Research On TCM Syndromes And Risk Assessment Model Of Venous Thromboembolism In Hospitalized Patients

BackgroundVenous thromboembolism(VTE),including pulmonary thromboembolism(PTE)and deep vein thrombosis(DVT),is an important cause of unexpected and perioperative death in hospitalized patients.The incidence of VTE in the Asian population has always been considered lower than that in the Western population.However,several studies in recent years have shown that the hospitalization rate of VTE in China is on the rise,which has become a public health problem in China.There are relatively few studies focused on the classification of the Traditional Chinese Medicine(TCM)syndrome of VTE.At present,there is no unified standard for the classification of TCM syndromes in PTE.Most studies named the TCM syndromes based on the clinical symptoms of patients.However,the names of syndromes classified by different studies are quite different.What's more,the sample size of the study focused on the TCM syndrome is relatively small,which may restrict the promotion of academic research and clinical experience of TCM in the diagnosis and treatment of VTEHospitalization is one of the risk factors for the occurrence of VTE.About half of the VTE events are related to the recent hospitalization experience of patients,and the risk of VTE exists after the patient discharged.To prevent VTE events related to hospitalization,the concept of hospital-associated VTE(HA-VTE)has been proposed,which focused on the VTE occurred during hospitalization or within 90 days after discharge.However,there are few studies focused on the HA-VTE at present.For hospitalized patients,if patients with a high risk of VTE can be identified by using the risk assessment model(RAM)and taken preventive measures,VTE events caused by insufficient prevention can be reduced.However,the risk assessment rate of VTE in hospitalized patients is relatively low in China.There is still a gap in the proportion of taking thromboprophylaxis properly between China and Western countries.And there are few RAMs established and validated based on Chinese population data.In clinical practice,a simple RAM that can predict the risk level of VTE in hospitalized patients is needed.ObjectiveThis research has two main research purposes.1.To investigate the distribution of TCM syndromes of VTE and the epidemiology of VTE in hospitalized patients in recent years2.To explore the risk factors of patients with HA-VTE,and establish a new risk assessment model to stratify the risk of VTE in hospitalized patients.Then validate the new risk assessment model and assess the value of the existing risk assessment model for the identification of patients at risk of VTE.MethodsThis study was divided into the following four partsFirstly,The study enrolled VTE patients discharged from China-Japan friendship hospital between 2011 to 2019.Then,analyze the tongue,pulse,TCM syndromes,and TCM syndrome elements of VTE patients hospitalized in the Chinese medicine departments.And compare the baseline data,comorbidities,and complications of patients with different syndrome types.Lately,analyze the epidemiology and mortality of VTE during the nine yearsSecondly,an analysis of hospital-associated VTE(HA-VTE)was conducted.The HA-VTE group and the community-associated VTE(CA-VTE)group were classified according to whether the VTE occurred during hospitalization or within a 90-day period of admission to hospital.Differences in the baseline,clinical features,TCM syndromes,risk factors,and mortality were compared between the two groupsThirdly,in the nested case-control study,patients were divided into the HA-VTE group(case group)and patients without-VTE group(control group).Multivariate logistic regression analysis was used to identify the independent predictors of HA-VTE.And a new risk assessment model that can stratify the risk of VTE in hospitalized patients was developed based on these predictors.Finally,external verification of the new risk assessment model was performed by using hospitalized patients discharged from different periods.All the involved patients were stratified according to the new risk assessment model,Caprini RAM,and Padua RAM,separately.The sensitivity and specificity of these models were calculated.The receiver operating characteristic curve(ROC curve)was conducted to determine the area under the curve(AUC)of different models about VTE event.Results1.A total of 4119 VTE patients admitted to the hospital from 2011 to 2019,and 599 of them have the TCM syndrome records.Phlegm and blood stasis syndrome(35.4%)and qi deficiency and blood stasis syndrome(26.4%)are the most common types of TCM syndromes in hospitalized patients with VTE.Blood stasis(70.3%),phlegm(59.4%)are the most common syndrome elements related to TCM pathogenesis in hospitalized VTE patients.About 92.3%of patients have at least one of the elements of sputum or blood stasis.Patients with different syndromes have differences in comorbidities.The proportion of patients combined with the lung infection in qi stagnation and blood stasis syndrome group(10.5%)is lower than that in