Study On The Diagnostic Criteria Of Binding Of Stasis And Toxin Pattern In Acute Coronary Syndrome

BackgroundAcute coronary syndrome(ACS)is a critical type of coronary heart disease(CHD)with high morbidity and mortality,which is the main cause of death worldwide.In traditional Chinese medicine(TCM),it can be classified as "chest depression","true heart pain",and "precordial pain".From traditional lipid deposition to inflammatory response,modern medicine’s understanding of coronary heart disease has undergone significant changes,and it is proposed that inflammatory response is a major contributor to plaque instability and ACS.Academician Chen Keji’s team hypothesized that "blood stasis and toxin-induced change" are important pathogenic transformations of stable coronary heart disease and recurrent ACS,with binding of blood stasis and toxin as an important etiology and pathogenesis of ACS,and this has been confirmed by large samples and randomized controlled trials.In light of this,early identification and intervention of patients with ACS with binding of blood stasis and toxin pattern should further improve the clinical diagnosis and treatment effect and improve the prognosis of patients.There is,however,a lack of relevant diagnostic criteria,which limits the clinical application of the "blood stasis theory" to coronary heart disease.An exploratory cross-sectional survey,systematic literature analysis,Delphi method,and analytic hierarchy process are employed to conduct qualitative and quantitative research.The aim of this study was to establish a diagnostic criteria for ACS with binding of blood stasis and toxin by using clinical cross-sectional survey,systematic literature analysis,Delphi method and analytic hierarchy process,to improve the level of clinical pattern differentiation and treatment of ACS.ObjectiveTo explore and establish the diagnostic criteria of ACS with binding of blood stasis and toxin pattern.Method1.From January 2022 to November 2022,200 patients were admitted to Xiyuan Hospital of China Academy of Chinese Medical Sciences with ACS and with binding of blood stasis and toxin pattern and stable coronary heart disease without binding of blood stasis and toxin pattern.We then collected the patients’ four diagnostic methods of TCM.The frequency statistics and the chi-square test was used to screen out the items with statistical significance from the item pool.In order to generate the item pool,a literature search strategy was developed,related literature about ACS with binding of blood stasis and toxin was collected,and the items were extracted from the literature and counted.2.The Delphi expert consultation process was conducted twice;Questionnaire-Star was used to design,distribute,and collect the data for the consultation questionnaire.A statistical analysis was performed using SPSS 26 to calculate the mean value,full score ratio,grade sum,and coefficient of variation of each item’s scores.An analysis was conducted to determine the reliability of the questionnaire and the degree of coordination between the expert opinions.3.In the analytic hierarchy process,a hierarchical model is constructed,expert consultations are conducted,weights are assigned to each item,primary indicators and secondary indicators are differentiated,values are assigned to items,and qualitative and quantitative diagnostic criteria are formed.Results1.The establishment of item poolBased on a clinical cross-sectional study,39 symptoms or signs are more likely to occur in patients suffering from ACS with blood stasis and toxin pattern as compared with those suffering from stable coronary heart disease without blood stasis or toxin pattern,and the difference is statistically significant.