| Objectives:This study aimed to clarify the clinical characteristics of severe and critical COVID-19,investigate the related factors of clinical cure,and evaluate the effectiveness of different drug treatments including traditional Chinese medicine（TCM）,Western medicine（WM）and integrated traditional Chinese with Western medicine（ITCM）based on the patients from 8 designated hospitals in Hubei province.Methods:In this study,605 valid cases of patients with severe or critical COVID-19 have been recruited.All enrolled patients were admitted to designated hospitals from January 10,2020,to March 14,2020.Related clinical data has been cleaned before analysis.The basic data of enrolled patients included gender,age,smoking history,underlying diseases,symptoms on admission,laboratory parameters,CT manifestations,and treatment plan.The primary endpoint was the clinical cure,other outcome measures include hospital length of stay,whether and the number of days required for fever reduction during hospitalization,whether and the number of days required for RT-PCR results to turn negative,changes in laboratory parameters before and after treatment,CT regression,and mortality.The safety index was the rate of in-hospital adverse events.TCM treatment was used as the exposure factor.Different medication regimens were given according to patients’ preferences and medical conditions.Following the drug treatments,patients were divided into the TCM group,WM group,and ITCM group.SPSS 26.0 software was used to estimate the clinical characteristics,efficacy and safety of different drug treatments by analyzing the basic data,outcome measures and safety index.Results:1.85.6% and 14.4% of enrolled patients were severe and critical COVID-19,respectively.Critical COVID-19（OR=0.363,95%CI 0.228-0.579,p<0.001）was the risk factor of clinical cure.2.49.0% of enrolled patients over the age of 65,male and female patients respectively accounted for 50.4% and 49.6%.Patients with underlying disease accounted for 69.5% of the total,hypertension was the most concomitant underlying disease（26.4%）.The smoking rate among the enrolled patients was 6.5%.3.The most frequent symptoms on admission were cough（69.6%）,malaise（49.7%）,fever（40.5%）,expectoration（31.4%）,shortness of breath（28.9%）and anorexia（21.5%）.Fever（OR = 0.363,95%CI 0.228-0.579,p <0.001）was the risk factor of clinical cure.4.The most frequent changes in laboratory parameters on admission were lymphopenia（53.9%）and the increase in CRP（81.0%）,blood glucose（56.7%）,LDH（45.3%）,Mb（41.4%）,and c Tn I（38.4%）.At the time of hospital discharge,33 non-diabetic patients still showed hyperglycemia,and 4 of them could be diagnosed with new-onset diabetes.After treatment,the number of patients with CRP and CK normal increased in the WM group,and the number of patients with lymphocytes,platelets,CRP,AST,albumin,blood glucose,serum potassium,and LDH normal increased in the ITCM group.ITCM group had better efficacy in lymphocyte count improvement and AST,ALT level reduction compared to the WM group.The above results were statistically significant（p<0.05）.5.ITCM was the main drug treatment for patients with severe and critical COVID-19.The usage rate of TCM and herbal decoction has reached 93.4%and 80.9%,respectively.50.9% of the enrolled patients received antibiotic therapy,48.1% and 25.1% received antiviral treatment with arbidol hydrochloride and oseltamivir phosphate,and 28.1% received glucocorticoids.6.Among three treatment groups,the ITCM group showed the highest cure rate（64.4%）,the shortest time required to fever reduction（M=1）,and the longest length of hospital stay（M = 20）;the TCM group showed the shortest time required for RT-PCR results turn negative（M = 2）;WM showed the highest mortality（12.5%）,in-hospital adverse events rates（25%）and the rate of RT-PCR results remained positive（60.0%）.The above differences were statistically significant（p < 0.001）.After the correction through logistic regression,the ITCM group had better efficacy than the TCM group and WM group with the primary endpoint evaluation index of clinical cure.Conclusions:Integrated with TCM treatment improved the clinical cure rate,reduced mortality,played a certain role in correcting lymphocyte count,AST,and ALT levels,and significantly helped to fever reduction,RT-PCR results turned negative and shortened the time required.Besides efficacy,it also showed high safety.Patients with fever or classified as critical COVID-19 were less likely to be clinically cured and discharged. |
PDF Full Text Request