| 1.Research background and purposeRenal cancer often has no obvious discomfort in the early stage,and surgical treatment is the first and only cure;about 25%to 57%of patients have distant metastasis when diagnosed;late prognosis is poor,5-year survival rate is less than 15%,median survival period OS is only 10.2 months.About 20%to 30%of patients with localized RCC will still develop metastatic cancer after surgery.They are highly resistant to conventional radiochemotherapy.Cytokine adjuvant therapy cannot benefit;targeted therapy is costly and objectively effective,and its objective efficiency is less than 30%,its adverse reactions are sereve,the quality of life of patients is also poor and there is no predictive index suitable for targeted therapy;cellular immune,immune checkpoint inhibitors are in the spotlight,but clinical efficacy and safety remains to be further observed and studied.The comprehensive treatment of traditional Chinese medicine is the advantage and characteristic of cancer treatment in China.The theory of traditional Chinese medicine believes that "the righteousness exists and the evil cannot be done." The individual’s constitution is the intrinsic condition that determines the onset of the body.Physique factors determine the individual’s susceptibility to the tumor to a certain extent,and also determine the tendency of the TCM syndrome after the onset of the human body.Lastly,it is also one of the key factors affecting the prognosis of the disease.The "Su Qian Meridian" states that "the brave actress has to behave,but the person who is deceived is also sick".Where the physique is strong,it is resistant to evil,disease course is also short and of good prognosis;otherwise,the disease resistance is weak,evil is easy to take advantage and invade to inset,so people will be more difficult to recover from illness.British doctor Stephen Paget’s "seed and soil theory" believes that tumor metastasis requires "seeds"(tumor cells)and "fertile soil"(the ideal environment for receiving organs)to adapt to tumor formation and metastasis.The specific physique that grows and transfers,that is,the tumor has a certain physical susceptibility.At present,the incidence of cancer is getting higher and higher.If we can use traditional chinese medicine theories and methods early to detect the populations of specific tumor-susceptible physique,and use chinese medicine to intervent and adjust the dysfunctions of organs,improve the physical status,the useful ideas and entry points may be provided for the early preventionand treatment of cancer..At present,research on the constitution of traditional Chinese medicine for malignant tumors such as lung cancer,liver cancer,stomach cancer,and breast cancer has made some progress,but rare kidney cancer physique studies have been reported.Based on the in-depth excavation of the dialectical syndromes of traditional Chinese medicine,the instructors emphasized the basic role of physical factors in the onset and prognosis of renal cancer,and advocated combining physical syndrome differentiation with disease,syndrome,syndrome differentiation and treatment,and practice in relieving renal cancer symptoms and improving kidneys.The quality of life of cancer patients shows a certain therapeutic advantage.However,there is still lack of support for clinical big data.This study is based on the experience of kidney cancer clinical trials of the four-in-one diagnosis and treatment of mentor,disease,syndrome,and disease.It investigates and analyzes the characteristics of TCM constitution and distribution patterns of TCM syndromes in patients with kidney cancer,and observes the clinical efficacy after TCM treatment based on syndrome differentiation.The experience of mentors provides data support for exploring the traditional Chinese medicine pathogenesis theory of TCM differentiation and treatment of kidney cancer and clinical research of integrated traditional Chinese and Western medicine.2.Research content and methodsThe patients diagnosed as having kidney cancer at the outpatient clinic of Guang’anmen Hospital of China Academy of Chinese Medical Sciences from January 1,2016 to December 31,2017 were collected.Prospective research methods were used to include patients who met the diagnostic criteria,guide patients to complete the series of questionnaires,collect relevant clinical data,and obtain the characteristics of syndrome distribution and physical characteristics of renal cancer patients.To adopt an open clinical trial method,select patients with syndromes of syndromes of spleen and kidney deficiency who have not been treated with targeted immunization,and use the core clinical prescriptions to add or subtract Yanghetang to intervene and fill out the symptom assessment form(including imaging assessments).Results)QLQ-C30 quality of life scale,Karnofsky scale,self-control before and after,observe the efficacy of the patient.The investigation was completed through face-to-face consultation and telephone.Using the statistical software SPSS 24.0,all patient data information obtained was made into an Excel spreadsheet,frequency