在急性支气管炎患者中YJP-40的有效性和安全性:一项随机,双盲,并行组研究
1Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea.
含有Pelargonium sidoides和常春藤叶提取物的YJP-40糖是一种安全有效的急性支气管炎治疗方法,证明与Umckamin®糖无劣. 这两种治疗方法在临床试验中都显示出类似的疗效和安全性.
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
- 草药是一种草药.
背景情况:
- 佩拉戈尼 (Pelargonium sidoides) 提取物 (Umckamin®) 已被批准用于治疗急性支气管炎.
- 常春藤叶提取物具有吐性质,对支气管炎有益.
- YJP-40结合了Pelargonium sidoides和常春藤叶的提取物.
研究的目的:
- 在急性支气管炎患者中,比较YJP-40糖与Umckamin®糖的疗效和安全性.
- 为了确定与Umckamin®相比,YJP-40的非劣等性.
主要方法:
- 一个多中心的,随机的,双盲的,主动控制的,非劣势的,III期临床试验.
- 240名患有急性支气管炎的患者被随机分配1:1到YJP-40 (测试) 或Umckamin® (对照).
- 主要终点:7天后支气管炎严重程度得分 (BSS) 总得分的变化.
主要成果:
- 7天后BSS总分数的平均变化为YJP-40的-4.31±2.09和Umckamin®的-4.36±1.71.
- 证明了YJP-40与Umckamin®的不劣.
- 在7天后,YJP-40的响应率为87.16%,Umckamin®的响应率为86.92% (P=0.9778).
- 两组之间不良事件发生率没有显著差异.
结论:
- YJP-40糖是一种安全有效的治疗急性支气管炎的选择.
- YJP-40的疗效和安全性与Umckamin®糖相似.
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