ABSTRACT
Traditional Chinese herbal medicine has provided clinical benefits to patients infected with coronavirus 2019 (COVID-19) in China. Jinhua Qinggan granule (JHQGG) is a Chinese multi-herbal formula previously developed for the treatment of H1N1 influenza and has been encouraged for use in patients with clinically suspected COVID-19 infection. However, the immunopharmacological mechanism for the efficacy of JHQGG has not yet been confirmed. To obtain insight into this issue, the present study examined the acute effects of JHQGG ingestion on hematological and immunological parameters using uninfected individuals as subjects. For this purpose, 18 healthy volunteers were enrolled, all of whom tested negative for prior and current severe acute respiratory syndrome coronavirus 2 infection. Peripheral blood samples were collected 1 h after a single oral JHQGG administration and subjected to hematological, biochemical and cytokine tests. JHQGG rapidly induced a significant decrease in the plasma level of interleukin (IL)-6 (P=0.00309) and an increase in the plasma level of interferon (IFN)-γ (P=0.0268). A decrease in IL-6 and an increase in IFN-γ levels were observed in 14 (77.8%) and 13 (72.2%) subjects, respectively. Notably, JHQGG significantly decreased the proportion of neutrophils (P=0.00561) and increased that of lymphocytes (P=0.00485);accordingly, the neutrophil/lymphocyte ratio (NLR) was significantly reduced by JHQGG (P=0.00649). These findings suggest that the clinical benefits of the use of JHQGG against COVID-19 are, at least in part, associated with its rapid modulatory effects on IL-6, IFN-γ and NLR. Considering that IL-6 and NLR are critical biomarkers for severe COVID-19 infection, JHQGG may thus be suitable not only for suppressing disease onset in suspected and asymptomatic cases, but also for preventing disease progression in patients with mild to severe infection. The present open-label, single-arm study has been prospectively registered on the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) under the trial no. UMIN000040407 on May 15, 2020. Copyright: © 2021 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/.
ABSTRACT
Qingfei Paidu decoction (QFPD) is a Chinese herbal medicine newly formulated for the treatment of COVID-19. QFPD significantly enhances the therapeutic effects of stan- dard pharmacotherapy in mild to critically ill patients with COVID-19. However, limited information is available on the immunological mechanisms underlying the efficacy of QFPD. In addition, the feasibility of the prophylactic administration of QFPD to uninfected individuals remains unconfirmed. To obtain insight into these issues, an open-label, single-arm pilot study was conducted using 19 healthy uninfected individuals as subjects, and the effects of QFPD ingestion at a dose lower than that recommended for therapeutic use on hematological and immunological parameters were examined. QFPD was prepared according to the Chinese official clinical guideline, except that the dose of each herb was reduced to 1/30 and administered orally to the participants twice daily for 3 days. Low-dose QFPD ingestion significantly increased the plasma levels of pro-inflammatory cytokines, tumor necrosis factor (TNF)-α (P=0.000107), interleukin (IL)-1β (P=0.000982), IL-18 (P=0.00105), IL-2 (P=0.0483) and IL-8 (P=0.000191), key mediators of a broad spectrum of antiviral immunity. No apparent adverse effects were observed during the trial. These findings suggest that the clinical efficacy of QFPD against COVID-19 is, at least in part, associated with its immunological activity to mimic the blood cytokine environ- ment produced by early antiviral immune responses, which are shown to be profoundly suppressed during the early stages of COVID-19. The daily ingestion of low-dose QFPD may thus be a possible option for the prevention of COVID-19 during the epidemic. The present study was prospectively registered at the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) under the trial no. UMIN000040341 on May 9, 2020. © 2021 Spandidos Publications. All rights reserved.