扶正解毒颗粒对非重症新型冠状病毒肺炎高危成人疾病进展的影响：一项多中心回顾性队列研究
Fuzheng Jiedu granules against disease progression among high-risk adults with non-severe COVID-19: a multicenter retrospective cohort study.
作者信息
Hua Qiaoli, Zheng Danwen, Shui Jingwei, Zhang Tong, Qin Shengle, Zhang Hanhong, Yu Bo, Wang Longde, He Hailang, Tan Xinghua, Chen Qiumin, Yang Yang, Heng Weng, Cai Yihang, Xu Xiaohua, Liu Qing, Liu Yuntao, Yang Rongyuan, Zhang Zhongde
机构信息
Department of Clinical Laboratory, Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, China.
Department of Emergency, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
出版信息
Front Pharmacol. 2025 May 12;16:1523004. doi: 10.3389/fphar.2025.1523004. eCollection 2025.
BACKGROUND
Fuzheng Jiedu (FZJD) granules are widely used to treat coronavirus disease (COVID-19) since their market approval, but their clinical effectiveness remains uncertain. In this study, we aimed to evaluate the effectiveness of FZJD in reducing disease progression in high-risk adults with COVID-19.
METHODS
A multicenter, retrospective cohort study involving high-risk adults with non-severe COVID-19 was conducted in China from May 2021 to December 2022. The study was registered at the Chinese Clinical Trial Registry (ChiCTR2200058097; https://www.chictr.org.cn/bin/project/edit?pid=160010). Patients were categorized into two groups based on the administration of FZJD granules. The outcomes included disease progression, mechanical ventilation, intensive care unit (ICU) admission, and mortality. Propensity-score analyses and multivariable regression were performed to assess the effectiveness of FZJD granules. The effectiveness was further analyzed in different subgroups.
RESULTS
A total of 1,644 patients (54.7% female patients; mean age, 62.3 years) were included, with 27.4% (451/1,644) receiving FZJD granules. After propensity score matching (PSM), 320 FZJD granule receivers and 320 non-receivers were matched. Those receiving FZJD granules were associated with lower risks of disease progression [adjusted odds ratio (OR), 0.21; 95% confidence interval (CI), 0.06-0.73], mechanical ventilation (OR, 0.15; 95% CI, 0.03-0.66), and ICU admission (OR, 0.08; 95% CI, 0.01-0.64) than those not receiving FZJD granules. The lower risk of disease progression in the FZJD group was confirmed by multivariable regression analysis and various propensity-score analyses. Furthermore, subgroup analyses demonstrated significant treatment benefits in patients with moderate COVID-19 at admission (no progression to severe disease) or in those who were not fully vaccinated (OR, 0.06; 95% CI, 0.01-0.50).
CONCLUSION
FZJD administration was significantly associated with a reduced risk of disease progression in high-risk adults with mild-to-moderate COVID-19.
背景
扶正解毒（FZJD）颗粒自获批上市以来被广泛用于治疗冠状病毒病（COVID-19），但其临床疗效仍不确定。在本研究中，我们旨在评估FZJD对降低COVID-19高危成年人疾病进展的有效性。
方法
2021年5月至2022年12月在中国进行了一项多中心回顾性队列研究，纳入非重症COVID-19高危成年人。该研究已在中国临床试验注册中心注册（ChiCTR2200058097；https://www.chictr.org.cn/bin/project/edit?pid=160010）。根据是否服用FZJD颗粒将患者分为两组。观察指标包括疾病进展、机械通气、重症监护病房（ICU）收治情况及死亡率。进行倾向得分分析和多变量回归分析以评估FZJD颗粒的有效性，并在不同亚组中进一步分析其有效性。
结果
共纳入1644例患者（女性患者占54.7%；平均年龄62.3岁），其中27.4%（451/1644）服用FZJD颗粒。倾向得分匹配（PSM）后，匹配了320例服用FZJD颗粒者和320例未服用者。与未服用FZJD颗粒者相比，服用FZJD颗粒者疾病进展风险较低[调整优势比（OR），0.21；95%置信区间（CI），0.06 - 0.73]、机械通气风险较低（OR，0.15；95% CI，0.03 - 0.66）以及ICU收治风险较低（OR，0.08；95% CI，0.01 - 0.64）。多变量回归分析和各种倾向得分分析均证实FZJD组疾病进展风险较低。此外，亚组分析显示，入院时为中度COVID-19患者（未进展为重症疾病）或未完全接种疫苗者接受治疗有显著益处（OR，0.06；95% CI，0.01 - 0.50）。
结论
在轻度至中度COVID-19高危成年人中，服用FZJD与疾病进展风险降低显著相关。
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