扶正化浊方对新型冠状病毒肺炎核酸持续阳性患者的疗效及安全性：一项回顾性队列研究
Effect and Safety of Fuzheng Huazhuo Decoction against Prolonged SARS-CoV-2 Clearance: A Retrospective Cohort Study.
作者信息
Zhang Wen, Wu Hong-Ze, Xu Xiang-Ru, Pu Yu-Ting, Chen Cai-Yu, Deng Rou, Cao Min, Sun Ding, Yi Hui, Zhou Shuang, Fang Bang-Jiang
机构信息
Department of Emergency, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Institute of Emergency and Critical Care Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
出版信息
Chin J Integr Med. 2025 May;31(5):387-393. doi: 10.1007/s11655-024-3921-3. Epub 2025 Jan 17.
OBJECTIVE
To evaluate the effect and safety of Chinese medicine (CM) Fuzheng Huazhuo Decoction (FHD) in treating patients with coronavirus disease 2019 (COVID-19) who persistently tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
METHODS
This retrospective cohort study was conducted at Shanghai New International Expo Center shelter hospital in China between April 1 and May 30, 2022. Patients diagnosed as COVID-19 with persistently positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test results for ⩾8 days after diagnosis were enrolled. Patients in the control group received conventional Western medicine (WM) treatment, while those in the FHD group received conventional WM plus FHD for at least 3 days. The primary outcome was viral clearance time. Secondary outcomes included negative conversion rate within 14 days, length of hospital stay, cycle threshold (Ct) values of the open reading frame 1ab (ORF1ab) and nucleocapsid protein (N) genes, and incidence of new-onset symptoms during hospitalization. Adverse events (AEs) that occurred during the study period were recorded.
RESULTS
A total of 1,765 eligible patients were enrolled in this study (546 in the FHD group and 1,219 in the control group). Compared with the control group, patients receiving FHD treatment showed shorter viral clearance time for nucleic acids [hazard ratio (HR): 1.500, 95% confidence interval (CI): 1.353-1.664, P<0.001] and hospital stays (HR: 1.371, 95% CI: 1.238-1.519, P<0.001), and a higher negative conversion rate within 14 days (96.2% vs. 82.6%, P<0.001). The incidence of new-onset symptoms was 59.5% in the FHD group, similar to 57.8% in the control group (P>0.05). The Ct values of ORF1ab and N genes increased more rapidly over time in the FHD group than those in the control group post-randomization (ORF1ab gene: β =0.436±0.053, P<0.001; N gene: β =0.415 ±0.053, P<0.001). The incidence of AEs in the FHD group was lower than that in the control group (24.2% vs. 35.4%, P<0.001). No serious AEs were observed.
CONCLUSION
FHD was effective and safe for patients with persistently positive SARS-CoV-2 PCR tests. (Registration No. ChiCTR2200063956).
目的
评估中药扶正化浊方（FHD）治疗新型冠状病毒肺炎（COVID-19）患者且严重急性呼吸综合征冠状病毒2（SARS-CoV-2）持续检测呈阳性的疗效和安全性。
方法
本回顾性队列研究于2022年4月1日至5月30日在中国上海新国际博览中心方舱医院开展。纳入诊断为COVID-19且确诊后严重急性呼吸综合征冠状病毒2逆转录聚合酶链反应（RT-PCR）检测结果持续阳性≥8天的患者。对照组患者接受常规西医（WM）治疗，而扶正化浊方组患者在接受常规西医治疗的基础上加用扶正化浊方至少3天。主要结局为病毒清除时间。次要结局包括14天内的转阴率、住院时间、开放阅读框1ab（ORF1ab）和核衣壳蛋白（N）基因的循环阈值（Ct）值以及住院期间新发症状的发生率。记录研究期间发生的不良事件（AE）。
结果
本研究共纳入1765例符合条件的患者（扶正化浊方组546例，对照组1219例）。与对照组相比，接受扶正化浊方治疗的患者核酸病毒清除时间更短[风险比（HR）：1.500，95%置信区间（CI）：1.353 - 1.664，P<0.001]，住院时间也更短（HR：1.371，95%CI：1.238 - 1.519，P<0.001），且14天内的转阴率更高（96.2%对82.6%，P<0.001）。扶正化浊方组新发症状的发生率为59.5%，与对照组的57.8%相似（P>0.05）。随机分组后，扶正化浊方组ORF1ab和N基因的Ct值随时间的升高速度比对照组更快（ORF1ab基因：β =0.436±0.053，P<0.001；N基因：β =0.415±0.053，P<0.001）。扶正化浊方组不良事件的发生率低于对照组（24.2%对35.4%，P<0.001）。未观察到严重不良事件。
结论
扶正化浊方对SARS-CoV-2 PCR检测持续阳性的患者有效且安全。（注册号：ChiCTR2200063956）
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