Clinical Study On Integrated Traditional And Western Medicine In Reducing Relapse And Metastasis Of Stage Ⅱ,Ⅲ Colorectal Cancer

Colorectal cancer is one of common malignant tumors. With the increase of incidence,it has become main malignant tumor that threatens our people's health in recent years. In our country,Traditional Chinese Medicine(TCM) is an improtant part of comprehensive treatment for colorectal cancer,it has positive effect on postoperative adjunctive therapy of colorectal cancer.Part 1 Systematic Review:Herbal medicine for relapse and metastasis in patients operated for colorectal cancerBackground: Large-scale randomized controlled trials(RCT) on herbal medicine for relapse and metastasis of postoperative colorectal cancer has not been carried out at present. There is also no systematic review regarding this aspect,so we collect all RCT researches on herbal medicine for relapse and metastasis of postoperative colorectal cancer,and perform systematic review according to methods required by cochrane co-operation web. Objective :1 To assess the effect of herbal medicine in preventing relapse and metastasis of postoperative colorectal cancer with no-intervention or chemotherapy or radiotherapy.2 Renew and add literatures in recent 3 years,apply Revman 5.0 software to record and analyse the studies included in English.Methods:Randomized controlled trials or quasi-randomized controlled trials that has been finished or is being done would be included. Electronic searching or hand searching ,or contacting authors are used to collect published or unpublished literature .Two researchers respectively search and extract the related data ,then evaluate the quality of included trials. Revman 5.0 software is used to analyse included studies. Results : Eight randomized controlled trials and one quasi-randomized controlled trial are included in this review, they are all from china. Two of them were published in foreign language database. Two trials that were not published belong to thesis. Locus flower deintoxication anticancer decoction plus chemotherapy may have the potential to improve the survival rate in patients with colorectal cancer after radical operation(OR=2.62, 95% CI1.05～6.53,P=0.04).Though survival rate of treatment group that applied Jianpi Xiaoliu decoction ,or spleen and kidney recipe,or Yiqi tiaofu decoction,or Changbi'an capsule, was higher than that of controlled group,significant difference could not be found in these studies. So it is uncertain that Jianpi Xiaoliu decoction ,or spleen and kidney recipe,or Yiqi tiaofu decoction,or Changbi'an capsule,can improve the survival rate in participants. The results show Jianpi Xiaoliu decoction plus chemotherapy decrease the 3-year rate of relapse and metastasis compared with controlled group(OR=0.21, 95% CI 0.05～0.91,P=0.04).Though the rate of relapse and metastasis in the studies of Yiqi tiaofu decoction,Changbi'an capsule,Locus flower deintoxication anticancer decoction,Tianma granulars , Quxie capsule was lower than that of controlled group,they have no statistical significance. The results also show most of Chinese herbs had the capacity to improve quality of life and immune function,and to degrade adverse events caused by chemotherapy/radiotherapy ,and prevent the blood cell from descending. Conclusions:Locus flower deintoxication anticancer decoction and Jianpi Xiaoliu decoction may have the potential to increase survival rate,decrease relapse and metastasis rate in radical postoperative patients with colorectal cancer. Most of Chinese herbs in this review had the capacity to improve quality of life and immune function,degrade adverse events caused chemotherapy/radiotherapy . But because the clinical studies on herbs medicine for relapse and metastasis are less and their qualities of methodology are low, so the conclusion of systematic review regarding the Herbal medicine for relapse and metastasis in patients operated for colorectal cancer is uncertain. It also need randomized controlled trial of large sample size and high quality to testify. Part 2 Clinical Study on Therapeutic Regimen of Integrated Traditional and Western Medicine in Reducing Relapse and Metastasis of Stage II,III Colorectal CancerBackground:Owing to the individual difference,constant change of symptom, and excess and weakness of pathogen and vital QI,traditional Chinese medicine for colorectal cancer should be performed according to determination of treatment based in pathogenesis obtained through differentiation of symptoms and signs. So we retrospectively evaluate the clinical efficacy of therapeutic regimen of integrated traditional and western medicine in radical postoperative patient with colorectal cancer via multiple cencer. Objective: To evaluate the clinical efficacy of integrated traditional and western medicine in radical postoperative patient with colorectal cancer .To provide reliable evidence in order to formulate the optimized therapeutic regimen Methods:Researchers filled in the "Retrospective Registration Form for Radical Postoperative Patient with Colorectal Cancer" ,according to records that are consistent with inclusion criteria. Follow-up that is mainly with telephone and looking up the illness records are carried out simultaneously. If the case records detailly recorded patients' information including position and time of relapse and metastasis ,then the patients who were not contacted by telephone will be judged by case records. SPSS15.0 software was used to analysed the collected data.Results:The incidence of male is higher than that of female,the older the patient get,the higher the incidence is,65-75 years of age is the climax of incidence. The rate of relapse and metastasis of integrated traditional and western group is lower than one of western group. There is significant difference in 2 year disease free survival rate between two groups. The median time of disease free surviva is prolonged 6.65 months. Logistic and Cox regression show that TNM stage,encroachment of cancer embolus ,and FOLFOX regimen plus treatment of TCM have statistical significance in relapse and metastasis of colorectal cancer. TNM stage,encroachment of cancer embolus are dangerous factors, FOLFOX regimen plus treatment of traditional Chinese medicine is protective factor.Conclusions:The patient with stage III and encroachment of cancer embolus have more possibility of relapse and metastasis. Treatment of integrated traditional and western medicine may reduce the relapse and metastasis of colorectal cancer compared with western medicine treatment.The therapeutic regimen including FOLFOX regimen and herbal medicine according to differentiation of symptoms and signs may provide better benefits for radical postoperative patients.Part 3 "International Multicentre Demonstration Study on Using Comprehensive Therapy of TCM to Increase Cure Rate in Patients with Colorectal Cancer after Radical Operation"—Summary of work done in Xiyuan HospitalIn order to verify therapeutic efficiency of comprehensive therapy of TCM in promoting radical cure rate of colorectal cancer, this study(number: 2006BAI11B01) was approved by the Ministry of Science and Technology People's Republic of China. The research unit is mainly composed of Xiyuan Hospital,Guanganmen Hospital,China-Japan Feriendship Hospital, Cancer Hospital Of Chinese Academy Of Medical Sciences,Beijing Cancer Hospital .Among them is declaring unit Xiyuan Hospital that take responsibility for making plan,performing study,55 patients enrollment ,training researchers etc. Quality control penetrates whole process of clinical study. The design of case report form(CRF)should include complete information of patient and be suitable for doctors filling out. The items for follow up and case flowchart are designed according to new guideline for colorectal cancer,all these things make follow up more reasonable. Patient diary is filled in by patients themselves. It includes the content of life quality,prescription drug information and change of illness. Researchers can judge compliance of patients and collect the related data that are used to evaluated the effiency and safety of treatment through patient diary. In order to prevent the subjective bias ,researchers should accept standard training. Application of admission procedure including original selection card for out patient clinic,patient coding card,and case file can ensure the continuity of patient enrollment .Using follow-up record card and case file is not only convient with researchers,but also is crucial to trace orginal data.