[Analyze the application rules and effects of "Four Elements, One Peptide, and Two Transplantations" based on bundle treatment in coronavirus disease 2019].

Objective: To explore the application rules and effects of "Four Elements, One Peptide, and Two Transplantations" in the bundle treatment of the patients with coronavirus disease 2019 (COVID-19), so as to provide a scientific evidence for effective treatment and prevention of severe type.

Methods: A retrospective comparative study method was used to analyze the clinical data of COVID-19 patients admitted to Wuxi Fifth People's Hospital from January 2020 to March 2022, including demographic information, underlying diseases, clinical classification, length of hospital stay, treatment cost, clinical symptoms, laboratory tests and other key indicators, and evaluate the application rules and effect of "Four Elements, One Peptide, and Two Transplantations" in the bundle treatment of the patients with COVID-19.

Results: The L-type new coronavirus strain was predominant in 2020, the Delta variant in 2021, and the Omicron variant in 2022. The proportion of mild cases was highest in 2022, with the highest proportion of > 65 years old patients developing severe and critical. Among the 150 patients, the proportion of interferon use (100.0%) was the highest in the bundle treatment regimen of "Four Elements, One Peptide, and Two Transplantation". The combined use of vitamin C, interferon and thymopeptide was highest in 2022. More than 75.0% of the age > 65 years old group had underlying diseases, which was also the age group with the highest proportion of "Four Elements, One Peptide, and Two transplantations". Compared with mild cases, the age, length of hospital stay, and hospitalization cost of patients with COVID-19 increased significantly with severity. Mild, ordinary, severe, and critically ill patients all had low lymphocyte counts, with 40.0% of severe patients having the lowest lymphocyte counts within 3 days of admission. The lymphocyte count of critically ill patients was reduced or continuously reduced after admission, and the use of the "Four Elements, One Peptide, and Two transplantations" method to regulate immunity can effectively save the lives of critically ill patients. Of all cases of COVID-19 infection, 51.3% were asymptomatic, followed by respiratory symptoms (48.7%) and lung lesions (38.0%). Patients with renal dysfunction received this bundle therapy was highest, followed abnormal coagulation and abnormal liver function. This bundle therapy promoted a significant increase in CD4 T lymphocytes and B lymphocytes in various cases. After treatment, as the virus turns negative, the proportion of M1 type macrophages increased, and the proportion of regulatory T cell (Treg cells) that suppress immunity and the infection related C-C chemokine receptor type (CCR10) Treg cells decreased. Mild adult cases showed a great change and declined rapidly.

Conclusions: Advanced age with underlying diseases is a risk factor for severe disease of COVID-19, the "Four Elements, One Peptide, and Two transplantations" bundle fine treatment of COVID-19 can improve the proportion of lymphocyte composition and organ function, which can control the occurrence and development of severe diseases. In addition to the proportion of CD4 T cells, the changes of the M1 macrophage, total Treg cell, and CCR10 Treg cell proportions can be used to determine disease changes of adult patients.