the other five groups of patients(all P<0.0033).The proportion of patients combined with the lung infection in qi deficiency and blood stasis syndrome group(30.4%)was lower than that in the sudden collapse of yang syndrome group(64.5%)(P<0.001).The proportion of patients combined with the malignant tumor in qi stagnation and blood stasis syndrome group(66.7%)was higher than that in the phlegm and blood stasis syndrome group(34.6%),qi deficiency and blood stasis syndrome group(33.5%),phlegm turbidity obstruction syndrome group(27.4%),dampness-heat amassment syndrome group(16.4%).And the proportion of patients combined with the malignant tumor in the sudden collapse of yang syndrome group(58.1%)was higher than the phlegm turbidity obstruction group,dampness-heat amassment syndrome group(16.4%),the difference was statistically significant(all P<0.0033).The number of VTE patients diagnosed each year increased significantly,from 130 in 2011 to 1054 in 2019.And the number of VTE patients diagnosed in TCM departments increased from 19 to 129.The number of departments involved in the diagnosis and treatment of VTE has increased significantly,and the proportion of patients who came from the other province has increased year by year.The length of stay for VTE patients declined from 15 days in 2011 to 10 days in 2019.The in-hospital all-cause mortality of VTE patients decreased from 12.5%in 2012 to 3.0%in 2019,and the DVT patients decreased from 7.0%in 2012 to 1.9%in 2019,PTE(with or without DVT)patients declined from 26.1%in 2012 to 4.4%in 2019.At the same time,it was found that acute myocardial infarction,congestive heart failure,lung infection,cerebrovascular disease,and malignant tumors are independent risk factors for death of VTE patients.2.Totally 437 patients with acute VTE in 2017 were analyzed,including 266 hospital-associated VTE(HA-VTE)patients and 1 71 community-associated VTE(CA-VTE)patients.Patients in the CA-VTE group were more likely to have varicose veins,sedentary,long-distance travel,and patients in the HA-VTE group were more complicated with recent surgery(<1 month),confined to bed,active malignant tumor,lung infections,acute cerebral infarction,fracture,the central venous catheter(P<0.05).There are differences between the two groups in the distribution of TCM syndromes and TCM syndrome elements.The CA-VTE group had more clinical symptoms such as lower extremity pain,dyspnea,chest pain,and chest tightness(P<0.05).HA-VTE patients had fewer clinical symptoms but were more severe than the CA-VTE patients,with more sudden deaths(0 vs 3.4%,P=0.035).Among HA-VTE patients,92.8%experienced VTE during hospitalization or within 1 month of the preceding hospital encounter,with a 13-day median time to VTE.The all-cause mortality rate was higher for the HA-VTE group than the CA-VTE group(8.3%vs 1.2%,P<0.001),and in-hospital compared to post-discharge diagnosed VTE patients(12.2%vs 3.4%,P<0.001).3.In the case-control study,492 patients with HA-VTE(case group)and 1970 patients without VTE(control group)were enrolled.Based on the risk factors found by the multivariate logistic regression analysis and literature review,a new VTE risk assessment model for hospitalized patients was established.The minor risk factors of age?70 years,varicose veins,respiratory disease(pulmonary infection,acute exacerbation of the chronic obstructive pulmonary disease,respiratory failure)(<1 month),heart and brain disease(acute myocardial infarction,heart failure,ischemic stroke,hemorrhagic stroke)(<1 month)were assigned a score of 1;and the major risk factors of already known thrombophilic condition,previous history of VTE,active malignant tumor,recent fracture/surgery/trauma(<1 month),confined to bed(>72h)were assigned a score of 2.The cumulative risk score categorized hospitalized patients as low risk(<3 points)or high risk(? 3 points)for VTE.And for non-surgical patients,?2 points are considered high risk of VTE.The related AUC was 0.84,as determined by the ROC curve,with relatively good sensitivity and specificity.4.Patients discharged from July 1,2018,to December 31,2018,were stratified according to the new risk assessment model,Caprini RAM,and Padua RAM.All the risk assessment models can identify the patients with a high risk of VTE and the incidence of VTE increased with risk stratifications.The new model had an optimum prognostic performance with the largest AUC value(AUC=0.773)and good sensitivity and specificity(69.2%and 72.2%).Conclusion1.Phlegm and blood stasis syndrome and qi deficiency and blood stasis syndrome are the most common types of TCM syndromes in hospitalized patients with VTE.Blood stasis,phlegm are the most common syndrome elements related to TCM pathogenesis in hospitalized VTE patients2.The hospitalization of VTE increased steadily,while the mortality sustained a decline.3.More than half of the VTE events were associated with recent hospitalization,and HA-VTE had special risk factors related to hospitalization4.The new risk assessment model had a good prognostic performance and can provide a reference for VTE risk assessment of hospitalized patients.