| Colorectal cancer is the world's third incidence rate of second mortality,third incidence rate of China's mortality rate of fifth of malignant tumors.The metastatic colorectal cancer(mCRC)is not yet cured.Western medicine has achieved some success.The research has shown that the median survival time of RAS wild type mCRC patients can reach 33 months,a real-world registered study shows that the median survival time of patients with mCRC is only 14 months.In the real world,the patients with the characteristics of old age,poor body condition,poor economic condition and weak treatment intention are the people who can not be covered by the standard treatment of Western medicine.Most of the patients in the hospital of traditional Chinese medicine are people who can not be covered by the standard treatment of Western medicine.Traditional Chinese medicine plays an important role in the comprehensive treatment of colorectal cancer.Professor Yang Yufei combined with more than 30 years of clinical experience,put forward the concept of Jianpi-Bushen-Jiedu treatment for mCRC,and flexibly applied the method of Jianpi-Bushen-Jiedu during the whole treatment of colorectal cancer.In different treatment routes,the focus of this method is different,but the principle of keeping the pathogenesis is the same.In different patient groups,it can play different roles,it can play a synergistic role in the effective cases of Western medicine treatment;It can play a leading role in those who cannot be covered by western medicine standard treatment.In order to observe the efficacy and safety of treatment of Jianpi-Bushen-Jiedu combined with low dose apatinib and tegio capsule,treatment of Jianpi-Bushen-Jiedu combined with furquitinib,traditional Chinese medicine treatment of Jianpi-Bushen-Jiedu,the following three clinical studies were carried out.Study 1:Clinical observation on the treatment of Jianpi-Bushen-Jiedu combined with low dose apatinib and tegio capsuleObjective:To observe the curative effect and safety of Jianpi-Bushen-Jiedu method combined with small dose apatinib and tegio capsule in the treatment of metastatic colorectal cancer.Methods:This study adopted prospective,open,single arm clinical research methods,and included the patients with stage IV colorectal cancer in the outpatient department of Yang Yufei,director of oncology department,Xiyuan Hospital,Chinese Academy of traditional Chinese medicine from February 2019 to December 2019.these patients have poor economic condition and high KPS score.They were treated with Jianpi-Bushen-Jiedu Fang,apatini and tegio capsules until disease progression,death or intolerable toxicity,the last time with The visiting time is April 22,2020.The main outcome measures were progression free survival(PFS),the safety of the treatment was observed with CTCAE 5.0.Results:(1)General characteristics:30 patients with metastatic colorectal cancer were enrolled,with a median age of 59.5 years.(2)Efficacy results:the PFS did not appear in first-line patients.the PFS of second-line patients was 8.25 months,and that of third-line patients was 5.42 months.PFS of second-line patients and third-line patients was longer than that of all the existing reports.The efficacy of patients who have previously failed to receive capecitabine or tegafur capsules combined with bevacizumab is not ideal.(3)Safety results:the incidence of adverse events in this study was lower than that in similar clinical studies,and there was no drug-related death.Conclusion:(1)Compared with the existing studies,Jianpi Bushen Jiedu method combined with low-dose apatinib and tegafur capsule in the second-line and later treatment of advanced colorectal cancer has longer PFS and better safety.(2)For mCRC patients with poor economic condition and high KPS score,this treatment may be an ideal choice.(3)However,patients who have previously failed to receive capecitabine or tegafur capsules combined with bevacizumab may not benefit from this treatment.Study 2:Clinical observation on the treatment of traditional Chinese Medicine of Jianpi-Bushen-Jiedu combined with furquitinibObjective:To observe the efficacy and safety of Jianpi-Bushen-Jiedu combined with furquitinib in the treatment of metastatic colorectal cancer.Methods:This study adopted prospective,open,single arm clinical research methods,the patients with metastatic colorectal cancer who were treated by the method of Jianpi-Bushen-Jiedu combined with furquitinib were included in the study from February 2019 to November 2019 in Professor Yang Yufei's clinic of Oncology Department of Xiyuan-Hospital,Chinese Academy of traditional Chinese medicine,these patients had better economic condition and lower KPS score.The patients' names,gender,age,tim e of stage IV diagnosis,time of progress or time of death and other information were collected.The last follow-up time was March 1,2020.The main outcome measures were PFS.Results:(1)General situation:there were 10 patients who met the acceptance criteria,the median age was 64.5 years old.