[咳治疗中的新医疗技术:双盲随机化安慰剂控制多中心临床试验的结果]
E A Polyakova1,2, S E Ushakova3, S V Okovityy4
1Pavlov First Saint Petersburg State Medical University.
Terapevticheskii arkhiv
|August 6, 2024
概括
与安慰剂相比,Eladis®显著降低了非生产性咳的频率和严重程度. 用Eladis®治疗的患者经历了更快的咳症状缓解和临床治愈,证明了其有效性和安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床医学 临床医学
- 呼吸系统医学 呼吸系统医学
背景情况:
- 非生产性咳是急性呼吸道病毒感染和急性支气管炎的常见症状.
- 目前对非生产性咳的治疗选择通常具有有限的疗效或副作用.
研究的目的:
- 在患有非生产性咳的患者中,与安慰剂相比,评估Eladis®的疗效和安全性.
- 评估Eladis®对咳频率,严重程度和临床治愈时间的影响.
主要方法:
- 进行了一项随机,双盲,安慰剂控制的III期临床试验.
- 招募了250名18-65岁的急性呼吸道病毒感染或急性支气管炎患者.
- 患者接受了Eladis® (40毫克片) 或安慰剂,每天两次服用1片,持续7-14天.
主要成果:
- 在第5天 (p<0.0001) 之前,Eladis®在减少咳发作频率≥50%方面显示出比安慰剂具有统计学意义的优势.
- 与安慰剂组 (中位数8天) 相比,Eladis®组 (中位数6天) 在临床上治愈咳的时间提前了2天.
- 治疗第5天观察到咳发作频率和严重程度显著下降 (超过3.5分).
结论:
- 埃拉迪斯 (Eladis®) 是一种有效的治疗与急性呼吸道病毒感染和急性支气管炎相关的非生产性咳.
- 该药物可显著减少咳症状,并加速临床治愈.
- 发现Eladis®在研究群体中使用是安全的.
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