The Clinical And Practicability Exploratory Study Of Diagnostic Criteria Of Classification Quantitation On Primary Lung Cancerwith Blood Stasis Syndrome

BackgroudCombination of disease and syndrome of blood stasis syndrome diagnostic criteria for Traditional Chinese Medic ine(TCM) syndromes of objective, standardized values an important task in the process. As the different study angles of scholars, diagnostic criterias of blood stasis syndrome are different. Whether many of the diagnostic criterias laid out are effective in clinic, most researchers have not been standardized clinical observation and testing.They only put standards written directly into clinical use, so the criterias may out of touch with clinical practice. As a result,putting the combination of disease and syndrome of blood stasis syndrome diagnostic criteria into clinical research to explore the established diagnostic criteria of blood stasis syndrome use the clinical study on combination of disease and syndrome has an significant role in clinical utility.ObjectiveTo explore clinical utility of diagnostic criteria of classification quantitation on primary lung cancer with blood stasis syndrome which the mentor team previously developed (referred to proposed quantitative criteria).Research object and methodsResearch objectThis study observed 63 cases of primary lung cancer in Guang’anmen Hospital,China Academy of Chinese Medical Sciences during December,2014 to December,2015.After out and shed with 8 cases of data entry, a total of 55 cases finally met the inclusion criteria, which the number of men were 32with a median age of 66 years and the number of women were 23 with a median age median age of 63 years.Research methods1 Diagnosis of blood stasis syndromewe compared proposed quantitative criteria with diagnostic criteria of blood stasis syndrome set by the China Society of integrated traditional and Western medicine in 2011 (referred to academy criterion), from blood stasis syndrome judgment to patients before treatment met the inclusion criteria and observed the sensitivity of proposed quantitative criteria to diagnosis of blood stasis syndrome on primary lung cancer.2 The judgment of clinical curative effectwe graded blood stasis levels of patients before treatment (none, mild, moderate, severe) by using proposed quantitative criteria, and by 2 weeks of standard chemotherapy or TCM treatment,we objectively evaluated according to international common evaluation standards(Response Evaluation Criteria in Solid Tumors, RECIST) for objective evaluation, to graded levels of blood stasis treated again, observe the development of quantitative criteria for curative effect.3 The relevance of common clinical indicatorsWe measured 46 laboratory indicators before and after treatment respectively (hemoglobin,red blood cell,hematocrit,mean corpuscular volume,white blood cell,plate let, proportion of neutrophilic granulocyte, quantity of lymphocyte, quantity of neutrophilic granulocyte,red cell distributin width-standard deviation, red cell distributin width-coefficient of variation, platelet distribution width, mean platelet volume, C reaction protein, glucose, creatinine, globulin, very low density lipoprotein, lipoprotein-a, total protein, albumin, blood urea nitrogen, superoxide dismutase, triglyceride, total cholesterol, low density lipoprotein, high density lipoprotein, lactate dehydrogenase, sialic acid, carcino-embryonic antigen, carbohydrate antigen-125, squamous cell carcinoma, cytokeratin-19 fragment, carbohydrate antigen-199, carbohydrate antigen-153, neuron specific enolase, activated partial thromboplastin time D-dimer, fibrinogen, activated partial thromboplastin time, fibrinogen degradation product, antithrombin III,total T celiauxiliary T cell,active auxiliary Tcell,B lymphocyte,cytotoxicity T cell,natural killer cell)and calculated scores of blood stasis before and after treatment by using quantitative criteria.Then,we compared correlation between changes of blood stasis scores and changes of common clinical indexes.Results1 Diagnosis of blood stasis syndromeWe could learn from diagnosis results by proposed quantitative criteria and academy criteria that a total of 32 cases of blood stasis syndrome were diagnosised by two criteria.While,33 cases were diagnosised as blood stasis syndrome by academy criteria, the incidence of blood stasis syndrome was 60%.44 cases were diagnosised as blood stasis syndrome by proposed quantitative criteria and the incidence of blood stasis syndrome was 80%, significantly higher than the academy criteria2 The judgment of clinical curative effect2.1 Differences between degree of blood stasis prior to treatment and treatment effectTo compare the difference between degree of blood stasis before treatment (none, mild, moderate, severe) and therapeutic effect of TCM group(valid, invalid),we found χ2=1.352,P=0.921>0.05 by statistical analysis,which suggesting the difference between 4 different blood classification and therapeutic effect of TCM was not statistically significant.To compare the difference between degree of blood stasis before treatment (none, mild, moderate, severe) and therapeutic effect of chemotherapy group (valid, invalid),we found χ2=1.762,P=0.743>0.05 by statistical analysis,which suggesting the difference between 4 different blood classification and therapeutic effect of chemotherapy was not statistically significant.To compare the difference between degree of blood stasis before treatment (none, mild, moderate, severe) and overall treatment effect of both groups (valid, invalid), we found χ2=3.942,P=0.258>0.05 by statistical analysis,which suggesting the difference between 4 different blood classification and overall therapeutic effect was not statistically significant.2.2 Two common methods for improving the degree of blood stasisThe result of Chi-square test was χ2=5.116, P=0.024<0.05, which suggesting that TCM group and chemotherapy group for the improvement of the degree of btood stasis had significant differences.Improvement rate of TCM group was less than chemotherapy (47% vs 80%)2.3 The difference between improvement degree of blood stasis and effectiveness of treatmentThe result of Chi-square test was χ2=2.073, P=0.15>0.05, which suggesting the difference between improvement degree of blood stasis and effectiveness of treatment was not statistically significant.We than analysised that the difference between improvement degree of blood stasis in TCM group and chemotherapy group and effectiveness of treatment, was no statistically significant.3 The relevance of common clinical indicators3.1Positive correlation of quantitative changes of blood stasis syndrome after treatment and changes of common clinical indexes:HGB、HCT、MCV、LYMPH#、PDW、CRP、GLB、TP、ALB、TC、LDL、 HDL、SA、FIB、FDP、AT-Ⅲ、D-Dimer、CD3+、CD4+/CD25+、CD8+/CD28+、 NK.3.2 Negative correlation of quantitative changes of blood stasis syndrome after treatment and changes of common clinical indexes:CR、SOD、CEA、Ca125、CD3+/CD4+、CD3-/CD19+3.3 No relevance indicators between quantitative changes of blood stasis syndrome after treatment and changes of common clinical indexes:RBC、WBC、PLT, NEUT%、NEUT#、RDW-SD、RDW-CV、MPV、GLU、 VLDL、LP-a、BUN、TG、LDH、SCC、CYFRA21-1、Ca199、NSE.ConclusionProposed quantitative criteria had a certain clinical practicability,as follows:1 In diagnosis of blood stasis:diagnosis of blood stasis syndrome on primary lung cancer was more sensitive.2 In terms of the correlation to clinical indicators quantitative numerical changes of blood stasis after treatment were positively correlated with changes in malnutrition correlating factors (HGB、ALB、GLB、TP、CR、HCT、MCV), blood coagulation related factors (AT-Ⅲ、D-Dimer、FIB、APTT、FDP), blood lipid parameter (TC, LDL、HDL) and partial immunity correlating factors (CD3+、CD4+/CD25+、 CD8+/CD28+、NK). Quantitative numerical changes of blood stasis after treatment were negatively correlated with changes in the other immunity correlating factors(CD3+/CD4+、CD3-/CD19+)and tumor markers (CEA, Ca125)3 In terms of clinical outcomes of judgement:the prediction of treatment effect by the degree of blood stasis and improvement of blood stasis consistency with the treatment required further research.