(2)Results:PFS was 4.70 months in the first-line treatment group and 5.61 months in the third-line and above patients.The PFS of this study is longer than that of 3.71 months in FRESCO study.The curative effect of patients with rapid tumor progression is not good.(3)Safety results:the overall incidence of adverse events in this study was lower than that in the FRESCO study,and there was no drug-related death.Conclusion:(1)Compared with FRESCO study,Jianpi Bushen Jiedu method combined with furquitinib in the third line and later treatment of mCRC has longer PFS and better safety.(2)For mCRC patients with better economic conditions and lower KPS score,this treatment may be an ideal choice.(3)However,patients with rapid tumor progression may not benefit from Jianpi Bushen Jiedu therapy combined with furquitinib.Study 3:Clinical observation on the treatment of traditional Chinese medicine of Jianpi-Bushen-JieduObjective:To observe the curative effect of traditional Chinese medicine of Jianpi-Bushen-Jiedu on mCRC.Methods:Using a combination of forward-looking and retrospective methods,the patients with metastatic colorectal cancer who were treated by traditional Chinese medicine of Jianpi-Bushen-Jiedu in the outpatient department of Professor Yang Yufei,cancer department,Xiyuan Hospital,Chinese Academy of traditional Chinese medicine from October 2016 to December 2019 were included in the study,these patients are old or only willing to receive traditional Chinese medicine treatment.The last follow-up time was March 1,2020.The patients' names,gender,age,diagnosis time of phase IV,time of death and other information were collected.The main outcome measures were the survival period of stage ?.Results:(1)General characteristics:15 patients were included in the study,the median age was 81 years;8 male patients and 7 female patients.(2)Survival results:by the end of the last follow-up,the median ? survival period of the group was 15 months,and 8 patients(53.3%)survived.The curative effect of patients with rapid tumor progression is not good.Conclusion:(1)The method of traditional Chinese medicine of Jianpi-Bushen-Jiedu has certain curative effect on metastatic colorectal cancer.(2)For mCRC patients with elderly patients,or only willing to receive traditional Chinese medicine,this treatment may be an ideal choice.(3)However,patients with rapid tumor progression may not benefit from the traditional Chinese medicine treatment of Jianpi-Bushen-Jiedu.For mCRC patients with high KPS score and poor economic condition,Jianpi-Bushen-Jiedu method combined with small dose of apatinib and tegafur capsule may be the ideal choice.At this time,Sijunzi Decoction plus shenghuangqi and Erzhi Pill,Gastrodia elata,uncaria,Psoralea corylifolia and Cuscuta chinensis;If necessary,add snake six grain,snake berry,Hedyotis diffusa,etc.Patients who have previously failed to receive capecitabine or tegafur capsules combined with bevacizumab may not benefit from this treatment.For mCRC patients with lower KPS score and better economic condition,Jianpi-Bushen-Jiedu method combined with furquitinib might be an ideal choice.At this time,Sijunzi Decoction plus shenghuang and Erzhi Pill,add Gastrodia elata,Uncaria uncaria,jinneijin,fried millet sprouts,fried three immortals.When necessary,stone penetration and ghost arrow feather were added.Patients with rapid tumor progression may not benefit from the treatment.For mCRC patients with elderly patients,or only willing to receive traditional Chinese medicine,the treatment of traditional Chinese medicine of Jianpi-Bushen-Jiedu may be the ideal choice.At this time,Sijunzi Decoction plus shenghuangqi and Erzhi Pill,shijianchuang,Banzhilian,Guijianyu,etc.When necessary,antinicol capsule,compound cantharis capsule and Pingxiao capsule are added.Patients with rapid tumor progression may not benefit from the treatment. |
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