2019-nCoV is a new coronavirus that is not completely equivalent to MERS and SARS [9], and humans are universally susceptible to it.[10] but elderly patients of are in more serious condition [11, 12]. The median age of patients in our ICU was 66 years old, which was similar to other report [3, 13, 14]. And our patients were severe or critically ill; in the first 72 hours of admission, 75% patients were given mechanical ventilation because of refractory respiratory distress or hypoxemia. Recently, Mahase [15] indicated that most patients require mechanical ventilation within 24 hours of critical care. Studies have also found that severe cases tend to have lower lymphocytes counts, higher leukocytes counts, NLR and inflammatory parameters, such as CRP [16, 17]. Among the above indicators reflecting the severity of COVID-19, there was no significant difference at admission between the two groups in our study.
The utilization of TCM for COVID-19 is substantial in China, over 85% of confirmed cases included TCM treatments nationally (Wuhan over 67%) [18]. Back in SARS epidemic, a report released by WHO and a meta-analysis indicated that ICWM treatment had the potential benefits to alleviate symptoms, reduce complications and cost, and was safe [19, 20]. Recently, Luo et. al [21] found that TCM had an advantage in keeping microenvironmental balance in treating COVID-19. Another study investigating the efficacy of ICWM treatment on COVID-19 found that ICWM treatments could improve clinical symptoms better and faster [22]. But TCM treatments in the study included TCM decoction, Chinese patent medicine and TCM injection simultaneously [22].
This study was a prospective cohort study of COVID-19 patients in ICU. It analyzed the clinical characteristics of 36 severe or critically patients, and the efficacy and safety of ICWM treatments. The total mortality was 50% which was similar to the current report, and the mortality in the ICWM group was lower than previously reported.[13] We found that adding TCM decoction to WM treatments could significantly reduce the mortality of COVID-19. After adjusting the risk factors associated to severity at admission, including VAS, NLR and CRP, there was still a significant difference between the two groups. And the degree of dyspnea was also alleviated more in the ICWM group (lower VAS score). However, we found that the hospital stay of patients in the ICWM group was longer. It seemed to be contradictory to the current report [22]. One explanation was that our patients were all severe or critically ill. Firstly, we assumed that the same severity will bring the same mortality. Secondly, our results presented the similar severity at admission between groups but a lower level of inflammation during hospitalization in the ICWM group. Then we suspected that TCM smoothed the rising slope of the inflammatory storm of these patients who should have died, but also bring longer inflammatory response time. As discovered by a network pharmacology study, Qing-fei -pai-du decoction can regulate excessive immune response by Th17 cell differentiation, T cell and B cell signaling, and TNF signaling pathway in COVID-19 [23]. We may call it “time for life”.
In terms of safety, the added TCM treatment did not significantly affect the coagulation, kidney, cardiac and liver function and other aspects of COVID-19 patients, and did not increase the incidence of COVID-19-related complications during hospitalization. We can see that the addition of TCM was safe for severe or critically ill COVID-19 patients. Until now, there are no antiviral drugs specifically targeting 2019-nCoV [24]. Remdesivir have been indicated promising anti-viral effects in both intracellular and extracellular [25, 26]; but its clinical efficacy and safety have not yet been proven [10]. Besides, the currently used antiviral drugs have different degrees of damage to the kidney, liver, bone marrow, and peripheral nerves [24]. And with the advantages of efficacy and safety and low cost (about 3–5 dollars per day), TCM treatments may be recommended currently, especially intensive care resources are scarce.
The main limit of this study was that it was observational, sample size was small, and there was an imbalance between the two groups at admission. However, we adjusted the risk factors in Multivariate regression analysis to minimize the effect of these baseline biases on the research results. Besides, due to the urgency of the epidemic situation and the research conditions, and the SaO2 was measured under oxygen inhalation, the patient's dyspnea was evaluated using the patient's self-assessed VAS score [8], which may lack objectivity, but can reflect the changes in the subjective feelings of patients to a certain extent. This study revealed that the addition of TCM decoction significantly reduced mortality and improved the clinical symptoms. But it is unknown how TCM plays a role in this disease, its pharmacological mechanism should be further explored.