| This project was supported by the National Key Research and Development Program of China and Project of China Academy of Chinese Medical Sciences "Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer"(2017YFC 1700604).This study was mainly divided into two parts:literature review and clinical study.Review:Current treatment status and research progress of chemotherapy compliance after radical resection of CRC;The current situation of clinical application of TCM in the prevention and treatment of chemotherapy-related gastrointestinal reactions and bone marrow suppression in CRC.The clinical study was divided into three parts:Professor Yang Yufei’s medication regularity in treating colon cancer during adjuvant chemotherapy;Effect of Jianpi Bushen Sequential Formula on adjuvant chemotherapy compliance of Colon Cancer;Effect of Jianpi Bushen Sequential Formula on adjuvant medication in patients with colon cancer after radical resection in chemotherapy period.Clinical researchPart Ⅰ:Professor Yang Yufei’s medication regularity in treating colon cancer during adjuvant chemotherapyObjectiveUsing data mining technology to analyze medication patterns and explore the medication characteristics and prescription rules of Professor Yang Yufei in the treatment of colon cancer during adjuvant chemotherapy.MethodsBy collecting clinical cases of patients with adjuvant chemotherapy period of colon cancer who attended the clinic of Prof.Yufei Yang between February 2018 and February 2023.The cases that met the nadir criteria were screened and a database was established,and drug frequency analysis,drug attribute analysis,cluster analysis and complex network analysis were performed through the ancient and modern medical case cloud platform.ResultsA total of 122 patients meeting the criteria of nadir were included,with a total of 238 consultations involving 140 Chinese medicines.Dang Shen was used with the highest frequency,with the most frequent use of warm and flat drugs,and the five flavors were mainly sweet,mainly attributed to the two meridians of spleen and kidney.The core prescription consists of dodder seed,astragalus,angelica sinensis,Codonopsis pilosula,Poria cocos,Atractylodes macrocephala,etc.ResultsProfessor Yang Yufei’s synergistic adjuvant chemotherapy treatment for colon cancer mostly uses spleen-strengthening,kidney-supplementing,food-eliminating and heat-clearing drugs,etc.The core prescription mainly consists of 12 drugs,including dodder seed,astragalus,angelica sinensis,Codonopsis pilosula,Poria cocos,Atractylodes macrocephala,etc.Part Ⅱ:Effect of Jianpi Bushen Sequential Formula on adjuvant chemotherapy compliance of Colon CancerObjectiveThe aim of this study was to understand the compliance status of adjuvant chemotherapy in patients after radical surgery for colon cancer through a multicenter,randomized,double-blind placebo clinical study,and to explore the effect of Jianpi Bushen Sequential Formula on the compliance of chemotherapy in patients after radical surgery for colon cancer,so as to provide a scientific basis for Chinese medicine to improve the compliance of adjuvant chemotherapy.MethodsThis study is based on the National Key Research and Development Program of China and Project of China Academy of Chinese Medical Sciences "Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer",and included the patients from Xiyuan Hospital of the China Academy of Chinese Medical Sciences,Beijing Chaoyang Hospital of Capital Medical University,Beijing Cancer Hospital and Civil Aviation General Hospital.A total of 190 patients who will receive adjuvant chemotherapy with CapeOX regimen after radical resection of colon cancer in the outpatient department and ward of the four sub-centers.This study is a multicenter,randomized controlled placebo clinical study.The patients were randomly divided into the test group and the placebo group by the central block randomization method.The patients in the test group and the placebo group took the Jianpi Bushen Sequential Formula or Jianpi Bushen Sequential Formula placebo respectively on the basis of receiving the adjuvant chemotherapy of CapeOX.The data collection content of this study mainly includes gender,age,clinical stage,etc.The main outcome measure was the compliance rate of chemotherapy.Compare the difference of chemotherapy compliance rate between the two groups with the analysis method of χ2 test or Fisher’s exact test.Binary logistic regression was used to analyze the related factors of the effect of the Jianpi Bushen Sequential Formula on the compliance of adjuvant chemotherapy.Results1.General informationIn this study,183 patients with colon cancer after radical resection,93 patients in the test group and 90 patients in the control group,were finally included.The distribution of gender,age,body mass index(BMI),education level,family monthly income,primary site,differentiation degree,clinical stage,combined disease and TCM syndrome type was compared and analyzed.There was no difference between the two groups of data(P>0.05),so follow-up research could be carried out.2.Comparison of compliance of adjuvant chemotherapy of two groupsThere were 25 patients in the test group with with complete compliance of adjuvant chemotherapy,accounting for 26.9%,and 13 patients in the control group with with complete compliance of adjuvant chemotherapy,accounting for 14.4%.There was statistically significant difference between the test group and the control group in compliance of adjuvant chemotherapy(χ2=4.300,P=0.038).3.Single factor analysis of the compliance of adjuvant chemotherapyThe results of univariate analysis showed that the compliance of adjuvant chemotherapy was related to BMI,education level,clinical stage,syndrome type of traditional Chinese medicine and combined diseases(P<0.05).It was not related to sex,age,family monthly income,primary location and differentiation degree(P>0.05).4.Multivariate binary logistic regression analysis of compliance of adjuvant chemotherapyThe results of multivariate binary logistic regression analysis showed that the syndrome type of traditional Chinese medicine,combined diseases and grouping were independent influencing factors for the compliance of adjuvant chemotherapy(P<0.05).TCM syndrome type is an independent protective factor(OR=0.187)for the compliance of adjuvant chemotherapy,that is,patients with spleen and kidney yang deficiency syndrome have better compliance of adjuvant chemotherapy;The combined diseases and grouping are independent risk factors(OR=7.235,OR=4.554)for the