Abstract
OBJECTIVE: Given traditional Chinese medicine (TCM)'s efficacy in influenza and severe acute respiratory syndrome (SARS), it was adopted clinically in the early stage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection outbreak in China. However, the therapeutic effects of Toujie Quwen (TJQW) Granules in treatment of (SARS-CoV-2) infection have not been fully elucidated. This study aimed to investigate the efficacy and safety of TJQW in patients infected with SARS-CoV-2 and provide evidence for clinical practice of TCM. METHODS: A cohort study was conducted on SARS-CoV-2 infection admitted between 20 January and 15 March 2020. Patients were divided into two cohorts based on their clinical medication plan: TJQW combined with Western medicine (TJQW + WM) group and Western medicine (WM) group. The WM group received conventional WM treatment (antibiotics, glucocorticoids, oxygen therapy, arbidol, chloroquine, lopinavir/ ritonavir, ambroxol hydrochloride), while the TJQW + WM group received TJQW in addition to WM (15 g/bag, two bags at a time, three times a day). The incidence of severe disease and chest computed tomography (CT) findings before and after treatment were compared between groups. Dynamic analysis was performed on white blood cell (WBC) count, lymphocyte count (LYM), lymphocyte percentage (LYM%), Krebs von den Lungen 6 (KL-6) and symptom scores within 15 d of enrolment. RESULTS: Six cases in the TJQW + WM group progressed to severe disease, with an incidence of 7.89% (6/76), while 16 cases in the WM group progressed to severe disease, with an incidence of 20% (16/80, P = 0.025), and the difference was significant. The CT scores of the TJQW + WM group decreased continuously from day 6 of disease onset and were significantly lower than those of the WM group on days 12 and 15, with significant differences. On day 12 of the disease, the improvements in WBC and LYM in the TJQW + WM group were superior to those in the WM group, with significant differences. The KL-6 levels of the two groups were compared by fitting the data to a generalised linear model. After controlling for the effects of time from onset to detection, the KL-6 level of the TJQW + WM group was significantly lower than that of the WM group (t = 3.703, P < 0.01). Repeated measures analysis of variance was performed on the total score of major symptoms and showed insignificant differences (F = 0.031, P = 0.871). However, there was an interaction effect between treatment plan and treatment duration, with significant differences in the degree of change at each time point for the global scores (F = 6.502, P < 0.01). The TJQW + WM group showed a better improvement in symptoms and a reduction in the expression of inflammatory factors than the WM group. CONCLUSION: TJQW could effectively decrease the incidence of severe disease, reduce pulmonary inflammation and fibrosis, and alleviate clinical symptoms.