在患有急性或慢性呼吸道症状的患者中,随机,双盲,多中心,AG NPP709与常春藤叶提取物相比的第三阶段研究
Young-Joo Cho1, Ho Joo Yoon2, Dae Hyun Lim3
1Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.
Journal of Korean medical science
|March 10, 2026
概括
AG NPP709是一种治疗呼吸系统症状的新疗法,其疗效和安全性与传统的常春藤叶提取物相美. 这项研究支持AG NPP709作为急性上呼吸道感染和慢性支气管炎的可行替代品.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床研究 临床研究
- 呼吸系统医学 呼吸系统医学
背景情况:
- AG NPP709,含有常春藤叶和Coptis chinensis提取物,显示出临床前的抗咳和吐性质.
- 一项临床试验旨在将AG NPP709与用于呼吸系统症状治疗的标准常春藤叶提取物进行比较.
研究的目的:
- 为了确定AG NPP709的疗效和安全性,与常春藤叶提取物相比.
- 评估AG NPP709作为急性上呼吸道感染 (URI) 和慢性炎症支气管炎症症状的治疗方法.
主要方法:
- 一个随机的,双盲的,主动控制的,非劣势的第三阶段试验,涉及236名患者.
- 患者接受了AG NPP709或常春藤叶提取物5天.
- 主要终点是使用五点利克特等级的临床改善率.
主要成果:
- 发现AG NPP709与常春藤叶提取物相比并非劣,临床改善率的差异为4.3% (95% CI: -8.9,17.5).
- 咳和的症状清除率在两组之间没有显著差异.
- 在AG NPP709 (11.0%) 和对照组 (11.1%) 之间,不良事件发生率相似,大多数事件是轻微的.
结论:
- 在治疗呼吸道症状方面,AG NPP709证明与常春藤叶提取物无劣.
- AG NPP709的安全性概况是可以接受的,轻度不良事件的发生率很低.
- AG NPP709为治疗急性URI和慢性支气管炎症状提供了潜在的替代治疗选择.
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