compliance of adjuvant chemotherapy,that is,patients combined with diseases and control group have poor compliance with adjuvant chemotherapy.ConclusionJianpi Bushen Sequential Formula can improve the compliance of adjuvant chemotherapy for patients with colon cancer after radical surgery.In addition,BMI,education level,combined basic diseases,TCM syndrome types and clinical stages can also affect the compliance of adjuvant chemotherapy for patients with colon cancer after surgery;After excluding the confounding factors of BMI,education level and clinical,Jianpi Bushen Sequential Formula,combined disease and TCM syndrome type can still independently affect the compliance of patients with adjuvant chemotherapy.Part Ⅲ:Effect of Jianpi Bushen Sequential Formula on adjuvant medication in patients with colon cancer after radical resection during chemotherapy period.ObjectiveThe aim of this study is to explore the effects of the Jianpi Bushen Sequential Formula on chemotherapy adjuvant medication and chemotherapy related adverse reactions in patients with colon cancer after radical surgery through a randomized controlled placebo clinical study,providing evidence-based medical evidence for traditional Chinese medicine to reduce the use of chemotherapy adjuvant medication and the incidence of chemotherapy related adverse reactions in patients.MethodsThis study is based on the National Key Research and Development Program of China and Project of China Academy of Chinese Medical Sciences "Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer",and included a total of 28 patients with completed medical order data enrolled from Xiyuan Hospital of the China Academy of Chinese Medical Sciences.This study is a randomized controlled placebo clinical study.The patients were randomly divided into the test group and the placebo group by the central block randomization method.The patients in the test group and the placebo group took the Jianpi Bushen Sequential Formula or Jianpi Bushen Sequential Formula placebo respectively on the basis of receiving the adjuvant chemotherapy of CapeOX.The data collection content of this study mainly includes gender,age,education,clinical stage,primary site,pathological type and chemotherapy cycle.The main observation indicator is the use rate of chemotherapy adjuvant drugs.Fisher’s exact test was used to compare the use rate of adjuvant chemotherapy and the incidence of bone marrow suppression between the two groups.Non-parameter test(Independent-Samples Mann-Whitney U Test)was used to compare the chemotherapy-related gastrointestinal reactions and depression and anxiety scores between the two groups.Results1.General informationIn this study,26 patients with colon cancer after radical resection,14 patients in the test group and 12 patients in the control group,were finally included.The distribution of gender,age,education level,family monthly income,primary site,differentiation degree,clinical stage,combined disease,pathological type and chemotherapy cycle of the two groups of patients was compared and analyzed.There was no difference between the two groups of data(P>0.05),so follow-up research could be carried out.2.Comparison of the use of adjuvant medication during chemotherapy(1)Drugs for prevention and treatment of leukopenia:the overall use rate of rhGCSF was 15.4%,of which the use rate of the test group was 0%,and the use rate of the control group was 33.3%.The use rate of the control group was higher than that of the test group,with a statistically significant difference(P=0.033).The overall use rate of Diyu Shengbai tablets was 57.7%,of which the use rate of the test group was 50%,and the use rate of the control group was 66.7%.The use rate of the control group was higher than that of the test group,but the difference was not statistically significant(P=0.453).(2)Drugs for prevention and treatment of thrombocytopenia:The overall use rate of Recombinant Human Interleukin-11 for Injection was 26.9%,including 7.1%in the test group and 50.0%in the control group.The difference was statistically significant(P=0.026).The overall use rate of Recombinant Human Thrombopoietin Injection was 23.1%,including 14.3%in the test group and 33.3%in the control group.The use rate in the control group was higher than that in the test group,but the difference was not statistically significant(P=0.325);The overall use rate of Jinshuye Zhixue Mixture was 57.7%,of which the use rate of the control group was 35.7%,and the use rate of the test group was 83.3%.The use rate of the control group was higher than that of the test group with a statistically significant difference(P=0.021).(3)Drugs for prevention and treatment of CINV:the overall use rate of Mosapride Citrate Tablets was 23.1%,of which the use rate of the test group was 21.4%,and the use rate of the control group was 25.0%.The use rate of the control group was higher than that of the test group,but the difference was not statistically significant(P=0.596).The overall use rate of Metoclopramide Dihydrochloride Injection was 7.7%,including 7.1%in the test group and 8.3%in the control group.The use rate in the control group was higher than that in the test group,but the difference was not statistically significant(P=0.720).(4)Drugs for prevention and treatment of constipation:the overall use rate of Simotang oral liquid was 19.2%,of which the use rate of the test group was 7.1%,and the use rate of the control group was 33.3%.The use rate of the control group was higher than that of the test group,but the difference was not statistically significant(P=0.148);The overall use rate of Biantong capsule was 7.7%,of which the use rate of the test group was 0.0%,and the use rate of the control group was 16.7%.The use rate of the control group was higher than that of the test group,but the difference was not statistically significant(P=0.203).3.Chemotherapy related adverse reactions and depression and anxiety scoresThe incidence of neutropenia and thrombocytopenia in the test group was significantly lower than that in the control group(P<0.05).There was no significant difference in the score of gastrointestinal side effects between the patients in the test group and the control group(P>0.05).ConclusionsJianpi Bushen Sequential Formula can reduce the use rate of rhG-CSF,Recombinant Human Interleukin-11,Jinshuye Zhixue Mixture and the incidence of neutropenia and thrombocytopenia in patients with colon cancer after radical surgery during adjuvant chemotherapy. |
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