and frequency descriptive methods were used,and t-tests were used before and afcter self-control,and continuous measurement data with normal distribution were described with mean±standard deviation.A value of<0.05 indicates statistical significance,and P<0.01 further indicates that the statistical difference is significant.3.Research results3.1.Patient general information distribution:Statistics 93 cases of kidney cancer patients,male patients 60 cases,accounting for 64.52%,33 cases of female patients,accounting for 35.48%,male to female ratio was 1.82:1.Age stratification was performed on 93 patients with renal cell carcinoma.Among the investigators,the youngest was 31 years old and the oldest was 75 years old.The median age was 56 years old.Among them,9(9.68%)were 30-39 years old,18(19.35%)were 40-49 years old,35(37.63%)were 50-59 years old,and 28(30.11%)were 60-69 years old.70 There were 3 cases(3.23%)in the 79-year-old group,of whom 50-59,60-69,and 40-49 were the most frequent.There were 31 cases(33.33%)in stage Ⅰ of TNM stage,35 cases(37.63%)in stage Ⅱ,21 cases(22.58%)in stage Ⅲ,and 6 cases(6.45%)in stage Ⅳ.Among pathological types,the most clear cell carcinomas were 84 cases(90.32%),6 cases(6.45%)of papillary cell carcinoma,2 cases of chromophobe carcinoma(2.15%),and 1 case of mixed cell carcinoma(1.07%).Among the grades of pathological differentiation,6 cases were poorly differentiated(6.45%),21 cases were moderately differentiated(22.58%),and 66 cases were highly differentiated(70.97%).There were 58 patients(62.37%)with a history of smoking and 72 patients(77:42%)with a history of drinking.There were 61 patients(65.59%)with comorbidities.There were 17 family history(18.28%).89 patients(95.70%)had surgery.Nineteen patients(20.43%)had undergone biological immunotherapy.Two patients had chemotherapy(2.15%).Four patients(4.3%)were targeted for treatment.3.2 Symptoms of traditional Chinese medicine:According to the frequency of symptoms,followed by fatigue(54.83%),poor appetite(49.46%),waist and knees(24.73%),limb weight(22.58%)dry mouth and throat(16.13%)Abnormal stool(12.90%),hematuria(10.75%)low back pain(9.68%),abdominal distention(8.60%),and five upset fever(3.22%).The top five frequencies of appearance were moss white(77.42%),dark tongue(55.91%),greasy moss(45.16%),pulse depth(32.26%),and pale tongue(31.18%).3.3 TCM syndrome distribution:According to the statistical analysis of the four diagnostic data of traditional Chinese medicine,the spleen and kidney deficiency syndrome was the highest(about 45.16%),the stasis blood resistance syndrome(about 25.81%),the dampness inner syndrome(about 20.43%),followed by the damp heat syndrome(About 6.45%),yin deficiency and toxic evidence(about 2.15%)are less.3.4 TCM constitution characteristics:It is characterized by a single constitution and multiple complexes.Among the single constitutions,yang deficiency(about 33.33%)and phlegm and dampness(about 27.78%)were more common,blood stasis(about 16.67%)followed,and the composite constitution was the most common with 2 complexes and 3 complexes..The existence of the two kinds of physique complexes is more common in the combination of yang deficiency and blood stasis(about 24%)and yang deficiency and phlegm moisture(21.33%).Among the three kinds of complex constitutions,qi deficiency,yang deficiency,and blood tannin complex(about 21.33%)were more common.The four kinds of composite physiques were more common in qi deficiency,yang deficiency,blood stasis,and phlegm and dampness(about 17.33%).3.5 Efficacy observation results:After treatment with addition and subtraction of Yang He Tang,the study subjects were stable in terms of imaging evaluation.Dry mouth,dry mouth,hematuria,five upset fever,limb weight,poor appetite and other symptoms of better improvement,the total effective rate of 90%.The fatigue,fatigue,waist and knees,back pain,abdominal distension and other symptoms are also more obvious improvement,the efficiency is above 80%.The EORTC QLQ-C30 quality of life scores showed that Chinese medicine treatment can significantly reduce the body,role,emotion,social,cognitive function and overall health of patients with renal cancer,statistically significant differences(P<0.01).The mean ± standard deviation after KPS score pretreatment was 72.5817.03 and 91.00±8.03,respectively.There was a significant difference(P<0.01).4.Research conclusion4.1 Renal cancer patients with traditional Chinese medicine syndrome characteri stics:spleen and kidney deficiency syndrome more common,blood stasis syndr-ome,dampness syndrome is the second.4.2 The characteristics of TCM constitution of patients with kidney cancer:It is more common to have yang deficiency,blood stasis,and phlegm.4.3 Based on the findings of 4.1 and 4.2,it can be inferred that "the deficiency of the spleen and the kidney and the imbalance of gasification" may be one of the keys to the pathogenesis of renal cell carcinoma.4.4 TCM syndrome differentiation(addition and subtraction of Yanghe Decoction)can significantly improve the symptoms of kidney cancer patients and improve the quality of life. |