慢性阻塞性肺病患者中雾化HL231吸入液的疗效,药理动力学和安全性:一项随机试验
Qingyuan Hu1,2, Li Zhao3, Guoping Yang4
1School of Pharmacy, Nantong University, Nantong, China.
Journal of thoracic disease
|November 13, 2025
概括
在慢性阻塞性肺病 (COPD) 患者中,新的雾化吸入溶液HL231显示出与Ultibro®可比的支气管扩张,药理动力学和安全性. 这一发现表明HL231作为一种潜在的替代治疗选择,用于控制COPD症状和恶化.
科学领域:
- 肺部医学 肺部医学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 长效β激动剂 (LABA) 和长效肌抗剂 (LAMA) 的组合可以改善肺功能,减少COPD的恶化.
- 确定新的吸入溶液的最佳剂量对于有效的COPD管理至关重要.
研究的目的:
- 为了确定雾化HL231吸入溶液的最佳剂量.
- 将HL231与Ultibro®在COPD患者的支气管扩张,药理动力学和安全性方面进行比较.
主要方法:
- 多中心,随机,单剂量,单盲,交叉研究设计.
- 有两个部分:A部分 (疗效,n=84) 和B部分 (药理动力学,n=18).
- 患者接受了HL231,Ultibro®或安慰剂的不同剂量,主要终点包括FEV1AUC0-12h,药理动力学参数 (AUC,Cmax) 和安全性.
主要成果:
- 与安慰剂相比,HL231剂量显示出显著的支气管扩张 (P<0.001).
- HL231 261 微克/141 微克显示与Ultibro®可比的AUC0-t和Cmax.
- 261μg/141μg的HL231剂量显示在DFEV1AUC0-12h中与Ultibro® (P=0.04) 相比,在统计学上有显著差异.
- 大多数治疗出现的不良事件是轻微的 (等级1-2),表明可接受的安全性.
结论:
- 雾化HL231 261 μg/141 μg在支气管扩张,药理动力学和安全性方面与Ultibro®相当.
- HL231为COPD管理提供了一个可行的替代治疗选择.
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