(P<0.05).A total of 158 articles were screened and 115 were included.After items extraction,43 items with frequency more than 2 were selected.The above-mentioned 82 items are summarized and classified to form the pool of items of the expert consultation questionnaire.There are 67 items in the pool,which are divided into four parts,including disease and pattern characteristics(4 items),symptoms and signs(32 items),pulse and tongue(17 items),and physical and chemical indexes(14 items).2.Delphi expert consultation resultsThere were 63 experts consulted in this study,including 50 with senior professional titles,with an average working experience of 24 years and from a variety of geographical locations.In the first and second rounds of expert consultation,63 questionnaires were distributed,and 63 valid questionnaires were recovered.The experts’ positive coefficient and questionnaire validity rate were 100%.Kendall’s concordance coefficient of the two rounds of expert questionnaires were 0.368 and 0.395,respectively,both P<0.01,indicating high consistency in expert opinion and high reliability.Both rounds of expert questionnaires had Cronbachs a coefficient greater than 0.7,suggesting that the results are highly reliable.After the first round of expert questionnaire consultation,the following items were removed from the list:fatigue,shortness of breath and reluctance to speak,lack of breath,palpitations,loss of appetite,dull complexion,lack of breath,weak breath,sore throat,toothache,dizziness,headache,acid regurgitation,upset,irritability,anger,dry mouth,spontaneous sweating,fever,difficulty falling asleep,dreaminess,insomnia after waking up,yellow urine,dry stool,intermittent pulse,dark tongue,peeling coating,CD40 ligand,P-selectin;added entry is the dynamic evolution of ST segment in the electrocardiogram.After the consultation of the second round of expert questionnaires,deleted entries are a bad breath,a bitter mouth,an old tongue,yellow dried coating,purplish-red sublingual vessel,elevated levels of interleukin-1(IL-1β),tumor necrosis factor(TNF)-α,and slippery pulse.3.Results of analytic hierarchy processAn analytical hierarchy process was used to consult 21 experts,21 questionnaires were distributed,and 21 were returned.The positive coefficient of experts and the effective rate of questionnaires were both 100%.Data from the expert questionnaire were be imported to the Analytic Hierarchy Process software,and a weight was assigned to each item.In the criterion layer,disease characteristics have the highest weight(0.4349),followed by symptoms and signs(0.2473),physical and chemical parameters(0.1307),tongue(0.1052),and pulse(0.0855).There are 28 items in the sub-criteria layer,which are divided into three weight categories:high,medium and low.In the category of high weight(weight greater than 0.0400),we find the following cases:sudden onset(0.1976),rapid transmission(0.1029),progressive aggravation of chest pain(0.0723),severe illness(0.0705),recurrent chest pain(0.0669),perniciousness and changeability(0.0648),astringent pulse(0.0566),squeezing chest pain(0.0474),and severe chest pain(0.0430).In the category of medium weight(weight less than 0.0400 and greater than 0.0150)includes stringy pulse(0.0289),elevated cardiac troponin(c-Tn)(0.0240),dark purple tongue(0.0199),dark red tongue(0.0191),elevated creatine kinase-MB(CK-MB)(0.0189),blue or purple tongue(0.0183),dynamic evolution of ST segment in the electrocardiogram(0.0173),increased C-reactive protein(CRP)and high sensitivity C-reactive protein(hs-CRP)(0.0161),and severe native multivessel coronary artery disease revealed by coronary angiography(0.0153).The low-weight categories(weight less than 0.0150)include tongues with ecchymosis and petechiae(0.0147),dark lips(0.0142),yellow greasy coating(0.0125),sublingual vein cyanosis(0.0106),increased low density lipoprotein(LDL)(0.0104),tortuous sublingual vein(0.0100),increased interleukin-6(IL-6)(0.0095),increased platelet aggregation rate(0.0067),increased fibrinogen(FIB)(0.0066),and increased total cholesterol(TC)(0.0060).The diagnostic criteria of binding of stasis and toxin pattern in ACS was made after discussion.The diagnostic criteria of binding of stasis and toxin pattern in ACSNote:The diagnostic criteria requires that patients meet the diagnostic criteria for an ACS and fulfill at least one necessary indicator,at least two physicochemical parameters,and at least two tongue and pulse manifestations.ConclusionIn this study,the diagnostic criteria of binding of stasis and toxin pattern in ACS were established for the first time by means of clinical cross-sectional survey,systematic literature analysis,Delphi method consultation and analytic hierarchy process.This diagnostic criteria adopts the mode of combining disease with pattern,combining macroscopic and microscopic indexes,and its items are simple and convenient for clinical practice.It plays an important role in improving the level of pattern differentiation and treatment of ACS.