福吉杜颗粒用于COVID-19的高风险成年人:一个随机,双盲,安慰剂控制的多中心试验
Jingwei Shui1, Xiaohua Xu1, Yuntao Liu2
1The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
概括
福杰杜颗粒 (FZJD) 在高风险的COVID-19患者中显示出症状改善. 虽然FZJD在统计学上并不显著,但与安慰剂相比,FZJD在数值上降低了疾病进展,不增加不良事件.
科学领域:
- 综合医学是一个整体医学.
- 传染性疾病 传染性疾病
- 临床药理学 临床药理学
背景情况:
- 福吉杜颗粒 (FZJD) 是一种用于COVID-19的中国传统医药.
- 之前的研究表明,在严重的COVID-19病例中,死亡率降低.
- 对具有新兴变异的高风险患者缺乏高水平的证据.
研究的目的:
- 评估FZJD在患有非严重COVID-19的高风险成年人中的疗效和安全性.
- 评估进展到严重的COVID-19的主要结果.
- 检查二次结果,包括症状解决时间.
主要方法:
- 进行了一项随机对照试验 (ChiCTR2200058181).
- 231名患有非严重COVID-19的高风险患者被随机分类.
- 患者接受了FZJD (15g每天三次,持续14天) 或安慰剂.
主要成果:
- 虽然FZJD在统计学上没有显著意义,但FZJD的严重COVID-19进展比例在数值上较低 (1.0%对2.1%).
- 在FZJD中观察到咳,发烧和胸痛的解决时间显著减少.
- 在FZJD和安慰剂组 (2.7%对1.9%) 之间,不良事件发生率是可比的.
结论:
- 在高风险的COVID-19患者中,FZJD显著改善了症状.
- 与安慰剂相比,这种治疗显示出数值较低的疾病进展率.
- 发现FZJD是安全的,没有观察到额外的不良事件.
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