美国 FDA 批准 ensifentrine 用于维持治疗
美国食品药品监督管理局(Food and Drug Administration, FDA)批准 ensifentrine 用于成人慢性阻塞性肺疾病(chronic obstructive pulmonary disease, COPD)的维持治疗。
ensifentrine(一款首创的磷酸二酯酶-3[PDE-3]和 PDE-4 双重抑制剂)单分子具有支气管保护和抗炎作用,通过标准规定雾化器给药。
在针对有症状的中至重度 COPD 患者的 3 期随机安慰剂对照试验中,ensifentrine:[229]
在 12 周时肺功能改善
24 周内的中度或重度急性加重率降低
展现出良好的耐受性;治疗组与安慰剂组中报告不良事件的患者比例相近。
预计 ensifentrine 将于 2024 年下半年在美国上市,而尚未在欧洲获批使用。
小结
定义
病史和体格检查
诊断性检查
治疗流程
撰稿人
作者
Manoochehr Abadian Sharifabad, MD
Fountain Valley Regional Medical Center
Fountain Valley
CA
利益声明
MAS declares that he has no competing interests.
鸣谢
Dr Manoochehr Abadian Sharifabad would like to gratefully acknowledge Dr Jonathan P. Parsons and Dr Michael Ezzie, the previous contributors to this topic.
利益声明
JPP has contributed at speakers' bureaus for GlaxoSmithKline, Inc., Schering-Plough, Inc., and AstraZeneca, Inc. ME declares that he has no competing interests.
同行评议者
Hormoz Ashtyani, MD, FCCP
Hackensack University Medical Center
Hackensack
NJ
利益声明
HA declares that he has no competing interests.
Alejandro Comellas, MD
Clinical Professor of Internal Medicine-Pulmonary, Critical Care and Occupational Medicine
University of Iowa
Iowa City
IA
利益声明
AC has received payments as a consultant for GSK and AstraZeneca. He also serves as a non-paid consultant for VIDA.
William Janssen, MD
Assistant Professor of Medicine
National Jewish Medical and Research Center
University of Colorado Health Sciences Center
Denver
CO
利益声明
WJ declares that he has no competing interests.
Francis Thien, MD, FRACP, FCCP
Associate Professor
Director of Respiratory Medicine
Eastern Health & Monash University
Victoria
Australia
利益声明
FT declares that he has no competing interests.
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