗新进展 • 上一篇    下一篇

吸入性生物制剂在哮喘疾病中的开发进展及前景

李光辉1,黄静1,朱敏1,赵芮3,万亚坤1,陈智鸿2   

  1. 1上海洛启生物医药技术有限公司,上海  201203;2复旦大学附属中山医院呼吸与危重医学科,上海  200032;3东海老年护理医院,上海  201303

  • 收稿日期:2023-09-01 修回日期:2023-11-03 出版日期:2024-04-26 发布日期:2024-03-25
  • 通讯作者: 陈智鸿,女,博士,教授,主任医师,研究方向:慢性气道炎症。 E-mail: chen.zhihong@zs-hospital.sh.cn
  • 作者简介:李光辉,男,硕士,研究方向:纳米抗体药物开发。 E-mail: ghli@novamab.com
  • 基金资助:
    国家自然科学基金(82270026);上海市重中之重临床医学中心和重点学科基金(2017ZZ02013);上海市临床重点专科建设项目(shslczdzk02201)

Progress and prospect of inhaled biological agents in asthma

LI Guanghui1, HUANG Jing1, ZHU Min1, ZHAO Rui3, WAN Yakun1, CHEN Zhihong2   

  1. 1 Shanghai Novamab Biopharmaceuticals Co.Ltd., Shanghai 201203, China; 2 Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China; 3 Shanghai Donghai Geriatric Nursing Hospital, Shanghai 201303, China
  • Received:2023-09-01 Revised:2023-11-03 Online:2024-04-26 Published:2024-03-25

摘要:

全球超过3亿人饱受哮喘困扰,且发病率逐年增加,作为最常见的慢性疾病之一,哮喘激发机制复杂,异质性强,是一类免疫介导的炎症疾病。随着基于生理、病理等机制深入研究,陆续推出的治疗性小分子和激素药物已实现对大多数患者的控制和治疗,但仍有5%~10%的患者为难控制、难治疗性哮喘,即重度哮喘。近十年来,得益于生物医药的迅猛发展,蛋白、抗体类药物凭借高有效性、高特异性、高安全性成为关键的重度哮喘治疗药物,然而由于生物制剂通常经注射给药,不可无创、快速地递送药物直接入肺迅速吸收起效,故而临床中亟需起效快、便捷、经济、安全的吸入式生物制剂。本综述通过对哮喘发病机制的阐释,概括现行的小分子、激素类和生物类治疗药物,并总结吸入式哮喘生物制剂的研发历程,对其未来前景进行分析,旨在加深对大分子吸入药物研究方向的认知,更新该领域前沿动态,以期为更多吸入式生物制剂的开发提供参考。

关键词: 哮喘, 给药途径, 吸入给药, 生物制剂

Abstract:

More than 300 million people worldwide suffer from asthma, and the incidence is increasing year by year. As one of the most common chronic diseases, asthma is an immune-mediated inflammatory disease with complex triggering mechanisms and strong heterogeneity. With the in-depth study of physiological and pathological mechanisms, therapeutic small molecule and hormone drugs have been introduced to control and treat most patients, but about 5%-10% of patients still suffer from various subtypes of difficult to control and treat asthma, that is, severe asthma. In the past decade, with the rapid development of biopharmaceutical research, protein and antibody have become the key drugs for the treatment of severe asthma with high efficacy, high specificity and high safety. However, biological drugs are usually administered by injection, they cannot be noninvasive and directly delivered into the lung to quickly absorb and take effect. Therefore, there is an urgent need for the introduction of inhaled biologics with quick effectiveness, convenience, economy and safety in clinical. The review summarizes the existing small molecule, hormone and biological therapy drugs, and summarizes the development of inhalable biological agents of asthma, and analyzes the future prospects of the inhalable biological drugs, which is designed to deepen the perception of the direction of the inhalable biological drugs research, and update the information of the field, in order to provide reference for the development of more inhalable biologics.

Key words: asthma, route of administration, administration by inhalation, biologics

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