Study On The Distribution Of TCM Syndrome Elements And The Degree Of Spleen Deficiency In Stage Ⅳ Colorectal Cancer

Purpose:1 Study the distribution of TCM syndrome elements in CRC patients during of stage Ⅳ;2 Study the distribution of spleen deficiency symptoms and the degree of spleen deficiency in CRC patients of stage Ⅳ;3 Study the influence of basic information of CRC patients of stage Ⅳ,primary and metastatic sites of malignant tumors,tumor cell pathological types,NRAS,KRAS,BRAF gene status,microsatellite stable state,surgery,radiotherapy,chemotherapy,targeted therapy,immunotherapy and other different treatment methods on TCM syndrome elements and the degree of spleen deficiency.Methods:Cross-sectional study method was used to collect clinical information of patients with stage Ⅳ CRC attending the oncology department of China academy of traditional Chinese medicine Xiyuan Hospital meeting the inclusion criteria between December 2021 and March 2023.The collected information content mainly includes:basic information of patients,disease diagnosis and treatment information,elements of TCM syndrome,spleen deficiency degree score,quality of life score,etc.Enter the collected information into the Excel information database.Statistical analysis was performed using the SPSS26.0 software.The elements of syndrome and the grade of spleen deficiency were related with the primary and metastatic sites of colorectal cancer,the pathological types of tumor cells and different treatment methods.Analysis of the count data is the influencing factors of the syndrome elements,syndrome elements of positive results>15%with binary logistic regression analysis,positive results with 15%use χ2 test or Fisher exact probability method.The analysis of the count data or measurement data on the degree of spleen deficiency is by using Kruskal-Wallis H test in nonparametric test.Results:①Population characteristics:A total of 137 patients were included,and the male to female ratio was about 1.28:1.The age distribution of the patients was from 25 to 88 years,and the median age was 62.5 years.Careers to retire the most.The BMI of 98 patients with height and weight data was distributed from 15.78Kg/m2 to 36.16Kg/m2.Among them,low weight people accounted for 8.16%,normal weight people people 59.18%,overweight people accounted for 22.45%and fat people accounted for 10.20%.There were 102 patients with recorded alcohol history entry information,including 35.29%patients with drinking history and 64.71%patients not.There were 102 patients with recorded smoking entry information,34.31%patients with smoking history and 65.69%patients not.②CRC diagnosis and treatment:among 137 patients,44.53%had primary lesions in the rectum,53.28%of patients in the colon,and 6.57%.Among them,6 patients had 2 primary sites.The metastatic sites included liver(48.18%),lung(43.07%),pelvic cavity(including uterus,ovary,vagina,etc.)(18.25%),distant lymph nodes 15.33%,peritoneal(12.41%),bone(3.65%),small intestine(2.19%),spleen(2.19%),stomach(1.46%),and others(10.95%).The most pathology types were adenocarcinoma(108 cases,78.83%),followed by adenocarcinoma(8.03%),mucinous adenocarcinoma(3.65%),adenocarcinoma with high-grade villous tubular adenoma(1.46%),signet-ring cell carcinoma(0.73%),adenocarcinoma with serous carcinoma(0.73%),and patients with unknown pathological type accounted for 6.57%.The degree of differentiation was the most common in moderate differentiation(49.64%),followed by low differentiation(16.06%)and high differentiation(1.46%).NRAS gene status was mutation(5.11%),NRAS wild type(43.80%),and unknown(51.09%);The gene status of KRAS was mutation(23.36%),wild type(27.01%),and unknown(49.64%);BRAF gene status was mutation(2.92%),wild type(45.99%),and unknown(51.09%);HER-2 gene status includes HER-2(-)(4.38%),HER-2(+)(6.57%),HER-2(2+)(9.49%);HER-2(3+)(0.73%),78.83%of the unknown HER-2 gene status;In the Ki67 gene expression situation,most of the expression ranged from 61%to 90%,accounting for 17.52%,Express from 0 to 30%,5.11%,31%～60%accounted for 1.46%;Expression ranged from 91%to 100%in 0.73%.The treatment history of 137 patients with stage Ⅳ CRC included surgical treatment(84.67%),radiotherapy(15.33%),chemotherapy(83.21%),targeted therapy(60.58%),and immunotherapy(11.68%).③Physical status:ECOG scores of stage Ⅳ CRC patients were distributed from 0 to 3,with the highest score of 1(66.42%),followed by 2(15.33%),3(9.49%)and 0(8.76%).④Bristol Fecal trait score:from high to low,4 points(accounting for 56.20%),5 points(accounting for 13.87%),6 points(accounting for 10.95%),3 points(accounting for 8.03%),7 points and 2 points(2.92%each),and 1 point(accounting for 0.73%).⑤Quality of life score:Patients with emotional function and cognitive function are relatively low;more patients with social function,role function and physical function;more fatigue,pain and insomnia;fewer patients with nausea and vomiting.⑥Distribution of TCM syndrome elements:28 stage Ⅳ CRC patients did not meet any one of the 8 syndrome elements(accounting for 20.44%of the total number).The patients were the most common(63.50%),followed by yin deficiency(26.28%),yang deficiency(14.60%),qi stagnation(14.60%),heat toxicity(10.22%),blood deficiency(9.49%),phlegm dampness(7.30%),and blood stasis(3.65%).⑦The degree of spleen deficiency and the distribution of spleen deficiency symptoms:the degree of spleen deficiency in patients was distributed from 0 to 28.Among the symptoms of spleen deficiency,fatigue were fatigue(67.15%),appetite(40.15%),mental fatigue(38.69%),abdominal distension(37.23%),bowel bowel(37.23%),abnormal stool(34.31%),yellow complexion(34.31%),abdominal pain(31.39%),weak thirst(29.20%),tightness(18.98%),weak defecation(16.06%),nausea and vomiting(14.60%),and edema(7.30%).⑧Impacting factors of syndrome elements:KRAS gene mutation status and history of immunotherapy are protective factors of gas deficiency syndrome elements;Smoking and alcohol history were risk factors for blood deficiency;On the elements of yang deficiency syndrome,there are differences in the proportion of stage Ⅳ CRC patients with different BMI intervals,but it is not the factor affecting yang deficiency syndrome;The number of metastatic sites was the influencing factor of blood stasis syndrome.Those with four places of metastasis had the highest proportion of blood stasis syndrome.The elements of gas stagnation syndrome are related to the primary site.The smallest proportion of qi stagnation occurred when the primary site was located in the colon.There was no statistical difference between the general information,stage Ⅳ CRC diagnosis and treatment information of stage Ⅳ CRC patients and the occurrence of yin deficiency syndrome elements,phlegm and dampness syndrome elements,and heat toxicity syndrome elements.⑨Factors affecting the degree of spleen deficiency:the degree of spleen deficiency in patients with CRC with surgical history was less than that of those without surgical history.Conclusion:①Stage Ⅳ CRC patients with TCM syndrome element is mainly qi deficiency,KRAS gene is the mutation state,and the history of immunotherapy is related to the low proportion of qi deficiency syndrome elements;②There is a correlation between blood stasis syndrome and metastatic sites,and the proportion of blood stasis syndrome is the highest;③The elements of gas stagnation are related to the primary site,with the smallest proportion of qi stagnation in the colon;④In terms of the degree of spleen deficiency,the degree of spleen deficiency was higher in patients with CRC without surgery than in patients with CRC with surgical treatment.However,the above results need to be further supported by increasing the clinical sample size and the trial.